MalariaPhase 1NCT00397449
GMZ2-Aluminum Hydroxide Phase I, Tübingen
A Phase 1 study testing GMZ2 (GLURP + MSP3 Hybrid) (malaria vaccine) in people with Malaria, run by European Vaccine Initiative at 1 site in Germany.
Trial summary
This is a randomized, open, dose-selection Phase 1 study. The study aims to evaluate the safety and immunogenicity of 3 doses (10,30 \& 100 micrograms) of the GMZ2 hybrid (GLURP and MSP3) blood stage vaccine in healthy non-immune European adults. The vaccines will be administered with aluminum hydroxide as adjuvant. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- GMZ2 (GLURP + MSP3 Hybrid) (malaria vaccine)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Dec 2007
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age > 18 and < 45 years healthy volunteers (males or females)
- General good health based on history and clinical examination
- All volunteers have to sign the informed consent form
- Negative pregnancy test
- Use of adequate contraception for females up to three months after the third injection (D140)
- Intention to not travel abroad and reachable by phone during the whole study period (15 months).
Who cannot join
- History of malaria or residence in malaria endemic areas for the past six months.
- Positive serology for malaria antigen GLURP and/or MSP3.
- Previously participated in a malaria vaccine studies.
- Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers
- Any laboratory abnormalities on screened blood samples beyond the normal range, as defined at Tübingen. Positive HIV, HBV or HCV tests
- Volunteers should not be enrolled in any other clinical trial during the whole trial period
Show all 14Show fewer
- Volunteers should not receive chronic medication, especially immunosuppressive agents (steroids, immuno-modulating or immunosuppressive drugs) during the three months preceding the screening visit or during the study period
- Pregnant or lactating women
- Volunteers unable to give written informed consent
- Volunteers unable to be closely followed for social, geographic or psychological reasons
- Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrollment in the study
- Volunteers should not perform exercise four hours before blood draw and should not donate blood for non study-related purposes during the entire duration of the study
- Known hypersensitivity to any of the vaccine components (adjuvant or peptide)
- Volunteers are not allowed to receive any vaccination or gammaglobulin during a period three months prior to the first immunization and up to six months after the 3rd immunization. If a vaccination is necessary during this period, the volunteer will be withdrawn from the study.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut for Tropical Medicine, University of Tubingen
Tübingen, D-72074 TÜBINGEN
About this study
Official title: Assessment of the Safety and Immunogenicity of the Recombinant Lactococcus Lactis Hybrid GMZ2 [GLURP+MSP3] a Malaria Vaccine in Healthy Adult Volunteers. A Phase I, Double-Blind, Randomised, Dose-Selection, Unicentre Trial
This is a randomized, open, dose-selection Phase 1 study. The study aims to evaluate the safety and immunogenicity of 3 doses (10,30 \& 100 micrograms) of the GMZ2 hybrid (GLURP and MSP3) blood stage vaccine in healthy non-immune European adults. The vaccines will be administered with aluminum hydroxide as adjuvant. The safety and the tolerability of the vaccine will be assessed on the rate of solicited and unsolicited events/reactions related to the vaccine. The safety profile will include local and systemic reactions/events as well as the biological safety, based on a clinically significant change of the baseline value of the main biological criteria. The immunogenicity of the different formulation of the vaccine will be assessed on the level and the quality of circulating antibodies as well as the stimulation of the T-cell immune response.
Read the detailed description
The trial is a randomised, open, dose-selection, single centre trial. One adjuvant will be assessed, aluminum hydroxide (alum). Three different dosages - 10µg, 30µg, and 100µg - of GMZ2 will be evaluated with the aluminum hydroxide adjuvant. A total of 30 volunteers will be enrolled and randomized into three groups of 10. As this is a dose escalation study, volunteers in Group 1 will receive the initial dose of 10µg on the first vaccination day. After a satisfactory safety profile at this dose (see sections 6.2.2 and 6.2.3), we will proceed to vaccinate volunteers in Group 2 with the higher dose of 30µg after a 2-week interval. The same procedure will also be followed for volunteers in Group 3, who will be administered their initial dose of 100µg GMZ2 if the review of the safety profile of Group 2 is satisfactory. The aim will be to recruit all volunteers before the intended start of the study. The randomization procedure will be performed in the following way: when participants are found to be eligible and have signed their informed consent they will be numbered sequentially (in order of enrollment). The numbers will be randomly assigned to 3 groups of 10 numbers through a specific randomization computer program. These groups will be the treatment groups.
- Conditions
- Malaria
- Being tested
- GMZ2 (GLURP + MSP3 Hybrid) (malaria vaccine)
- Keywords
- Malaria, malaria vaccine, randomised, safety, 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 (GLURP + MSP3 Hybrid) (malaria vaccine)Biological
| Study group | Role | What they receive |
|---|---|---|
| 1, 2, 3 | Experimental | Not described Receives: Biological: GMZ2 (GLURP + MSP3 Hybrid) (malaria vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: one year
Immunogenicity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startOct 2006
- Study completionDec 2007 (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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Vaccine Initiative
- Sponsor type
- University, hospital or other
- Investigators
- Jurgen Knobloch, MD, Principal investigator, Insitut of Tropical Medicine, University of TubingenPeter Kremsner, MD, PhD, Study director, Insitut of Tropical Medicine, University of Tubingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397449
- Sponsor's protocol ID
- EudraCT: 2005-004568-22
- Status last verified
- Aug 2007
- First submitted
- 8 Nov 2006
- Last updated
- 10 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Immunogenicity of the Recombinant Lactococcus Lactis Hybrid GMZ2 [GLURP+MSP3] a Malaria Vaccine in Healthy Adult Volunteers. A Phase I, Double-Blind, Randomised, Dose-Selection, Unicentre Trial
- ClinicalTrials.gov ID
- NCT00397449
- Acronym / sponsor ID
- EudraCT: 2005-004568-22
- Conditions
- Malaria
- Keywords
- Malaria, malaria vaccine, randomised, safety, immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- European Vaccine InitiativeUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Dec 2007 (estimated)
- First posted
- 9 Nov 2006 (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.
This is a randomized, open, dose-selection Phase 1 study. The study aims to evaluate the safety and immunogenicity of 3 doses (10,30 \& 100 micrograms) of the GMZ2 hybrid (GLURP and MSP3) blood stage vaccine in healthy non-immune European adults. The vaccines will be administered with aluminum hydroxide as adjuvant. The safety and the tolerability of the vaccine will be assessed on the rate of solicited and unsolicited events/reactions related to the vaccine. The safety profile will include local and systemic reactions/events as well as the biological safety, based on a clinically significant change of the baseline value of the main biological criteria. The immunogenicity of the different formulation of the vaccine will be assessed on the level and the quality of circulating antibodies as well as the stimulation of the T-cell immune response.
Detailed description
The trial is a randomised, open, dose-selection, single centre trial. One adjuvant will be assessed, aluminum hydroxide (alum). Three different dosages - 10µg, 30µg, and 100µg - of GMZ2 will be evaluated with the aluminum hydroxide adjuvant. A total of 30 volunteers will be enrolled and randomized into three groups of 10. As this is a dose escalation study, volunteers in Group 1 will receive the initial dose of 10µg on the first vaccination day. After a satisfactory safety profile at this dose (see sections 6.2.2 and 6.2.3), we will proceed to vaccinate volunteers in Group 2 with the higher dose of 30µg after a 2-week interval. The same procedure will also be followed for volunteers in Group 3, who will be administered their initial dose of 100µg GMZ2 if the review of the safety profile of Group 2 is satisfactory. The aim will be to recruit all volunteers before the intended start of the study. The randomization procedure will be performed in the following way: when participants are found to be eligible and have signed their informed consent they will be numbered sequentially (in order of enrollment). The numbers will be randomly assigned to 3 groups of 10 numbers through a specific randomization computer program. These groups will be the treatment groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1, 2, 3 | Experimental | Biological: GMZ2 (GLURP + MSP3 Hybrid) (malaria vaccine) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age > 18 and < 45 years healthy volunteers (males or females)
- General good health based on history and clinical examination
- All volunteers have to sign the informed consent form
- Negative pregnancy test
- Use of adequate contraception for females up to three months after the third injection (D140)
Key exclusion criteria (14 listed)
- History of malaria or residence in malaria endemic areas for the past six months.
- Positive serology for malaria antigen GLURP and/or MSP3.
- Previously participated in a malaria vaccine studies.
- Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers
- Any laboratory abnormalities on screened blood samples beyond the normal range, as defined at Tübingen. Positive HIV, HBV or HCV tests
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 (GLURP + MSP3 Hybrid) (malaria vaccine) | Biological | 1, 2, 3 |
Primary outcome
Safety
Time frame: one year
Immunogenicity
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2007.
- website of the European Malaria Vaccine InitiativeLink provided by the sponsor.
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.
Jurgen Knobloch, MD principal investigator
Insitut of Tropical Medicine, University of Tubingen
Peter Kremsner, MD, PhD study director
Insitut of Tropical Medicine, University of Tubingen
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 (GLURP + MSP3 Hybrid) (malaria vaccine) in people with Malaria, run by European Vaccine Initiative at 1 site in Germany.
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 6 inclusion and 14 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 10 Aug 2007. 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 Germany. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: one year). The study lists 2 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 10 Aug 2007.