Trials; 8 (11), 2007
Publication year: 2007
Results:
Both vaccines were safe and had similar reactogenicity profiles. All subjects with paired pre and post-vaccination
samples showed a vaccine response with respect to anti-circumsporozoite (CS) antibodies irrespective of initial anti-CS
serostatus. Geometric mean titers (GMTs) were 191 EU/ml (95% CI 150–242) in recipients of RTS, S/AS02D compared
to 180 EU/ml (95% CI 146–221) in recipients of RTS, S/AS02A. For the anti-hepatitis B surface antigen (HBsAg), all
subjects were seroprotected at day 90, and the GMTs were 23978 mIU/ml (95% CI 17896–32127) in RTS, S/AS02D
recipients and 17410 mIU/ml (95% CI 13322–22752) in RTS, S/AS02A recipients. There was a decrease in anti-CS GMTs
between months 3 and 14 in both groups (191 vs 22 EU/mL in RTS, S/AS02D group and 180 vs 29 EU/mL in RTS, S/
AS02A group).
Conclusion:
Our data show that the RTS, S/AS02D is safe, well tolerated, and demonstrates non-inferiority (defined as
upper limit of the 95% confidence interval of the anti-CS GMT ratio of RTS, S/AS02A to RTS, S/AS02D below 3.0) of the
antibody responses to circumsporozoite and HBsAg induced by the RTS, S/AS02D as compared to the RTS, S/AS02A.