Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) to Evaluate the Safety and Efficacy of the Plasmodium Falciparum Vaccine Candidate FMP012 Administered Intramuscularly With AS01B Adjuvant System in Healthy Malaria-Naïve Adults

Completed · Phase 1

Conditions studied: Malaria

In brief

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.

Key facts

Study ID: NCT02174978
Run by: U.S. Army Medical Research and Development Command
People needed: 39
Starts: 2014-08-01
Expected to finish: 2015-10-01
Last updated by the study team: 2017-10-13

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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
Subjects must score at least 80% correct on a multiple-choice quiz that assesses their understanding of this study
If a subject is active duty military, he or she must obtain approval from his or her supervisor per Walter Reed Army Institute of Rese (WRAIR) Policy 11-45

You may not qualify if…

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
Allergy to antimalarial drugs or use of medications known to interact with chloroquine (CQ)
Significant (eg, systemic) hypersensitivity reactions to mosquito bites (local hypersensitivity reactions at the site of mosquito bites are not an exclusion criterion)
History of sickle cell disease
History of psoriasis or porphyria
History of splenectomy
Any confirmed or suspected immunodeficiency, including HIV infection
Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune-modifying drugs within 6 months of vaccination
History of autoimmune disease
Family history of congenital or hereditary immunodeficiency
Acute or chronic, clinically significant, pulmonary, cardiovascular, endocrine, hepatic, or renal functional abnormality, as determined by history, physical examination, or laboratory evaluation
Chronic or active neurologic disease including seizure disorder and chronic migraine headaches
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or any planned administration during the study period
Any abnormal baseline laboratory screening tests to include:
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) above normal range,
Creatinine above normal range,

Where it is running

Clinical Trials Center, WRAIR — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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