Rotavirus specific maternal antibodies and immune response to RV3-BB rotavirus vaccine in central java and yogyakarta, Indonesia

Background: Placental or breast milk maternal antibodies can potentially reduce oral rotavirus vaccine
efficacy in developing countries. We aimed to examine the relationship between the level of rotavirus
specific immunoglobulin A (IgA) and neutralising antibodies (NA) in colostrum and breast milk and cord
IgG, with cumulative vaccine take following one and three doses of oral RV3-BB rotavirus vaccine within
a Phase IIb trial in Indonesia.
Methods: 196 infants received three doses of RV3-BB in a randomized, double-blinded trial, using a
neonatal schedule (first dose at 0–5 days of age, n = 61), an infant schedule (first dose at ~ 8 weeks of
age, n = 67) or placebo (n = 68). Rotavirus specific IgA and NA in colostrum and breast milk, rotavirus
specific cord IgG, Serum IgA and stool excretion were measured.
Results: There was little evidence of an association between IgA in colostrum or breast milk and cumu-
lative vaccine take after three doses in the neonatal or infant groups. In the neonatal group, there was a
negative association between IgG titre in cord blood and cumulative vaccine take (odds ratio [OR] 0.96;
95% confidence interval [CI] 0.92–1.00; p = 0.03) and serum IgA response (OR 0.94; 95%CI 0.89–0.99;
p = 0.02) after one dose of vaccine, which were not evident after three doses in the neonatal or infant
groups.
Conclusions: Amongst Indonesian infants we did not find an association between IgA in colostrum or
breast milk and vaccine take after 3 doses of RV3-BB vaccine. Maternal rotavirus antibodies in breast milk
appear to have minimal impact on RV3-BB vaccine take when administered with a short delay in breast-
feeding in settings with a high rotavirus disease burden.