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Phase Ib Trial of Two Virosome Formulated Malaria Vaccine Components (PEV 301, PEV 302) in Tanzania (PMAL03)

This study has been completed.
Sponsor:
Collaborators:
Mymetics Corporation
Pevion Biotech Ltd
Information provided by (Responsible Party):
Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier:
NCT00513669
First received: August 8, 2007
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

This is a phase Ib double-blind randomized placebo controlled age-deescalating trial to assess sagety and immunogenicity of two virosome formulated anti-malaria vaccine components (PEV 301 and PEV 302) administered in combination to healthy semi-immune Tanzanian adult and children.


Condition Intervention Phase
Falciparum Malaria
Biological: PEV 301& 302 in virosomes
Biological: Inflexal V (active comparator)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase Ib Double-blind Randomized Placebo Controlled Age-deescalating Trial of Two Virosome Formulated Anti-malaria Vaccine Components (PEV 301 and PEV 302) Administered in Combination to Healthy Semi-immune Tanzanian Volunteers

Resource links provided by NLM:


Further study details as provided by Swiss Tropical & Public Health Institute:

Primary Outcome Measures:
  • Safety (incidence of local and systemic adverse events) Humoral immunity [ Time Frame: 30 days post-injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cell-mediated immunity [ Time Frame: 14 days post-injection ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 PEV301&302
The vaccine includes two antigens (CSP and AMA1- derived)in combination and formulated with virosomes
Biological: PEV 301& 302 in virosomes
PEV 301 50 µg plus PEV 302 10 µg formulated in virosomes and injected at day 0 and 90
Active Comparator: 2 Influenza vaccine
Inflexal V is the comparator that includes 3 antigens from flu formulated in virosomes
Biological: Inflexal V (active comparator)
Inflexal V is a marketed influenza vaccine that will be given at day 0 and 90

Detailed Description:

Volunteers will be screened, enrolled, injected with the vaccine or comparator and followed by the clinicians at the Bagamoyo Research and Training Unit of the the Ifakara Health Research and Development Center (BRTU-IHRDC).

First, 10 adult males will be enrolled and randomized in 2 groups: Group AV (n=8) will be injected with the vaccine combination and group AP (n=2) will be vaccinated with the placebo=comparator (Inflexal V). 5 weeks later, 8 children will be enrolled first and randomized in 2 groups: Group CV (n=6) will be injected with the vaccine combination and group CP (n=2) will be vaccinated with comparator. 1 week later, the rest of the cohort (n=32) will be enrolled and randomized in 2 groups: Group CV (n=26) will be injected with the vaccine combination and group CP (n=6) will be vaccinated with comparator.

Immunogenicity assessments for humoral immune response will be made at baseline (days -10 to -2), day 30 (+4), day 90 (+4) (day of 2nd vaccination), 120 (+4), 180 (+7), and 365 (+14).

Cellular immune responses will be assessed before 1st vaccination (day 0), two weeks after 2nd vaccination (day 104 ±2), and one year after the 1st vaccination (day 365) Safety assessments will be made by the investigator at baseline (days -10 to -2, before the 1st immunization) and at day 1, 2, 3, 7, 14, 30 after each vaccination.

  Eligibility

Ages Eligible for Study:   5 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male volunteers aged between 18 and 45 years for the adult group, and children of both sexes aged 5-9 years for schoolchildren group
  2. Written informed consent obtained from the volunteer (adult) or guardian/ legal representative (children). In case patient is illiterate, an impartial witness should be present during the entire consent procedure
  3. Free of obvious health problems as established by medical history and clinical examination before entering the study
  4. Body Mass Index between 18 and 30 for adults; MUAC less than 12 for children

Exclusion Criteria:

  1. Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up
  2. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
  3. Any chronic drug therapy to be continued during the study period
  4. Any confirmed or suspected acquired immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, or history of congenital or hereditary immunodeficiency
  5. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
  6. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever (defined as temperature more than 37.5°C)
  7. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
  8. Acute or chronic diabetes
  9. History of chronic alcohol consumption and/or intravenous drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513669

Locations
Tanzania
Bagamoyo Research and Training Unit
Bagamoyo, Tanzania
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Mymetics Corporation
Pevion Biotech Ltd
Investigators
Principal Investigator: Blaise Genton, MD PhD Swiss tropical institute, Ifakara Health Research and Development Center
  More Information

Additional Information:
No publications provided by Swiss Tropical & Public Health Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT00513669     History of Changes
Other Study ID Numbers: PMAL03
Study First Received: August 8, 2007
Last Updated: March 14, 2013
Health Authority: Tanzania: Tanzania Food and Drug Authority

Keywords provided by Swiss Tropical & Public Health Institute:
Malaria
Vaccine
Falciparum
Trial
Phase I
Safety
Immunogenicity

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on November 20, 2014