NCT03867331

To Assess the Safety, Immunogenicity and Efficacy of VLPM01 in Healthy, Malaria-Naïve Volunteers

A Phase I Dose Escalation Study With Controlled Human Malaria Infection (CHMI) to Assess the Safety, Immunogenicity and Efficacy of VLPM01 in Healthy, Malaria-Naïve Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: VLP Therapeutics · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This study is a proof-of-concept, first in human, Phase I, single center study designed to evaluate the safety, tolerability, immunogenicity and experimental efficacy of VLPM01 in healthy, malaria-naïve adult volunteers. The VLPM01 product will be adjuvanted with alhydrogel. The study design was based on the FDA's guidance "General Principles for the Development of Vaccines to protect Against Global Infectious Diseases" (2011).

Detailed description

The study will have four (4) phases: Screening, Dose Escalation, Controlled Human Malaria Infection (CHMI) and Follow-Up. The study will be conducted at the Walter Reed Army Institute of Research in Silver Spring, Maryland (WRAIR), as this institute has extensive experience in conducting clinical studies of malaria vaccines with CHMI. A total of 36 participants will be enrolled in this study. Thirty (30) eligible participants will participate in the Dose Escalation Phase as vaccinees and 6 eligible participants will be added during the CHMI Phase to act as infectivity controls. Up to 6 additional eligible participants will serve as alternate vaccinees during the Dose Escalation Phase and up to 6 eligible participants will as act as alternate infectivity controls during the CHMI Phase. Alternates are only enrolled if a designated vaccinee is not eligible on the day of first vaccination or if a designated infectivity control is not eligible on the Day of Challenge. Withdrawn participants will not be replaced.

Conditions

• Malaria,Falciparum

Interventions

Type	Name	Description
BIOLOGICAL	5 microgram VLPM01	VLPM01 is an alpha-VLP pre-erythrocytic malaria vaccine which targets circumsporozoite protein (CSP), adjuvanted with 0.75 mg alum.
BIOLOGICAL	15 microgram VLPM01	VLPM01 is an alpha-VLP pre-erythrocytic malaria vaccine which targets circumsporozoite protein (CSP), adjuvanted with 0.75 mg alum.
BIOLOGICAL	30 microgram VLPM01	VLPM01 is an alpha-VLP pre-erythrocytic malaria vaccine which targets circumsporozoite protein (CSP), adjuvanted with 0.75 mg alum.
OTHER	Plasmodium falciparum challenge	Expose forearms to five (5) Plasmodium falciparum (strain NF54; clone 3D7) bites

Timeline

• Start date: 2019-03-13
• Primary completion: 2020-05-21
• Completion: 2020-05-21
• First posted: 2019-03-08
• Last updated: 2021-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study