Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America

NCT ID: NCT00312702

Last Updated: 2018-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-04-30

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 15 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 15 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 at the site.

Conditions

Malaria; Plasmodium Falciparum Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

10µg dose FMP011

Falciparum Malaria Protein 11 with AS02A adjuvant

Group Type: EXPERIMENTAL

Falciparum Malaria Protein 11 with AS02A adjuvant

Intervention Type: BIOLOGICAL

vaccine

50µg dose FMP011

Falciparum Malaria Protein 11 with AS02A adjuvant

Group Type: EXPERIMENTAL

Falciparum Malaria Protein 11 with AS02A adjuvant

Intervention Type: BIOLOGICAL

vaccine

Interventions

Falciparum Malaria Protein 11 with AS02A adjuvant

vaccine

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

The PATH Malaria Vaccine Initiative (MVI)

OTHER

Sponsor Role: collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James F Cummings, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Institute of Research (WRAIR)

Locations

Walter Reed Army Institute of Research

Silver Spring, Maryland, United States

Countries

United States

Other Identifiers

HSRRB A-13732

Identifier Type: OTHER

Identifier Source: secondary_id

WRAIR 1249

Identifier Type: -

Identifier Source: org_study_id