NCT00349713

Brief Summary

Malaria is a disease that affects many people in Africa and in Mali. It is caused by germs that are spread by mosquito bites. This study will look at the safety, effectiveness, and best dose of an experimental malaria vaccine in people who are regularly exposed to malaria. Study participants will be 60 adults, 18-55 years old, who live in Bandiagara, Mali. Volunteers will get either 3 full doses of the experimental malaria vaccine, 3 half doses of the malaria vaccine, or a rabies vaccine that has been approved in Mali. (Rabies is an infection of the brain that usually causes death, and can be caught from being bitten by infected dogs or bats.) The 3 vaccinations will be given by injection into the upper arm 30 days apart. Volunteers will be enrolled in the study for approximately 12 months after the first vaccination. Volunteers will have 14 blood samples collected during the study for testing to make sure that the vaccine is not harmful and to measure the effect of the vaccine.

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 Nov 2004

Typical duration for phase_1

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

November 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
10.7 years until next milestone

Results Posted

Study results publicly available

July 24, 2017

Completed
Last Updated

July 24, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

July 6, 2006

Results QC Date

December 20, 2016

Last Update Submit

April 25, 2017

Conditions

MalariaPlasmodium Falciparum Malaria

Keywords

Plasmodium falciparum Malaria, Mali, adjuvant

Outcome Measures

Primary Outcomes (1)

  • Safety and Reactogenicity (SAEs and AEs)

    The primary objective was to evaluate the safety and reactogenicity of 2 dose levels of WRAIR's AMA1 malaria antigen (FMP2.1) adjuvanted in GlaxoSmithKline Biologicals' (GSK) AS02A compared to rabies vaccine in malaria-experienced Malian adults aged 18-55 years inclusive. Solicated AEs were recorded for the 7 day surveillance period after each vaccination. Unsolicited AEs were recorded for 30 days after each vaccination.

    12 months

Secondary Outcomes (4)

  • Antibody Response to FMP2.1 Over Time

    90 Days

  • Anti-AMA1 Log Antibody Titers Over Time

    90 Days

  • Geometric Mean Antibody Titers Over Time

    90 Days

  • Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time

    90 Days

Study Arms (3)

Cohort 1: 25ug FMP2.1 / AS02A

EXPERIMENTAL

20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A

Biological: FMP2.1/AS02A

Cohort 2: 50ug FMP2.1 / AS02A

EXPERIMENTAL

20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A

Biological: FMP2.1/AS02A

Cohorts 1 and 2: Rabies vaccine (RabAvert)

ACTIVE COMPARATOR

20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2 Rabies vaccine (RabAvert): RabAvert Rabies vaccine

Biological: FMP2.1/AS02ABiological: Rabies vaccine (RabAvert)

Interventions

FMP2.1/AS02ABIOLOGICAL

FMP2.1 in GSK Biologicals' AS02A

Cohort 1: 25ug FMP2.1 / AS02ACohort 2: 50ug FMP2.1 / AS02ACohorts 1 and 2: Rabies vaccine (RabAvert)
Rabies vaccine (RabAvert)BIOLOGICAL

RabAvert Rabies vaccine

Cohorts 1 and 2: Rabies vaccine (RabAvert)

Eligibility Criteria

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

You may qualify if:

  • A male or non-pregnant female aged 18-55 years inclusive at the time of screening
  • For women, willingness not to become pregnant until 1 month after the last immunization (pre-menopausal female participants will be referred to the local family planning clinic in Bandiagara, which offers several means of contraception that are approved and recommended by the Malian Ministry of Health)
  • Separate written informed consent obtained from the participant before screening and study start, respectively
  • Available and willing to participate in follow-up for the duration of study (12 months)

You may not qualify if:

  • Previous vaccination with any investigational vaccine or with any rabies vaccine
  • Use of any 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 immuno-suppressants or other immune-modifying drugs within six months prior to the first immunization. This will include any dose level of oral steroids or inhaled steroids, but not topical steroids
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first study immunization with the exception of tetanus toxoid
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  • Any 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 tetracycline, doxycycline, nickel, Imidazole, chicken eggs, processed bovine gelatin, chicken protein, neomycin, or amphotericin B
  • History of splenectomy
  • Serum ALT \>/=43 IU/L
  • Serum creatinine level \>113 µmol /L for males and 70 µmol /L for females
  • Hgb \<11 g/dL for males and \<10 g/dL for females
  • WBC \<4.0 x 1000/cubic mm or \>13 x 1000/cubic mm
  • Absolute lymphocyte count \</=1.4 x 1000 /µl
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bamako, Malaria Research and Training Center

Bamako, Mali

Location

MeSH Terms

Conditions

MalariaMalaria, Falciparum

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Mahamadou A. Thera, MD, MPH, Professor
Organization
University of Bamako
mthera@icermaili.org
223-20-22-81-09

Study Officials

  • Mahamadou A. Thera, M.D.

    University of Bamako

    PRINCIPAL INVESTIGATOR

  • Chris V. Plowe, M.D.

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 10, 2006

Study Start

November 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2006

Last Updated

July 24, 2017

Results First Posted

July 24, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Plan to share data with National Institute of Allergy and Infectious Diseases (NIAID) Walter Reed Army Institute of Research (WRAIR) GlaxoSmithKline University of Maryland

Locations

MA(1)