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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
The PATH Malaria Vaccine Initiative (MVI)
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00312702
First received: April 6, 2006
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Malaria
Plasmodium Falciparum Malaria
Biological: Falciparum Malaria Protein 11 with AS02A adjuvant
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I/IIa Controlled Study of the Safety, Immunogenicity and Preliminary Efficacy of FMP011/AS02A Candidate Malaria Vaccine in Malaria-naive Adults Living in the United States

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Safety - adverse events [ Time Frame: 7 days post dose ] [ Designated as safety issue: Yes ]
  • Reactogenicity [ Time Frame: study duration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antibody Response. [ Time Frame: 60 days post dose ] [ Designated as safety issue: No ]
  • Efficacy [ Time Frame: 60 days post immunization ] [ Designated as safety issue: No ]
    malaria infection


Enrollment: 36
Study Start Date: April 2006
Study Completion Date: April 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10µg dose FMP011
Falciparum Malaria Protein 11 with AS02A adjuvant
Biological: Falciparum Malaria Protein 11 with AS02A adjuvant
vaccine
Experimental: 50µg dose FMP011
Falciparum Malaria Protein 11 with AS02A adjuvant
Biological: Falciparum Malaria Protein 11 with AS02A adjuvant
vaccine

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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312702

Locations
United States, Maryland
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
GlaxoSmithKline
The PATH Malaria Vaccine Initiative (MVI)
Walter Reed Army Institute of Research (WRAIR)
Investigators
Principal Investigator: James F Cummings, MD Walter Reed Army Institute of Research (WRAIR)
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00312702     History of Changes
Other Study ID Numbers: WRAIR 1249, HSRRB A-13732
Study First Received: April 6, 2006
Last Updated: August 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
Vaccine
Malaria
Liver Stage Antigen-1
Falciparum Malaria Protein-11
AS02A
adjuvant

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 28, 2014