TY - JOUR
T1 - Safety, immunogenicity, and protective efficacy of one and three doses of the tetravalent rhesus rotavirus vaccine in infants in Lima, Peru
AU - Lanata, Claudio F.
AU - Midthun, Karen
AU - Black, Robert E.
AU - Butron, Betzabe
AU - Huapaya, Ana
AU - Penny, Mary E.
AU - Ventura, Gladis
AU - Gil, Ana
AU - Jett-Goheen, Mary
AU - Davidson, Bruce L.
N1 - Funding Information:
Financial support: Wyeth-Ayerst Research; United Kingdom Overseas Development Administration (for C.F.L. as a Visiting Research Fellow at London School of Hygiene and Tropical Medicine).
Funding Information:
The study was approved by the Peruvian Ministry of Health, community leaders of the study area, and the human research committees of the lnstituto de Investigaci6n Nutricional and the Johns Hopkins School of Hygiene and Public Health. Informed consent was obtained from the parents of study children, and human experimentation guidelines of the Department of Health and Human Services were followed.
PY - 1996
Y1 - 1996
N2 - An oral rhesus-human rotavirus tetravalent (RRV-TV) vaccine (104 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 < .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.
AB - An oral rhesus-human rotavirus tetravalent (RRV-TV) vaccine (104 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 < .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.
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U2 - 10.1093/infdis/174.2.268
DO - 10.1093/infdis/174.2.268
M3 - Article
C2 - 8699054
AN - SCOPUS:8944236540
SN - 0022-1899
VL - 174
SP - 268
EP - 275
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 2
ER -