A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016) - Full Text...
Other: Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine Biological: Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) Biological: Comparator: Placebo to MRKAd5 HIV-1 gag vaccine ...
NIH Guide: INACTIVATION: HIV VACCINE RESEARCH AND DESIGN - R01 GRANTS
INACTIVATION: HIV VACCINE RESEARCH AND DESIGN - R01 GRANTS Release Date: October 4, 1999 PA NUMBER: PA-98-089 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID) is inactivating program announcement PA 98-089, HIV VACCINE RESEARCH AND DESIGN - RESEARCH PROJECT GRANTS, which appeared in the NIH Guide, July 9, 1998. The areas of investigator-initiated vaccine research this PA targeted have received numerous responses that have been well-received in the NIH peer review system. Accordingly NIAID will no longer give special consideration for funding to applications in response to this PA received after January 2, 2000. NIAID will, however, continue to give special consideration for funding to applications in response to PAR 98-090, HIV VACCINE RESEARCH AND DESIGN - PROGRAM PROJECT GRANTS, which also appeared in the NIH Guide, July 9, 1998. NIAID supports highly scientifically meritorious applications in all areas of research within ...
Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial - Full...
Prospective cohort study of the clinical course of HIV-1 infection occurring after candidate HIV-1 vaccination (breakthrough infection) with ALVAC-HIV (vcP1521) and AIDSVAX B/E. This study will enroll volunteers who become HIV-infected during the course of follow up in a phase III preventive HIV vaccine trial conducted in Rayong and Chon Buri, Thailand. Volunteers will be enrolled in this protocol to provide additional long-term follow up to establish whether differences in viral load after infection (comparing vaccine to placebo) are associated with altered disease outcomes, as well as provide more detailed immunologic and virologic assessment of these volunteers ...
Whats What in NIAID-Supported HIV Vaccine Research | News | AIDSinfo
AIDS Cooperative Adjuvant Groups conduct preclinical studies of adjuvants and vaccine-adjuvant combinations.. AIDS Vaccine Reagent Project provides large quantities of reagents for preclinical and clinical studies related to vaccines.. Antibody Serologic Project identifies and standardizes monoclonal antibodies to characterize specific components of HIV and SIV.. AVEG (AIDS Vaccine Evaluation Group) includes six centers conducting Phase I and II trials of potential HIV vaccines.. AVEU (AIDS Vaccine Evaluation Unit) is an individual clinical site in the AVEG.. Chimpanzee Unit is a site for the evaluation of HIV vaccine concepts and products in chimpanzees.. Cooperative Mucosal Immunology Group for Investigations on AIDS Vaccines examines ways to stimulate and evaluate mucosal immune responses to HIV and SIV infection and vaccines.. DSMB (Data and Safety Monitoring Board) is an independent committee associated with the AVEG that reviews data of trials in progress to ensure that no participant is ...
SFU HIV/AIDS vaccine research gets financial boost - University Communications - Simon Fraser University
Jamie Scott, a Simon Fraser University professor and Canada Research Chair in molecular immunity, and three international collaborators are getting a hefty financial boost in their efforts to develop an effective HIV/AIDS vaccine.. The United States National Institutes of Health (NIH) has awarded the four researchers $2.7 million to help them improve the effectiveness of a DNA-based vaccine that Marinieve Montero first conceived of eight years ago. Montero was a student of Scotts whose work was also funded by the NIH, the U.S.s largest government-funded medical research agency.. Scotts current collaborators are at the University of the Basque Country, the University of Massachusetts School of Medicine and the University of California, San Francisco.. The researchers will use their new funding to strengthen a vaccine theyve made from a DNA fragment taken from the HIV genome. The fragment encodes something that is highly prized in HIV/AIDS vaccine research. Called the MPER, its a region of ...
HIV Vaccine Research and Design (HIVRAD) Program (P01) - Federal Grant
FederalGrants.com opportunity listing for the HIV Vaccine Research and Design (HIVRAD) Program (P01) federal grant. Includes information on eligibility, deadlines, requirements, and guidelines.
Preventative HIV vaccine candidate triggers desired immune responses in humans and monkeys, and protects monkeys from infection...
BOSTON - More than three decades after the identification of the human immunodeficiency virus (HIV), scientists are still working to develop a preventative vaccine that could finally put an end to the..
Effective AIDS Vaccine Probably at Least a Decade Away, Researcher Says - TheBodyPRO.com
Important unanswered questions remain in the development of an effective AIDS vaccine, which could be a decade or more away, a top AIDS Researcher said ...
Ethics, human rights and HIV vaccine trials in low-income settings | Journal of Medical Ethics
The massive growth in global health research in past decades has posed many challenges for its effective ethical oversight, not least of which is how best to provide effective protection of research participants. The extent of the HIV epidemic in sub-Saharan Africa in particular makes research into prevention technologies for HIV, including HIV vaccine research, a global priority. However, the need for vaccine research must be considered in conjunction with the individuals right to informed consent, which is based on the principle of respect for autonomy. One of the primary human rights violations likely to occur in the context of HIV vaccine research is that potential research participants may not fully understand what participation in research studies entails. People who elect to enrol in HIV vaccine trials are required to understand both the potential negative effects of participation (eg, discrimination) as well as complex scientific concepts such as randomisation and prophylaxis in order ...
HIV/AIDS Vaccine Candidates Enter Crucial Stage As Clinical Trials End, IAVI Head Says - TheBody.com
Experimental HIV/AIDS vaccines under development by Merck and Sanofi-Aventis are entering crucial stages, and results from clinical trials for both ...
Reasons for Ineligibility in Phase 1 and 2A HIV Vaccine Clinical Trials at Kenya Aids Vaccine Initiative (KAVI), Kenya
Background With the persistent challenges towards controlling the HIV epidemic, there is an ongoing need for research into HIV vaccines and drugs. Sub-Saharan African countries - worst affected by the HIV pandemic - have participated in the conduct of clinical trials for HIV vaccines. In Kenya, the Kenya AIDS Vaccine Initiative (KAVI) at the University of Nairobi has conducted HIV vaccine clinical trials since 2001. Methodology Participants were recruited after an extensive informed consent process followed by screening to determine eligibility. Screening included an assessment of risk behavior, medical history and physical examination, and if clinically healthy, laboratory testing. In the absence of locally derived laboratory reference ranges, the ranges used in these trials were derived from populations in the West. Principal findings Two hundred eighty-one participants were screened between 2003 and 2006 for two clinical trials. Of these, 167 (59.4%) met the inclusion/exclusion criteria. Overall,
Clinical Trial of GeoVaxs AIDS Vaccine Moves Forward
A year ago, we reported on the push to discover an effective AIDS vaccine. As President Obama prepares to release his U.S. AIDS strategy, at least one pharmaceutical company is readying a crucial clinical trial of its vaccine against HIV/AIDS.. The AIDS Research Consortium of Atlanta recently put out a call for volunteers to test a DNA-based AIDS vaccine developed by GeoVax. Participants must have had a negative HIV test followed by a positive test six months later, and must have started drugs to fight the virus within the past six months. A total of 10 to 12 patients will be enrolled in the Phase I study. Participants will be monitored for up to 77 weeks. Although GeoVax is already testing the vaccine for virus prevention, this will be the first study to test the vaccine in individuals who already have the virus.. Other updates: A lab devoted to developing an HIV/AIDS vaccine has opened in Brooklyn, New York. Researchers at SUNY Downstates Incubator will work with the International AIDS ...
Vax Report - Understanding How Viral Vector-based AIDS Vaccine Candidates are Manufactured
Vax Report - Understanding How Immune Responses to AIDS Vaccine Candidates are Measured
Researchers Identify New Approach for an Effective HIV Vaccine
American researchers have come up with a new approach to vaccine design that could help them overcome the difficulties faced in developing an effective HIV vaccine.
HIV/AIDS Vaccines | News | AIDSinfo
To augment the immune responses elicited by these and other vaccines, scientists use immunologic adjuvants. Currently, only one adjuvant -- alum, first discovered in 1926 -- is incorporated into vaccines licensed for human use by the U.S. Food and Drug Administration (FDA). An adjuvant may work well with one experimental vaccine and not another. Therefore, the FDA licenses the vaccine formulation, or the antigen-adjuvant combination, rather than the adjuvant alone. Experimental adjuvants can increase the type, strength and durability of immune responses evoked by an experimental vaccine. For example, some vaccine antigen/adjuvant combinations can induce cell-mediated immune responses, even if the vaccine antigen by itself does not. Some adjuvants also stimulate mucosal immunity. Alum primarily increases the strength of antibody responses generated by the vaccine antigen. Because of its limited activity, other adjuvants may be better suited for the newer candidate HIV vaccines ...
Mymetics HIV Vaccine Candidate Confirms Promise in Preclinical Study With the Texas Biomedical Research Institute
EPALINGES, SWITZERLAND--(Marketwired - April 11, 2016) - Mymetics Corporation (OTCQB:MYMX), a pioneer in the research and development of virosome-based vaccines to prevent transmission of human infectious diseases across mucosal membranes, announced today that its innovative HIV vaccine candidate has shown to generate significant protection in groups of twelve female monkeys...
HIV/AIDS Vaccines: Defining What Works - Fighting AIDS Continuously Together
Designing an effective HIV/AIDS vaccine is something of a paradox: a good vaccine would be safe and look enough like HIV to kick-start the immune system into neutralizing the virus - but the problem is that this is exactly what the human immune system has trouble doing even when its exposed to the real thing.. Now a team of researchers led by scientists at The Scripps Research Institute in La Jolla, CA has developed a strategy for inducing a key part of an effective immune response to HIV. By tracing the evolution of HIV-recognizing molecules called antibodies taken from the blood of rare individuals whose immune systems are naturally able to target and neutralize the virus, they may have found a way to replicate this for everybody.. At a talk next week at the American Crystallographic Association meeting in Hawaii, the team will present multiple crystal structures, which like detailed architectural blueprints show how the virus interacts with components of the immune system. Examining these ...
PLOS Medicine: Estimating the Demand for a Preventive HIV Vaccine: Why We Need to Do Better
Pharmaquest - GeoVax Partners with Vivalis to manufacture MVA HIV/AIDS Vaccine
The breakthrough manufacturing technology developed by Vivalis, and now to be further developed through collaboration with GeoVax, will create a new standard for manufacture of the MVA component of the GeoVax HIV/AIDS vaccine, making present manufacturing technologies which have limited production capabilities, less competitive. Vivalis EBx® manufacturing platform, with its increased effectiveness, superior quality and reliability, will speed time to market MVA vaccine product availability in ample quantities to meet sizeable demand and expectedly at a lesser cost ...
Towards an HIV vaccine | The Herald
A vaccine efficacy trial (known as HVTN 702) in South Africa (started 2016),. The AMP study in the Americas, Europe and Africa (started 2016), and. A vaccine trial (known as HPX2008/HVTN 705) in several African countries (expected to start in 2017/2018). HVTN 702 is testing a vaccine adapted from the one in RV144, while AMP, which stands for Antibody Mediated Prevention, is testing a different approach known as passive immunization. In the AMP study, participants will receive anti-HIV antibodies directly through an intravenous infusion, commonly known as an IV or getting a drip. The findings of the AMP study will advance the HIV vaccine field.. Zimbabwe is part of the global partnership dedicated to HIV vaccine research, and is part of the AMP study.. The University of Zimbabwe-University of California San Francisco Collaborative Research Programme (UZ-UCSF)s Seke South Clinical Research Site (CRS) was selected as a protocol-specific site by the US National Institutes of Healths HIV ...
Phase 3 study of ALVAC HIV and AidsVax B/E prime-boost vaccine combination for HIV - MPR
UR Tests HIV Vaccine Pill - Healthcanal.com : Healthcanal.com
Researchers hope that this oral vaccine will create a more robust immune response against HIV. We think that an oral approach may be the way to create a more effective vaccine and Im sure that most people would rather get a vaccine in a pill rather than by yet another shot, said Michael C. Keefer, M.D., professor of Medicine and director of the Universitys NIH-supported HIV Vaccine Trials Unit. John J. Treanor, M.D., professor of Medicine and chief of Infectious Diseases at UR Medicines Strong Memorial Hospital is leading the study with support from Keefer, who has more than 20 years of experience in the preventive HIV vaccine field. They will monitor how peoples immune systems respond to the vaccine and if the vaccine causes any symptoms. The University has a long track record of conducting detailed studies of HIV vaccines, but Keefer says that this is the first time an oral vaccine has been tested in Rochester. Though the research is in its early stages, he believes the information ...
Global HIV/AIDS Vaccine Conference in South Africa to Seek New Strategies Against Disease - TheBody.com
Experts at a four-day global HIV/AIDS vaccine conference in Cape Town, South Africa, that opened Monday plan to seek fresh strategies against the ...
RFA-AI-04-051: Center for HIV/AIDS Vaccine Immunology (CHAVI)
NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Center for HIV/AIDS Vaccine Immunology (CHAVI) RFA-AI-04-051. NIAID
Critical considerations for adenovirus-based HIV vaccine trials
A clinical trial testing a candidate HIV vaccine known as the STEP study was halted in September 2007 after interim analysis indicated that the vaccine did not work. Moreover, subsequent analyses indicated that the vaccine made some individuals more susceptible to HIV, in particular individuals who had pre-existing immune effectors (antibodies) that recognized a component of the vaccine (adenovirus serotype 5 [Ad5]).
Preventive Vaccines: Your Best Shot for Good Health at 65-Plus - Robb Report
What can you do to maintain your health at age 65 or older? More than you might think! This article will focus on one aspect of health maintenance: preventive vaccines. Flu vaccine During flu epidemics, the hospitalization rate for older people increases two to five times.
Challenges in designing HIV env immunogens for developing a vaccine<...
TY - CHAP. T1 - Challenges in designing HIV env immunogens for developing a vaccine. AU - Srivastava, Indresh K.. AU - Holland Cheng, R.. PY - 2008/1/1. Y1 - 2008/1/1. N2 - HIV continues to be a major health problem worldwide; however, the situation is particularly serious in Asian and Sub-Saharan countries. Development of an effective HIV vaccine could help to reduce the severity of the disease and prevent infection. Over the last two decades significant efforts have been made toward inducing potent humoral and cellular immune responses by vaccination; however, it appears that either antibodies or CTL may not be sufficient alone for the induction of sterilizing immunity or long-term control of viral replication. Therefore, it is generally believed that both humoral and cellular responses will be needed for an effective HIV vaccine. It has been shown in passive transfer experiments using broadly neutralizing monoclonal antibodies (mAb) such as b12, 2F5, and 2G12 that these mAbs either alone or ...
AIDS Vaccine Advocacy Coalition Voices Disappointment in Trial Result - Applauds Mercks Leadership and Calls for Reinvigorated...
New York, September 21, 2007 -- The AIDS Vaccine Advocacy Coalition (AVAC) released the following statement from Executive Director Mitchell Warren about the announcement that vaccinations have been discontinued in the STEP Study, a test-of-concept trial of the MRK-Ad5 AIDS vaccine candidate developed by the Merck Research Laboratories:Todays announcement about the STEP
Preventive Vaccines Market - Size, Outlook, Trends and Forecasts
Global Preventive Vaccines Market - offers growth, outlook, trends, shares, Industry Analysis, opportunities, Key Players Forecast 2018 to 2024
JCI - DNA priming and gp120 boosting induces HIV-specific antibodies in a randomized clinical trial
BACKGROUND RV144 is the only preventive HIV vaccine regimen demonstrating efficacy in humans. Attempting to build upon RV144 immune responses, we conducted a phase 1, multicenter, randomized, double-blind trial to assess the safety and immunogenicity of regimens substituting the DNA-HIV-PT123 (DNA) vaccine for ALVAC-HIV in different sequences or combinations with AIDSVAX B/E (protein).METHODS One hundred and four HIV-uninfected participants were randomized to 4 treatment groups (T1, T2, T3, and T4) and received intramuscular injections at 0, 1, 3, and 6 months (M): T1 received protein at M0 and M1 and DNA at M3 and M6; T2 received DNA at M0 and M1 and protein at M3 and M6; T3 received DNA at M0, M1, M3, and M6 with protein coadministered at M3 and M6; and T4 received protein and DNA coadministered at each vaccination visit.RESULTS All regimens were well tolerated. Antibodies binding to gp120 and V1V2 scaffold were observed in 95%-100% of participants in T3 and T4, two weeks after final ...
Merck HIV Vaccine Trial Kills Participants: Could This Have Been Avoided?
Recently, the Merck pharmaceutical company reported that its experimental HIV vaccine raised the rate of HIV infection among people who got the trial vaccine. Yes, you read that right. It was worse than nothing. This vaccine was composed of a few HIV proteins strapped onto an adenovirus, which causes colds. Among people with good immunity to this common cold virus, about 80% of the population, it increased the chances of contracting HIV. The saddest part is that this is not surprising. Virologists have long been skeptical about the possibility of an effective HIV vaccine. HIV infects the very immune cells that you stimulate to defend your body against it. Stimulating these cells increases the rate at which HIV can infect those cells and the rate of HIV replication in these cells. Thus, an HIV vaccine can make it more likely that you’ll get AIDS, and you might get it sooner and worse than if you weren’t immunized. So far, no one has found the Holy Grail of HIV vaccines: a ...
JCI - Volume 129, Issue 11
BACKGROUND RV144 is the only preventive HIV vaccine regimen demonstrating efficacy in humans. Attempting to build upon RV144 immune responses, we conducted a phase 1, multicenter, randomized, double-blind trial to assess the safety and immunogenicity of regimens substituting the DNA-HIV-PT123 (DNA) vaccine for ALVAC-HIV in different sequences or combinations with AIDSVAX B/E (protein).METHODS One hundred and four HIV-uninfected participants were randomized to 4 treatment groups (T1, T2, T3, and T4) and received intramuscular injections at 0, 1, 3, and 6 months (M): T1 received protein at M0 and M1 and DNA at M3 and M6; T2 received DNA at M0 and M1 and protein at M3 and M6; T3 received DNA at M0, M1, M3, and M6 with protein coadministered at M3 and M6; and T4 received protein and DNA coadministered at each vaccination visit.RESULTS All regimens were well tolerated. Antibodies binding to gp120 and V1V2 scaffold were observed in 95%-100% of participants in T3 and T4, two weeks after final ...
JCI - Volume 129, Issue 11
BACKGROUND RV144 is the only preventive HIV vaccine regimen demonstrating efficacy in humans. Attempting to build upon RV144 immune responses, we conducted a phase 1, multicenter, randomized, double-blind trial to assess the safety and immunogenicity of regimens substituting the DNA-HIV-PT123 (DNA) vaccine for ALVAC-HIV in different sequences or combinations with AIDSVAX B/E (protein).METHODS One hundred and four HIV-uninfected participants were randomized to 4 treatment groups (T1, T2, T3, and T4) and received intramuscular injections at 0, 1, 3, and 6 months (M): T1 received protein at M0 and M1 and DNA at M3 and M6; T2 received DNA at M0 and M1 and protein at M3 and M6; T3 received DNA at M0, M1, M3, and M6 with protein coadministered at M3 and M6; and T4 received protein and DNA coadministered at each vaccination visit.RESULTS All regimens were well tolerated. Antibodies binding to gp120 and V1V2 scaffold were observed in 95%-100% of participants in T3 and T4, two weeks after final ...
JCI - Welcome
BACKGROUND RV144 is the only preventive HIV vaccine regimen demonstrating efficacy in humans. Attempting to build upon RV144 immune responses, we conducted a phase 1, multicenter, randomized, double-blind trial to assess the safety and immunogenicity of regimens substituting the DNA-HIV-PT123 (DNA) vaccine for ALVAC-HIV in different sequences or combinations with AIDSVAX B/E (protein).METHODS One hundred and four HIV-uninfected participants were randomized to 4 treatment groups (T1, T2, T3, and T4) and received intramuscular injections at 0, 1, 3, and 6 months (M): T1 received protein at M0 and M1 and DNA at M3 and M6; T2 received DNA at M0 and M1 and protein at M3 and M6; T3 received DNA at M0, M1, M3, and M6 with protein coadministered at M3 and M6; and T4 received protein and DNA coadministered at each vaccination visit.RESULTS All regimens were well tolerated. Antibodies binding to gp120 and V1V2 scaffold were observed in 95%-100% of participants in T3 and T4, two weeks after final ...
Study: Many Americans think HIV vaccine already exists (8677) | Advocate.com
A new study by the federal National Institute of Allergy and Infectious Diseases shows that many Americans think a preventive vaccine for HIV already exists and is being kept secret. NIAID surveys showed that 48% of African-American and 28% of Latino respondents believe that such a vaccine has been developed and is being kept from the public. Overall, about 20% of the 3,500 adults surveyed reported believing that a secret vaccine exists. Other widely reported misconceptions include a fear that HIV vaccines can cause HIV infection in clinical trial volunteers.. To help debunk such beliefs, NIAID is sponsoring the sixth annual HIV Vaccine Awareness Day on May 18. The goal of the event is to provide accurate information about HIV/AIDS and HIV vaccine research to the public. HIV vaccine research is our best hope, along with other prevention and treatment efforts, to slow the spread of HIV, said NIAID director Anthony Fauci. NIAID is committed to educating the public to help correct misconceptions ...
Toward an AIDS Vaccine: Lessons From Natural Simian Immunodeficiency Virus Infections of African Nonhuman Primate Hosts - PubMed
The design of an effective AIDS vaccine has eluded the efforts of the scientific community to the point that alternative approaches to classic vaccine formulations have to be considered. We propose here that HIV vaccine research could greatly benefit from the study of natural simian immunodeficiency …
OHSU AIDS vaccine candidate appears to completely clear virus from the body
The Picker lab is now investigating the possible reasons why only a subset of the animals treated had a positive response in hopes that the effectiveness of the vaccine candidate can be further boosted.. This research was funded by several grants from the National Institutes of Health, funding from the International AIDS Vaccine Initiative and a CAVD grant from the Bill & Melinda Gates Foundation.. In the interest of ensuring the integrity of our research and as part of our commitment to public transparency, OHSU actively regulates, tracks and manages relationships that our researchers may hold with entities outside of OHSU. In regards to this research project, OHSU has licensed a CMV technology, of which Picker is an inventor, to the International AIDS Vaccine Initiative. In addition, CMV vector technology is being commercialized by TomegaVax, Inc., a company in which both OHSU and Picker have a significant financial interest.. More information on OHSUs conflict of interest policies and ...
Willingness to participate in an HIV vaccine trial : construction and initial validation of the Willingness to Participate...
ENGLISH ABSTRACT: Background South Africa is the country with the largest number of HIV infections in the world. As behaviour change initiatives have been suboptimal in curbing the spread of the pandemic, an HIV vaccine is likely to be an important development as a biological agent may circumvent some of the challenges of initiating widespread behaviour change. The development of an HIV vaccine will require several thousands of HIV negative participants who are at high risk of HIV infection to participate in HIV vaccine clinical trials. Before recruitment for such trials may begin, various scientific, ethical, and sociobehavioural issues need to be considered. One of the key sociobehavioural issues concerns the willingness of individuals at high risk of HIV infection to participate in HIV vaccine trials. However, a psychometric measure of willingness to participate (WTP) has not been constructed, and there is a paucity of theory to guide studies of WTP. Objectives The first objective of this ...
Clinical Alert: Immunizations Are Discontinued in Two HIV Vaccine Trials
An independent Data and Safety Monitoring Board (DSMB) met this week to review interim data from a large, international HIV vaccine clinical trial known as the STEP study - also referred to as the HVTN 502 or Merck V520-023 study. The clinical trial, which began enrolling volunteers in December 2004, is co-sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the pharmaceutical company Merck & Co. Inc., which also developed and supplied the candidate vaccine. Based on a review of interim data, the DSMB concluded that the vaccine cannot be shown in this trial to prevent HIV infection or affect the course of the disease in those who become infected with HIV (the vaccine itself cannot cause HIV infection because it contains only synthetically produced snippets of viral material). Therefore, Merck and NIAID instructed all study sites to cease administering the investigational vaccine but continue scheduled follow-up ...
New developments in a South African HIV vaccine trial | ViroBlogy
Subtype C gp140 Vaccine Boosts Immune Responses Primed by the South African AIDS Vaccine Initiative DNA-C2 and MVA-C HIV Vaccines after More than a 2-Year Gap A phase I safety and immunogenicity study investigated South African AIDS Vaccine Initiative (SAAVI) HIV-1 subtype C (HIV-1C) DNA vaccine encoding Gag-RT-Tat-Nef and gp150, boosted with modified vaccinia Ankara…
Nabi Biopharmaceuticals Announces Successful Final Results of NicVAX(R) Immunogenicity Study; Increased Antibody Response...
ROCKVILLE, Md., Oct. 29, 2008 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI) announced today positive final results from its Phase 2 NicVAX(r) (Nicotine Conjugate Vaccine) schedule optimization immunogenicity study to assess the antibody response and safety of a 400 microgram, six dose immunization schedule. The vaccine lot used in this study is from the same lot used in the Phase 2b proof-of-concept trial whose results were announced in November 2007. Final results from the study confirmed the positive interim results announced in July that significantly higher anti-nicotine antibody levels can be generated three months earlier and in a much higher percentage of subjects for sustained periods of time than observed in previous NicVAX studies. Antibody levels achieved at 14 weeks were more than 2-fold higher than those achieved at the same time point in the Phase 2b proof-of-concept study as a result of the added injection. Moreover, greater than 80% of subjects who completed the six- ...
Effect of therapeutic HIV recombinant poxvirus vaccines on the size of by Deborah Persaud, Katherine Luzuriaga et al.
OBJECTIVES: Therapeutic HIV vaccinations may alter the size of the resting memory CD4 T-cell latent HIV reservoir as HIV establishes latency when memory responses are formed, including those toward HIV. Alternatively, latently infected CD4 T cells maybe killed, while exiting the reservoir upon activation.
METHODS: The effect of therapeutic immunization with modified vaccinia Ankara and Fowlpox-based HIV vaccines on the latent reservoir was examined in 19 young adults who were receiving effective antiretroviral therapy. Correlations between size of the reservoir [measured in infectious units per million (IUPM)] resting CD4 T cells and HIV-specific immune responses, including immune activation were examined. Decay of the reservoir was assessed using random-effects model.
RESULTS: A modest transient decrease in the size of the reservoir was observed at week 40 [mean -0.31 log(10) IUPM (95% confidence interval: -0.60 to -0.03; P = 0.03] following HIV vaccinations. The estimated half-life (T1/2) of the
Antibody-Dependent Cellular Cytotoxicity-Mediating Antibodies from an HIV-1 Vaccine Efficacy Trial Target Multiple Epitopes and...
The ALVAC-HIV/AIDSVAX-B/E RV144 vaccine trial showed an estimated efficacy of 31%. RV144 secondary immune correlate analysis demonstrated that the combination of low plasma anti-HIV-1 Env IgA antibodies and high levels of antibody-dependent cellular cytotoxicity (ADCC) inversely correlate with infection risk. One hypothesis is that the observed protection in RV144 is partially due to ADCC-mediating antibodies. We found that the majority (73 to 90%) of a representative group of vaccinees displayed plasma ADCC activity, usually (96.2%) blocked by competition with the C1 region-specific A32 Fab fragment. Using memory B-cell cultures and antigen-specific B-cell sorting, we isolated 23 ADCC-mediating nonclonally related antibodies from 6 vaccine recipients. These antibodies targeted A32-blockable conformational epitopes (n = 19), a non-A32-blockable conformational epitope (n = 1), and the gp120 Env variable loops (n = 3). Fourteen antibodies mediated cross-clade target cell killing. ADCC-mediating ...
HIV vaccines may induce HIV antibodies in trial participants, can cause false-positive test result
Harvard Medical School Vaccine Clinical Trials Unit - Raphael Dolin
This proposal describes the Harvard Medical School (HMS) Vaccine Clinical Trials Unit (CTU), which is comprised of an administrative component at HMS, two Clini...
British Library EThOS: Formulation strategies for the mucosal delivery of HIV vaccines
Vaccination seems to be the key to curtailing the HIV epidemic but all efforts to make a clinically effective vaccine have failed to date. Eliciting high titres of neutralising antibodies at the mucosal portals of viral entry is a key goal in HIV vaccine research. Thus, this thesis specifically focuses at the strategic development and evaluation of women-controlled mucosal vaccine delivery systems for HIV envelope based constructs, H4A, gp140 and FP-A for the purpose of eliciting high antibody titres at the vaginal mucosa. Sustained release rod-insert vaginal rings (RiRs) loaded with gp140, quick release rods containing H4A, FP-A loaded liposomal gels and microneedles in conjunction with mucosal inoculations were evaluated for induction of specific antibodies in animal models (sheep/mice/rabbits). The formulations were evaluated mainly using vaginal delivery with nasal route being used as an auxiliary. However, we found that the nasal route was extremely potent compared to the vaginal route for ...
JCI - Antibody Fc effector functions and IgG3 associate with decreased HIV-1 risk
HVTN 505 is a preventative vaccine efficacy trial testing DNA followed by recombinant adenovirus serotype 5 (rAd5) in circumcised, Ad5-seronegative men and transgendered persons who have sex with men in the United States. Identified immune correlates of lower HIV-1 risk and a virus sieve analysis revealed that, despite lacking overall efficacy, vaccine-elicited responses exerted pressure on infecting HIV-1 viruses. To interrogate the mechanism of the antibody correlate of HIV-1 risk, we examined antigen-specific antibody recruitment of Fcγ receptors (FcγRs), antibody-dependent cellular phagocytosis (ADCP), and the role of anti-envelope (anti-Env) IgG3. In a prespecified immune correlates analysis, antibody-dependent monocyte phagocytosis and antibody binding to FcγRIIa correlated with decreased HIV-1 risk. Follow-up analyses revealed that anti-Env IgG3 breadth correlated with reduced HIV-1 risk, anti-Env IgA negatively modified infection risk by Fc effector functions, and that vaccine ...
JCI - Antibody Fc effector functions and IgG3 associate with decreased HIV-1 risk
HVTN 505 is a preventative vaccine efficacy trial testing DNA followed by recombinant adenovirus serotype 5 (rAd5) in circumcised, Ad5-seronegative men and transgendered persons who have sex with men in the United States. Identified immune correlates of lower HIV-1 risk and a virus sieve analysis revealed that, despite lacking overall efficacy, vaccine-elicited responses exerted pressure on infecting HIV-1 viruses. To interrogate the mechanism of the antibody correlate of HIV-1 risk, we examined antigen-specific antibody recruitment of Fcγ receptors (FcγRs), antibody-dependent cellular phagocytosis (ADCP), and the role of anti-envelope (anti-Env) IgG3. In a prespecified immune correlates analysis, antibody-dependent monocyte phagocytosis and antibody binding to FcγRIIa correlated with decreased HIV-1 risk. Follow-up analyses revealed that anti-Env IgG3 breadth correlated with reduced HIV-1 risk, anti-Env IgA negatively modified infection risk by Fc effector functions, and that vaccine ...
Frontiers | Enforced OX40 Stimulation Empowers Booster Vaccines to Induce Effective CD4+ and CD8+ T Cell Responses against...
There is an imperative need for effective preventive vaccines against human cytomegalovirus (HCMV) as it poses a significant threat to the immunologically immature, causing congenital disease, and to the immune compromised including transplant recipients. In this study we examined the efficacy of synthetic long peptides (SLPs) as a CD4+ and CD8+ T cell-eliciting preventive vaccine approach against mouse CMV (MCMV) infection. In addition, the use of agonistic OX40 antibodies to enhance vaccine efficacy was explored. Immunocompetent C57BL/6 mice were vaccinated in a prime-boost vaccination regiment with SLPs comprising various MHC class I and II-restricted peptide epitopes of MCMV-encoded antigens. Enforced OX40 stimulation resulted in superior MCMV-specific CD4+ as CD8+ T cell responses when applied during booster SLP vaccination. Vaccination with a mixture of SLPs containing MHC class II epitopes and OX40 agonistic antibodies resulted in a moderate reduction of the viral titers after challenge with
NIH-Led Scientists Find Antibodies that Prevent Most HIV Strains from Infecting Human Cells - Healthcanal.com : Healthcanal.com
The discovery of these exceptionally broadly neutralizing antibodies to HIV and the structural analysis that explains how they work are exciting advances that will accelerate our efforts to find a preventive HIV vaccine for global use, says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health. In addition, the technique the teams used to find the new antibodies represents a novel strategy that could be applied to vaccine design for many other infectious diseases. Led by a team from the NIAID Vaccine Research Center (VRC), the scientists found two naturally occurring, powerful antibodies called VRC01 and VRC02 in an HIV infected individuals blood using a novel molecular device they developed that hones in on the specific cells that make antibodies against HIV. The device is an HIV protein that the scientists modified so it would react only with antibodies specific to the site where the virus binds to cells it ...
Independent Evaluation Group - Wikipedia
The Independent Evaluation Group (IEG) is an independent unit within the World Bank Group charged with objectively evaluating the activities of the International Bank for Reconstruction and Development (IBRD) and International Development Association (IDA; collectively, the World Bank), the work of International Finance Corporation (IFC) in private sector development, and Multilateral Investment Guarantee Agencys (MIGA) guarantee projects and services to provide accountability, and determine what works, what doesnt and why. The head of IEG, the Director-General, Evaluation, reports directly to the Bank Groups Board of Executive Directors and not to Bank Group management. The World Bank Group has twin goals: to end extreme poverty and boost shared prosperity. To achieve these goals, the World Bank Group needs to better understand what works and why, to draw lessons and good practices from experience, deepening the evidence base to inform decision making and future action. IEG evaluations seek ...
Consequences of Adenovirus Vector Vaccination on T Cell Activation and by Irene Bukh
The quest for an efficacious HIV vaccine has resulted in several clinical trial failures, including the Step Trial, which used a replication-incompetent adenovirus (AdV) vector called human adenovirus type 5 (HAdV-5). Despite eliciting strong cellular immune responses, these trials were prematurely halted due to statistical futility resulting from increased HIV acquisition in vaccinated individuals. The Step Study showed increased HIV susceptibility in HAdV-5 baseline seropositive subjects, which complicates the use of HAdV-5 vectors since pre-existing neutralizing antibodies (nAb) to HAdV-5 are prevalent worldwide. Sampling the unique immunological phenotypes of the rectal mucosa - the site of HIV infection in the Step Study, and of AdV persistence and trafficking - could help explain this trial, since only peripheral blood (PBMC) was collected from subjects. We obtained rectal lamina propria T lymphocytes (rLPL) from a rhesus macaque (RM) model vaccinated with a species-specific simian Ad type 7 (SAdV
Advertising=S Longitudinal Effects on Brand Attitudes: the Moderating Roles of Evaluation Goals and Attitude Confidence by...
Table 3 shows the results. The hypotheses predict a positive parameter for Ab1 X Cf term and a negative parameter for Cb2 X Cf term. Results support this prediction: The parameter estimate was positive and significant for Ab1 X Cf term (bAb1xCf=.387, t=3.286, p , .01) and negative and significant for Cb2 X Cf term (bCb2xCf= -.325, t= -3.154, p , .01). As expected, the parameter estimate was insignificant for attitude confidence (bCf= -.017, t= -.280). These results support H4-a and H4-b.. Although our major concern was the effect of ad exposure on brand attitudes at a later time, we additionally investigated the effects of Aad1 and Ab1 on Aad2 in each evaluation group. In the ad evaluation group, Aad2 appeared to be influenced by Aad1 more than by Ab1 (.357 vs. -.122), whereas in the brand evaluation group Aad2 appeared to be influenced by Ab1 more than by Aad1 (.605 vs. .046). The reason is thought to be that in the ad evaluation group Aad1 is more salient than Ab1, whereas in the brand ...
Modeling the economic benefits of an AIDS vaccine<...
TY - JOUR. T1 - Modeling the economic benefits of an AIDS vaccine. AU - Bishai, David. AU - Lin, Maria K.. AU - Kiyonga, C. W.B.. N1 - Funding Information: The authors gratefully acknowledge the suggestions of seminar participants at the World Bank, The Welch Center, and The International Health Economics Association, and UNAIDS. Special thanks are due to Martha Ainsworth, Amie Batson, Stefano Bertozzi, Don Burke, José Esparza, Mark Kane, Bob Lawrence, Richard Mahoney, Philip Musgrove, Ken Nelson, and Tomas Philipson. All errors are our own. Grant support: World Bank (DB, MKL), the Hopkins Population Center, NIH Grant SP30HD06268-25(DB), and the Bill and Melinda Gates Institute for Population and Reproductive Health (CWBK). Copyright: Copyright 2007 Elsevier B.V., All rights reserved.. PY - 2001/11/12. Y1 - 2001/11/12. N2 - Economic models were used to describe the potential for an AIDS vaccine to prevent medical spending and lost productivity throughout the world. In terms of avoided medical ...
Comparative Immunogenicity in Rhesus Monkeys of DNA Plasmid, Recombinant Vaccinia Virus, and Replication-Defective Adenovirus...
There is increasing interest in the use of viral and nonviral systems as vectors to elicit anti-HIV-1 immune responses. The human clinical testing of these vectors can be guided by results of comparative studies in appropriate nonhuman primate immunogenicity and challenge model systems. Recently, we reported on the ability of SIV Gag delivered by DNA, MVA, or adenovirus type 5 vectors to inhibit viral replication and disease progression in rhesus macaques following challenge with SHIV89.6P (25). The best degree of viremia control and CD4 cell count preservation was observed in animals that had been immunized with the adenovirus type 5 vector either by itself or in a prime-boost combination with DNA. In contrast, only 50% of the animals that received MVA alone or in combination with DNA were able to effectively control viremia.. In this report, we evaluated the cellular immune responses to HIV-1 Gag induced by similar DNA, MVA, and adenovirus vectors. The studies were conducted with macaques that ...
Corrigendum to The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for three parallel multi-site...
TY - JOUR. T1 - Corrigendum to The Starting Treatment for Ethanol in Primary care Trials (STEP Trials). T2 - Protocol for three parallel multi-site stepped care effectiveness studies for unhealthy alcohol use in HIV-positive patients (Contemp. Clin. Trials (2017) 52 (80-90) (S1551714416302130) (10.1016/j.cct.2016.11.008)). AU - Edelman, E. Jennifer. AU - Maisto, Stephen A.. AU - Hansen, Nathan B.. AU - Cutter, Christopher J.. AU - Dziura, James. AU - Fiellin, Lynn E.. AU - OConnor, Patrick G.. AU - Bedimo, Roger. AU - Gibert, Cynthia. AU - Marconi, Vincent C.. AU - Rimland, David. AU - Rodriguez-Barradas, Maria C.. AU - Simberkoff, Michael S.. AU - Justice, Amy C.. AU - Bryant, Kendall J.. AU - Fiellin, David A.. N1 - Publisher Copyright: © 2017. PY - 2017/9. Y1 - 2017/9. N2 - The authors regret that there was an error in the description of the randomization procedures previously published in the manuscript. Randomization is stratified based only on site.. AB - The authors regret that there ...
AIDS vaccine fails to give total protection from HIV (7753) | Advocate.com
The death of three monkeys that had been administered an AIDS vaccine in a Boston lab suggests that vaccines intended to prime the immune system to control HIV in the body and prevent disease progression may not offer total protection from AIDS. Numerous HIV vaccines in development aim to boost the bodys defenses to hold the virus in check, with animal studies to date suggesting that the protection offered by the vaccines could last for years, if not indefinitely. However, researchers at the 10th annual Conference on Retroviruses and Opportunistic Infections in Boston on Wednesday reported that three of four monkeys involved in such a study at Beth Israel Deaconess Medical Center in Boston eventually fell sick and died, even after initially showing strong resistance to the virus. All three died within three years of receiving the experimental vaccine developed by Merck.. Researchers were split on their opinions of the Merck vaccine data. David Ho, scientific director of the Aaron Diamond AIDS ...
Vaccine regimen fails to prevent HIV-1 infection in South Africa.
Glenda E. Gray, M.B., B.Ch., from the Fred Hutchinson Cancer Research Center in Seattle, and colleagues randomly assigned 5,404 adults (median age, 24 years; 70 percent women) without HIV-1 infection to receive canarypox-protein HIV vaccine or placebo (2,704 and 2,700 participants, respectively) in a phase 2b-3 trial in South Africa. The vaccine regimen included injections of ALVAC-HIV at months 0 and 1 followed by ALVAC-HIV plus bivalent subtype C gp120-MF59 adjuvant booster injections at months 3, 6, 12, and 18.. The researchers found that at an interim analysis in January 2020, prespecified criteria for nonefficacy were met, and further vaccinations were subsequently halted. There was a similar incidence of adverse events in the vaccine and placebo groups. HIV-1 infection was diagnosed in 138 and 133 participants in the vaccine and placebo groups, respectively, during the 24-month follow-up (hazard ratio, 1.02; 95 percent confidence interval, 0.81 to 1.30; P = 0.84).. Despite promising ...
AIDS2016: The time for an HIV vaccine is now | Kaya FM Gauteng
HIV vaccines were not part of the main stage at the Durban Aids Conference held in 2000. Our knowledge and experience in HIV vaccine development were rudimentary at this time; our journey to understanding the complexity of designing immunogens to elicit effective immune responses was just beginning. But HIV vaccines are a now pivotal part of the prevention research agenda: there is scientific optimism about the ability to develop an effective vaccine and South Africa is now a central point in this research. The intervening 16 years between the Durban conferences has brought a series of hard-won understandings about how HIV works in orchestrating its transmission from person to person and between communities. Our past approaches to vaccine development have largely been ineffective because the viruss exterior coating, what we call its envelope structure, has areas of immune dampening. In these areas, immune decoys are set up and evolve so cleverly that the initial, critical antibodies that are made to
Synthesis and Vaccine Evaluation of the Tumor Associated Carbohydrate Antigen RM2 from Prostate Cancer - Hong-Yang Chuang -...
Synthesis and Vaccine Evaluation of the Tumor Associated Carbohydrate Antigen RM2 from Prostate Cancer : This thesis focuses on the synthesis and vaccine evaluation of the prostate tumor- associated carbohydrate antigen RM2. The author first presents the use of the [1+2+3] one-pot sequential strategy to successfully synthesise the RM2 antigen and its analogues as single stereoisomers in every glycosylation step, producing good yields and stereoselectivity. He then introduces the conjugation of the
GeoVax Vaccine Only 5th AIDS Vaccine Moving to Phase 2 Hu... ( ATLANTA Feb. 25 /- GeoVax Labs In...)
... ATLANTA Feb. 25 /- GeoVax Labs Inc. (OTC...GeoVaxs AIDS vaccine is believed to be only the fifth [5th] HIV/AIDS...Most recently GeoVax Senior Vice President of Research & Development...Attended by over 20 HVTN personnel and key GeoVax personnel this even...,GeoVax,Vaccine,Only,5th,AIDS,Vaccine,Moving,to,Phase,2,Human,Trials,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
HCV Research and News: Promising AIDS Vaccine Being Developed
Image Credit: Thinkstock.com. September 11, 2013 Brett Smith for redOrbit.com - Your Universe Online A promising new AIDS vaccine being developed at Oregon Health & Science University has demonstrated the capacity to effectively remove all traces of an AIDS-causing virus from non-human primates, according to a newly published report in the journal Nature. The vaccine is being tested on a primate form of HIV, called simian immunodeficiency virus (SIV), which causes AIDS in monkeys. After working further to refine the vaccine, OHSU scientists said they hoped an HIV-form of the potential vaccine could soon be tested in human subjects. To date, HIV infection has only been cured in a very small number of highly-publicized but unusual clinical cases in which HIV-infected individuals were treated with anti-viral medicines very early after the onset of infection or received a stem cell transplant to combat cancer, said Dr. Louis Picker, associate director of the OHSU Vaccine and Gene Therapy ...