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

NCT00424944 | Unknown Phase 1 DMC

• 1 other identifier: GMZ2_2_07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Malaria

Keywords

Malaria; Vaccine; GMZ2; Safety; African; immunogenicity

Outcome Measures

Primary Outcomes (4)

• Local and systemic reactogenicity

  28 days following each immunization

• Unsolicited adverse events

  1 year

• Occurrence of serious adverse events

  1 year

• Biological safety

  1 year

Secondary Outcomes (2)

• Humoral immune response to GLURP and MSP 3

  1 year

• Cellural immune response

  1 year

Study Arms (2)

I, GMZ2 vaccine arm

EXPERIMENTAL

20 volunteers will receive GMZ2 vaccine on days 0, 28, and 56

Biological: GMZ2 (malaria vaccine); Biological: GMZ2 malaria vaccine; Biological: Verorab vaccine

II, Rabies vaccine arm

ACTIVE COMPARATOR

20 volunteers will receive standard vaccine against rabies on the similar schedule on days 0, 28, and 56

Biological: GMZ2 (malaria vaccine); Biological: Verorab vaccine

Interventions

GMZ2 malaria vaccine BIOLOGICAL

100 micrograms of GMZ2

I, GMZ2 vaccine arm

Verorab vaccine BIOLOGICAL

Anti-rabies vaccine

I, GMZ2 vaccine arm; II, Rabies vaccine arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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,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.

Sponsors & Collaborators

• African Malaria Network Trust: lead

Study Sites (1)

Medical Research Unit, Albert Schweitzer Hospital

Lambaréné, Gabon

RECRUITING

MeSH Terms

Conditions

Malaria

Interventions

Malaria Vaccines

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Protozoan Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Peter Kremsner, MD, PhD

  Medical research Unit, Albert Schweitzer Hospital

  STUDY DIRECTOR

Central Study Contacts

Saadoul Issifou, MD, PhD

CONTACT

+241 7847740; issadou2002@yahoo.fr

Saadou Issifou, MD, PhD

CONTACT

+241 7847740; issifou@lambarene.mimcom.net

Study Design

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

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 22, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 3, 2008

Record last verified: 2008-04

Locations

GA (1)