Measles and BCG Vaccines for Mother and Child
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Vaccine Preventable Disease, Measles, Mother-Infant Interaction, BCG Vaccination Reaction
In brief
In Africa, the mortality from infectious diseases remains high. The investigators have discovered that live vaccines such as the BCG vaccine against tuberculosis and the measles vaccine can strengthen resistance to other infections: they have beneficial "non-specific effects". The investigators have now seen signs that these non-specific effects for children are stronger if their mother has been given the same vaccines. In Africa, BCG vaccine is recommended at birth and measles vaccine at 9 months of age. They are not used beyond childhood. The investigators will randomize 2400 women to BCG vaccine, measles vaccine, or placebo. The investigators will further randomize their children to an extra early measles vaccine or placebo. The investigators will assess which of the resulting six vaccination schedules are best for women's and children's protection against measles, for the child's immune system, and for general health. The project will be the first in the world to investigate the importance of vaccinating women with live vaccines.
Key facts
- Study ID
- NCT04899765
- Run by
- Bandim Health Project
- People needed
- 2400
- Starts
- 2021-05-20
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2024-01-19
Who can join
Age: 15 and older, up to 35. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female women in the fertile age
- Non-pregnant
- HIV-negative
- Living in the BHP HDSS study area
- Delivered a child that has reached 12 months of age
- Currently not using contraceptives.
You may not qualify if…
- Positive pregnancy test
- Positive HIV test
- Tuberculosis (previous or current)
- Immunodeficiency
- Cancer within the last 2 years
- Mid-upper-arm-circumference<200
- Acute ongoing infection
Where it is running
- Bandim Health Project — Bissau, Bissau Codex, Guinea-Bissau (enrolling)
Full record on ClinicalTrials.gov
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