Early Versus Late BCG Vaccination in HIV-1 Exposed Infants in Uganda in Uganda

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2024-06-21

Brief Summary

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BCG vaccination may have non-specific effects (NSE) i.e., additional benefits on childhood morbidity and mortality that are separate the vaccine's effect on the incidence of disseminated tuberculosis. Though the available literature is mostly from observational study designs, and is fraught with controversy, BCG vaccination at birth, in a high risk population of HIV exposed children, may protect infants against serious infections other than TB. Yet, other studies indicate that giving BCG later in infancy, when the immune system is more mature, may offer even greater protection. The appropriate timing of BCG vaccination could therefore be up for revision. This study will therefore compare BCG vaccination at birth with BCG vaccination at 14 weeks of age in HIV exposed (HE) babies.

Methods: This is an individually randomized clinical trial in 4,500 HIV exposed infants. The intervention is an intra-dermal administration of 0.05 ml of BCG vaccine within 24 hours of birth while the comparator will be an intra-dermal administration of 0.05ml of BCG vaccine at 14 weeks of age.

The main study outcomes include:

1. Severe illness in the first 14 weeks of life,
2. Innate and adaptive immune responses to mycobacterial, non-mycobacterial antigens and TLR-agonists
3. Severe illness in the first 14-52 weeks and 0-52 weeks of life.

The study will be carried in two health centers and one district hospital in Uganda.

Implications: A well-timed BCG vaccination could have important additional benefits in HE infants. This trial could inform the development of programmatically appropriate timing of BCG vaccination for HE infants.

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Detailed Description

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Conditions

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Severe Illness Septicaemia Diarrhoea Lower Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention arm: BCG at birth

Infants randomized to this arm will receive an intra-dermal administration of 0.05 ml of BCG vaccine within 24h of birth

Group Type EXPERIMENTAL

BCG at birth

Intervention Type BIOLOGICAL

See previous description

Control arm: BCG at 14 weeks of age

Infants randomized to this arm will receive intra-dermal administration of 0.05 ml of BCG vaccine at 14 weeks of age

Group Type ACTIVE_COMPARATOR

Control arm: Delayed BCG

Intervention Type BIOLOGICAL

See previous description

Interventions

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BCG at birth

See previous description

Intervention Type BIOLOGICAL

Control arm: Delayed BCG

See previous description

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

A baby born at a participating study clinic will be included if s/he:

1. has a mother with a positive HIV test (ELISA or rapid test)
2. is receiving peri-exposure prophylaxis as part of the standard/national guidelines in Uganda
3. has a mother that is of legal age for participation in clinical research studies in Uganda or is an emancipated minor
4. has a mother/caregiver that resides within the study area, is not intending to move out of the area in the next 4 months and is likely to be traceable for up to 12 months
5. has a mother/caregiver that gives informed consent to random assignment to either of the two trial arms
6. has a mother that has received antiretroviral therapy (ART) for at least 4 weeks

Exclusion Criteria

A new-born child will be excluded if she/he has:

1. an identified serious congenital malformation(s)
2. severe illness requiring hospitalization
3. a birth weight \< 2.0 kg
4. a mother participating in another clinical trial on the day of enrolment or a mother who will participate in another clinical trial within the next month.
5. a mother or other household member with symptoms and signs of tuberculosis on the day of enrolment
6. a severely ill mother with (a) condition(s) requiring hospitalization
7. a baby with an Apgar score at 5 minutes \<7
8. a twin or triplet

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes