MalariaPhase 1NCT00703066
Safety and Immunogenicity of 30 and 100 µg of GMZ2 in Gabonese Children Aged 1-5 Years
A Phase 1 study testing GMZ 2 vaccine (GLURP + MSP 3) and Rabies 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. 30 Gabonese children aged 1-5 years 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 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- GMZ 2 vaccine (GLURP + MSP 3) and Rabies vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGabon
- Study dates
- Jun 2008to Aug 2009
- 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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children age 1-5 years inclusive at the time of screening;
- Residing in Lambaréné for the duration of the study;
- 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 any other malaria candidate vaccine.
- Concomitant 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 vaccination, or planned use up to 30 days after the third vaccination;
- Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs within six months prior to the first vaccination. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids;
- Confirmed or suspected immunosuppressive or immuno-deficient condition, including human immunodeficiency virus (HIV) infection;
- Confirmed or suspected autoimmune disease;
Show all 15Show fewer
- History of allergic reactions or anaphylaxis to immunizations or to any of the vaccine components, or of serious allergic reactions to any substance, requiring hospitalization or emergent medical care;
- History of splenectomy;
- Laboratory evidence of liver disease (Alanine aminotransferase [ALT] greater than 1.25 times the upper limit of normal (<45 U/L) 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 haematological disease (absolute leukocyte count 3.5-11/µL, absolute lymphocyte count 560-5280/µL, platelet count 120,000-400,000/µL, or haemoglobin 10.0-16.5g/dL);
- Administration of immunoglobulins and/or any blood products within the three months preceding the first study vaccination 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.
About this study
Official title: A Phase I, Randomized, Controlled, Double-Blind, Single Centre Trial to Evaluate the Safety and Immunogenicity of 30 and 100 µg of GMZ2 in Gabonese Children Aged 1-5 Years
The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already publicly used vaccine against rabies. 30 Gabonese children aged 1-5 years 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. 30 and 100µg doses for the candidate malaria vaccine GMZ 2 will be evaluated for safety.
This is the second time that candidate malaria vaccine GMZ 2 is being tested in Africa, the first time being in Gabonese adults where the product was found to be safe.
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 State Serum Institute/EMVI in Denmark and Batch released by Henogen of Belgium. The phase Ia trial in malaria naive volunteers was done in Germany, at Tuebingen University. This phase Ia trial established safety of the vaccine and also assisted in selecting the best dosage (10, 30 or 100 µg). The dosage with the best safety and immunogenicity profile will be tested for the phase Ib trials in Gabon, including this phase Ib trial in children.
Objectives:
Primary objective:
To evaluate the safety and reactogenicity of three doses of 30 and 100µg GMZ2, adsorbed on aluminium hydroxide, in comparison with three doses of the control vaccine (rabies), in healthy Gabonese children aged 1-5 years.
Secondary objectives:
To assess the humoral immune response to the vaccine antigens GMZ2, GLURP and MSP3 by measuring the total IgG concentration and IgG isotypes against GMZ2 by ELISA.
To assess B-cell memory by memory B-cell ELISPOT.
Exploratory Objectives:
To assess the functionality of the immune response by measuring the Growth Inhibition of P. falciparum in the presence or absence of Monocytes, and by measuring the recognition of native antigen of P. falciparum by IFA.
Study Design:
Phase Ib double-blind, randomised, and controlled trial with three groups at one study site; rabies vaccine,30µg and 100 µg GMZ 2 vaccine.
- Conditions
- Malaria
- Being tested
- GMZ 2 vaccine (GLURP + MSP 3), Rabies 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.
GMZ 2 vaccine (GLURP + MSP 3)Biological
three doses of 30µg of GMZ 2 vaccine,
GMZ 2 vaccine (GLURP + MSP 3)Biological
100 µg of GMZ 2 vaccine
Rabies vaccineBiological
3 doses of Rabies vaccine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | three doses of 30µg GMZ2, Receives: Biological: GMZ 2 vaccine (GLURP + MSP 3) |
| 2 | Experimental | 3 doses of 100 µg of GMZ2 Receives: Biological: GMZ 2 vaccine (GLURP + MSP 3) |
| 3 | Active comparator | Rabies vaccine Receives: Biological: Rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate reactogenicity.
Measured: within 30 minutes after each injection
Local and systemic reactogenicity
Measured: 14 days following each immunization
unsolicited Adverse events
Measured: up to 1 month after the 3rd vaccination
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
Cellular 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 posted23 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 30 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
- NCT00703066
- Sponsor's protocol ID
- GMZ2_3_08
- Status last verified
- Nov 2008
- First submitted
- 20 Jun 2008
- Last updated
- 25 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Belard S, Issifou S, Hounkpatin AB, Schaumburg F, Ngoa UA, Esen M, Fendel R, de Salazar PM, Murbeth RE, Milligan P, Imbault N, Imoukhuede EB, Theisen M, Jepsen S, Noor RA, Okech B, Kremsner PG, Mordmuller B. A randomized controlled phase Ib trial of the malaria vaccine candidate GMZ2 in African children. PLoS One. 2011;6(7):e22525. doi: 10.1371/journal.pone.0022525. Epub 2011 Jul 28.
PubMed 21829466
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Controlled, Double-Blind, Single Centre Trial to Evaluate the Safety and Immunogenicity of 30 and 100 µg of GMZ2 in Gabonese Children Aged 1-5 Years
- ClinicalTrials.gov ID
- NCT00703066
- Acronym / sponsor ID
- GMZ2_3_08
- Conditions
- Malaria
- Keywords
- Malaria, Vaccine, GMZ2, Safety, African, immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- African Malaria Network TrustResearch network
- Study start
- Jun 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 23 Jun 2008 (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. 30 Gabonese children aged 1-5 years 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. 30 and 100µg doses for the candidate malaria vaccine GMZ 2 will be evaluated for safety.
This is the second time that candidate malaria vaccine GMZ 2 is being tested in Africa, the first time being in Gabonese adults where the product was found to be safe.
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 State Serum Institute/EMVI in Denmark and Batch released by Henogen of Belgium. The phase Ia trial in malaria naive volunteers was done in Germany, at Tuebingen University. This phase Ia trial established safety of the vaccine and also assisted in selecting the best dosage (10, 30 or 100 µg). The dosage with the best safety and immunogenicity profile will be tested for the phase Ib trials in Gabon, including this phase Ib trial in children.
Objectives:
Primary objective:
To evaluate the safety and reactogenicity of three doses of 30 and 100µg GMZ2, adsorbed on aluminium hydroxide, in comparison with three doses of the control vaccine (rabies), in healthy Gabonese children aged 1-5 years.
Secondary objectives:
To assess the humoral immune response to the vaccine antigens GMZ2, GLURP and MSP3 by measuring the total IgG concentration and IgG isotypes against GMZ2 by ELISA.
To assess B-cell memory by memory B-cell ELISPOT.
Exploratory Objectives:
To assess the functionality of the immune response by measuring the Growth Inhibition of P. falciparum in the presence or absence of Monocytes, and by measuring the recognition of native antigen of P. falciparum by IFA.
Study Design:
Phase Ib double-blind, randomised, and controlled trial with three groups at one study site; rabies vaccine,30µg and 100 µg GMZ 2 vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: GMZ 2 vaccine (GLURP + MSP 3)three doses of 30µg GMZ2, |
| 2 | Experimental | Biological: GMZ 2 vaccine (GLURP + MSP 3)3 doses of 100 µg of GMZ2 |
| 3 | Active comparator | Biological: Rabies vaccineRabies vaccine |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children age 1-5 years inclusive at the time of screening;
- Residing in Lambaréné for the duration of the study;
- 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 any other malaria candidate vaccine.
- Concomitant 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 vaccination, or planned use up to 30 days after the third vaccination;
- Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs within six months prior to the first vaccination. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids;
- Confirmed or suspected immunosuppressive or immuno-deficient condition, including human immunodeficiency virus (HIV) infection;
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 |
|---|---|---|
| GMZ 2 vaccine (GLURP + MSP 3)three doses of 30µg of GMZ 2 vaccine, | Biological | 1 |
| GMZ 2 vaccine (GLURP + MSP 3)100 µg of GMZ 2 vaccine | Biological | 2 |
| Rabies vaccine3 doses of Rabies vaccine | Biological | 3 |
Primary outcome
Immediate reactogenicity.
Time frame: within 30 minutes after each injection
Local and systemic reactogenicity
Time frame: 14 days following each immunization
unsolicited Adverse events
Time frame: up to 1 month after the 3rd vaccination
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
Cellular 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 25 Nov 2008.
- Derived from this study: PubMed 21829466Belard S, Issifou S, Hounkpatin AB, Schaumburg F, Ngoa UA, Esen M, Fendel R, de Salazar PM, Murbeth RE, Milligan P, Imbault N, Imoukhuede EB, Theisen M, Jepsen S, Noor RA, Okech B, Kremsner PG, Mordmuller B. A randomized controlled phase Ib trial of the malaria vaccine candidate GMZ2 in African children. PLoS One. 2011;6(7):e22525. doi: 10.1371/journal.pone.0022525. Epub 2011 Jul 28.
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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 GMZ 2 vaccine (GLURP + MSP 3) and Rabies 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 25 Nov 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?
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?
Immediate reactogenicity. (time frame: within 30 minutes after each injection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00703066, which also lists 1 linked publication.
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 25 Nov 2008.