Safety and immunogenicity of two live attenuated human rotavirus vaccine candidates, 116E and I321, in infants: results of a randomised controlled trial.
We evaluated safety and immunogenicity of two orally administered human rotavirus vaccine candidates 116E and I321. Ninety healthy infants aged 8 weeks received a single dose of 116E (10(5)FFu (florescence focus units)), I321 (10(5)FFu) or placebo. There were no significant differences in the number of adverse events. Fever was reported by 6/30, 1/30 and 5/30 in the 116E, I321 and placebo groups; the corresponding figures for diarrhoea were 5/30, 8/29 and 3/30. Serum IgA seroconversion rates were 73%, 39% and 20% in the 116E, I321 and placebo groups, respectively. Vaccine virus was shed on days 3, 7 or 28 in 11/30 infants of the 116E and none in the other two groups. The 116E strain is attenuated, clinically safe and highly immunogenic with a single dose.
Bhandari
Nita
N
Society for Applied Studies, New Delhi, India.
Sharma
Pooja
P
Glass
Roger I
RI
Ray
Pratima
P
Greenberg
Harry
H
Taneja
Sunita
S
Saksena
Manju
M
Rao
C Durga
CD
Gentsch
Jon R
JR
Parashar
Umesh
U
Maldonado
Yvonne
Y
Ward
Richard L
RL
Bhan
M K
MK
D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D012401:Rotavirus / Q000235:genetics / Q000276:immunology*; D012400:Rotavirus Infections / Q000235:genetics / Q000276:immunology / Q000517:prevention & control; D022243:Rotavirus Vaccines / Q000009:adverse effects* / Q000235:genetics / Q000276:immunology*
D022243:Rotavirus Vaccines