Early Versus Delayed BCG Vaccination of HIV-exposed Infants

Status Completed

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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02062580
Study type	Interventional
Source	University of Cape Town
Contact
Status	Completed
Phase	Phase 2
Start date	June 2010

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02135419` - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions	Phase 3
Active, not recruiting	`NCT02663856` - My Smart Age With HIV: Smartphone Self-assessment of Frailty
Completed	`NCT02921516` - Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings	N/A
Completed	`NCT02663869` - Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
Completed	`NCT02846402` - Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda	N/A
Completed	`NCT02659306` - Metformin Immunotherapy in HIV Infection	Phase 1
Terminated	`NCT02743598` - Liraglutide for HIV-associated Neurocognitive Disorder	Phase 4
Completed	`NCT02564341` - Targeting Effective Analgesia in Clinics for HIV - Intervention	N/A
Active, not recruiting	`NCT02302950` - A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas	N/A
Completed	`NCT01830595` - Lactoferrin Treatment in HIV Patients	Phase 2
Terminated	`NCT01902186` - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir	Phase 4
Terminated	`NCT02109224` - Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection	Phase 1
Completed	`NCT02269605` - Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment	Phase 1
Completed	`NCT01852942` - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV	Phase 2
Completed	`NCT01946217` - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials	N/A
Completed	`NCT02118168` - Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002	N/A
Completed	`NCT02527135` - Text Messaging to Improve HIV Testing Among Young Women in Kenya	N/A
Completed	`NCT02525146` - Birmingham Access to Care Study	N/A
Active, not recruiting	`NCT02602418` - Neural Correlates of Working Memory Training for HIV Patients	N/A
Completed	`NCT01805427` - Antiretroviral Therapy and Extreme Weight	N/A