Safety of Recombinant Hybrid GMZ 2 [GLURP + MSP 3] Blood Stage Malaria Vaccine
NCT ID: NCT00424944
Last Updated: 2008-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2007-06-30
2008-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is the first time this product will be tested in Africa
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
I, GMZ2 vaccine arm
20 volunteers will receive GMZ2 vaccine on days 0, 28, and 56
GMZ2 (malaria vaccine)
100 micrograms of GMZ2 in each vaccination
GMZ2 malaria vaccine
100 micrograms of GMZ2
Verorab vaccine
Anti-rabies vaccine
II, Rabies vaccine arm
20 volunteers will receive standard vaccine against rabies on the similar schedule on days 0, 28, and 56
GMZ2 (malaria vaccine)
100 micrograms of GMZ2 in each vaccination
Verorab vaccine
Anti-rabies vaccine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GMZ2 (malaria vaccine)
100 micrograms of GMZ2 in each vaccination
GMZ2 malaria vaccine
100 micrograms of GMZ2
Verorab vaccine
Anti-rabies vaccine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
45 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
African Malaria Network Trust
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
African Malaria Network Trust
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Kremsner, MD, PhD
Role: STUDY_DIRECTOR
Medical research Unit, Albert Schweitzer Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Research Unit, Albert Schweitzer Hospital
Lambaréné, , Gabon
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GMZ2_2_07
Identifier Type: -
Identifier Source: org_study_id