Clinical trial NCT00312663: Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America
Official title: A Phase I/IIa Controlled Study of the Safety, Immunogenicity and Preliminary Efficacy of FMP011/AS01B Candidate Malaria Vaccine in Malaria-naive Adults Living in the United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Plasmodium Falciparum Malaria
Keywords: Vaccine
Phase I/II
Malaria
Liver Stage Antigen -1
Falciparum Malaria Protein -11
AS01B
adjuvant
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: GlaxoSmithKline
name: The PATH Malaria Vaccine Initiative (MVI)
name: Walter Reed Army Institute of Research (WRAIR)
First posted: 2006-04-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.

Detailed description: * Controlled challenge, Phase I/IIa WRAIR study.
* Healthy, malaria-naive adults aged 18 - 50 years.
* 2 groups, 5 subjects in group A (10µg dose) and 13 subjects in group B(50µg dose).
* Control: none for immunization phase; infectivity controls for challenge and rechallenge phases. Six infectivity controls per day of challenge will be enrolled for the challenge phases, with 3 alternates available for challenge if needed.
* Vaccination schedule of 0, 1 months.
* Challenge of up to 13 subjects in Group B.
* Contingent upon short term efficacy, rechallenge of initially protected subjects 6 months (+/- 2 months) after second dose of vaccine.
* Self-contained study.
* Duration of the study, per subject: approximately 15 months (screening, enrollment, vaccination, challenge and rechallenge).
* Data collection will be by done onsite.

Eligibility criteria: Inclusion Criteria:

* A male or non-pregnant female 18 to 50 years of age (inclusive) at the time of screening.
* Written informed consent obtained from the subject before screening procedures.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\*
* Available to participate for duration of study (approximately 15 months).
* If the subject is female, she must be currently using birth control, must be surgically sterilized, or must be at least 1-year post menopausal.
* Pass a comprehension assessment test.

Exclusion Criteria:

* Prior receipt of an investigational malaria vaccine.
* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 28 days preceding the first dose of study vaccine, or planned use during the study period.
* Administration of chronic immunosuppressants or other immune modifying drugs within six months of vaccination.
* Chronic use of antibiotics with anti-malarial effects.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
* History of use of anti-malarial medication within 60 days prior to vaccination.
* Any history of malaria.
* Known exposure to malaria within the previous 12 months.
* Planned travel to malarious areas during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Chronic or active neurologic disease including seizures, but not including a single febrile seizure as a child.
* History of splenectomy.
* Acute disease at the time of enrollment.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Personal history of autoimmune disease or subjects who describe a first-degree relative with clearly documented autoimmune disease.
* Seropositive for hepatitis B surface antigen.
* Seropositive for Hepatitis C virus (antibodies to HCV).
* 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 as defined by the American Psychiatric Association in DSM IV.
* Chronic or active intravenous drug use.
* History of severe reactions to mosquito bites as defined as anaphylaxis.
* Female who intends to become pregnant during the study.
* Any history of anaphylaxis in reaction to vaccination.
* A clinical history of sickle cell disease or sickle cell trait.
* 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.

Primary outcomes:
measure: Safety - Most Frequently Reported Adverse Events and Grade
timeFrame: 30 days post vaccination
Secondary outcomes:
measure: Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84
timeFrame: Days 0, 28, 42, and 84
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Walter Reed Army Institute of Research
state: Maryland
Study officials:
affiliation: Walter Reed Army Institute of Research (WRAIR)
name: James F. Cummings, MD
role: PRINCIPAL_INVESTIGATOR
References: