TY - JOUR
T1 - The effect of probiotics and zinc supplementation on the immune response to oral rotavirus vaccine
T2 - A randomized, factorial design, placebo-controlled study among Indian infants
AU - Lazarus, Robin P.
AU - John, Jacob
AU - Shanmugasundaram, E.
AU - Rajan, Anand K.
AU - Thiagarajan, S.
AU - Giri, Sidhartha
AU - Babji, Sudhir
AU - Sarkar, Rajiv
AU - Kaliappan, P. Saravankumar
AU - Venugopal, Srinivasan
AU - Praharaj, Ira
AU - Raman, Uma
AU - Paranjpe, Meghana
AU - Grassly, Nicholas C.
AU - Parker, Edward P.K.
AU - Parashar, Umesh D.
AU - Tate, Jacqueline E.
AU - Fleming, Jessica A.
AU - Steele, A. Duncan
AU - Muliyil, Jayaprakash
AU - Abraham, Asha M.
AU - Kang, Gagandeep
N1 - Publisher Copyright:
© 2017 The Author(s)
PY - 2018/1/4
Y1 - 2018/1/4
N2 - Background Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function. Methods Infants 5 weeks old living in urban Vellore, India were enrolled in a randomized, double-blind, placebo-controlled trial with a 4-arm factorial design to assess the effects of daily zinc (5 mg), probiotic (1010 Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix® GlaxoSmithKline Biologicals) given at 6 and 10 weeks of age. Infants were eligible for participation if healthy, available for the study duration and without prior receipt of RV or oral poliovirus vaccine other than the birth dose. The primary outcome was seroconversion to rotavirus at 14 weeks of age based on detection of VP6-specific IgA at ≥20 U/ml in previously seronegative infants or a fourfold rise in concentration. Results The study took place during July 2012 to February 2013. 620 infants were randomized equally between study arms and 551 (88.9%) completed per protocol. Seroconversion was recorded in 54/137 (39.4%), 42/136 (30.9%), 40/143 (28.0%), and 37/135 (27.4%) infants receiving (1) probiotic and zinc, (2) probiotic and placebo, (3) placebo and zinc, (4) two placebos. Seroconversion showed a modest improvement among infants receiving probiotic (difference between groups 1, 2 and 3, 4 was 7.5% (97.5% Confidence Interval (CI): −1.4%, 16.2%), p = 0.066) but not zinc (difference between groups 1, 3 and 2, 4 was 4.4% (97.5% CI: −4.4%, 13.2%), p = 0.272). 16 serious adverse events were recorded, none related to study interventions. Conclusions Zinc or probiotic supplementation did not significantly improve the low immunogenicity of rotavirus vaccine given to infants in a poor urban community in India. A modest effect of combined supplementation deserves further investigation. Trial registration The trial was registered in India (CTRI/2012/05/002677).
AB - Background Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function. Methods Infants 5 weeks old living in urban Vellore, India were enrolled in a randomized, double-blind, placebo-controlled trial with a 4-arm factorial design to assess the effects of daily zinc (5 mg), probiotic (1010 Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix® GlaxoSmithKline Biologicals) given at 6 and 10 weeks of age. Infants were eligible for participation if healthy, available for the study duration and without prior receipt of RV or oral poliovirus vaccine other than the birth dose. The primary outcome was seroconversion to rotavirus at 14 weeks of age based on detection of VP6-specific IgA at ≥20 U/ml in previously seronegative infants or a fourfold rise in concentration. Results The study took place during July 2012 to February 2013. 620 infants were randomized equally between study arms and 551 (88.9%) completed per protocol. Seroconversion was recorded in 54/137 (39.4%), 42/136 (30.9%), 40/143 (28.0%), and 37/135 (27.4%) infants receiving (1) probiotic and zinc, (2) probiotic and placebo, (3) placebo and zinc, (4) two placebos. Seroconversion showed a modest improvement among infants receiving probiotic (difference between groups 1, 2 and 3, 4 was 7.5% (97.5% Confidence Interval (CI): −1.4%, 16.2%), p = 0.066) but not zinc (difference between groups 1, 3 and 2, 4 was 4.4% (97.5% CI: −4.4%, 13.2%), p = 0.272). 16 serious adverse events were recorded, none related to study interventions. Conclusions Zinc or probiotic supplementation did not significantly improve the low immunogenicity of rotavirus vaccine given to infants in a poor urban community in India. A modest effect of combined supplementation deserves further investigation. Trial registration The trial was registered in India (CTRI/2012/05/002677).
KW - India
KW - Lactobacillus GG
KW - Poliovirus vaccine
KW - Rotavirus vaccines
KW - Zinc
UR - http://www.scopus.com/inward/record.url?scp=85028687174&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2017.07.116
DO - 10.1016/j.vaccine.2017.07.116
M3 - Article
C2 - 28874323
AN - SCOPUS:85028687174
SN - 0264-410X
VL - 36
SP - 273
EP - 279
JO - Vaccine
JF - Vaccine
IS - 2
ER -
