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Assessment of Three Formulations of the Candidate Vaccine AMA 1 in Healthy Dutch Adult Volunteers

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ClinicalTrials.gov Identifier: NCT00730782
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : August 8, 2008
Sponsor:
Collaborators:
Radboud University
Biomedical Primate Research Centre
GlaxoSmithKline
SEPPIC, Paris
Information provided by:
European Malaria Vaccine Initiative

Brief Summary:
The objective of this study was to evaluate the safety of a candidate malaria vaccine (PfAMA-1) at 3 doses given at monthly intervals of 2 different dosages of AMA-1 (10 μg or 50 μg ) adjuvanted either with alum hydroxide or AS02A or Montanide ISA 720 in healthy adults not previously exposed to the parasite Plasmodium falciparum.

Condition or disease Intervention/treatment Phase
Plasmodium Falciparum Malaria Biological: PfAMA-1-FVO[25-545] Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Assessment of the Safety and Immunogenicity of Three Formulations of the Recombinant Pichia Pastoris Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]), Blood-Stage Malaria Vaccine in Healthy Dutch Adult Volunteers : a Phase 1, Single- Blind, Randomised, Dose-Escalating, Unicentre Trial
Study Start Date : November 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
The experimental vaccine PfAMA1 formulated in Alhydrogel
Biological: PfAMA-1-FVO[25-545]
Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1
Active Comparator: 2
The experimental vaccine PfAMA1 formulated in Montanide ISA720
Biological: PfAMA-1-FVO[25-545]
Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1
Active Comparator: 3
The experimental vaccine PfAMA1 formulated in ASO2A
Biological: PfAMA-1-FVO[25-545]
Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1



Primary Outcome Measures :
  1. Local and systemic reactogenicity [ Time Frame: Day 0-14 after each vaccination ]

Secondary Outcome Measures :
  1. Biological Safety [ Time Frame: 28 days after each vaccination ]
  2. Humoral and Cellular immunogenicity [ Time Frame: until 365 days after the first immunisation ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 18 and < 45 years healthy volunteers.
  • 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).
  • Reachable by phone during the whole study period (18 months).

Exclusion Criteria:

  • History of malaria or residence in malaria endemic areas within the past six months.
  • Positive serology for malaria antigen PfAMA-1
  • Previously participated in any malaria vaccine study
  • 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 UMC St Radboud. 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, immunomodulating 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.
  • Volunteers are not allowed to travel to malaria endemic countries during the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730782


Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Biomedical Primate Research Centre
Rijswijk, Netherlands
Sponsors and Collaborators
European Malaria Vaccine Initiative
Radboud University
Biomedical Primate Research Centre
GlaxoSmithKline
SEPPIC, Paris
Investigators
Principal Investigator: Robert Sauerwein, Prof. MD Radboud University