Tuberculosis Clinical Trial
Official title:
Vitamin D Supplementation Enhances Immune Response to BCG Vaccination in Infants
The purpose of this study is to determine whether a single oral dose of vitamin D given to infants prior to Bacille-Calmette-Guerin (BCG) vaccination will enhance the immune response to BCG vaccination.
In 2000, there were an estimated 884,000 cases of tuberculosis (TB) in children with many
developing severe, disseminated disease. Widespread immunization with
Bacille-Calmette-Guerin (BCG) vaccine has not been effective in preventing primary TB
infection or in halting the progression from latent to active disease. Poor vaccine efficacy
has prompted investigators to develop novel TB vaccines and to experiment with enhancing the
immune response to the current BCG vaccine.
Increasing data indicate that children with low vitamin D levels and specific genetic
variants that lower functional levels of vitamin D are at increased risk for severe
tuberculosis. Elegant studies investigating Mycobacterium tuberculosis (Mtb) infection have
shown that mycobacteria are able to reside in endosomes within macrophages by preventing
endosome-lysosome fusion; a critical step in autophagy, a cellular process used to recycle
cytoplasmic organelles and proteins, and to degrade microbial organisms including Mtb.
In-vitro studies have shown that vitamin D increases autophagy and triggers the production
of antimicrobial peptides including cathelicidin. This leads to increased intracellular
killing of Mtb and increased Mtb antigen presentation to the immune system. Anti-tuberculous
vaccines that over-express Mtb antigens generate a stronger immune response than wild type
BCG vaccine.
The investigators hypothesis is that a single oral dose of vitamin D3 (cholecalciferol)
given to infants prior to BCG administration will enhance the immune response to vaccination
through improved MHC class I and class II presentation of the vaccine.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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