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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
United States Agency for International Development (USAID)
Walter Reed Army Institute of Research (WRAIR)
Kenya Medical Research Institute
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00666380
First received: April 22, 2008
Last updated: May 27, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Malaria
Biological: Plasmodium falciparum Malaria Protein 010 (FMP010)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 1a Open-label Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Candidate Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered Intramuscularly With GSK Biologicals' Adjuvant AS01B in Healthy Malaria-Naïve Adults

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of solicited adverse events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Occurrence and intensity of solicited symptoms on day of vaccination and Days 1-7 after each vaccination

  • Number of unsolicited adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Occurrence and intensity of unsolicited symptoms over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination

  • Number of serious adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent parasite growth inhibition [ Time Frame: Up to 112 days ] [ Designated as safety issue: No ]
    Functionality of antibodies elicited as measured by percent parasite growth inhibition in GIA against homologous (FVO) and heterologous (3D7) parasites


Enrollment: 26
Study Start Date: April 2008
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10 ug of FMP010 antigen in 0.5 mL AS01B adjuvant Biological: Plasmodium falciparum Malaria Protein 010 (FMP010)
Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK
Experimental: 50 ug of FMP010 antigen in 0.5 mL AS01B adjuvant Biological: Plasmodium falciparum Malaria Protein 010 (FMP010)
Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK

Detailed 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.

  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, 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
  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: NCT00666380

Locations
United States, Maryland
Department of Clinical Trials, WRAIR
Silver Spring, Maryland, United States, 20910
Kenya
USAMRU-K/ KEMRI. Walter Reed Project
Kombewa, Kisumu, Nyanza Province, Kenya
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
GlaxoSmithKline
United States Agency for International Development (USAID)
Walter Reed Army Institute of Research (WRAIR)
Kenya Medical Research Institute
Investigators
Principal Investigator: Michele D Spring, MD, M.S.P.H. Walter Reed Army Institute of Research (WRAIR)
Principal Investigator: Nekoye N. Otsyula, M.B. Ch. B. Kenya Medical Research Institute
  More Information

No publications provided by U.S. Army Medical Research and Materiel Command

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00666380     History of Changes
Other Study ID Numbers: A-14620.a, A-14620 (HSRRB), WRAIR 1417
Study First Received: April 22, 2008
Last Updated: May 27, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
Malaria
Vaccine
MSP-1 (merozoite surface protein-1)
Phase 1

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on August 27, 2015