Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) Open-label Dose Safety, Reactogenicity, Immunogenicity, and Efficacy of the Vaccine Candidate Plasmodium Falciparum Malaria Protein (FMP012), Administered Intramuscularly With AS01B Adjuvant System in Healthy Malaria-Naïve Adults

U.S. Army Medical Research and Development Command1 site in 1 country39 target enrollmentAugust 2014

ConditionsMalaria

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Malaria
Sponsor: U.S. Army Medical Research and Development Command
Enrollment: 39
Locations: 1
Primary Endpoint: Number of unsolicited AEs
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The proposed study is a Phase 1 study with controlled human malaria infection (CHMI) designed primarily to evaluate the safety of the FMP012 combined with AS01B adjuvant system. AS01B is a proprietary current good manufacturing practices (cGMP) grade adjuvant manufactured by GlaxoSmithKline (GSK) Biologicals. It is a formulation based on liposomes mixed with the immunostimulants monophosphoryl lipid (MPL) and Quillaja saponaria (QS)-21. The immunogenicity and efficacy of this new candidate vaccine will be evaluated in addition to safety.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

October 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

U.S. Army Medical Research and Development Command

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adults (male or non-pregnant, non-lactating female) 18 to 50 years of age (inclusive) at the time of screening
•If the subject is female,
•Non-childbearing potential (ie, either surgically sterilized or one year post-menopausal), abstinent or using adequate contraceptive precautions (eg, intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or Depo-Provera®) during this study and must agree to continue such precautions until three months after challenge
•A negative pregnancy test at the time of enrollment
•Free of significant health problems as established by medical history, laboratory, and clinical examination before entering the study
•Subjects must have low cardiac risk factors according to the National Health and Nutrition Examination Survey (NHANES) I criteria, medical history and family history, blood pressure measurements, and a normal or normal variant ECG
•Available to participate and reachable by phone for duration of study (approximately 8-14 months) and reachable by phone at the 6 month post Controlled Human Malaria Infection (CMHI) follow-up
•No plans to travel to outside the Washington DC area between the day of challenge and either completion of treatment course (post-challenge) or, if subject remains uninfected, 28 days post-challenge
•No plans to travel to a malaria endemic area during the course of the study
•Written informed consent must be obtained from the subject before screening procedures are performed

Exclusion Criteria

•Any history of malaria infection
•History of travel to P falciparum endemic areas in the 3 months prior to day of first vaccination (Vaccination Groups) or day of challenge (Infectivity Control Group)
•Any history of receiving a malaria vaccine
•Receipt of any licensed vaccine within 7 days prior to first vaccination (Note: subjects are encouraged to get recommended licensed preventive vaccinations during the course of the study but are requested to schedule any routine preventive vaccinations for at least 7 days before or after a scheduled FMP012/AS01B vaccination day)
•History of receipt of malaria prophylaxis during the 2 months prior to day of first vaccination (Vaccination Groups) or day of challenge (Infectivity Control Group)
•History of use of any antibiotics with significant antimalarial activity (examples include tetracycline, doxycycline, clindamycin, azithromycin, and sulfa drugs) during the course of the study period (period starting one month prior to challenge, Infectivity Control Group)
•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 (Vaccination Groups)
•Allergy to egg protein (Vaccination Groups)
•Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at screening or plans to become pregnant or breastfeed from the time of enrollment until three months after challenge