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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Plasmodium Falciparum Malaria
Interventions
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

Trial Locations (3)

SO16 6YD

NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton, Southampton

W2 1NY

NIHR Wellcome Trust Clinical Research Facility (NIHR WTCRF), Hammersmith Hospital, London

OX3 7LE

Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Oxford

All Listed Sponsors
collaborator

The PATH Malaria Vaccine Initiative (MVI)

OTHER

collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

lead

University of Oxford

OTHER

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 | Biotech Hunter | Biotech Hunter