NCT00666380

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2008

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

8 months

First QC Date

April 22, 2008

Last Update Submit

May 27, 2015

Conditions

Malaria

Keywords

MalariaVaccineMSP-1 (merozoite surface protein-1)Phase 1

Outcome Measures

Primary Outcomes (3)

  • Number of solicited adverse events

    Occurrence and intensity of solicited symptoms on day of vaccination and Days 1-7 after each vaccination

    7 days

  • Number of unsolicited adverse events

    Occurrence and intensity of unsolicited symptoms over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination

    30 days

  • Number of serious adverse events

    1 year

Secondary Outcomes (1)

  • Percent parasite growth inhibition

    Up to 112 days

Study Arms (2)

10 ug of FMP010 antigen in 0.5 mL AS01B adjuvant

EXPERIMENTAL
Biological: Plasmodium falciparum Malaria Protein 010 (FMP010)

50 ug of FMP010 antigen in 0.5 mL AS01B adjuvant

EXPERIMENTAL
Biological: Plasmodium falciparum Malaria Protein 010 (FMP010)

Interventions

Plasmodium falciparum Malaria Protein 010 (FMP010)BIOLOGICAL

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

10 ug of FMP010 antigen in 0.5 mL AS01B adjuvant50 ug of FMP010 antigen in 0.5 mL AS01B adjuvant

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • ALT above normal range
  • Creatinine above normal range
  • Hemoglobin below normal range
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Clinical Trials, WRAIR

Silver Spring, Maryland, 20910, United States

Location

USAMRU-K/ KEMRI. Walter Reed Project

Kombewa, Kisumu, Nyanza Province, Kenya

Location

Related Publications (2)

  • Bashir IM, Otsyula N, Awinda G, Spring M, Schneider P, Waitumbi JN. Comparison of PfHRP-2/pLDH ELISA, qPCR and microscopy for the detection of plasmodium events and prediction of sick visits during a malaria vaccine study. PLoS One. 2013;8(3):e56828. doi: 10.1371/journal.pone.0056828. Epub 2013 Mar 15.

    PMID: 23554856DERIVED

  • Otsyula N, Angov E, Bergmann-Leitner E, Koech M, Khan F, Bennett J, Otieno L, Cummings J, Andagalu B, Tosh D, Waitumbi J, Richie N, Shi M, Miller L, Otieno W, Otieno GA, Ware L, House B, Godeaux O, Dubois MC, Ogutu B, Ballou WR, Soisson L, Diggs C, Cohen J, Polhemus M, Heppner DG Jr, Ockenhouse CF, Spring MD. Results from tandem Phase 1 studies evaluating the safety, reactogenicity and immunogenicity of the vaccine candidate antigen Plasmodium falciparum FVO merozoite surface protein-1 (MSP1(42)) administered intramuscularly with adjuvant system AS01. Malar J. 2013 Jan 23;12:29. doi: 10.1186/1475-2875-12-29.

    PMID: 23342996DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

US(1)KE(1)