Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants.
OBJECTIVE
To investigate safety, efficacy, and immunogenicity of live quadrivalent rotavirus vaccine (QRV) containing human-bovine (WC3) reassortant rotavirus serotypes G1, G2, G3, and P1a.


METHODS
This was a randomized, double-blinded, placebo-controlled trial. During 1993 to 1994, at 10 US study sites, 439 healthy infants approximately 2 to 6 months of age, were enrolled to receive 3 doses of oral QRV or placebo at approximately 8-week intervals.


RESULTS
The vaccine was generally well tolerated; no serious vaccine-related adverse experiences were reported. Risk differences and 95% confidence intervals suggested no differences between vaccine and placebo recipients in the incidences of fever, irritability, vomiting, or diarrhea during the 14 days after any dose. QRV was 74.6% efficacious (95% CI: 49.5%, 88.3%) in preventing rotavirus acute gastroenteritis (AGE), regardless of severity and 100% efficacious (95% CI: 43.5%, 100%) in preventing severe rotavirus AGE through one rotavirus season. Serotype G1 was identified in most infants with rotavirus AGE. A >or=3-fold rise in serum neutralizing antibody to G1 was observed in 57% (45/79) of vaccinees. A >or=3-fold rise in serum anti-rotavirus IgA and fecal anti-rotavirus IgA was observed in 88% (162/185) and 65% (104/159) of vaccinees, respectively.


CONCLUSIONS
QRV was generally well tolerated, immungenic, and highly effective against rotavirus gastroenteritis.
Clark
H Fred
HF
University of Pennsylvania School of Medicine, Philadelphia, and Merck & Co, Inc, West Point, Pennsylvania 19486, USA.
Bernstein
David I
DI
Dennehy
Penelope H
PH
Offit
Paul
P
Pichichero
Michael
M
Treanor
John
J
Ward
Richard L
RL
Krah
David L
DL
Shaw
Alan
A
Dallas
Michael J
MJ
Laura
Digilio
D
Eiden
Joseph J
JJ
Ivanoff
Nathalie
N
Kaplan
Karen M
KM
Heaton
Penny
P
D000818:Animals; D000914:Antibodies, Viral / Q000096:biosynthesis / Q000097:blood; D002417:Cattle; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005243:Feces / Q000821:virology; D005260:Female; D005759:Gastroenteritis / Q000517:prevention & control / Q000821:virology; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood / Q000276:immunology; D007223:Infant; D008297:Male; D016865:Reassortant Viruses / Q000276:immunology*; D012401:Rotavirus / Q000276:immunology*; D012400:Rotavirus Infections / Q000276:immunology* / Q000517:prevention & control; D022243:Rotavirus Vaccines / Q000009:adverse effects / Q000276:immunology*; D012703:Serotyping; D014613:Vaccines, Attenuated / Q000276:immunology
D000914:Antibodies, Viral; D007070:Immunoglobulin A; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated