Phase I challenge study to evaluate safety, immunogenicity, and efficacy of a recombinant sporozoite protein (rCSP) adjuvanted with AP 10-602 (GLA-LSQ), in healthy adults

This is a phase I, single-site, dose escalation study. 59 healthy adult, malaria naive volunteers aged 18 to 45 will receive vaccination with or without adjuvant (10 of those volunteers will receive rCSP alone) in five dose escalating groups. Each group will receive 3 vaccination doses total, with intramuscular (IM) injections on days 1, 29, and 85. A sixth group of 6 volunteers will receive no vaccinations and will participate as a control in a Controlled Human Malaria Infection (CHMI) challenge with two of the vaccinated groups. The study will be conducted at the Center for Vaccine Development (CVD) in Baltimore, Maryland. The patient participation duration is expected to be up to 886 days (up to 117 days for the nonvaccination group). This study will test two hypotheses: (1) the rCSP/AP 10-602 (GLA-LSQ) candidate malaria vaccine will induce an immune response in a dose-dependent manner as measured by anti-CSP antibody titer via ELISA and (2) the rCSP/AP 10-602 (GLA-LSQ) candidate malaria vaccine will provide a minimum of 50% efficacy in vaccines compared to unvaccinated infectivity controls. The primary objective is to assess the safety and reactogenicity of candidate rCSP/AP 10-602 (GLA-LSQ) malaria vaccine when administered intramuscularly on a 1, 29, and 85 day schedule (Groups 1-3, 4B, 5) and a 1 and 490 day schedule (Group 4) to healthy malaria-naive adults aged 18-45 years.

Study type: Interventional
Enrollment: 65 participants
Primary purpose: Prevention
Allocation:Non-Randomized
Interventional Model: Sequential assignment
Masking: Open label
NCT number: NCT03589794
Phase: Phase I

Clinical trial registration

Vaccines

Dec 2018 — Jul 2022

United States