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RECRUITING
NCT04899765
PHASE4

Measles and BCG Vaccines for Mother and Child

Sponsor: Bandim Health Project

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

FEMALE

Age Range

15 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

2400

Start Date

2021-05-20

Completion Date

2027-12-31

Last Updated

2024-01-19

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

BCG vaccine

It is an attenuated live bacterial vaccine. This vaccine is a freeze-dried product that must be reconstituted.

BIOLOGICAL

Measles vaccine

It is an attenuated live virus vaccine. This vaccine is a freeze-dried product that must be reconstituted.

OTHER

Placebo

Saline

Locations (1)

Bandim Health Project

Bissau, Bissau Codex, Guinea-Bissau