Assessment of Three Formulations of the Candidate Vaccine AMA 1 in Healthy Dutch Adult Volunteers
NCT ID: NCT00730782
Last Updated: 2008-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2005-11-30
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
The experimental vaccine PfAMA1 formulated in Alhydrogel
PfAMA-1-FVO[25-545]
Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1
2
The experimental vaccine PfAMA1 formulated in Montanide ISA720
PfAMA-1-FVO[25-545]
Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1
3
The experimental vaccine PfAMA1 formulated in ASO2A
PfAMA-1-FVO[25-545]
Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1
Interventions
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PfAMA-1-FVO[25-545]
Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
MALE
Yes
Sponsors
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Radboud University Medical Center
OTHER
Biomedical Primate Research Centre
OTHER
GlaxoSmithKline
INDUSTRY
Seppic
INDUSTRY
European Vaccine Initiative
OTHER
Responsible Party
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Radboud University Nijmegen Medical Centre
Principal Investigators
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Robert Sauerwein, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Biomedical Primate Research Centre
Rijswijk, , Netherlands
Countries
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References
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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.
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.
Other Identifiers
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EUDRACT No 2005-00232-24
Identifier Type: -
Identifier Source: secondary_id
AMA-1_1_03
Identifier Type: -
Identifier Source: org_study_id