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

Who is this study for? Patients without Vaccines
Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Maximum Age: 35
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Guinea-Bissau
Bandim Health Project
RECRUITING
Bissau
Contact Information
Primary
Isaquel da Silva, MD
isabarsila@gmail.com
+245966654873
Backup
Christine Benn, MD
cbenn@health.sdu.dk
+4525883964
Time Frame
Start Date: 2021-05-20
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 2400
Treatments
Experimental: Measles vaccine
Measles vaccine in standard dose of 0.5 ml.
Experimental: BCG vaccine
BCG vaccine in standard dose of 0.1 ml.
Placebo_comparator: Placebo
Saline injection
Related Therapeutic Areas
Sponsors
Collaborators: The University of Western Australia, Université Libre de Bruxelles
Leads: Bandim Health Project

This content was sourced from clinicaltrials.gov