Measles and BCG Vaccines for Mother and Child

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.

Conditions

• Vaccine Preventable Disease
• Measles
• Mother-Infant Interaction
• BCG Vaccination Reaction

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

Sponsors & Collaborators

• The University of Western Australia

  collaborator OTHER

• Université Libre de Bruxelles

  collaborator OTHER

• Bandim Health Project

  lead OTHER

Principal Investigators

• Christine Benn, DMSc · University of Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

15 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-20

Primary Completion

2025-12-31

Completion

2027-12-31

Countries

• Guinea-Bissau

Study Locations