The effect of probiotics and zinc supplementation on the immune response to oral rotavirus vaccine: A randomized, factorial design, placebo-controlled study among Indian infants

• DOI: 10.1016/j.vaccine.2017.07.116
• Publication Date: 2017-09-02T17:30:42Z
• Authors: Robin P. Lazarus; Jacob John; E. Shanmugasundaram; Anand K. Rajan; S. Thiagarajan; Sidhartha Giri; Sudhir Babji; Rajiv Sarkar; P. Saravankumar K...; Srinivasan Venugopal; Ira Praharaj; Uma Raman; Meghana Paranjpe; Nicholas C. Grassly; Edward P.K. Parker; Umesh D. Parashar; Jacqueline E. Tate; Jessica A. Fleming; A. Duncan Steele; Jayaprakash Muliyil; Asha M. Abraham; Gagandeep Kang
• Keywords: Seroconversion; Lactobacillus rhamnosus; Rotavirus vaccine

Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could RV immunogenicity by altering the intestinal microbiota immune function. Infants 5 weeks old living urban Vellore, India were enrolled a randomized, double-blind, placebo-controlled trial with 4-arm factorial design assess effects of daily (5 mg), probiotic (1010 Lactobacillus rhamnosus GG) or placebo on two doses (Rotarix®, GlaxoSmithKline Biologicals) given at 6 10 age. eligible for participation if healthy, available study duration without prior receipt poliovirus other than birth dose. The primary outcome was seroconversion 14 age based detection VP6-specific IgA ≥20 U/ml previously seronegative infants fourfold rise concentration. took place during July 2012 February 2013. 620 randomized equally between arms 551 (88.9%) completed per protocol. Seroconversion recorded 54/137 (39.4%), 42/136 (30.9%), 40/143 (28.0%), 37/135 (27.4%) receiving (1) zinc, (2) placebo, (3) (4) placebos. showed modest improvement among (difference groups 1, 2 3, 4 7.5% (97.5% Confidence Interval (CI): −1.4%, 16.2%), p = 0.066) but not 3 2, 4.4% CI: −4.4%, 13.2%), 0.272). 16 serious adverse events recorded, none related interventions. Zinc did significantly low poor community India. A effect combined deserves further investigation. registered (CTRI/2012/05/002677).