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

Autor: 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
Přispěvatelé: Medical Research Council (MRC)
Rok vydání: 2018
Předmět:
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
Zdroj: Vaccine. 36:273-279
ISSN: 0264-410X
Popis: 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).
Databáze: OpenAIRE
Externí odkaz: