Mass vaccination for malaria elimination in The Gambia and Burkina Faso
Seasonal R21 Mass Vaccination for Malaria Elimination
This study is testing if giving a malaria vaccine to people in villages in The Gambia and Burkina Faso can help reduce the number of malaria cases during peak transmission season.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 16200 (estimated) |
| Ages | 5 Months to 99 Years |
| Sex | All |
| Sponsor | London School of Hygiene and Tropical Medicine Academic / other |
| Locations | 2 sites (Nanoro and 1 other locations) |
| Trial ID | NCT06578572 on ClinicalTrials.gov |
What this trial studies
This cluster randomized trial aims to evaluate the effectiveness of seasonal mass vaccination with the R21/MM malaria vaccine across 54 villages in The Gambia and Burkina Faso. Participants will be divided into intervention groups receiving the vaccine and control groups receiving no vaccination. The study will assess the prevalence of malaria at peak transmission, as well as the safety and tolerability of the vaccine through reported adverse events. Additionally, the incidence of malaria infections and clinical cases will be monitored during the malaria transmission season following vaccination.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 5 months and older who are willing to participate and comply with trial procedures.
Not a fit: Patients who are pregnant, have a history of allergic reactions to vaccine components, or have significant chronic illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccination approach could significantly reduce malaria transmission and morbidity in affected populations.
How similar studies have performed: Previous studies have shown promise in malaria vaccine efficacy, but this specific mass vaccination approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age≥ 5 months. 2. Willingness to comply with trial procedures. 3. Individual written informed consent obtained at the beginning of the study. Exclusion Criteria: 1. Pregnancy 2. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone. 3. Any history of anaphylaxis in relation to vaccination. 4. Known chronic illness. 5. Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Where this trial is running
Nanoro and 1 other locations
- Clinical Research Unit of Nanoro, Burkina Faso — Nanoro, Burkina Faso (Recruiting)
- MRC Unit The Gambia at LSHTM — Fajara, The Gambia (Recruiting)
Study contacts
- Principal investigator: Umberto D'Alessandro, MD, MSc, PhD — MRCG at LSHTM
- Study coordinator: Umberto D'Alessandro, MD, DHTM, MSc, PhD
- Email: Umberto.Dalessandro@lshtm.ac.uk
- Phone: +220449544
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.