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A Study of the Interaction Between BCG And MenC Immunisation: BAM

NCT02002156 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-10-18

No results posted yet for this study

Summary

The Bacille Calmette-Guérin (BCG) vaccine is the only vaccine licenced to prevent tuberculosis (TB). The stimulus it gives to the immune system allows it to respond more effectively to a subsequent infection with TB.

Many studies have shown that BCG is effective in reducing deaths from TB disease, particularly in children. However, there is also evidence that in countries with a relatively high death rate, BCG reduces this death rate but by more than would be expected by its effect on TB alone. This controversial but important finding warrants further and serious consideration. One possibility is that BCG, in addition to stimulating the immune system against TB, also has a positive effect on the way the immune system works more generally. This might mean a more effective response to serious infections that are completely unrelated to TB, or the ability to respond better to other routine childhood vaccines, or to maintain such responses for longer. In these examples, the timing of BCG administration in relation to other vaccines could be crucial.

This study will recruit 30 healthy babies who would not routinely be offered the BCG vaccine in the UK within the first week of life. Babies will be assigned at random to one of three groups of ten babies each. BCG will be given to one group of babies around birth, one at three months old and the last group will not get BCG during the study. Babies will stay in the study until 13 months old and have five blood tests over this period.

This preliminary study will look at the participants' blood to see if there are differences in the immune system, or its response to the MenC childhood meningitis vaccine or the pattern of genes activated after BCG has been given.

Conditions

  • BCG Infection
  • Reaction - Vaccine
  • Immune Response

Interventions

BIOLOGICAL

BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®

This group will receive BCG at birth and all routine vaccinations.

BIOLOGICAL

BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®

This group will receive BCG at three months old and all routine vaccinations.

BIOLOGICAL

NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®

This group will receive no BCG but will receive all routine vaccinations.

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-20
Primary Completion
2016-08-31
Completion
2018-06-27

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02002156 on ClinicalTrials.gov