NCT01739036View on ClinicalTrials.gov

A Phase I/IIa Sporozoite Challenge Study to Assess the Efficacy of Candidate Combination Malaria Vaccine Approaches Using the ChAd63 and MVA Vectors Encoding the Antigens ME-TRAP, CS and AMA1

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Plasmodium Falciparum Malaria
Interventions
BIOLOGICAL

ChAd63 CS/ME-TRAP

Mixture of ChAd63 CS 5 x 1010 vp and ChAd63 ME-TRAP 5 x 1010 vp. Intramuscular needle injection.

BIOLOGICAL

MVA CS/ME-TRAP

Mixture of MVA CS 2 x 108 pfu and MVA ME-TRAP 2 x 108 pfu. Intramuscular needle injection.

BIOLOGICAL

ChAd63 CS/ME-TRAP/AMA1

Mixture of ChAd63 CS 5 x 1010 vp, ChAd63 ME-TRAP 5 x 1010 vp, and ChAd63 AMA1 5 x 1010 vp. Intramuscular needle injection.

BIOLOGICAL

MVA CS/ME-TRAP/AMA1

Mixture of MVA CS 1.33 x 108 pfu, MVA ME-TRAP 1.33 x 108 pfu, and MVA AMA1 1.33 x 108 pfu. Intramuscular needle injection.

OTHER

Controlled Human Malaria Infection Administered by Mosquito Bite

Approximately three weeks post MVA dosing.

Trial Locations (3)

SO16 6YD

Wellcome Trust CRF, Southampton General Hospital, Southampton

OX3 7LE

Centre for Clinical Vaccinology and Tropical Medicine, Oxford

SW7 2AZ

Infection and Immunity Section, Imperial College of Science, Technology and Medicine, London

All Listed Sponsors
lead

University of Oxford

OTHER

NCT01739036 - A Phase I/IIa Sporozoite Challenge Study to Assess the Efficacy of Candidate Combination Malaria Vaccine Approaches Using the ChAd63 and MVA Vectors Encoding the Antigens ME-TRAP, CS and AMA1 | Biotech Hunter | Biotech Hunter