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

This study has been completed.
Sponsor:
Collaborators:
Radboud University
Biomedical Primate Research Centre
GlaxoSmithKline
SEPPIC, Paris
Information provided by:
European Malaria Vaccine Initiative
ClinicalTrials.gov Identifier:
NCT00730782
First received: August 6, 2008
Last updated: August 7, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Plasmodium Falciparum Malaria
Biological: PfAMA-1-FVO[25-545]
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by European Malaria Vaccine Initiative:

Primary Outcome Measures:
  • Local and systemic reactogenicity [ Time Frame: Day 0-14 after each vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biological Safety [ Time Frame: 28 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Humoral and Cellular immunogenicity [ Time Frame: until 365 days after the first immunisation ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: November 2005
Study Completion Date: August 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided by European Malaria Vaccine Initiative

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. R.W. Sauerwein, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00730782     History of Changes
Other Study ID Numbers: AMA-1_1_03, EUDRACT No 2005-00232-24
Study First Received: August 6, 2008
Last Updated: August 7, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 28, 2014