drugset / Trial / NCT02600975
A Study to Assess the Safety and Immunogenicity of a Malaria Vaccine Candidate, R21, Administered With AS01B
Non-randomizedParallel-groupOpen-labelPrevention
Summary
This is a clinical trial in which healthy volunteers will be administered an experimental malaria vaccine, R21. The R21 vaccine will be administered with the adjuvant AS01B. All vaccinations will be administered intramuscularly. Each volunteer will receive three vaccinations in total. There are two different vaccine schedules: Group 1 will receive R21 10µg with AS01B on days 0, 28, and 56. Group 2 will receive R21 50µg with AS01B on days 0, 28, and 56. The study will assess the safety of the vaccine, and the immune responses to the vaccination. Immune responses are measured by tests on blood samples. Healthy adult volunteers will be recruited in Oxford and Southampton, England.
Timeline
- Start
- 2015-12-08
- Primary completion
- 2017-01-19
- Completion
- 2017-01-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | R21 | Vaccine | 10 ug | Intramuscular |
| Comparator | R21 | Vaccine | 50 ug | Intramuscular |
| Comparator | ASO1B | Unknown | — | Intramuscular |