Specific and Non-specific Effects of Measles and BCG Vaccines for Mother and Child

MATVAC

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.

2021-05-20

2025-12-31

2027-12-31

Recruiting

Early phase I

2400

Inclusion Criteria: * 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. Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'We plan a trail randomising non-pregnant women of fertile age 1:1:1 to MV, BCG or placebo. The first children to be born will also be randomised to early MV or no early MV at 20 weeks of age. All children will get the recommended MV by 9 months of age.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'BCG is given intradermally and typically results in a local skin reaction that heals leaving a small scar. Measles vaccine is given subcutaneously and typically does not leave any sign of vaccination. Though we do not believe women will be able to distinguish between intradermal and subcutaneous injections, complete blinding on the recipient side will not be possible; those who get a skin reaction after BCG will most likely be able to guess what they received, whereas MV and placebo recipients will not. We do not believe this will influence the results of the blood testing or their treatment of their offspring.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2400, 'type': 'ESTIMATED'}}

2024-01-19