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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by African Malaria Network Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
African Malaria Network Trust
ClinicalTrials.gov Identifier:
NCT00424944
First received: January 19, 2007
Last updated: April 1, 2008
Last verified: April 2008

January 19, 2007
April 1, 2008
June 2007
July 2008   (final data collection date for primary outcome measure)
  • Local and systemic reactogenicity [ Time Frame: 28 days following each immunization ] [ Designated as safety issue: Yes ]
  • Unsolicited adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Biological safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Local and systemic reactogenicity
  • Unsolicited adverse events
  • Occurence of serious adverse events
  • Biological safety
Complete list of historical versions of study NCT00424944 on ClinicalTrials.gov Archive Site
  • Humoral immune response to GLURP and MSP 3 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cellural immune response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Humoral immune response to GLURP and MSP 3
  • Cellural immune response
Not Provided
Not Provided
 
Safety of Recombinant Hybrid GMZ 2 [GLURP + MSP 3] Blood Stage Malaria Vaccine
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

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Malaria
  • 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
  • Experimental: I, GMZ2 vaccine arm
    20 volunteers will receive GMZ2 vaccine on days 0, 28, and 56
    Interventions:
    • Biological: GMZ2 (malaria vaccine)
    • Biological: GMZ2 malaria vaccine
    • Biological: Verorab 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
    Interventions:
    • Biological: GMZ2 (malaria vaccine)
    • Biological: Verorab vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
August 2008
July 2008   (final data collection date for primary outcome measure)

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.
Male
18 Years to 45 Years
Yes
Contact: Saadoul Issifou, MD, PhD +241 7847740 issadou2002@yahoo.fr
Contact: Saadou Issifou, MD, PhD +241 7847740 issifou@lambarene.mimcom.net
Gabon
 
NCT00424944
GMZ2_2_07
Yes
Roma Chilengi, African Malaria Network Trust
African Malaria Network Trust
Not Provided
Study Director: Peter Kremsner, MD, PhD Medical research Unit, Albert Schweitzer Hospital
African Malaria Network Trust
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP