A Trial For The Study of Falciparum Malaria Protein 014 Administered Via Intramuscular Injection in Healthy Adults

NCT04296279 | Unknown Phase 1 FDA Drug

• 1 other identifier: S-19-05
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, open label clinical study to evaluate the safety, immunogenicity, tolerability and efficacy of Plasmodium falciparum Malaria Protein 014 (FMP014) combined with (ALF with QS-21), saponin molecule derived from the bark of Quillaja species (ALFQ)) in healthy adult volunteers at different doses and dosing schedules.

Conditions

Vaccine Reaction

Keywords

Plasmodioum falciparum 014

Outcome Measures

Primary Outcomes (2)

• Safety Dosage of Candidate Malaria Vaccine FMP014/ALFQ

  To assess the safety of candidate malaria vaccine FMP014/ALFQ. Safety dosage as indicated by incidence of solicited adverse events and serious adverse events through the end of the study.

  393 Days (+/- 14)

• Assess expected immunological response associated with Candidate Malaria Vaccine FMP014/ALFQ

  Measuring the number of local (signs and symptoms) adverse events reported by candidates receiving the candidate malaria vaccine FMP014/ALFQ.

  393 Days (+/- 14)

Secondary Outcomes (3)

• Determine the number of days before Plasmodium falciparum infection in controlled humans vaccinated with FMP014/ALFQ

  505 Days (+/- 14)

• Measure (Quantitative) Immune Responses to CSP, induced by FMP014/ALFQ using various immunoassays.

  505 Days (+/- 14)

• Measure (Qualitative) Immune Responses to CSP, induced by FMP014/ALFQ using various immunoassays.

  505 Days (+/- 14)

Other Outcomes (1)

• Compare the efficacy of standard, delayed dosing, and delayed fractional dosing: Proportion of vaccinated subjects without P. falciparum parasitemia

  505 Days (+/- 14)

Study Arms (6)

Part A - "Low" Dose

ACTIVE COMPARATOR

Part A vaccinees in the "low dose" arm will receive the lower dosing (20 μg FMP014 per 0.5 mL ALFQ) approximately 2 weeks prior to each vaccination. Vaccination to be delivered on 0,1,2 month.

Drug: FMP014; Drug: ALFQ

Part A - "High" Dose

ACTIVE COMPARATOR

Part A vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP014 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination. Vaccination to be delivered on 0,1,2 month.

Drug: FMP014; Drug: ALFQ

Part B - "Standard" Dose

ACTIVE COMPARATOR

Part B vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP014 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination. Vaccination to be delivered on 4,5,6 month.

Drug: FMP014; Drug: ALFQ

Part B - "Delayed" Dose

ACTIVE COMPARATOR

Part B vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP014 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination. Vaccination to be delivered on 0,1,6 month.

Drug: FMP014; Drug: ALFQ

Part B - "Delayed Fractional" Dose

ACTIVE COMPARATOR

Part B vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP014 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination. Vaccination to be delivered on 0,1,6 month.

Drug: FMP014; Drug: ALFQ

Control

NO INTERVENTION

Up to 6 subjects will be enrolled (defined as receiving malaria challenge) later in the trial to serve as challenge controls. Additional subjects may be recruited as alternates to ensure that 6 control subjects undergo the challenge. Any alternates not challenged will be released from the study at day of challenge.

Interventions

FMP014 DRUG

Falciparum Malaria Protein-14

Part A - "High" Dose; Part A - "Low" Dose; Part B - "Delayed Fractional" Dose; Part B - "Delayed" Dose; Part B - "Standard" Dose

ALFQ DRUG

ALF with QS-21, saponin molecule derived from the tree bark of Quillaja species

Part A - "High" Dose; Part A - "Low" Dose; Part B - "Delayed Fractional" Dose; Part B - "Delayed" Dose; Part B - "Standard" Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults between the ages 18-55 (inclusive);
• Able and willing to provide written, informed consent;
• Able and willing to comply with all research requirements, in the opinion of the Investigator;
• Agreement to refrain from blood donation during the course of the study. Volunteers who have undergone CHMI can donate to other research once the study is complete but cannot donate to the American Red Cross for at least 3 years after the CHMI event;
• Laboratory Criteria within 90 days before enrollment:
• Hemoglobin ≥ 11.7 g/dL for women; ≥ 12.0 g/dL for men;
• White Blood Cell count = 3,800-10,800 cells/mm3;
• Platelets = 140,000-400,000/mm3;
• Alanine aminotransferase (ALT; SGPT) 9-46 U/L male and 6-29 U/L female;
• Serum creatinine ≤ 1.5 mg/dL;
• Negative HIV testing (HIV Ab / antigen 4th generation screen with reflex confirmatory RNA testing);
• Negative hepatitis B surface antigen (HBsAg) and hepatitis C antibody testing; Note: As above, Grade 1 lab abnormalities detected on screening may be repeated at PI discretion. Persistent Grade 1 abnormalities that are felt to represent the non-pathologic baseline for the subject will be discussed with the research monitor and documented before a subject is enrolled in the trial, and are allowable per discretion and agreement of the PI and Research Monitor
• Birth control requirements:
• Female subjects must meet one of the following 2 criteria:
• No reproductive potential due to post-menopausal status (12 months of natural \[spontaneous\] amenorrhea) or hysterectomy, bilateral oophorectomy or tubal ligation;

You may not qualify if:

• History of malaria infection (any species) or residence in a malaria-endemic area for more than 5 years (includes previous participation in CHMI studies).
• Any history of receiving a malaria vaccine.
• Received an investigational product in the 30 days before enrollment, or planned to receive during the study period.
• Concurrent participation in another clinical research study.
• Any use of medications that prevent or treat malaria during the 1 month prior to challenge or planned use during the study (outside of the drugs provided by the study team).
• Any serious medical illness or condition involving the heart, liver, lungs, or kidneys.
• Any significant risk for developing heart disease in the next 5 years, assessed according to clinical Gaziano (NHANES I) criteria assessed at screening, and an ECG.
• Receipt of immunoglobulins or blood products within 3 months before enrollment.
• Any history of anaphylaxis.
• History of sickle cell trait or disease, or any condition that could affect susceptibility to malaria infection, per subject verbal report.
• Pregnancy, lactation, or intention to become pregnant during the study, and 3 months after malaria challenge, if applicable.
• History of active/recent cancer still within treatment or active surveillance follow-up (except basal cell carcinoma of the skin and cervical carcinoma in situ). Treated/resolved cancers with no likelihood of recurrence may be deemed acceptable at Principal investigator discretion
• History of autoimmune disease.
• Suspected or known current alcohol or drug abuse as defined by an alcohol intake of greater than 3 drinks a day on average for a man, and greater than 2 drinks a day on average for a woman.
• Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to give informed consent, participate in the study, or impair interpretation of the study data, in the opinion of the Investigator.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

RECRUITING

Central Study Contacts

Jack N Hutter MD, MPH&TM, MAJ, MC, USA

CONTACT

301-319-3095; jack.n.hutter.mil@mail.mil

Study Design

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

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: March 5, 2020
• Study Start: March 20, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)