RecruitingPhase 4NCT04899765

Measles and BCG Vaccines for Mother and Child

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


Sponsor

Bandim Health Project

Enrollment

2,400 participants

Start Date

May 20, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 15 YearsMax Age: 35 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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

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Interventions

BIOLOGICALBCG vaccine

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

BIOLOGICALMeasles vaccine

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

OTHERPlacebo

Saline


Locations(1)

Bandim Health Project

Bissau, Bissau Codex, Guinea-Bissau

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NCT04899765


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