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Trial record 13 of 48 for:    ( Map: Gabon )

Safety of Recombinant Hybrid GMZ 2 [GLURP + MSP 3] Blood Stage Malaria Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00424944
Recruitment Status : Unknown
Verified April 2008 by African Malaria Network Trust.
Recruitment status was:  Recruiting
First Posted : January 22, 2007
Last Update Posted : April 3, 2008
Information provided by:
African Malaria Network Trust

Brief Summary:

The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already publicly used vaccine against rabies. 40 adult male Gabonese volunteers will be enrolled and randomly allocated to receive either malaria vaccine or rabies vaccine without the investigator or the participants knowing what they received. They will receive 3 doses each at one month intervals, and will be followed up for one year to evaluate safety parameters.

This is the first time this product will be tested in Africa

Condition or disease Intervention/treatment Phase
Malaria Biological: GMZ2 (malaria vaccine) Biological: GMZ2 malaria vaccine Biological: Verorab vaccine Phase 1

Detailed Description:

Background. GMZ2 is a recombinant hybrid of the Glutamate Rich Protein (GLURP) and the Merozoite Surface Protein 3 (MSP 3).This product has been developed at Sate Serum Institute in Denmark and Bacth released by Henogen of Belgium. The phase Ia trial in malaria naive volunteers is currently ongoing in Germany, at Tuebingen University. This phase Ia trial will establish safety of the vaccine and also select the best dosage (10, 30 or 100 µg). The dosage with the best safety and immunogenicity profile will be recommended for the phase Ib trial in Gabon.

2. Study Design This will be a single center, randomized, blinded and controlled study involving 40 adult male volunteers. The entire study duration will be 16 months with each participant remaining 13 months in the study.There will be 15 scheduled hospital visits and 11 scheduled field worker home visits. The Rabies vaccine will be used as control vaccine.

3. Objectives:

- The primary objective of this trial to evaluate the safety of 3 doses of GMZ2 when administered on Days 0, 28 & 56, adjuvanted with aluminum hydroxide in healthy Gabonese adults.

- Secondary objectives include the following: (i). To assess the humoral response to the vaccine antigens GLURP and MSP3 by measuring the antibody response by ELISA and IFA.

(ii). To assess the cellular immune response by profiling the Th1/Th2-type cytokines after 24 and 48 hours stimulation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Single Centre, Randomised Controlled Trial to Evaluate the Safety and Immunogenicity of Recombinant Lactococcus Lactis Hybrid GMZ 2 [GLURP + MSP 3] Blood Stage Malaria Vaccine Versus Rabies Vaccine in Healthy Gabonese Adult Volunteers
Study Start Date : June 2007
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria Rabies

Arm Intervention/treatment
Experimental: I, GMZ2 vaccine arm
20 volunteers will receive GMZ2 vaccine on days 0, 28, and 56
Biological: GMZ2 (malaria vaccine)
100 micrograms of GMZ2 in each vaccination

Biological: GMZ2 malaria vaccine
100 micrograms of GMZ2

Biological: Verorab vaccine
Anti-rabies vaccine

Active Comparator: II, Rabies vaccine arm
20 volunteers will receive standard vaccine against rabies on the similar schedule on days 0, 28, and 56
Biological: GMZ2 (malaria vaccine)
100 micrograms of GMZ2 in each vaccination

Biological: Verorab vaccine
Anti-rabies vaccine

Primary Outcome Measures :
  1. Local and systemic reactogenicity [ Time Frame: 28 days following each immunization ]
  2. Unsolicited adverse events [ Time Frame: 1 year ]
  3. Occurrence of serious adverse events [ Time Frame: 1 year ]
  4. Biological safety [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Humoral immune response to GLURP and MSP 3 [ Time Frame: 1 year ]
  2. Cellural immune response [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adult male Gabonese 18-45 years inclusive at the time of screening
  • Residing in Lambarene 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 (13 months)
  • General good health based on history and clinical examination

Exclusion Criteria:

  • 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,or 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 3.5-11/µL, absolute lymphocyte count 560-5280/µL, platelet count 120,000-400,000/µL, or hemoglobin 10.0-16.5g/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 clinical investigator may increase the risk of participating in the study
  • Other condition that in the opinion of the clinical investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00424944

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Contact: Saadoul Issifou, MD, PhD +241 7847740
Contact: Saadou Issifou, MD, PhD +241 7847740

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Medical Research Unit, Albert Schweitzer Hospital Recruiting
Lambarene, Gabon
Principal Investigator: Michel Missinou, PhD         
Sub-Investigator: Saadou Issifou, MD, PhD         
Sponsors and Collaborators
African Malaria Network Trust
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Study Director: Peter Kremsner, MD, PhD Medical research Unit, Albert Schweitzer Hospital

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Responsible Party: Roma Chilengi, African Malaria Network Trust Identifier: NCT00424944     History of Changes
Other Study ID Numbers: GMZ2_2_07
First Posted: January 22, 2007    Key Record Dates
Last Update Posted: April 3, 2008
Last Verified: April 2008
Keywords provided by African Malaria Network Trust:
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases
Immunologic Factors
Physiological Effects of Drugs