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February 5, 2019

FDA clears VLP Therapeutics’ application for malaria vaccine trial

The US Food and Drug Administration (FDA) has granted clearance for VLP Therapeutics’ investigational new drug (IND) application to conduct a Phase I/IIa clinical trial of its malaria vaccine, VLPM01.

VLPM01 is a pre-erythrocytic vaccine designed to deliver the circumsporozoite (CSP) antigen on the company’s inserted alphavirus virus-like particle (i-αVLP) vaccine platform.

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To be conducted at the Walter Reed Army Institute of Research (WRAIR) in Maryland, the Phase I/IIa trial will evaluate the safety, immunogenicity and efficacy of the vaccine.

The trial will start enrolling volunteers this month.

It will use mosquito-bite induced controlled human malaria infection (CHMI) with Plasmodium falciparum parasite, which causes the disease in humans.

Participants, after receiving the vaccines, will be exposed to disease-causing parasites through mosquito bites under controlled laboratory settings.

In case the trial participants get infected, antimalarial drugs are used for their treatment.

CHMI is performed in malaria-naive adults to study the protective efficacy of vaccines. The approach is said to act as a precursor for field studies in malaria-endemic regions.

VLP Therapeutics CEO Wataru Akahata 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.”

Statistics show that malaria is responsible for nearly 200 million illness cases and more than 400,000 deaths each year.

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