GMZ2-Aluminum Hydroxide Phase I, Tübingen

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00397449
• Date of registration: 08/11/2006
• Prospective Registration: No
• Primary sponsor: European Malaria Vaccine Initiative
• Public title: GMZ2-Aluminum Hydroxide Phase I, Tübingen
• Scientific 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
• Date of first enrolment: October 2006
• Target sample size: 30
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00397449
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Peter Kremsner, MD, PhD
• Affiliation: Insitut of Tropical Medicine, University of Tubingen

• Name: Jurgen Knobloch, MD
• Affiliation: Insitut of Tropical Medicine, University of Tubingen

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Biological: GMZ2 (GLURP + MSP3 Hybrid) (malaria vaccine)

Primary Outcome(s)

Safety [Time Frame: one year]

Immunogenicity [Time Frame: one year]

Secondary ID(s)

EudraCT: 2005-004568-22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors