Trial reportBulletin of the World Health Organization1996
Immunogenicity, safety and efficacy of tetravalent rhesus-human, reassortant rotavirus vaccine in Belém, Brazil.
Trial report in Bulletin of the World Health Organization, 1996. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Rotavirus vaccine for preventing diarrhoea.The Cochrane database of systematic reviews · 2004Pooled it
- Human infection with Ascaris lumbricoides is associated with suppression of the interleukin-2 response to recombinant cholera toxin B subunit following vaccination with the live oral cholera vaccine CVD 103-HgR.Infection and immunity · 2001Trial
- The performance of licensed rotavirus vaccines and the development of a new generation of rotavirus vaccines: a review.Human vaccines & immunotherapeutics · 2021Review
- Lymphoid tissue fibrosis is associated with impaired vaccine responses.The Journal of clinical investigation · 2018Article
- Article
- Effect of pentavalent rotavirus vaccine introduction on hospital admissions for diarrhoea and rotavirus in children in Rwanda: a time-series analysis.The Lancet. Global health · 2016Article
- Rotavirus vaccines in routine use.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2014Review
- Review
- Development of a Bacillus subtilis-based rotavirus vaccine.Clinical and vaccine immunology : CVI · 2010Article
- Immunogenicity and efficacy of oral vaccines in developing countries: lessons from a live cholera vaccine.BMC biology · 2010Review
- Performance of rotavirus vaccines in developed and developing countries.Human vaccines · 2010Review
- Effectiveness of rotavirus vaccination against childhood diarrhoea in El Salvador: case-control study.BMJ (Clinical research ed.) · 2010Article
- Oral rotavirus vaccines: how well will they work where they are needed most?The Journal of infectious diseases · 2009Review
- A review of changing episode definitions and their effects on estimates of diarrhoeal morbidity.Journal of health, population, and nutrition · 2007Article
- Surveillance of rotavirus strains in Rio de Janeiro, Brazil, from 1997 to 1999.Journal of clinical microbiology · 2003Article
- Emergence of G9 P[6] human rotaviruses in Argentina: phylogenetic relationships among G9 strains.Journal of clinical microbiology · 2001Article
- Rotavirus strains bearing genotype G9 or P[9] recovered from Brazilian children with diarrhea from 1997 to 1999.Journal of clinical microbiology · 2001Article
- Functional mapping of protective domains and epitopes in the rotavirus VP6 protein.Journal of virology · 2000Article
- Antibody-independent protection against rotavirus infection of mice stimulated by intranasal immunization with chimeric VP4 or VP6 protein.Journal of virology · 1999Article
- Detection of porcine rotavirus type G9 and of a mixture of types G1 and G5 associated with Wa-like VP4 specificity: evidence for natural human-porcine genetic reassortment.Journal of clinical microbiology · 1999Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A tetravalent rhesus-human reassortant rotavirus (RRV-TV) vaccine (4 x 10(4) plaque-forming units/dose) was evaluated for safety, immunogenicity and efficacy in a prospective, randomized, double-blind, placebo-controlled trial involving 540 Brazilian infants. Doses of vaccine or placebo were given at ages 1, 3 and 5 months. No significant differences were noted in the occurrence of diarrhoea or vomiting in vaccine and placebo recipients following each dose. Low-grade fever occurred on days 3-5 in 2-3% of vaccinees after the first dose, but not after the second or third doses of vaccine. An IgA antibody response to rhesus rotavirus (RRV) occurred in 58% of vaccinees and 33% of placebo recipients. Neutralizing antibody responses to individual serotypes did not exceed 20% when measured by fluorescent focus reduction, but exceeded 40% when assayed by plaque reduction neutralization. There were 91 cases of rotavirus diarrhoea among the 3-dose (vaccine or placebo) recipients during two years of follow-up, 36 of them among children given the vaccine. Overall vaccine efficacy was 8% (P = 0.005) against any diarrhoea and 35% (P = 0.03) against any rotavirus diarrhoea. Protection during the first year of follow-up, when G serotype 1 rotavirus predominated, was 57% (P = 0.008), but fell to 12% in the second year. Similar results were obtained when analysis was restricted to episodes in which rotavirus was the only identified pathogen. There was a tendency for enhanced protection by vaccine against illness associated with an average of 6 or more stools per day. These results are sufficiently encouraging to warrant further studies of this vaccine in developing countries using a higher dosage in an attempt to improve its immunogenicity and efficacy.
Indexed as
Identifiers
9002329PMC2486862What 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.