Safety, immunogenicity, and protective efficacy of one and three doses of the tetravalent rhesus rotavirus vaccine in infants in Lima, Peru. Lanata, C F, Midthun, K, Black, R E, Butron, B, Huapaya, A, Penny, M E, Ventura, G, Gil, A, Jett-Goheen, M, & Davidson, B L The Journal of Infectious Diseases, 174(2):268–275, August, 1996.
Safety, immunogenicity, and protective efficacy of one and three doses of the tetravalent rhesus rotavirus vaccine in infants in Lima, Peru [link]Paper  abstract   bibtex   
An oral rhesus-human rotavirus tetravalent (RRV-TV) vaccine (10(4) pfu of rhesus rotavirus [type G3] and of 3 human-rhesus reassortants [G1, G2, and G4]) was evaluated in a field trial in Lima, Peru. At 2, 3, and 4 months of age, infants received either a dose of RRV-TV, an initial dose of vaccine followed by a dose of placebo at 3 and 4 months, or a dose of placebo. Rotavirus-specific IgA responses were detected by ELISA in 75% of the three-dose vaccine group, 59% of the one-dose vaccine group (P = .05), and 24% of the placebo group (P \textless .001): 64%, 48%, and 12% of each group, respectively, had a neutralizing antibody response to at least 1 serotype. Both one and three doses of vaccine failed to induce a significant level of protection against rotavirus diarrhea; however, they did provide some protection (range, 35%-66%) against more severe rotavirus diarrhea, especially for episodes caused by type G1.
@article{lanata_safety_1996,
	title = {Safety, immunogenicity, and protective efficacy of one and three doses of the tetravalent rhesus rotavirus vaccine in infants in {Lima}, {Peru}},
	volume = {174},
	issn = {0022-1899},
	url = {http://www.ncbi.nlm.nih.gov/pubmed/8699054},
	abstract = {An oral rhesus-human rotavirus tetravalent (RRV-TV) vaccine (10(4) pfu of rhesus rotavirus [type G3] and of 3 human-rhesus reassortants [G1, G2, and G4]) was evaluated in a field trial in Lima, Peru. At 2, 3, and 4 months of age, infants received either a dose of RRV-TV, an initial dose of vaccine followed by a dose of placebo at 3 and 4 months, or a dose of placebo. Rotavirus-specific IgA responses were detected by ELISA in 75\% of the three-dose vaccine group, 59\% of the one-dose vaccine group (P = .05), and 24\% of the placebo group (P {\textless} .001): 64\%, 48\%, and 12\% of each group, respectively, had a neutralizing antibody response to at least 1 serotype. Both one and three doses of vaccine failed to induce a significant level of protection against rotavirus diarrhea; however, they did provide some protection (range, 35\%-66\%) against more severe rotavirus diarrhea, especially for episodes caused by type G1.},
	number = {2},
	urldate = {2010-11-10},
	journal = {The Journal of Infectious Diseases},
	author = {Lanata, C F and Midthun, K and Black, R E and Butron, B and Huapaya, A and Penny, M E and Ventura, G and Gil, A and Jett-Goheen, M and Davidson, B L},
	month = aug,
	year = {1996},
	pmid = {8699054},
	keywords = {Animals, Antibodies, Viral, Developing Countries, Diarrhea, Infantile, Dose-Response Relationship, Drug, Enzyme-Linked Immunosorbent Assay, Female, Humans, Immunoglobulin A, Infant, Macaca mulatta, Male, Neutralization Tests, Peru, Placebos, Plaque Assay, Rotavirus Infections, Suburban Population, Viral Vaccines},
	pages = {268--275},
}

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