A Study to Assess the Immunogenicity, Tolerability and Safety of a Malaria Vaccine and Also Its Protective Efficacy in a Malaria Challenge Model

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Malaria
Interventions
BIOLOGICAL

Ad35.CS.01/Ad26.CS.01 low dose (1 x 10^10 vp)

Prime-boost schedule: Each subject receives two injections of Ad35.CS.01 (on Days 0 and 28) followed by one injection of Ad26.CS.01 (on either Day 55 or 59).

BIOLOGICAL

Ad 35.CS.01/Ad 26.CS.01 high dose (5 x 10^10 vp)

Prime-boost schedule: Each subject receives two injections of Ad35.CS.01 (on Days 0 and 28) followed by one injection of Ad26.CS.01 (on either Day 55 or 59).

BIOLOGICAL

Placebo

Each placebo subject receives in total three injections of placebo: Day 0, Day 28, and either Day 55 or 59

Trial Locations (1)

98109

Malaria Clinical Trials Center at Seattle Biomedical Research Institute, Seattle

All Listed Sponsors
collaborator

The PATH Malaria Vaccine Initiative (MVI)

OTHER

collaborator

Seattle Children's Hospital

OTHER

lead

Crucell Holland BV

INDUSTRY

NCT01397227 - A Study to Assess the Immunogenicity, Tolerability and Safety of a Malaria Vaccine and Also Its Protective Efficacy in a Malaria Challenge Model | Biotech Hunter | Biotech Hunter