Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life.
BACKGROUND
Rotavirus is the leading cause of dehydrating acute gastroenteritis in infants worldwide. Previous studies of a live pentavalent human-bovine reassortant rotavirus vaccine have shown it to be efficacious across a range of potencies.


OBJECTIVE
Our goal was to evaluate the efficacy, immunogenicity, and safety of pentavalent rotavirus vaccine at the end of shelf life in healthy infants.


METHODS
During 2002-2004, 1312 healthy infants approximately 6 to 12 weeks old from the United States (47%) and Finland (53%) were randomly assigned to receive 3 oral doses of vaccine (vaccine at approximately 1.1 x 10(7) infectious U per dose) or placebo approximately 4 to 10 weeks apart. Infants were to be followed for acute gastroenteritis through 1 rotavirus season after vaccination and for adverse events postvaccination.


RESULTS
Three doses of pentavalent rotavirus vaccine at the end of shelf life demonstrated efficacy against rotavirus gastroenteritis caused by human G-serotypes included in the vaccine (G1-G4). Efficacy against severe rotavirus gastroenteritis was 100%, and efficacy against any rotavirus gastroenteritis regardless of severity was 72.5%. A threefold rise in G1 serum neutralizing was observed in 57% and in anti-rotavirus immunoglobulin A in 96% of pentavalent rotavirus vaccine recipients. No statistically significant increase in vomiting, diarrhea, or irritability was observed among pentavalent rotavirus vaccine recipients compared with placebo recipients within the 7-day period from each dose. A statistically significant increase in fevers (> or = 100.5 degrees F, rectal equivalent) was observed among pentavalent rotavirus vaccine recipients compared with placebo recipients after dose 1.


CONCLUSIONS
This pentavalent human-bovine rotavirus vaccine was generally well tolerated, efficacious, and immunogenic at the end of shelf life.
Block
Stan L
SL
Kentucky Pediatric/Adult Research, Bardstown, Kentucky, USA.
Vesikari
Timo
T
Goveia
Michelle G
MG
Rivers
Stephen B
SB
Adeyi
Ben A
BA
Dallas
Michael J
MJ
Bauder
Jeffrey
J
Boslego
John W
JW
Heaton
Penny M
PM
D000208:Acute Disease; D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D005243:Feces / Q000821:virology; D005260:Female; D005759:Gastroenteritis / Q000517:prevention & control / Q000821:virology; D006760:Hospitalization; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007223:Infant; D008297:Male; D012401:Rotavirus / Q000276:immunology / Q000302:isolation & purification; D012400:Rotavirus Infections / Q000517:prevention & control / Q000821:virology; D022243:Rotavirus Vaccines / Q000009:adverse effects / Q000276:immunology*; D014611:Vaccination
D000914:Antibodies, Viral; D007070:Immunoglobulin A; D022243:Rotavirus Vaccines; C058442:WC3 rotavirus vaccine