NCT02044198

A Phase I/IIa Study of the Safety, Immunogenicity and Efficacy of FMP2.1/AS01B, an Asexual Blood-Stage Vaccine for Plasmodium Falciparum Malaria

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate an experimental malaria vaccine for its ability to prevent malaria infection or disease in a blood-stage challenge model (when volunteers are infected with malaria parasites using malaria-infected red blood cells). The vaccine being testing is a protein called FMP2.1, which is given with an adjuvant (a substance to improve the body's response to a vaccination) called AS01B. The aim is to use this protein and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will enable assessment of: 1. The ability of the vaccine to prevent malaria infection. 2. The safety of the vaccine in healthy participants. 3. The response of the human immune system to the vaccine. This will be done by giving participants three vaccinations and then exposing them to malaria infection by transfusing a small number of red blood cells infected with malaria under carefully regulated conditions. Participants will be followed closely to observe if and when they develop malaria. If the vaccine provides some protection against malaria, participants will take longer to develop malaria than usual or will not develop malaria at all. The study will enrol 15 participants to be vaccinated and then challenged with malaria in addition to recruit 15 individuals to be control subjects.

Conditions

• Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
BIOLOGICAL	FMP2.1/AS01B	50 µg FMP2.1 in 0.5 mL of the adjuvant AS01B (containing 50 mcg MPL + 50 mcg QS21) is administered via intramuscular (IM) injection in the deltoid region of the non-dominant arm

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-01-23
• Last updated: 2015-01-09

Locations

3 sites across 1 country: United Kingdom