A field study of the safety and efficacy of two candidate rotavirus vaccines in a Native American population.
A double-blind, randomized, placebo-controlled trial was conducted to evaluate the safety and efficacy of a rhesus rotavirus vaccine and RIT 4237, a bovine rotavirus vaccine, in a Navajo population. Infants aged 2-5 months were randomized to receive one dose of either 10(4) pfu of the rhesus rotavirus vaccine or 10(8) pfu of the RIT 4237 vaccine or placebo. Eleven (10.2%) of 108 infants in the rhesus vaccine group, 11 (10.4%) of 106 in the RIT 4237 group, and 9 (8.4%) of 107 in the placebo group experienced rotavirus diarrhea during the follow-up period of 17 months. Thus, in this population, neither vaccine was efficacious in preventing rotavirus diarrhea.
Santosham
M
M
Department of International Health, Johns Hopkins University School of Hygiene and Public Health, Baltimore, MD 21205.
Letson
G W
GW
Wolff
M
M
Reid
R
R
Gahagan
S
S
Adams
R
R
Callahan
C
C
Sack
R B
RB
Kapikian
A Z
AZ
D003968:Diarrhea, Infantile / Q000208:ethnology / Q000382:microbiology / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007198:Indians, North American; D007223:Infant; D008297:Male; D012400:Rotavirus Infections / Q000150:complications / Q000208:ethnology / Q000517:prevention & control*; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated / Q000009:adverse effects; D014765:Viral Vaccines / Q000009:adverse effects
C041165:RIT 4237 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated; D014765:Viral Vaccines; C052014:rhesus rotavirus vaccine