A Study to Determine the Effects of an Investigational Malaria Vaccine Given to Adults Living in the United States and Thereafter to Adults Living in Kenya

United States Army Medical Research and Development Command (USAMRDC)

Status and phase

Completed

Phase 1

Conditions

Malaria

Treatments

Biological: Plasmodium falciparum Malaria Protein 010 (FMP010)

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Industry

Identifiers

NCT00666380

WRAIR 1417 (Other Identifier)

A-14620.a

A-14620 (HSRRB)

Details and patient eligibility

About

The purpose of this study is to determine whether an investigational malaria vaccine is safe and induces an immune response against malaria when tested in adults living in the United States.

Full description

The study begins with the US phase in which 26 volunteers aged 18 to 50 years will be enrolled to receive an investigational malaria vaccine. The vaccine is made of a malaria protein FMP010 mixed in the adjuvant AS01B. Since this vaccine has not yet been in humans, first, 5 volunteers will get a small (10 µg) dose of FMP010 in AS01B. If it is safe, then 20 volunteers will get 50 µg FMP010 in AS01B. Vaccinations are given IM in the deltoid of the non-dominant arm, every month for 3 months. After each vaccination, the subjects will follow up at clinical trials for evaluation of any adverse events. There will be blood draws to assess safety of the vaccine as well as the level of immune response generated to the vaccine.

Upon receipt of preliminary safety results, the Kenya phase begins in which 30 volunteers who are randomized to receive either 50 µg FMP010 in AS01B (20) or the rabies vaccine (10). Vaccination and is on the same schedule as in the US phase and follow-up is for 112 days.

Enrollment

26 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

A male or non-pregnant, non-lactating female 18 to 50 years of age (inclusive) at the time of screening
Free of significant health problems as established by medical history and clinical examination before entering into the study
Available to participate for duration of study (approximately seven months)
If the subject is female, she must be of non-childbearing potential (either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must be capable of preventing pregnancy, have a negative pregnancy test at the time of each vaccination, and must agree to continue such precautions for two months after completion of the vaccination series.
If the volunteer indicates he/she is active duty military (on the DCT sign-in page and intake form), approval from their supervisor through the Division Director using the Statement of Supervisor's Approval Form must be signed and on file prior to receipt of any test product
Written informed consent must be obtained from the subject before screening procedures.
Test of Understanding
Prior to entry into this study, subjects must score at least 80% correct on a 10- question multiple-choice quiz that assesses their understanding of this study. If they do not score 80% on the initial quiz, the protocol information will be reviewed with them to ensure comprehension, and they will have the opportunity to retest. If a volunteer fails to correctly answer 8 of 10 questions after two attempts they will be excluded from the study.

Exclusion criteria

Prior receipt of any investigational malaria vaccine
Prior receipt of a vaccine containing either QS-21, MPL or AS02 or AS01
Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period
Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. For corticosteroids, this is defined as prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
Planned administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the study vaccine
Any past history of malaria
Planned travel to malarious areas during the study period
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
A family history of congenital or hereditary immunodeficiency
Chronic or active neurologic disease including seizure disorder
History of splenectomy
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or abnormal baseline laboratory screening tests
1. ALT above normal range
2. Creatinine above normal range
3. Hemoglobin below normal range
4. Platelet count below normal range
5. Total white cell count below normal range
Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness, such as diarrhea or mild upper respiratory infection without fever, i.e., Oral temperature < 37.5°C.
Hepatomegaly, right upper quadrant abdominal pain or tenderness
Seropositive for HIV, Hepatitis C virus (antibodies to HCV) and/or HBsAg
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
Pregnant or lactating female
Suspected or known current alcohol abuse/drug abuse as obtained by history and physical examination
Female who is willing or intends to become pregnant during the study
Any history of allergic reaction or anaphylaxis to previous vaccination
Inability to make follow-up visits or complete diary cards
Allergy to kanamycin, nickel, or imidazole
Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study