Safety and immunogenicity. Medical search. Frequent questions

There is a need for improved immunogenicity of hepatitis B virus (HBV) vaccines among young adults with risk of infection. (nih.gov)
To demonstrate manufacturing equivalence of a 3-antigen (3A) HBV vaccine, evaluate noninferiority of seroprotection rate (SPR) of 3A-HBV vs single-antigen (1A) HBV after 2 and 3 vaccine doses, and compare safety and reactogenicity between 3A-HBV and 1A-HBV vaccines. (nih.gov)
These findings demonstrate that after the first, second, and third vaccinations, elderly patients with chronic lung illness produce persistent functional serotype-specific IgG, and they support the safety of the second and third vaccines. (physiciansweekly.com)
A study published in the Lancet looks at the safety and immunogenicity of seven COVID-19 vaccines as a third (booster) dose following two doses of Oxford-AstraZeneca or Pfizer-BioNTech vaccine in the UK. (sciencemediacentre.org)
Prelicensure clinical trials indicate that the immunogenicity of Twinrix is equivalent to that of the single antigen hepatitis vaccines. (cdc.gov)
Studies have been performed with all four Hib conjugate vaccines to determine immunogenicity in infants 2-6 months of age. (cdc.gov)
Here, we report the safety and immunogenicity of heterologous schedules with the ChAd and BNT vaccines. (lstmed.ac.uk)
Along with the higher immunogenicity of ChAd/BNT compared with ChAD/ChAd, these data support flexibility in the use of heterologous prime-boost vaccination using ChAd and BNT COVID-19 vaccines. (lstmed.ac.uk)
It may be wanted or unwanted: Wanted immunogenicity typically relates to vaccines, where the injection of an antigen (the vaccine) provokes an immune response against the pathogen, protecting the organism from future exposure. (wikipedia.org)
Another challenge is considering how the immunogenicity of vaccines changes with age. (wikipedia.org)
Yuzhou Gui et al, Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SYS6006, as a fourth-dose booster following three doses of inactivated vaccines in healthy adults: an open-labeled Phase 1 trial, Life Metabolism (2023). (globalwomenshealthacademy.org)

In conclusion, F4/AS01 showed a clinically acceptable reactogenicity and safety profile, and induced polyfunctional HIV-1-specific CD4(+) T-cell responses in ART-experienced and ART-naive subjects. (uni-koeln.de)
Conclusions A fourth dose of NVX-CoV2373 enhanced immunogenicity without increasing reactogenicity. (medrxiv.org)
We assessed the safety, reactogenicity, and immunogenicity of a viral vectored coronavirus vaccine that expresses the spike protein of SARS-CoV-2. (liverpool.ac.uk)
Here, we report the preliminary findings on safety, reactogenicity, and cellular and humoral immune responses. (liverpool.ac.uk)
The safety and reactogenicity profile of the mRNA-1273.211 booster (50-µg) was comparable to mRNA-1273 (50-µg). (researchsquare.com)
We aimed to assess the humoral response to and reactogenicity of coronavirus disease 2019 (COVID-19) vaccination according to the vaccine type and to analyze factors associated with immunogenicity in actively treated solid cancer patients (CPs). (e-crt.org)

We investigated safety, tolerability, and immunogenicity of the heterologous 2-dose Ebola vaccination regimen in healthy and HIV-infected adults with different intervals between Ebola vaccinations. (plos.org)
Here, we report the safety, tolerability, and immunogenicity of a replication-defective recombinant adenovirus serotype 5 (rAd5) vector HIV-1 candidate vaccine. (emmes.com)
Researchers found that the proposed biosimilar demonstrated pharmacokinetic similarity to the reference product, and the safety and tolerability of the 2 products were also comparable. (centerforbiosimilars.com)
This study compared safety, tolerability, and immunogenicity of the Oka/Merck varicella vaccine and VARILRIX™ [Oka-RIT strain SmithKline Beecham Biologicals] in healthy children 12-24 months of age. (tmu.edu.tw)

The study was amended to evaluate safety and immunogenicity of a booster vaccination with Ad26.ZEBOV, administered approximately 1 year after the first vaccination, in healthy adults. (plos.org)
We conducted a randomised trial to assess the safety and the immunogenicity of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen in 3 different vaccination intervals in healthy and HIV-infected adults. (plos.org)
Immunogenicity data for boosters given 5 or 6 months after initial vaccination will emerge in the next few weeks but are likely to be broadly similar. (sciencemediacentre.org)
Safety, HIV-1-specific CD4(+) and CD8(+) T-cell responses, absolute CD4(+) T-cell counts and HIV-1 viral load were monitored for 12 months post-vaccination. (uni-koeln.de)
Secondary outcomes include antibody titre changes, longevity of the immune response, safety assessment using clinical data, the nature and magnitude of the cellular immune response and post-vaccination control of viremia by vaccine dose. (ox.ac.uk)
Safety was assessed over 28 days after vaccination. (liverpool.ac.uk)
BACKGROUND: This phase I trial evaluated the safety and immunogenicity of a candidate tuberculosis vaccination regimen, ChAdOx1 85A prime-MVA85A boost, previously demonstrated to be protective in animal studies, in healthy UK adults. (ox.ac.uk)
RÉSUMÉ En 2001, le programme de vaccination antirougeoleuse en Arabie saoudite est passé à deux doses du vaccin antirougeoleux-antiourlien-antirubéoleux, la première à 12 mois et la seconde à 6 ans. (who.int)
Le programme de vaccination antirougeoleuse en deux doses peut induire une protection optimale à l'entrée à l'école primaire lorsqu'une forte couverture vaccinale est assurée. (who.int)
Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. (medscape.com)

Abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO 2023) emphasized the safety and efficacy of a trastuzumab biosimilar in treating HER2-positive breast cancer and growing utilization of trastuzumab biosimilars over time. (centerforbiosimilars.com)

Preliminary aggregate safety and immunogenicity results from three trials of a purified inactivated Zika virus vaccine candidate: phase 1, randomised, double-blind, placebo-controlled clinical trials. (emmes.com)
Study assesses the safety and immunogenicity of an inactivated Zika virus vaccine candidate. (news-medical.net)

Safety and immunogenicity of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine (Com-COV): a single-blind, randomised, non-inferiority trial. (lstmed.ac.uk)
Immunogenicity and safety of heterologous boost immunization with PastoCovac Plus against COVID-19 in ChAdOx1-S or BBIBP-CorV primed individuals. (bvsalud.org)

The immunogenicity, safety, and effectiveness of ARPV/ZIKV a chimeric insect-specific flavivirus (ISFV)-Zika vaccine. (news-medical.net)
NCT00943722 ) assessed the immunogenicity and effectiveness of the vaccine after the third dose in 301 boys and 971 girls. (empr.com)
Ten-year follow-up of 9-valent human papillomavirus vaccine: immunogenicity, effectiveness, and safety. (empr.com)

The co-primary outcomes are to assess efficacy, as measured by cases of symptomatic virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events. (liverpool.ac.uk)
Safety was determined by collection of solicited and unsolicited vaccine-related adverse events (AEs). (ox.ac.uk)

This Phase II study was part of this accelerated program, evaluating the safety and immunogenicity of the 2-dose vaccine regimen in healthy and HIV-infected African adults, with 28-, 56-, and 84-day intervals between doses. (plos.org)
We will recruit healthy adult volunteers, adults living with HIV, and children to a series of randomized controlled trials aiming to determine the immunogenicity and safety of fractional vaccine doses in comparison to the standard vaccine dose. (ox.ac.uk)
This phase 2/3 study evaluated the safety and immunogenicity of the bivalent vaccine candidate mRNA-1273.211 (equal mRNA amounts of ancestral SARS-CoV-2 and Beta variant spike proteins) as 50-µg (n=300) and 100-µg (n=595) first booster doses approximately 8.8-9.8 months after the mRNA-1273 primary series. (researchsquare.com)
To evaluate the safety and inimunogenicity of palivizumab, 55 children who received palivizumab in the IMpact-RSV trial received 5 monthly doses of 15 mg/kg palivizumab (Synagis) during the subsequent year. (elsevierpure.com)
The researchers compared the efficacy and safety of the new quadrivalent HPV vaccine, given in two doses to girls and boys aged 9-14 years, with those of a comparable vaccine, given in three doses to women aged 15-26 years. (who.int)

Secondary outcomes included loss of response, treatment persistence, and immunogenicity. (medscape.com)

Safety and immunogenicity of a tetravalent dengue vaccine in children " by Vianney Tricou, Xavier Sáez-Llorens et al. (edu.ph)

By enrolling eligible healthy subjects and convalescent COVID-19 patients, researchers from Shanghai Xuhui Central Hospital have worked to unveil the first clinical safety and efficacy profile of SYS6006. (globalwomenshealthacademy.org)
The vaccine was shown to be immunogenic and no safety concerns have been identified in clinical studies. (who.int)

The safety and efficacy of 3A-HBV shows its usefulness for the prevention of hepatitis B in young healthy adults. (nih.gov)

Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. (emmes.com)
DESTINY-Breast09 is a global head-to-head phase 3 trial evaluating the safety and efficacy of ENHERTU (5.4 mg/kg) with or without pertuzumab compared to standard of care (THP: taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) as a first-line treatment in patients with HER2 positive metastatic breast cancer. (biospace.com)
Based on a review of safety and preliminary genetic stability data from initial campaigns held in Nigeria, Liberia, Benin and Congo, SAGE has endorsedi, a transition to the next rollout phase for the vaccine. (who.int)

Immunogenicity is influenced by multiple characteristics of an antigen: Phylogenetic distance Molecular size :- Molecules having bigger size, particularly those greater than10kDa, will be more immunogenic Epitope density Chemical composition and heterogeneity Protein structure Synthetic polymers D-amino acids Degradability (ability to be processed & presented as MHC peptide to T cells) T cell epitope content is one of the factors that contributes to antigenicity. (wikipedia.org)
Although this has reduced the sometimes extreme immunogenicity associated with murine mAbs, the anticipation that all fully human mAbs would have not possess unwanted immunogenic properties remains unfulfilled. (wikipedia.org)

An observational study was undertaken in a cohort of 16 older individuals with chronic lung disorders to measure immunogenicity before and after the first, second, and third immunizations with the 23-valent pneumococcal polysaccharide vaccine. (physiciansweekly.com)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. (clinicaltrials.gov)
Safety oversight for the study was provided by an independent Safety Monitoring Committee. (medrxiv.org)
Scholars@Duke grant: A 52-week multicenter, randomized, double-masked, 2-arm parallel study to compare efficacy, safety and immunogenicity of SOK583A1 to Eylea, administered intravitreally, in patients with neovascular age-related macular degeneration. (duke.edu)
The results of the study will allow us to understand the safety and immunogenicity outcome of the HL-OCV compared to Shanchol vaccine. (clinicaltrials.gov)
In addition, the study also evaluated the safety and immunogenicity of the potential biosimilar compared with the originator as secondary endpoints. (centerforbiosimilars.com)
Safety analyses were done among participants receiving at least one dose of a study vaccine. (lstmed.ac.uk)
The aim of the present study was to test the safety and immunogenicity of this VLP candidate vaccine in horses, and to consider ways in which the production platform could be scaled up in a cost-effective manner. (biomedcentral.com)
Subjects were randomized in this double blind study to receive either a single dose of Oka/Merck varicella vaccine, (∼50,000 plaque forming units (PFU), Group A or ∼16,000PFU, Group B) or 1 dose of VARILRIX™, (∼40,000PFU/dose, Group C). Safety profiles in each treatment group were similar. (tmu.edu.tw)

Title : Work Group summary and interpretation of TAK-003 efficacy, efficacy, safety, and immunogenicity data Personal Author(s) : Paz-Bailey, Gabriela Corporate Authors(s) : National Center for Emerging and Zoonotic Infectious Diseases (U.S.). Division of Viral Diseases. (cdc.gov)
Early data on safety and dRsp favored enrollment on arm D. Total enrollment on Arms A-D were 3, 7, 6, and 32, respectively. (bmj.com)
For example, immunogenicity data from high-income countries are not always transferable to low-income and middle-income countries. (wikipedia.org)
Note that in June 2013, the FDA approved required labeling for RotaTeq regarding intussusception data from the Mini-Sentinel's Postlicensure Rapid Immunization Safety Monitoring (PRISM) program, the largest vaccine safety surveillance program in the United States. (medscape.com)
Data to date indicate that the vaccine's safety profile is similar to mOPV2. (who.int)

This may result in unwanted immunogenicity, including ADAs and autoimmune diseases, such as autoimmune thrombocytopenia (ITP) following exposure to recombinant thrombopoietin and pure red cell aplasia, which was associated with a particular formulation of erythropoietin (Eprex). (wikipedia.org)

Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. (wikipedia.org)
Unwanted immunogenicity is an immune response by an organism against a therapeutic antigen. (wikipedia.org)
Therefore, as stated by the World Health Organization, immunogenicity should be investigated in a target population since animal testing and in vitro models cannot precisely predict immune response in humans. (wikipedia.org)
However, strictly speaking, immunogenicity refers to the ability of an antigen to induce an adaptive immune response. (wikipedia.org)

Their primary outcomes were efficacy and safety for patients who had switched from an originator therapy to a biosimilar. (medscape.com)

Antibody responses after the 50-µg mRNA-1273.211 booster dose were also higher than that after a 50-µg mRNA-1273 booster dose for the ancestral SARS-CoV-2, Beta, Omicron and Delta variants (28 days after the booster dose) and for the ancestral SARS-CoV-2, Beta and Omicron (180 days after the booster dose), and the immunogenicity objectives were met. (researchsquare.com)

Safety, immunogenicity, and efficacy of a recombinantly produced Plasmodium falciparum circumsporozoite protein-hepatitis B surface antigen subunit vaccine. (ajtmh.org)
Primary endpoints are safety and FLU-v induced CMI, evaluated by cytokine production by antigen specific T cell populations (flow-cytometry and ELISA). (rki.de)
Immunogenicity was measured by antigen-specific ex-vivo IFN-γ ELISpot, IgG serum ELISA, and antigen-specific intracellular IFN-γ, TNF-α, IL-2 and IL-17. (ox.ac.uk)

Previously, we reported on the immunogenicity of a plant-produced AHS serotype 5 virus-like particle (VLP) vaccine, which stimulated high titres of AHS serotype 5-specific neutralizing antibodies in guinea pigs. (biomedcentral.com)

Identification of immunogenicity risk is performed for all therapeutic proteins. (pegsummit.com)

This presentation will focus on the human immunogenicity risk assessment platforms and other developability assessment tools at Lonza to aid the selection and optimization of lead candidates. (pegsummit.com)

This trial is designed to evaluate the immunogenicity and safety of FLU-v, a vaccine composed of four synthetic peptides with conserved epitopes from influenza A and B strains expected to elicit both cell mediated immunity (CMI) and humoral immunity providing protection against a broad spectrum of influenza viruses. (rki.de)

The primary endpoint was safety, and the secondary endpoint was immunogenicity. (plos.org)

Strategies for low immunogenicity risk and de-immunization will be discussed. (pegsummit.com)

On the basis of findings establishing comparable immunogenicity, a third conjugate vaccine, PRP-T (ActHIB{TM}, OmniHIB{TM}) has now been licensed for use among infants. (cdc.gov)

The primary objective was safety and immunogenicity of the ZPIV candidate. (emmes.com)

There's been a lot of variety in opinion about the appropriateness and safety of switching from an innovator biologic to a biosimilar. (medscape.com)
Overall, this review gives reassurance to clinicians that there isn't a signal for significant loss of response or concern for safety with biosimilar switch. (medscape.com)

Several innovations in genetic engineering has resulted in the decrease in immunogenicity, (also known as deimmunization), of mAbs. (wikipedia.org)

The safety and efficacy of treating human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer with pyrotinib. (news-medical.net)

Incorporating immunogenicity and developability risk assessment into the early stages of development is important for optimal lead selection. (pegsummit.com)

Presentations at Immunogenicity Prediction and Mitigation will enable attendees to make informed decisions on candidate selection, dosing and formulation, with a view to producing safe and efficacious products in the clinic and beyond. (pegsummit.com)

This is the first report demonstrating the safety and immunogenicity of plant-produced AHS VLPs in horses. (biomedcentral.com)

Comparison of Safety and. (checkorphan.org)

Anatomy13

Organisms36

Diseases17

Chemicals and Drugs117

Analytical, Diagnostic and Therapeutic Techniques and Equipment37

Phenomena and Processes25

Disciplines and Occupations2

Anthropology, Education, Sociology and Social Phenomena1

Technology, Industry, Agriculture4

Information Science2

Named Groups1

Health Care17

Geographicals1

Vaccines11

Reactogenicity6

Tolerability4

Vaccination10

20231

Inactivated Zika virus vaccine candidate2

Heterologous2

Effectiveness3

Adverse events2

Doses5

Persistence1

Dengue1

Clinical2

Adults1

PHASE3

Immunogenic2

Study9

Data5

Recombinant1

Immune4

Efficacy and safety1

Booster dose1

Antigen3

Serotype1

Therapeutic1

Candidates1

Influenza1

Secondary1

Immunization1

Comparable1

Primary1

Biosimilar2

Genetic1

Human1

Assessment1

Candidate1

Report1

Comparison1