Clinical trial NCT00730782: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Plasmodium Falciparum Malaria
Lead sponsor: European Vaccine Initiative
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
name: Biomedical Primate Research Centre
name: GlaxoSmithKline
name: Seppic
First posted: 2008-08-08
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Local and systemic reactogenicity
timeFrame: Day 0-14 after each vaccination
Secondary outcomes:
measure: Biological Safety
timeFrame: 28 days after each vaccination
measure: Humoral and Cellular immunogenicity
timeFrame: until 365 days after the first immunisation
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
city: Rijswijk
country: Netherlands
facility: Biomedical Primate Research Centre
Study officials:
affiliation: Radboud University Medical Center
name: Robert Sauerwein, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.