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

Plasmodium Falciparum Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730782
• Other study ID #: AMA-1_1_03
• Secondary ID: EUDRACT No 2005-
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2008
• Last updated: August 7, 2008
• Start date: November 2005
• Est. completion date: August 2008

Study information

• Verified date: August 2008
• Source: European Malaria Vaccine Initiative
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria

Intervention

Biological:
• PfAMA-1-FVO[25-545]
Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen
Netherlands	Biomedical Primate Research Centre	Rijswijk

Sponsors (5)

Lead Sponsor	Collaborator
European Malaria Vaccine Initiative	Biomedical Primate Research Centre, GlaxoSmithKline, Radboud University, SEPPIC, Paris

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local and systemic reactogenicity		Day 0-14 after each vaccination	Yes
Secondary	Biological Safety		28 days after each vaccination	Yes
Secondary	Humoral and Cellular immunogenicity		until 365 days after the first immunisation	No

External Links

•   Information on current recruitment at Radboud University Nijmegen Medical Centre