NCT04899765 Measles and BCG Vaccines for Mother and Child
| NCT ID | NCT04899765 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Bandim Health Project |
| Condition | Vaccine Preventable Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2021-05-20 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,400 participants in total. It began in 2021-05-20 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Christine Benn, DMSc
PRINCIPAL INVESTIGATOR
University of Southern Denmark
Frequently Asked Questions
Who can join the NCT04899765 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 35 Years, studying Vaccine Preventable Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04899765 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04899765 currently recruiting?
Yes, NCT04899765 is actively recruiting participants. Contact the research team at isabarsila@gmail.com for enrollment information.
Where is the NCT04899765 trial being conducted?
This trial is being conducted at Bissau, Guinea-Bissau.
Who is sponsoring the NCT04899765 clinical trial?
NCT04899765 is sponsored by Bandim Health Project. The principal investigator is Christine Benn, DMSc at University of Southern Denmark. The trial plans to enroll 2,400 participants.