Measles Clinical Trial
— MATVACOfficial title:
Specific and Non-specific Effects of Measles and BCG Vaccines for Mother and Child
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.
Status | Recruiting |
Enrollment | 2400 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 35 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Guinea-Bissau | Bandim Health Project | Bissau | Bissau Codex |
Lead Sponsor | Collaborator |
---|---|
Bandim Health Project | The University of Western Australia, Université Libre de Bruxelles |
Guinea-Bissau,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of children with maternal measles antibody | Children with maternal measles antibody | 20 weeks of age | |
Primary | Proportion of children with maternal measles antibody | Children with maternal measles antibody | 9 months of age | |
Primary | Yellow fever viral load after yellow fever vaccine | The level of yellow fever virus in the blood following yellow fever vaccine | 9 months of age | |
Secondary | Measles antibody levels in the women | Measles antibody levels in the women | 4 weeks after MV or BCG vaccine | |
Secondary | Measles antibody levels in children | Measles antibody levels in the children | 13.5 months of age | |
Secondary | Incidence of morbidity in women after MV or BCG compared with placebo | Diseases occurring post-randomisation in women | Up to 12 months following vaccination | |
Secondary | Incidence of morbidity in children subsequently born to BCG, MV or placebo vaccinated mothers | Diseases occurring in children of randomised women | Up to age 13.5 months |
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