Development of pre-erythrocytic malaria vaccines

Objectives

The aim of this project is to determine whether PfSPZ Vaccine is safe, well tolerated, immunogenic, and efficacious in reducing Pf malaria incidence in infants in an area of high malaria transmission. 

This objective will be achieved through:

• Primary Objectives:
  • Age de-escalation and dose escalation trial in children and infants (5 months – 9 years)
  • Safety and efficacy trial in infants (5-12M inclusive) living in an area of high malaria transmission
• Secondary Objectives:
  • Determine safety and efficacy of alternative dosages of PfSPZ Vaccine at 6 months after last vaccination
  • Determine safety and efficacy of each dosage of PfSPZ Vaccine at 12 months after last vaccination
  • Determine whether PfSPZ Vaccine administered by DVI to infants (5-12M inclusive) of age at any of the given doses of PfSPZ Vaccine provides high-level (point estimate >       60%) protection
  • Assess the cellular immunity and antibody responses induced by PfSPZ Vaccine
  • Determine whether measured immune responses correlate with   protection against Pf infection
  • Determine the safety, tolerability, efficacy and immunological response provided by the addition of a booster dose 12–15 months after the primary vaccination series in infants 5M-12M of age

We hypothesize that PfSPZ Vaccine will be safe, well-tolerated, and immunogenic and can reduce malaria incidence in infants by at least 60% during 6 months following the last vaccination.