Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults

NCT01540474 | Completed Phase 1 Results

• 2 other identifiers: S-11-21IND 014962
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Malaria has remained a major concern for the US military. During World War II, malaria was the leading cause of disease and non-battle injury with 500-700 men infected per day, resulting in 24,000 malaria-related casualties.(10) Currently, the methods used for protecting troops against malaria are insecticidal nets, clothing, and antimalarial treatment. To be effective, these methods must be self-administered and be used consistently, often unattainable in field or combat situations. The United States Army Medical Research and Development Command (USAMRMC), through the United States Army Medical Materiel Development Activity (USAMMDA) and the Walter Reed Army Institute of Research (WRAIR) are actively pursuing the development of an effective vaccine against P. falciparum malaria; development of such a vaccine is a high priority for the US military and other individuals who travel to endemic regions, and is equally important to populations residing in those areas. A Phase 1 study using FMP012, a recombinant E.coli expressed malaria protein (CelTOS) vaccine will

1. 1.assess the safety and reactogenicity of candidate P. falciparum malaria vaccine FMP012/GLA-SE
2. 2.measure the humoral immune response to FMP012/GLA-SE using enzyme-linked immunosorbent assay (ELISA)
3. 3.assess the protective efficacy of FMP012/GLA-SE against a P. falciparum sporozoite challenge.

Conditions

Malaria

Keywords

Interference of malaria infection

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period

  Number of participants for each dose (1 through 3) that experienced any symptom, general solicited symptoms, and local solicited symptoms

  From vaccination day through 7 days post vaccination (for all three doses)

• Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period

  Incidence of erythema and pain (solicited local symptoms) reported after each dose (1-3) of vaccination. Results for groups 1, 2 and 3 only as control group did not receive any vaccinations and only participated in the malaria challenge portion of the study.

  From vaccination day through 7 days post vaccination for each does (1-3)

• Subjects Reporting the Occurrence of Unsolicited Adverse Events Related to Vaccination

  Number of participants with at lease one administered dose presenting with at least one specified symptom within 28 days after vaccination

  28 days after each vaccination

Secondary Outcomes (2)

• Humoral Immune Response to FMP012/GLA-SE

  Up to 1 year

• Time to Onset of Parasitemia Following Sporozoite Challenge

  Up to 1 year

Study Arms (4)

Group 1: 10 ug FMP012 with 2 ug GLA-SE

EXPERIMENTAL

Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant

Biological: Group 1: 10 ug FMP012 with 2 ug GLA-SE

Group 2: 10 ug FMP012 with 5 ug GLA-SE

EXPERIMENTAL

Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant

Biological: Group 2: 10 ug FMP012 with 5 ug GLA-SE

Group 3: 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE

EXPERIMENTAL

Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant

Biological: 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE

Control group-Challenged Only

OTHER

Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant

Other: Controlled group-Challenged Only: no vaccination

Interventions

Group 1: 10 ug FMP012 with 2 ug GLA-SE BIOLOGICAL

Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant

Group 1: 10 ug FMP012 with 2 ug GLA-SE

Group 2: 10 ug FMP012 with 5 ug GLA-SE BIOLOGICAL

E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant

Group 2: 10 ug FMP012 with 5 ug GLA-SE

50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE BIOLOGICAL

E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant

Group 3: 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE

Controlled group-Challenged Only: no vaccination OTHER

The control group participated in the primary malaria sporozoite challenge.E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant

Control group-Challenged Only

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• History of malaria infection
• History of travel to P. falciparum endemic areas in the 3 months prior to day of first vaccination or day of challenge
• History of receiving a malaria vaccine
• Receipt of any licensed vaccine within 7 days prior to first vaccination
• History of receipt of malaria prophylaxis during the 2 months prior to day of first vaccination or day of challenge
• History of use of any drugs with significant antimalarial activity during the course of the study period
• Prior receipt of any vaccine containing either QS-21, MPL or GLA-SE in the previous 5 years (including Cervarix®, GSK)
• Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine or planned use during the study period.
• Any history of allergic reaction or anaphylaxis to previous vaccination
• Allergy to kanamycin, nickel, or imidazole Pregnant or lactating female at screening or plans to become pregnant or breastfeed from the time of enrollment until three months after challenge
• Allergy to antimalarial drugs or use of medications known to interact with both CQ and artemether/lumefantrine
• Significant (eg, systemic) hypersensitivity reactions to mosquito bites
• History of sickle cell disease
• History of psoriasis or porphyria
• History of splenectomy

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• United States Agency for International Development (USAID): collaborator
• Access to Advanced Health Institute (AAHI): collaborator

Study Sites (1)

Clinical Trials Center, WRAIR

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Results Point of Contact

• Title: Jason W. Bennett
• Organization: Walter Reed Institute of Research

jason.w.bennett.mil@mail.mil

3013199477

Study Officials

• Jessica J. Cowden, MD

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 28, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 8, 2021
• Results First Posted: June 8, 2021

Record last verified: 2021-05

Locations

US (1)