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
  Purpose

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 Intervention Phase
Malaria
Biological: GMZ2 (malaria vaccine)
Biological: GMZ2 malaria vaccine
Biological: Verorab vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by African Malaria Network Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: June 2007
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424944

Contacts
Contact: Saadoul Issifou, MD, PhD +241 7847740 issadou2002@yahoo.fr
Contact: Saadou Issifou, MD, PhD +241 7847740 issifou@lambarene.mimcom.net

Locations
Gabon
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
Investigators
Study Director: Peter Kremsner, MD, PhD Medical research Unit, Albert Schweitzer Hospital
  More Information

No publications provided

Responsible Party: Roma Chilengi, African Malaria Network Trust
ClinicalTrials.gov Identifier: NCT00424944     History of Changes
Other Study ID Numbers: GMZ2_2_07
Study First Received: January 19, 2007
Last Updated: April 1, 2008
Health Authority: Gabon: Ministry of Health

Keywords provided by African Malaria Network Trust:
Malaria
Vaccine
GMZ2
Safety
African
immunogenicity

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on September 18, 2014