Trial reportHuman vaccines & immunotherapeutics2014
Association of serum anti-rotavirus immunoglobulin A antibody seropositivity and protection against severe rotavirus gastroenteritis: analysis of clinical trials of human rotavirus vaccine.
Trial report in Human vaccines & immunotherapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00385320 (To Assess the Efficacy, Immuno & Safety of 2 Doses of GSK HRV Vaccine at Different Virus Concentrations in Healthy Infants Aged 2 Months & Previously Uninfected With HRV, Concurrently Given With DTPw-HBV, Hib.), which is not on this map. Cited by 41 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
To Assess the Efficacy, Immuno & Safety of 2 Doses of GSK HRV Vaccine at Different Virus Concentrations in Healthy Infants Aged 2 Months & Previously Uninfected With HRV, Concurrently Given With DTPw-HBV, Hib.
Who cites it
41 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.
- Immunogenicity of different dosing schedules of the human live attenuate rotavirus vaccine (RV1) in infants and children: a meta-analysis.Human vaccines & immunotherapeutics · 2019Pooled it
- Randomized controlled trial evaluating immunogenicity and safety of a porcine circovirus-free rotavirus vaccine in healthy Chinese infants.Human vaccines & immunotherapeutics · 2026Trial
- Safety and immunogenicity of inactivated human Rotavirus vaccine in young children and infants: a randomized, placebo-controlled, double-blind, phase I clinical trial.Nature communications · 2026Trial
- Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants.Frontiers in public health · 2024Trial
- Immunogenicity of a Third Scheduled Dose of Rotarix in Australian Indigenous Infants: A Phase IV, Double-blind, Randomized, Placebo-Controlled Clinical Trial.The Journal of infectious diseases · 2022Trial
- A phase III randomized, open-label, non-inferiority clinical trial comparing liquid and lyophilized formulations of oral live attenuated human rotavirus vaccine (HRV) in Indian infants.Human vaccines & immunotherapeutics · 2021Trial
- Immunogenicity and safety of the diphtheria, pertussis, tetanus and inactivated poliovirus vaccine when co-administered with the human rotavirus vaccine (Rotarix) in healthy Japanese infants: a phase IV randomized study.Human vaccines & immunotherapeutics · 2019Trial
- Association of human leukocyte antigen alleles and supertypes with immunogenicity of oral rotavirus vaccine given to infants in China.Medicine · 2018Trial
- Evaluation of a Booster Dose of Pentavalent Rotavirus Vaccine Coadministered With Measles, Yellow Fever, and Meningitis A Vaccines in 9-Month-Old Malian Infants.The Journal of infectious diseases · 2018Trial
- Rotavirus-Specific Immunoglobulin A Responses Are Impaired and Serve as a Suboptimal Correlate of Protection Among Infants in Bangladesh.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Trial
- A Randomized, Controlled Trial of the Impact of Alternative Dosing Schedules on the Immune Response to Human Rotavirus Vaccine in Rural Ghanaian Infants.The Journal of infectious diseases · 2016Trial
- Immunogenicity and reactogenicity of the human rotavirus vaccine, RIX4414 oral suspension, when co-administered with routine childhood vaccines in Chinese infants.Human vaccines & immunotherapeutics · 2016Trial
- Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules.Pediatrics · 2016Trial
- Immune response to rotavirus vaccines in low- and middle-income countries: Challenges and perspectives.Human vaccines & immunotherapeutics · 2026Review
- Nanomaterial-based vaccines: An advanced approach against rotavirus: A review article.Human vaccines & immunotherapeutics · 2026Review
- Repeated-dose toxicity and immunogenicity evaluation of norovirus P particle-based rotavirus vaccine in juvenile cynomolgus monkeys.Frontiers in immunology · 2026Article
- Article
- Correlates of immune protection against human rotaviruses: natural infection and vaccination.Archives of virology · 2024Review
- Article
- Maternal Breast Milk Secretor Phenotype Does Not Affect Infant Susceptibility to Rotavirus Diarrhea.Open forum infectious diseases · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 7 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Clinical trials of the human rotavirus vaccine Rotarix™ (RV1) have demonstrated significant reductions in severe rotavirus gastroenteritis (RVGE) in children worldwide. However, no correlate of vaccine efficacy (VE) has yet been established. This paper presents 2 analyses which aimed to investigate whether serum anti-RV IgA measured by ELISA 1 or 2 mo post-vaccination can serve as a correlate of efficacy against RVGE: (1) In a large Phase III efficacy trial (Rota-037), the Prentice criteria for surrogate endpoints was applied to anti-RV IgA seropositivity 1 mo post-vaccination. These criteria determine whether a significant vaccine group effect can be predicted from the surrogate, namely seropositivity (anti-RV IgA concentration>20 U/mL); (2) Among other GSK-sponsored RV1 VE studies, 8 studies which assessed immunogenicity at 1 or 2 mo post-vaccination in all or a sub-cohort of enrolled subjects and had at least 10 RVGE episodes were included in a meta-analysis to measure the regression between clinical VE and VE predicted from immunogenicity (VE1). In Rota-037, anti-RV IgA seropositivity post-vaccination was associated with a lower incidence of any or severe RVGE, however, the proportion of vaccine group effect explained by seropositivity was only 43.6% and 32.7% respectively. This low proportion was due to the vaccine group effect observed in seronegative subjects. In the meta-analysis, the slope of the regression between clinical VE and VE1 was statistically significant. These two independent analyses support the hypothesis that post-vaccination anti-RV IgA seropositivity (antibody concentration ≥20 U/mL) may serve as a useful correlate of efficacy in clinical trials of RV1 vaccines.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.