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

Summary

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. 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 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 on a 1 and 490 day schedule (Group 4) to healthy malaria-naive adults aged 18-45 years.

Timeline

Start

2018-12-21

Primary completion

2022-07-05

Completion

2022-07-05

Publications

• Friedman-Klabanoff DJ, Berry AA, Travassos MA, Shriver M, Cox C, Butts J, Lundeen JS, Strauss KA, Joshi S, Shrestha B, Mo AX, Nomicos EYH, Deye GA, Regules JA, Bergmann-Leitner ES, Pasetti MF, Laurens MB. Recombinant Full-length Plasmodium falciparum Circumsporozoite Protein-Based Vaccine Adjuvanted With Glucopyranosyl Lipid A-Liposome Quillaja saponaria 21: Results of Phase 1 Testing With Malaria Challenge. J Infect Dis. 2024 Jun 14;229(6):1883-1893. doi: 10.1093/infdis/jiae062.
• Friedman-Klabanoff DJ, Berry AA, Travassos MA, Cox C, Zhou Y, Mo AX, Nomicos EYH, Deye GA, Pasetti MF, Laurens MB. Low dose recombinant full-length circumsporozoite protein-based Plasmodium falciparum vaccine is well-tolerated and highly immunogenic in phase 1 first-in-human clinical testing. Vaccine. 2021 Feb 22;39(8):1195-1200. doi: 10.1016/j.vaccine.2020.12.023. Epub 2021 Jan 22.

Drugs

Indications