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

Primary Purpose

Plasmodium Falciparum Malaria

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
PfAMA-1-FVO[25-545]
Sponsored by
European Vaccine Initiative
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plasmodium Falciparum Malaria

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Radboud University Nijmegen Medical Centre
  • Biomedical Primate Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

The experimental vaccine PfAMA1 formulated in Alhydrogel

The experimental vaccine PfAMA1 formulated in Montanide ISA720

The experimental vaccine PfAMA1 formulated in ASO2A

Outcomes

Primary Outcome Measures

Local and systemic reactogenicity

Secondary Outcome Measures

Biological Safety
Humoral and Cellular immunogenicity

Full Information

First Posted
August 6, 2008
Last Updated
August 7, 2008
Sponsor
European Vaccine Initiative
Collaborators
Radboud University Medical Center, Biomedical Primate Research Centre, GlaxoSmithKline, Seppic
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1. Study Identification

Unique Protocol Identification Number
NCT00730782
Brief Title
Assessment of Three Formulations of the Candidate Vaccine AMA 1 in Healthy Dutch Adult Volunteers
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 Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
European Vaccine Initiative
Collaborators
Radboud University Medical Center, Biomedical Primate Research Centre, GlaxoSmithKline, Seppic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
The experimental vaccine PfAMA1 formulated in Alhydrogel
Arm Title
2
Arm Type
Active Comparator
Arm Description
The experimental vaccine PfAMA1 formulated in Montanide ISA720
Arm Title
3
Arm Type
Active Comparator
Arm Description
The experimental vaccine PfAMA1 formulated in ASO2A
Intervention Type
Biological
Intervention Name(s)
PfAMA-1-FVO[25-545]
Intervention Description
Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1
Primary Outcome Measure Information:
Title
Local and systemic reactogenicity
Time Frame
Day 0-14 after each vaccination
Secondary Outcome Measure Information:
Title
Biological Safety
Time Frame
28 days after each vaccination
Title
Humoral and Cellular immunogenicity
Time Frame
until 365 days after the first immunisation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Sauerwein, Prof. MD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
Country
Netherlands
Facility Name
Biomedical Primate Research Centre
City
Rijswijk
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22768052
Citation
Remarque EJ, Roestenberg M, Younis S, Walraven V, van der Werff N, Faber BW, Leroy O, Sauerwein R, Kocken CH, Thomas AW. Humoral immune responses to a single allele PfAMA1 vaccine in healthy malaria-naive adults. PLoS One. 2012;7(6):e38898. doi: 10.1371/journal.pone.0038898. Epub 2012 Jun 29.
Results Reference
derived
PubMed Identifier
19093004
Citation
Roestenberg M, Remarque E, de Jonge E, Hermsen R, Blythman H, Leroy O, Imoukhuede E, Jepsen S, Ofori-Anyinam O, Faber B, Kocken CH, Arnold M, Walraven V, Teelen K, Roeffen W, de Mast Q, Ballou WR, Cohen J, Dubois MC, Ascarateil S, van der Ven A, Thomas A, Sauerwein R. Safety and immunogenicity of a recombinant Plasmodium falciparum AMA1 malaria vaccine adjuvanted with Alhydrogel, Montanide ISA 720 or AS02. PLoS One. 2008;3(12):e3960. doi: 10.1371/journal.pone.0003960. Epub 2008 Dec 18.
Results Reference
derived

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

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