Early Versus Delayed BCG Vaccination of HIV-exposed Infants

HIV Infection Clinical Trial

Official title:

Influence of BCG Immunization on Immune Responses and Disease Progression in South African HIV Exposed and Infected Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062580
• Other study ID #: MV-00-9-900-01871
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2014
• Last updated: February 12, 2014
• Start date: June 2010

Study information

• Verified date: February 2014
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

In sub-Saharan Africa (SSA), more than 300,000 babies with HIV die each year. HIV-infected children develop AIDS and die faster in SSA than those in developed countries. Bacille Calmette-Guerin (BCG) vaccine is given to infants at birth in SSA to protect them from severe forms of TB. BCG is known to cause immune cells to be active and replicate faster. The immune system of neonates also responds differently to BCG that to other vaccines and infections. We hypothesize that the routine immunization of neonates with BCG contributes to generalized immune activation in HIV-exposed infants resulting in skewed immune responses to vaccines and infections and increased rates of disease progression in those infants that become HIV-infected. However, delaying BCG until HIV testing is completed would result in operational difficulties, and may not induce the appropriate immune response. Delayed BCG would also render many HIV-exposed uninfected infants at high risk for disseminated TB. We plan to assess immune cells in infants to determine the impact of the timing of BCG vaccination on immune responses to tuberculosis (TB) and other vaccines. We will also compare the immune activation and disease progression of those infants that become HIV-infected in the BCG or control arms. Our results will provide key insights into the effect of BCG vaccination on immune responses to HIV as well as inform the optimal timing of BCG vaccination for HIV-exposed infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

Inclusion Criteria:

• Healthy neonate

• Maternal HIV

• > 36 weeks gestation

• Birth weight > 2.4kg

• Remaining in area 4 months

Exclusion Criteria:

• Complications during pregnancy and delivery

• Household TB contacts

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• HIV Exposure
• HIV Infection

Intervention

Biological:
• BCG

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Cape Town	Seattle Biomedical Research Institute, University of Stellenbosch

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HIV disease progression		14 weeks	Yes
Primary	T cell activation		up to 14 weeks	No
Secondary	Vaccine Immunogenicity		6, 8, and 14 weeks of age	No