Sanaria™ PfSPZ Challenge Vaccine

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Malaria
Interventions
BIOLOGICAL

Sanaria™ PfSPZ Vaccine

30 subjects in 3 cohorts, 6 groups in different doses of PfSPZ vaccine via the intradermal route. Cohort 1 Medium Dose, Medium Aliquot: Group a: 10,000 PfSPZ in 2 divided doses (e.g., 5000 PfSPZ per 50 microliter (mcL) dose), Group b: 10,000 PfSPZ in 8 divided doses (e.g., 1250 PfSPZ per 50 mcL dose). Cohort 2: Medium dose, Low Aliquot: Group c: 10,000 PfSPZ in 2 divided doses (e.g., 5000 PfSPZ per 10 mcL dose), Group d: 10,000 PfSPZ in 8 divided doses (e.g., 1250 PfSPZ per 10 mcL dose), Cohort 3: High Dose, Low Aliquot; Group e: 50,000 PfSPZ in 2 divided doses (e.g., 25,000 PfSPZ per 10 mcL dose), Group f: 50,000 PfSPZ in 8 divided doses (e.g., 6,250 PfSPZ per 10 mcL dose)

DRUG

Chloroquine

Rescue therapy after challenge: 1500 mg chloroquine base orally, over 48 hours (600 mg at time 0 followed by 300 mg oral base at hours 6, 24 and 48)

Trial Locations (1)

21201-1509

University of Maryland School of Medicine - Center for Vaccine Development - Baltimore, Baltimore

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01546389 - Sanaria™ PfSPZ Challenge Vaccine | Biotech Hunter | Biotech Hunter