Actively Recruiting
Specific and Non-specific Effects of Measles and BCG Vaccines for Mother and Child
Led by Bandim Health Project · Updated on 2024-01-19
2400
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Bandim Health Project
Lead Sponsor
T
The University of Western Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of measles vaccine (MV) and Bacille Calmette-Guérin vaccine (BCG) given to women of fertile age before pregnancy, and the impact of providing early measles vaccination to their children. The study aims to understand both measles-specific and general immune benefits in mothers and children, focusing on antibody responses, viral loads after yellow fever vaccination, and overall health outcomes. This is a phase 4 randomized, triple-blind trial conducted in Guinea-Bissau, exploring the novel concept that vaccinating mothers with live vaccines may enhance protection for their children. In this trial, 2400 non-pregnant, HIV-negative women aged 15 to 35 will be randomly assigned to receive either the measles vaccine, BCG vaccine, or a saline placebo. Their children, all receiving BCG at birth as per local recommendations, will be further randomized at 20 weeks of age to receive either an early measles vaccine or placebo. All children will then receive the standard measles and yellow fever vaccines at 9 months. The study will create six groups combining maternal and child vaccination schedules to compare outcomes. Participants will be followed through regular home visits and health center monitoring. Women will have blood samples taken before and after vaccination to measure antibody levels. Children will be closely monitored monthly and have blood samples taken at specified ages to assess immune responses and viral loads. The study tracks morbidity and mortality data for both mothers and children over time, using interviews, hospital records, and vaccination documentation. The trial will continue until 2027, assessing which vaccination schedules best support health and immunity.
CONDITIONS
Brief Title
Measles and BCG Vaccines for Mother and Child
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female women in fertile age
- Non-pregnant
- HIV-negative
- Living in the Bandim Health Project study area
- Delivered a child who has reached at least 12 months of age
- Currently not using contraceptives
You will not qualify if you...
- Positive pregnancy test
- Positive HIV test
- Previous or current tuberculosis
- Immunodeficiency
- Cancer within the last 2 years
- Mid-upper-arm circumference less than 200 mm
- Acute ongoing infection
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until pregnancy occurs or study completion
Participants receive one of three injections: measles vaccine, BCG vaccine, or placebo before pregnancy to study effects on immunity and overall health.
1 vaccination visit (in-person)
Duration - Up to 12 months following vaccination
Participants are followed for pregnancy status and morbidity with interviews and documentation of hospitalizations and consultations every 2 months.
Bi-monthly interviews and continuous health monitoring
Duration - At 20 weeks of age
Children born to enrolled mothers are followed monthly and at 20 weeks of age are randomized to receive early measles vaccine or placebo.
1 visit (in-person) for randomization and vaccination
Duration - From birth to 13.5 months of age
Children receive routine vaccinations including BCG at birth, measles vaccine at 9 months, and yellow fever vaccine. Selected children receive yellow fever vaccine and measles vaccine 5 days later at 9 months for further study.
Monthly home visits and scheduled vaccination visits
Duration - Up to 13.5 months of age
Children are observed for morbidity and mortality through regular home visits, health center consultations, and hospital admissions.
Monthly home visits and health center monitoring
Trial Site Locations
Total: 1 location
1
Bandim Health Project
Bissau, Bissau Codex, Guinea-Bissau, 1004
Actively Recruiting
Research Team
I
Isaquel da Silva, MD
C
Christine Benn, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
3
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