MalariaPhase 1NCT00424944
Safety of Recombinant Hybrid GMZ 2 [GLURP + MSP 3] Blood Stage Malaria Vaccine
A Phase 1 study testing GMZ2 (malaria vaccine), GMZ2 malaria vaccine and Verorab vaccine in people with Malaria, run by African Malaria Network Trust at 1 site in Gabon.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- GMZ2 (malaria vaccine), GMZ2 malaria vaccine and Verorab vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGabon
- Study dates
- Jun 2007to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Gabon1 site, 1 recruiting
- Recruiting
Medical Research Unit, Albert Schweitzer Hospital
Lambaréné
Michel Missinou, PhD
Saadou Issifou, MD, PhD
About this study
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
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
Read the 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.
- 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.
- 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
- Malaria
- Being tested
- GMZ2 (malaria vaccine), GMZ2 malaria vaccine, Verorab vaccine
- Keywords
- Malaria, Vaccine, GMZ2, Safety, African, immunogenicity
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMZ2 (malaria vaccine)Biological
100 micrograms of GMZ2 in each vaccination
GMZ2 malaria vaccineBiological
100 micrograms of GMZ2
Verorab vaccineBiological
Anti-rabies vaccine
| Study group | Role | What they receive |
|---|---|---|
| I, GMZ2 vaccine arm | Experimental | 20 volunteers will receive GMZ2 vaccine on days 0, 28, and 56 Receives: 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 Receives: Biological: GMZ2 (malaria vaccine); Biological: Verorab vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic reactogenicity
Measured: 28 days following each immunization
Unsolicited adverse events
Measured: 1 year
Occurrence of serious adverse events
Measured: 1 year
Biological safety
Measured: 1 year
Secondary outcomes (2)
Humoral immune response to GLURP and MSP 3
Measured: 1 year
Cellural immune response
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2008 (estimated)
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- African Malaria Network Trust
- Sponsor type
- Research network
- Investigators
- Peter Kremsner, MD, PhD, Study director, Medical research Unit, Albert Schweitzer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424944
- Sponsor's protocol ID
- GMZ2_2_07
- Status last verified
- Apr 2008
- First submitted
- 19 Jan 2007
- Last updated
- 3 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00424944
- Acronym / sponsor ID
- GMZ2_2_07
- Conditions
- Malaria
- Keywords
- Malaria, Vaccine, GMZ2, Safety, African, immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- African Malaria Network TrustResearch network
- Study start
- Jun 2007
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Aug 2008 (estimated)
- First posted
- 22 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I, GMZ2 vaccine arm | Experimental | Biological: GMZ2 (malaria vaccine), Biological: GMZ2 malaria vaccine, Biological: Verorab vaccine20 volunteers will receive GMZ2 vaccine on days 0, 28, and 56 |
| II, Rabies vaccine arm | Active comparator | Biological: GMZ2 (malaria vaccine), Biological: Verorab vaccine20 volunteers will receive standard vaccine against rabies on the similar schedule on days 0, 28, and 56 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMZ2 (malaria vaccine)100 micrograms of GMZ2 in each vaccination | Biological | I, GMZ2 vaccine arm, II, Rabies vaccine arm |
| GMZ2 malaria vaccine100 micrograms of GMZ2 | Biological | I, GMZ2 vaccine arm |
| Verorab vaccineAnti-rabies vaccine | Biological | I, GMZ2 vaccine arm, II, Rabies vaccine arm |
Primary outcome
Local and systemic reactogenicity
Time frame: 28 days following each immunization
Unsolicited adverse events
Time frame: 1 year
Occurrence of serious adverse events
Time frame: 1 year
Biological safety
Time frame: 1 year
2 secondary outcomes
Humoral immune response to GLURP and MSP 3
Time frame: 1 year
Cellural immune response
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2008.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Kremsner, MD, PhD study director
Medical research Unit, Albert Schweitzer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GMZ2 (malaria vaccine), GMZ2 malaria vaccine and Verorab vaccine in people with Malaria, run by African Malaria Network Trust at 1 site in Gabon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Gabon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saadoul Issifou, MD, PhD (+241 7847740, issadou2002@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local and systemic reactogenicity (time frame: 28 days following each immunization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2008.