Safety, efficacy, and immunogenicity of 2 doses of bovine-human (UK) and rhesus-rhesus-human rotavirus reassortant tetravalent vaccines in Finnish children.
BACKGROUND
Live oral rhesus-rhesus-human rotavirus reassortant tetravalent (RRV-TV) vaccine was efficacious against rotavirus gastroenteritis but was withdrawn because of a rare association with intussusception. A corresponding tetravalent (types G1, G2, G3, and G4) reassortant vaccine based on bovine-human (UK) rotavirus reassortant tetravalent (BRV-TV) vaccine was developed concurrently.


METHODS
Before the withdrawal of RRV-TV vaccine, parallel placebo-controlled trials of BRV-TV vaccine (observer blinded) versus RRV-TV vaccine (double blinded) with a 2 : 1 ratio of vaccine : placebo were conducted in Finland in a total of 510 infants. Two doses of study vaccine or placebo were administered at ages 3 and 5 months.


RESULTS
The first dose of RRV-TV vaccine was followed by a significant excess rate of febrile reactions (36%), whereas the rate of fever after the administration of BRV-TV vaccine did not differ significantly from that in the placebo group. Neither vaccine induced diarrhea. A seroresponse was detected in 97% of BRV-TV vaccine recipients and 94% of RRV-TV vaccine recipients. Both vaccines were equally effective, with 68%-69% efficacy against any and 88%-100% efficacy against severe rotavirus gastroenteritis during the first epidemic season.


CONCLUSIONS
BRV-TV vaccine is a promising new candidate rotavirus vaccine, with low reactogenicity and high efficacy. Two doses of BRV-TV or RRV-TV vaccine are sufficient for the induction of protection against severe rotavirus disease.
Vesikari
Timo
T
Vaccine Research Center, University of Tampere Medical School, Tampere, Finland. timo.vesikari@uta.fi
Karvonen
Aino V
AV
Majuri
Jukka
J
Zeng
Shang-Qin
SQ
Pang
Xiao-Li
XL
Kohberger
Robert
R
Forrest
Bruce D
BD
Hoshino
Yasutaka
Y
Chanock
Robert M
RM
Kapikian
Albert Z
AZ
D000818:Animals; D002417:Cattle; D004311:Double-Blind Method; D005260:Female; D005387:Finland; D005759:Gastroenteritis / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D006801:Humans; D007077:Ileal Diseases / Q000209:etiology; D007223:Infant; D007231:Infant, Newborn; D007443:Intussusception / Q000209:etiology; D008253:Macaca mulatta; D008297:Male; D012401:Rotavirus / Q000276:immunology; D012400:Rotavirus Infections / Q000276:immunology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*
D022243:Rotavirus Vaccines; C052014:rhesus rotavirus vaccine