Measles and BCG Vaccines for Mother and Child

NCT04899765 | Recruiting Phase 4 DMC

• 1 other identifier: MATVAC
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Non-specific effects of vaccines

Outcome Measures

Primary Outcomes (3)

• Proportion of children with maternal measles antibody

  Children with maternal measles antibody

  20 weeks of age

• Proportion of children with maternal measles antibody

  Children with maternal measles antibody

  9 months of age

• 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 Outcomes (4)

• Measles antibody levels in the women

  4 weeks after MV or BCG vaccine

• Measles antibody levels in children

  13.5 months of age

• Incidence of morbidity in women after MV or BCG compared with placebo

  Up to 12 months following vaccination

• Incidence of morbidity in children subsequently born to BCG, MV or placebo vaccinated mothers

  Up to age 13.5 months

Study Arms (3)

Measles vaccine

EXPERIMENTAL

Measles vaccine in standard dose of 0.5 ml.

Biological: Measles vaccine

BCG vaccine

EXPERIMENTAL

BCG vaccine in standard dose of 0.1 ml.

Biological: BCG vaccine

Placebo

PLACEBO COMPARATOR

Saline injection

Other: Placebo

Interventions

BCG vaccine BIOLOGICAL

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

BCG vaccine

Measles vaccine BIOLOGICAL

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

Measles vaccine

Placebo OTHER

Saline

Placebo

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bandim Health Project: lead
• The University of Western Australia: collaborator
• Université Libre de Bruxelles: collaborator

Study Sites (1)

Bandim Health Project

Bissau, Bissau Codex, 1004, Guinea-Bissau

RECRUITING

MeSH Terms

Conditions

Vaccine-Preventable Diseases; Measles

Interventions

BCG Vaccine; Measles Vaccine

Condition Hierarchy (Ancestors)

Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Viral Vaccines

Study Officials

• Christine Benn, DMSc

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isaquel da Silva, MD

CONTACT

+245966654873; isabarsila@gmail.com

Christine Benn, MD

CONTACT

+4525883964; cbenn@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: BCG is given intradermally and typically results in a local skin reaction that heals leaving a small scar. Measles vaccine is given subcutaneously and typically does not leave any sign of vaccination. Though we do not believe women will be able to distinguish between intradermal and subcutaneous injections, complete blinding on the recipient side will not be possible; those who get a skin reaction after BCG will most likely be able to guess what they received, whereas MV and placebo recipients will not. We do not believe this will influence the results of the blood testing or their treatment of their offspring.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We plan a trail randomising non-pregnant women of fertile age 1:1:1 to MV, BCG or placebo. The first children to be born will also be randomised to early MV or no early MV at 20 weeks of age. All children will get the recommended MV by 9 months of age.

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 24, 2021
• Study Start: May 20, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)