1. 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
- Author
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Meghana Paranjpe, Srinivasan Venugopal, Jacqueline E. Tate, Jessica A. Fleming, Sudhir Babji, E. Shanmugasundaram, P. Saravankumar Kaliappan, Asha Mary Abraham, Rajiv Sarkar, Umesh D. Parashar, Edward P.K. Parker, Uma Raman, Jacob John, Nicholas C. Grassly, A. Duncan Steele, Jayaprakash Muliyil, Gagandeep Kang, Ira Praharaj, Robin P. Lazarus, Sidhartha Giri, S. Thiagarajan, Anand K. Rajan, and Medical Research Council (MRC)
- Subjects
Male ,0301 basic medicine ,Placebo-controlled study ,DIARRHEAL HOSPITALIZATIONS ,Administration, Oral ,CHILDREN ,Research & Experimental Medicine ,IMMUNOGENICITY ,Antibodies, Viral ,medicine.disease_cause ,law.invention ,Placebos ,DOUBLE-BLIND ,0302 clinical medicine ,Randomized controlled trial ,LESS-THAN-5 YEARS ,law ,Rotavirus ,030212 general & internal medicine ,DEVELOPING-COUNTRIES ,Lacticaseibacillus rhamnosus ,Poliovirus vaccine ,11 Medical And Health Sciences ,Rotavirus vaccine ,Vaccination ,Zinc ,Treatment Outcome ,Infectious Diseases ,Medicine, Research & Experimental ,Molecular Medicine ,Female ,HEALTH IMPACT ,Life Sciences & Biomedicine ,medicine.medical_specialty ,Immunology ,India ,CONTROLLED-TRIAL ,Vaccines, Attenuated ,Placebo ,03 medical and health sciences ,CHOLERA VACCINE ,Double-Blind Method ,Virology ,Internal medicine ,medicine ,Humans ,Seroconversion ,Adverse effect ,Science & Technology ,General Veterinary ,General Immunology and Microbiology ,business.industry ,Probiotics ,Rotavirus Vaccines ,Public Health, Environmental and Occupational Health ,Infant ,Lactobacillus GG ,06 Biological Sciences ,Immunoglobulin A ,030104 developmental biology ,07 Agricultural And Veterinary Sciences ,business - Abstract
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).
- Published
- 2018