Trial reportJournal of clinical microbiology1990
Clinical studies of a quadrivalent rotavirus vaccine in Venezuelan infants.
Trial report in Journal of clinical microbiology, 1990. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
What it found
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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
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Rotavirus vaccine for preventing diarrhoea.The Cochrane database of systematic reviews · 2004Pooled it
- Immunogenicity, safety and efficacy of tetravalent rhesus-human, reassortant rotavirus vaccine in Belém, Brazil.Bulletin of the World Health Organization · 1996Trial
- Reactogenicity and immunogenicity of a high-titer rhesus rotavirus-based quadrivalent rotavirus vaccine.Journal of clinical microbiology · 1993Trial
- Serum and salivary responses to oral tetravalent reassortant rotavirus vaccine in newborns.Clinical and experimental immunology · 1993Trial
- Overview of the Development, Impacts, and Challenges of Live-Attenuated Oral Rotavirus Vaccines.Vaccines · 2020Review
- Molecular characterization of a new variant of rotavirus P[8]G9 predominant in a sentinel-based survey in central Italy.Journal of clinical microbiology · 2007Article
- Heterotypic protection and induction of a broad heterotypic neutralization response by rotavirus-like particles.Journal of virology · 1999Article
- Serotype specificity of the neutralizing-antibody response induced by the individual surface proteins of rotavirus in natural infections of young children.Clinical and diagnostic laboratory immunology · 1998Article
- Rotavirus vaccines: an overview.Clinical microbiology reviews · 1996Review
- Heterogeneity of VP4 neutralization epitopes among serotype P1A human rotavirus strains.Clinical and diagnostic laboratory immunology · 1995Article
- Preferential selection of VP7 gene from a parent rotavirus strain (SA11) in sequential passages after mixed infection with SA11 and SA11-human rotavirus single-VP7 gene-substitution reassortants.Archives of virology · 1995Article
- Rotavirus-specific intestinal immune response in mice assessed by enzyme-linked immunospot assay and intestinal fragment culture.Clinical and diagnostic laboratory immunology · 1994Article
- Serotypic differentiation of rotaviruses in field samples from diarrheic pigs by using nucleic acid probes specific for porcine VP4 and human and porcine VP7 genes.Journal of clinical microbiology · 1994Article
- Rotaviruses: immunological determinants of protection against infection and disease.Advances in virus research · 1994Review
- Rotavirus vaccine administered parenterally induces protective immunity.Journal of virology · 1993Article
- Immunodominance of the VP4 neutralization protein of rotavirus in protective natural infections of young children.Journal of virology · 1993Article
- Humoral immune responses to VP4 and its cleavage products VP5* and VP8* in infants vaccinated with rhesus rotavirus.Journal of clinical microbiology · 1992Article
- Protection of agammaglobulinemic piglets from porcine rotavirus infection by antibody against simian rotavirus SA-11.Journal of clinical microbiology · 1991Article
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Phase I studies of an oral quadrivalent rotavirus vaccine were conducted in 130 Venezuelan infants 10 to 20 weeks of age. The vaccine consists of a mixture of equal amounts of rhesus rotavirus (RRV) vaccine (serotype 3 [VP7]) and each of three human rotavirus-RRV reassortant strains: D x RRV (serotype 1 [VP7]), DS1 x RRV (serotype 2 [VP7]), and ST3 x RRV (serotype 4 [VP7]). Three different doses of the quadrivalent vaccine (0.25 x 10(4), 0.5 x 10(4), and 10(4) PFU of each component) were evaluated sequentially for safety and antigenicity in placebo-controlled, double-blind trials. Starting the day after vaccination, the infants were monitored by daily home visits for 7 days. Only minor reactions were observed during this period; these were limited to mild transient febrile episodes which began day 2 or 3 after vaccination and lasted 1 to 2 days in 15 to 30% of the infants. Serological studies demonstrated that 68 to 96% of the infants developed a rotavirus serum immunoglobulin A response following vaccination. However, when tested by plaque reduction neutralization assay against individual human rotavirus serotype 1, 2, 3, or 4, the response rates ranged from 4 to 23% with the low dose, 21 to 33% with the medium dose, and 32 to 58% with the high dose. Most (73 to 79%) infants developed neutralizing antibodies to RRV following administration of each dose schedule. Vaccine virus shedding was analyzed by utilizing tissue culture isolation of virus from stool. All of the infants who received the lower of medium dose and 89% of those fed the high dose shed one or more components of the vaccine. Analyses of rotavirus serotypes isolated from the stool of infants who received the 0.25 x 10(4) -PFU dose revealed that DS1 x RRV was the most commonly shed vaccine component, followed by RRV, D x RRV, and ST3 x RRV in that order.
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