Clinical Trial

Malaria Vaccine

Study Description

rCSP/AP10-602 [GLA-LSQ] Vaccine Trial

This is a study to evaluate the safety, immunogenicity, and efficacy of a recombinant circumsporozoite protein (rCSP) malaria vaccine administered with and without AP 10-602 [Glucopyranosyl Lipid A (GLA) in liposome Quillaja saponaria 21 formulation (LSQ)] adjuvant. Fifty 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 510 days (up to 117 days for 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 to healthy malaria-naive adults aged 18-45 years.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Malaria challenge

Exposure to mosquitoes infected with P. falciparum.

AP10-602

Glucopyranosyl Lipid A -liposome-Quillaja Saponaria 21 (GLA-LSQ).

Biological - rCSP

The rCSP malaria vaccine is a recombinant full-length P. falciparum circumsporozoite protein comprised of an amino terminus that binds heparin-sulfate proteoglycans, a four-amino-acid repeat region and a carboxy-terminus that contains a thrombospondin-like Type I region domain.

Additional Information

Official Study Title

A Phase I Challenge Study to Evaluate Safety, Immunogenicity, and Efficacy of a Malaria Vaccine (rCSP Adjuvanted With AP 10-602 [GLA-LSQ]), in Healthy Adults

Clinical Trial ID

NCT03589794

ParticipAid ID

av225a