Clinical Trial of PfSPZ Vaccine Administered by Direct Venous Inoculation: Dose Optimization With Heterologous Challenge in Healthy Malaria-Naïve Adults

NCT02601716 Phase 2 COMPLETED

This is an open-label evaluation of the safety, tolerability, immunogenicity and efficacy of PfSPZ Vaccine administered by direct venous inoculation (DVI) in healthy, malaria-naïve adult subjects.

Details

Lead sponsor	Sanaria Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	92
Start date	2016-01
Completion	2017-11

Conditions

• Malaria

Interventions

• PfSPZ Vaccine
• CHMI (7G8)
• CHMI (NF135.C10)

Primary outcomes

• Incidence and type of Adverse Events — 52 weeks
  Incidence and type of adverse events (including breakthrough infections), vital signs, clinical laboratory assessments, physical examination findings post first immunization onwards.
• Efficacy — 28 days post-CHMI
  Evidence of vaccine-mediated protection against CHMI at 28 and 40 weeks in Groups 1 and 2 by preventing blood stage infection for 28 days (as detected by qPCR) following CHMI. Evidence of vaccine-mediated protection against CHMI at 40 and 66 weeks in Groups 3 and 4 by preventing blood stage infection for 28 days (as detected by blood smear analysis) following CHMI.
• Immunological response — 2 weeks post-immunization and 28 days post-CHMI
  Antibody responses by PfCSP ELISA two weeks after the second, third and booster immunizations (Groups 2-4) or after the fourth, fifth and booster immunizations (Group 1) (serum dilution at which the optical density is 1.0 referred to as the OD 1.0) Positive predictive values for anti-PfCSP antibody responses at or above a threshold for predicting sterile protection following CHMI (threshold = OD 1.0 of 2,000)

Countries

United States