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

NCT00730782 | Completed Phase 1

• 2 other identifiers: AMA-1_1_03EUDRACT No 2005-00232-24
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Plasmodium Falciparum Malaria

Outcome Measures

Primary Outcomes (1)

• Local and systemic reactogenicity

  Day 0-14 after each vaccination

Secondary Outcomes (2)

• Biological Safety

  28 days after each vaccination

• Humoral and Cellular immunogenicity

  until 365 days after the first immunisation

Study Arms (3)

1

ACTIVE COMPARATOR

The experimental vaccine PfAMA1 formulated in Alhydrogel

Biological: PfAMA-1-FVO[25-545]

2

ACTIVE COMPARATOR

The experimental vaccine PfAMA1 formulated in Montanide ISA720

Biological: PfAMA-1-FVO[25-545]

3

ACTIVE COMPARATOR

The experimental vaccine PfAMA1 formulated in ASO2A

Biological: PfAMA-1-FVO[25-545]

Interventions

PfAMA-1-FVO[25-545] BIOLOGICAL

Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Vaccine Initiative: lead
• Radboud University Medical Center: collaborator
• Biomedical Primate Research Centre: collaborator
• GlaxoSmithKline: collaborator
• Seppic: collaborator

Study Sites (2)

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Location

Biomedical Primate Research Centre

Rijswijk, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 22768052 DERIVED

• 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.

  PMID: 19093004 DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Robert Sauerwein, Prof. MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: November 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: August 1, 2008
• Last Updated: August 8, 2008

Record last verified: 2008-08

Locations

NL (2)