NCT00320658

Brief Summary

The purpose of this study is to determine the safety of and immune response to a preventive malaria vaccine, MSP1 42-C1/Alhydrogel, in healthy adults. This study will also compare responses to two different doses of the malaria vaccine given with or without the adjuvant CPG 7909.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

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

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 21, 2008

Status Verified

January 1, 2008

Enrollment Period

1.3 years

First QC Date

May 1, 2006

Last Update Submit

January 18, 2008

Conditions

Malaria

Keywords

Plasmodium falciparum

Outcome Measures

Primary Outcomes (2)

  • Frequency of vaccine-related adverse events, as classified by both intensity and severity through active and passive surveillance

    Throughout study

  • Anti-MSP1 42 antibody concentration as measured by ELISA

    At Day 70

Secondary Outcomes (2)

  • To demonstrate that the addition of CPG 7909 improves the specific immune responses to MSP142-FVO and MSP142-3D7, as compared to MSP142-C1/Alhydrogel

    At Day 70

  • To determine the dose of MSP142-C1/Alhydrogel + CPG 7909 that generates the highest serum antibody levels of MSP142-FVO and MSP142-3D7

    At Day 70

Study Arms (4)

A

EXPERIMENTAL

3 vaccinations with a dose of 40 mcg MSP1 42-C1/Alhydrogel given into the deltoid muscle of either arm. Each vaccination will be given 1 month apart. This arm will enroll concurrently with Arm B.

Biological: MSP1 42-C1/Alhydrogel

B

EXPERIMENTAL

3 vaccinations with a dose of 40 mcg MSP1 42-C1/Alhydrogel and CPG7909 given into the deltoid muscle of either arm. Each vaccination will be given 1 month apart. This arm will enroll concurrently with Arm A.

Biological: MSP1 42-C1/AlhydrogelBiological: CPG 7909

C

EXPERIMENTAL

3 vaccinations with a dose of 160 mcg MSP1 42-C1/Alhydrogel given into the deltoid muscle of either arm. Each vaccination will be given 1 month apart. This arm will enroll concurrently with Arm D after review of the results from Arms A and B.

Biological: MSP1 42-C1/Alhydrogel

D

EXPERIMENTAL

3 vaccinations with a dose of 160 mcg MSP1 42-C1/Alhydrogel and CPG7909 given into the deltoid muscle of either arm. Each vaccination will be given 1 month apart. This arm will enroll concurrently with Arm C after review of the results from Arms A and B.

Biological: MSP1 42-C1/AlhydrogelBiological: CPG 7909

Interventions

MSP1 42-C1/AlhydrogelBIOLOGICAL

Recombinant MSP1 42-C1/Alhydrogel vaccine (one of two doses)

ABCD
CPG 7909BIOLOGICAL

Adjuvant

BD

Eligibility Criteria

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

You may qualify if:

  • Good general health
  • Willing to be followed for the duration of the study
  • Willing to use acceptable methods of contraception

You may not qualify if:

  • Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may affect the ability of the volunteer to understand and cooperate with the study
  • Liver disease (ALT greater than upper limit of normal \[ULN\])
  • Kidney disease (serum creatinine greater than ULN)
  • Hematologic disease (absolute neutrophil count of less than 1,500 cells/mm3; hemoglobin less than lower limit of normal, by sex; OR platelet count less than 140,000 mm3)
  • Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
  • Participation in another investigational vaccine or drug trial within 30 days of study entry or while this study is ongoing
  • Active drug or alcohol abuse causing medical, occupational, or family problems during the 12 months prior to study entry
  • History of severe allergic reaction or anaphylaxis
  • HIV-1 infected
  • Hepatitis C virus infected
  • Hepatitis B surface antigen positive
  • Known immunodeficiency syndrome
  • Use of corticosteroids or immunosuppressive drugs within 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.
  • Live vaccine within 4 weeks prior to study entry
  • Killed vaccine within 2 weeks prior to study entry
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Immunization Research, Johns Hopkins University, Bloomberg School of Public Health

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (5)

  • Boutlis CS, Riley EM, Anstey NM, de Souza JB. Glycosylphosphatidylinositols in malaria pathogenesis and immunity: potential for therapeutic inhibition and vaccination. Curr Top Microbiol Immunol. 2005;297:145-85. doi: 10.1007/3-540-29967-x_5.

    PMID: 16265905BACKGROUND

  • Hill AV. Pre-erythrocytic malaria vaccines: towards greater efficacy. Nat Rev Immunol. 2006 Jan;6(1):21-32. doi: 10.1038/nri1746.

    PMID: 16493425BACKGROUND

  • Reed ZH, Friede M, Kieny MP. Malaria vaccine development: progress and challenges. Curr Mol Med. 2006 Mar;6(2):231-45. doi: 10.2174/156652406776055195.

    PMID: 16515513BACKGROUND

  • Saul A, Lawrence G, Smillie A, Rzepczyk CM, Reed C, Taylor D, Anderson K, Stowers A, Kemp R, Allworth A, Anders RF, Brown GV, Pye D, Schoofs P, Irving DO, Dyer SL, Woodrow GC, Briggs WR, Reber R, Sturchler D. Human phase I vaccine trials of 3 recombinant asexual stage malaria antigens with Montanide ISA720 adjuvant. Vaccine. 1999 Aug 6;17(23-24):3145-59. doi: 10.1016/s0264-410x(99)00175-9.

    PMID: 10462251BACKGROUND

  • Ellis RD, Martin LB, Shaffer D, Long CA, Miura K, Fay MP, Narum DL, Zhu D, Mullen GE, Mahanty S, Miller LH, Durbin AP. Phase 1 trial of the Plasmodium falciparum blood stage vaccine MSP1(42)-C1/Alhydrogel with and without CPG 7909 in malaria naive adults. PLoS One. 2010 Jan 22;5(1):e8787. doi: 10.1371/journal.pone.0008787.

    PMID: 20107498DERIVED

MeSH Terms

Conditions

MalariaMalaria, Falciparum

Interventions

ProMune

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Anna Durbin, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 1, 2006

First Posted

May 3, 2006

Study Start

March 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

January 21, 2008

Record last verified: 2008-01

Locations

US(1)