Vaccines for mothers and their children to improve health
Specific and Non-specific Effects of Measles and BCG Vaccines for Mother and Child
This study is testing whether giving the measles and BCG vaccines to women and their children can improve their health and immunity in Guinea-Bissau.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2400 (estimated) |
| Ages | 15 Years to 35 Years |
| Sex | Female |
| Sponsor | Bandim Health Project Academic / other |
| Locations | 1 site (Bissau, Bissau Codex) |
| Trial ID | NCT04899765 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of administering the measles and BCG vaccines to women of childbearing age and their children in Guinea-Bissau. It aims to determine how these vaccines can enhance immunity against measles and improve overall health outcomes for both mothers and infants. The study will randomly assign 2400 women to receive either the BCG vaccine, measles vaccine, or a placebo, and their children will also be randomized to receive an early measles vaccine or placebo. The research will assess the effectiveness of different vaccination schedules on immune responses and health metrics.
Who should consider this trial
Good fit: Ideal candidates for this study are non-pregnant women of fertile age living in the Bandim Health Project area who are HIV-negative and have delivered a child that has reached 12 months of age.
Not a fit: Patients who are pregnant, HIV-positive, or have a history of tuberculosis or immunodeficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved vaccination strategies that enhance immunity and reduce disease morbidity in mothers and children.
How similar studies have performed: While the specific combination of vaccines in this study is novel, previous studies have shown that live vaccines can have beneficial non-specific effects on health.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bissau, Bissau Codex
- Bandim Health Project — Bissau, Bissau Codex, Guinea-Bissau (Recruiting)
Study contacts
- Principal investigator: Christine Benn, DMSc — University of Southern Denmark
- Study coordinator: Isaquel da Silva, MD
- Email: isabarsila@gmail.com
- Phone: +245966654873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.