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GMZ2-Aluminum Hydroxide Phase I, Tübingen

Primary Purpose

Malaria

Status

Unknown status

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

GMZ2 (GLURP + MSP3 Hybrid) (malaria vaccine)

About this trial

This is an interventional prevention trial for Malaria focused on measuring Malaria, malaria vaccine, randomised, safety, immunogenicity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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
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.

Sites / Locations

Institut for Tropical Medicine, University of Tubingen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1, 2, 3

Arm Description

Outcomes

Primary Outcome Measures

Safety

Immunogenicity

Secondary Outcome Measures

Full Information

NCT ID

NCT00397449

First Posted

November 8, 2006

Last Updated

August 9, 2007

Sponsor

European Vaccine Initiative

1. Study Identification

Unique Protocol Identification Number

NCT00397449

Brief Title

GMZ2-Aluminum Hydroxide Phase I, Tübingen

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Unknown status

Study Start Date

October 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

European Vaccine Initiative

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

Malaria, malaria vaccine, randomised, safety, immunogenicity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1, 2, 3

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

GMZ2 (GLURP + MSP3 Hybrid) (malaria vaccine)

Primary Outcome Measure Information:

Title

Safety

Time Frame

one year

Title

Immunogenicity

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jurgen Knobloch, MD

Organizational Affiliation

Insitut of Tropical Medicine, University of Tubingen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Peter Kremsner, MD, PhD

Organizational Affiliation

Insitut of Tropical Medicine, University of Tubingen

Official's Role

Study Director

Facility Information:

Facility Name

Institut for Tropical Medicine, University of Tubingen

City

Tubingen

ZIP/Postal Code

D-72074 TÜBINGEN

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.emvi.org

Description

website of the European Malaria Vaccine Initiative

Learn more about this trial

GMZ2-Aluminum Hydroxide Phase I, Tübingen

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