GMZ2-Aluminum Hydroxide Phase I, Tübingen

NCT00397449 | Unknown Phase 1

• 1 other identifier: EudraCT: 2005-004568-22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

Malaria, malaria vaccine, randomised, safety, immunogenicity

Outcome Measures

Primary Outcomes (2)

• Safety

  one year

• Immunogenicity

  one year

Study Arms (1)

1, 2, 3

EXPERIMENTAL

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

Interventions

GMZ2 (GLURP + MSP3 Hybrid) (malaria vaccine) BIOLOGICAL

1, 2, 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Vaccine Initiative: lead

Study Sites (1)

Institut for Tropical Medicine, University of Tubingen

Tübingen, D-72074 TÜBINGEN, Germany

Location

Related Links

• website of the European Malaria Vaccine Initiative

MeSH Terms

Conditions

Malaria

Interventions

Malaria Vaccines

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Protozoan Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Jurgen Knobloch, MD

  Insitut of Tropical Medicine, University of Tubingen

  PRINCIPAL INVESTIGATOR

• Peter Kremsner, MD, PhD

  Insitut of Tropical Medicine, University of Tubingen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2006
• First Posted: November 9, 2006
• Study Start: October 1, 2006
• Study Completion: December 1, 2007
• Last Updated: August 10, 2007

Record last verified: 2007-08

Locations

DE (1)