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

NCT03867331 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-04-08

No results posted yet for this study

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).

Conditions

  • Malaria,Falciparum

Interventions

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

Sponsors & Collaborators

  • VLP Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-13
Primary Completion
2020-05-21
Completion
2020-05-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03867331 on ClinicalTrials.gov