HIV InfectionsPhase 1/2NCT00331474
The Effect of Bacille Calmette Guerin (BCG) Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
A Phase 1/2 study testing BCG delayed in people with HIV Infections, run by University of Stellenbosch at 1 site in South Africa.
Trial summary
Background: Each year, more than half a million babies are infected with HIV by mother-to child transmission in developing countries. Many of these babies get sick and develop HIV disease (AIDS) at a very young age. Exposure to other infectious diseases may influence this early progression to AIDS. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- HIV Infections
- What is being tested?
- BCG delayed
- Type of treatment
- Vaccines
- How many people
- 180 participants
- Where
- 1 siteSouth Africa
- Study dates
- May 2006to Aug 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Maternal HIV status verified
- Study consent
- Uncomplicated singleton pregnancy with delivery planned at local health facility
- Resident in study area
Who cannot join
- Active tuberculosis or tuberculosis contact in mother
- No consent
- Planning to move out of study area
- Not planning on delivering at local maternal obstetric unit
- Not planning on attending local baby clinic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
Background:
Each year, more than half a million babies are infected with HIV by mother-to child transmission in developing countries. Many of these babies get sick and develop HIV disease (AIDS) at a very young age. Exposure to other infectious diseases may influence this early progression to AIDS. BCG is a live tuberculosis vaccine made from cow tuberculosis. It is routinely given at birth to most babies, also to babies born to HIV-positive mothers. BCG can cause disease (BCGosis) in HIV-infected babies. More importantly, BCG may also trigger immune responses in the body that lead to the spread of the HIV virus and early progression to AIDS.
Read more
Objective(s) and Hypothesis:
The researchers will investigate whether BCG causes progression of HIV by doing a clinical trial: babies born to HIV-positive mothers will be randomly allocated to get the BCG vaccine at birth or at 14 weeks of age. In these 2 groups of babies, the researchers will compare:
- The percentage of babies who progress to HIV disease
- Blood markers of HIV disease (the amount of virus and protective white blood cells in the body)
- The body's immune response to BCG vaccine and other childhood vaccines
- The percentage of children who develop BCG scarring, BCG vaccine complications and tuberculosis.
Potential Impact:
BCG is the most widely given vaccine worldwide and is routinely given to babies born to HIV-positive mothers in developing countries. Any effect that BCG has on HIV progression in babies will have a significant public health impact in settings with a high burden of HIV disease.
- Conditions
- HIV Infections
- Being tested
- BCG delayed
- Keywords
- BCG, HIV, Immune responses, Delayed vaccination, Infant morbidity, Nutritional status, Morbidity, Mortality
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG delayedBiological
Also called early vs. delayed BCG
early (birth) and delayed (14 weeks) intradermal BCG vaccination
What is being measured
The primary outcome is the main question the study is designed to answer.
BCG-induced cellular immune responses
Measured: 1 year
Secondary outcomes (3)
BCG scarring
Measured: 18 months
Serum antibody responses
Measured: 52 weeks
Tuberculosis incidence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2008
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Stellenbosch
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Investigators
- Anneke C Hesseling, MD, Principal investigator, Desmond Tutu TB Centre, Dept. Pediatrics and Child Health, Stellenbosch University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331474
- Sponsor's protocol ID
- N06/04/071
- Status last verified
- Feb 2009
- First submitted
- 30 May 2006
- Last updated
- 16 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
- ClinicalTrials.gov ID
- NCT00331474
- Acronym / sponsor ID
- N06/04/071
- Conditions
- HIV Infections
- Keywords
- BCG, HIV, Immune responses, Delayed vaccination, Infant morbidity, Nutritional status, Morbidity, Mortality
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of StellenboschUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- May 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2009 (estimated)
- First posted
- 31 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Each year, more than half a million babies are infected with HIV by mother-to child transmission in developing countries. Many of these babies get sick and develop HIV disease (AIDS) at a very young age. Exposure to other infectious diseases may influence this early progression to AIDS. BCG is a live tuberculosis vaccine made from cow tuberculosis. It is routinely given at birth to most babies, also to babies born to HIV-positive mothers. BCG can cause disease (BCGosis) in HIV-infected babies. More importantly, BCG may also trigger immune responses in the body that lead to the spread of the HIV virus and early progression to AIDS.
Objective(s) and Hypothesis:
The researchers will investigate whether BCG causes progression of HIV by doing a clinical trial: babies born to HIV-positive mothers will be randomly allocated to get the BCG vaccine at birth or at 14 weeks of age. In these 2 groups of babies, the researchers will compare:
- The percentage of babies who progress to HIV disease
- Blood markers of HIV disease (the amount of virus and protective white blood cells in the body)
- The body's immune response to BCG vaccine and other childhood vaccines
- The percentage of children who develop BCG scarring, BCG vaccine complications and tuberculosis.
Potential Impact:
BCG is the most widely given vaccine worldwide and is routinely given to babies born to HIV-positive mothers in developing countries. Any effect that BCG has on HIV progression in babies will have a significant public health impact in settings with a high burden of HIV disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Maternal HIV status verified
- Study consent
- Uncomplicated singleton pregnancy with delivery planned at local health facility
- Resident in study area
Key exclusion criteria (5 listed)
- Active tuberculosis or tuberculosis contact in mother
- No consent
- Planning to move out of study area
- Not planning on delivering at local maternal obstetric unit
- Not planning on attending local baby clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG delayedAlso: early vs. delayed BCGearly (birth) and delayed (14 weeks) intradermal BCG vaccination | Biological | – |
Primary outcome
BCG-induced cellular immune responses
Time frame: 1 year
3 secondary outcomes
BCG scarring
Time frame: 18 months
Serum antibody responses
Time frame: 52 weeks
Tuberculosis incidence
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anneke C Hesseling, MD principal investigator
Desmond Tutu TB Centre, Dept. Pediatrics and Child Health, Stellenbosch University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BCG delayed in people with HIV Infections, run by University of Stellenbosch at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCG-induced cellular immune responses (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2009.