Skip to main content
OpenTrials
Completed

NCT Number: NCT01288950

Vitamin D Supplementation Enhances Immune Response to Bacille-Calmette-Guerin (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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tijuana General Hospital

Tijuana, Estado de Baja California, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy mothers > 18 years of age
  • Term, healthy infants eligible to receive the Bacille-Calmette- Guerin (BCG) vaccine

Exclusion criteria

  • Recent maternal history of tuberculosis (within 1 year) or active tuberculosis
  • Known maternal human immuno-deficiency virus (HIV) infection
  • Maternal fever or chorio-amnionitis
  • Maternal use of vitamin D, steroids or immuno-regulatory medications
  • Household member with active tuberculosis

Treatment and study plan

vitamin D3 (cholecalciferol)

Dietary Supplement

A single oral dose of 50,000 IU of vitamin D3 (cholecalciferol) will be given prior to Bacille-Calmette-Guerin (BCG) vaccination

Other names: Carlson Ddrops liquid vitamin D3 2,000 IU per drop

Primary outcomes

  1. Bacille-Calmette-Guerin (BCG) vaccine efficacy

    Time frame: 2 months

    BCG vaccine efficacy will be assessed by measuring the host immune response against BCG at 2 months, 6 months and one year after BCG immunization. A whole blood assay will be used to measure multiple cytokines and mycobacterial growth suppression.

  2. Bacille-Calmette-Guerin (BCG) vaccine efficacy

    Time frame: 6 months

  3. Bacille-Calmette-Guerin (BCG) vaccine efficacy

    Time frame: 1 year

Secondary outcomes

  1. Effect of a single dose of 50,000 IU vitamin D3 on serum vitamin D levels

    Time frame: 2 months

    Serum 25 hydroxy (OH) vitamin D levels will be measured prior to vitamin D supplementation and at 2 months, 6 months and one year after BCG immunization. The investigators will also determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect baseline vitamin D levels and alter the response to vitamin D supplementation.

  2. Bacille-Calmette-Guerin (BCG) vaccine efficacy

    Time frame: 1 year

    The investigators will determine whether specific host genetic variants including the Fok-I(rs2228570T/C), Bsm-I(rs1544410A/G), GC(rs2282679A/C), DHCR7(rs12785878G/T) and CYP2R1 (rs10741657A/G) polymorphisms affect the response to BCG vaccine in infants receiving either vitamin D or placebo.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Thrasher Research Fund

Registry information

Official study title

Vitamin D Supplementation Enhances Immune Response to BCG Vaccination in Infants

Acronym: BCG-25-D

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 3, 2011
Registry last updated
Aug 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.