Safety, immunogenicity, and protective efficacy of one and three doses of the tetravalent rhesus rotavirus vaccine in infants in Lima, Peru.
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 < .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.
Lanata
C F
CF
Instituto de Investigación Nutricional, Lima, Peru.
Midthun
K
K
Black
R E
RE
Butron
B
B
Huapaya
A
A
Penny
M E
ME
Ventura
G
G
Gil
A
A
Jett-Goheen
M
M
Davidson
B L
BL
D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D003906:Developing Countries; D003968:Diarrhea, Infantile / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D004305:Dose-Response Relationship, Drug; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007223:Infant; D008253:Macaca mulatta / Q000821:virology; D008297:Male; D009500:Neutralization Tests; D010568:Peru / Q000453:epidemiology; D010919:Placebos; D012400:Rotavirus Infections / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control*; D013383:Suburban Population; D010948:Viral Plaque Assay; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*
D000914:Antibodies, Viral; D007070:Immunoglobulin A; D010919:Placebos; D014765:Viral Vaccines