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Sponsors and Collaborators: |
Swiss Tropical Institute Mymetics Corporation Pevion Biotech Ltd |
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Information provided by: | Swiss Tropical Institute |
ClinicalTrials.gov Identifier: | NCT00513669 |
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 |
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Falciparum Malaria |
Biological: PEV 301& 302 in virosomes Biological: Inflexal V (active comparator) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 PEV301&302: Experimental
The vaccine includes two antigens (CSP and AMA1- derived)in combination and formulated with virosomes
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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
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2 Influenza vaccine: Active Comparator
Inflexal V is the comparator that includes 3 antigens from flu formulated in virosomes
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Biological: Inflexal V (active comparator)
Inflexal V is a marketed influenza vaccine that will be given at day 0 and 90
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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.
Ages Eligible for Study: | 5 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Tanzania | |
Bagamoyo Research and Training Unit | |
Bagamoyo, Tanzania |
Principal Investigator: | Blaise Genton, MD PhD | Swiss tropical institute, Ifakara Health Research and Development Center |
Responsible Party: | Swiss Tropical Institute / Ifakara Health Research and Development Center ( Genton Blaise, principal investigator ) |
Study ID Numbers: | PMAL03 |
Study First Received: | August 8, 2007 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00513669 History of Changes |
Health Authority: | Tanzania: Tanzania Food and Drug Authority |
Malaria Vaccine Falciparum Trial |
Phase I Safety Immunogenicity |
Protozoan Infections Parasitic Diseases Malaria Healthy Malaria, Falciparum |
Protozoan Infections Coccidiosis Parasitic Diseases Malaria Malaria, Falciparum |