NCT00431808

Brief Summary

This study will be the first time that the candidate malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO\[25-545\]) will be tested in malaria endemic populations. The phase Ib study will include adults who will be randomly allocated to either receive the malaria vaccine or the vaccine against Tetanus. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be follow-up up for immediate reactions to vaccination, and also over a longer term of one year. Blood will be taken to evaluate the biological safety parameters and also immune responses.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 3, 2008

Status Verified

April 1, 2008

Enrollment Period

1.1 years

First QC Date

February 5, 2007

Last Update Submit

April 1, 2008

Conditions

Malaria

Keywords

MalariavaccineApical Membrane AntigeneMaliAdults

Outcome Measures

Primary Outcomes (6)

  • *Safety evaluation through:

    1 year

  • Solicited adverse events measured from day 0 to day 7 after each dose;

    7 days

  • Unsolicited adverse events measured up to one month after each dose;

    84 days

  • Serious Adverse Events measured during the 12 months of study duration.

    1 year

  • Biological safety: two and four weeks after each vaccination, and thereafter every 12 weeks, in reference with the baseline before the first dose, by measuring the following :

    1 year

  • RBC, hemoglobin, hematocrit, MCV, MCH, MCHC, platelets, WBC with differential counts, potassium, sodium, ASAT, ALAT, total bilirubin, alkaline phosphatase, γGT, creatinin

    1 year

Secondary Outcomes (3)

  • *Immunogenicity evaluation through:

    84 days

  • The humoral response to the vaccine antigen: assessed by measuring the level of IgG by ELISA.

    84 days

  • An IFA for at least two parasite strains will be used to verify that the antibodies elicited by the vaccine recognize the native protein on merozoites.

    84 days

Study Arms (1)

I, AMA1 vaccine

EXPERIMENTAL

20 volunteers will receive 3 doses of the vaccine

Biological: Malaria vaccine AMA1 (PfAMA-1-FVO[25-545]Biological: AMA1

Interventions

Malaria vaccine AMA1 (PfAMA-1-FVO[25-545]BIOLOGICAL

3 doses of AMA 1 vaccine

I, AMA1 vaccine
AMA1BIOLOGICAL

50 micrograms of AMA1

I, AMA1 vaccine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-55 years inclusive at the time of screening
  • Residing in Bandiagara for the duration of the study
  • Separate written informed consent obtained before screening and study start, respectively
  • Available to participate in follow-up for the duration of study (14 months)
  • General good health based on history and clinical examination
  • Willingness not to become pregnant during the first five months of the study for female participants

You may not qualify if:

  • Previous vaccination with a investigational vaccine or a rabies vaccine
  • Use of a investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization, or planned use up to 30 days after the third immunization
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first immunization. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids
  • Confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  • Confirmed or suspected autoimmune disease
  • History of allergic reactions or anaphylaxis to immunizations or to any vaccine component
  • History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care
  • History of allergy to vaccines components
  • History of splenectomy
  • Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25 times the upper limit of normal of the testing laboratory).
  • Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory, or more than trace protein or blood on urine dipstick testing).
  • Laboratory evidence of hematologic disease (absolute leukocyte count \<4000/mm3 or \>14,500/mm3, absolute lymphocyte count \<1500/mm3, platelet count \<120,000/mm3, or hemoglobin \<10.0 g/dL).
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period.
  • Simultaneous participation in any other interventional clinical trial
  • Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, malnutrition, or any other clinical findings that in the opinion of the PI may increase the risk of participating in the study
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaria Research and Training Center

Bandiagara, Mali

RECRUITING

Related Publications (1)

  • Thera MA, Coulibaly D, Kone AK, Guindo AB, Traore K, Sall AH, Diarra I, Daou M, Traore IM, Tolo Y, Sissoko M, Niangaly A, Arama C, Baby M, Kouriba B, Sissoko MS, Sagara I, Toure OB, Dolo A, Diallo DA, Remarque E, Chilengi R, Noor R, Sesay S, Thomas A, Kocken CH, Faber BW, Imoukhuede EB, Leroy O, Doumbo OK. Phase 1 randomized controlled trial to evaluate the safety and immunogenicity of recombinant Pichia pastoris-expressed Plasmodium falciparum apical membrane antigen 1 (PfAMA1-FVO [25-545]) in healthy Malian adults in Bandiagara. Malar J. 2016 Aug 30;15(1):442. doi: 10.1186/s12936-016-1466-4.

    PMID: 27577237DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Mahamadou A Thera, MD MPH

    Malaria Research and Training Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

February 5, 2007

First Posted

February 6, 2007

Study Start

May 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 3, 2008

Record last verified: 2008-04

Locations

MA(1)