VLP Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a clinical trial of the Company’s VLPM01 malaria vaccine. The Phase I/IIa clinical trial will begin recruiting participants in February 2019, and is designed to assess the safety, immunogenicity and efficacy of the VLPM01 vaccine. The clinical trial will be conducted at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, MD.
Clinical trials utilizing mosquito-bite induced controlled human malaria infection, or CHMI, with P. falciparum are conducted in malaria-naive adults in order to determine the protective efficacy of malaria vaccines. Following vaccinations, clinical trial participants will be exposed to malaria-causing parasites via mosquito bites under controlled laboratory conditions. CHMI allows researchers to evaluate a malaria vaccine candidate’s efficacy and serves as a precursor to field studies in malaria-endemic regions of the world. Volunteers who become infected with malaria are treated with antimalarial drugs to clear their infections.
VLPM01 is a pre-erythrocytic vaccine delivering the circumsporozoite (CSP) antigen on VLP Therapeutics’ proprietary inserted alphavirus virus-like particle (i-αVLP) vaccine platform and is the Company’s first vaccine candidate to enter human clinical trials. Dr. Wataru Akahata, PhD, CEO of VLP Therapeutics said, “This clinical trial represents an important milestone for VLP Therapeutics as we initiate our first clinical trial and is a great accomplishment for the team at VLP Therapeutics. This represents the culmination of several years of work by our team and our partners and we are grateful for the support we have received from our partners, including the US Department of Defense.”
Malaria is a parasitic disease transmitted by mosquitoes that causes approximately 200 million cases of illness and more than 400,000 deaths per year. While the most significant incidence is in sub-Saharan Africa, malaria is also a significant threat to US military forces deployed in malaria-prone regions.