Phase Ib Trial of Two Virosome Formulated Malaria Vaccine Components (PEV 301, PEV 302) in Tanzania (PMAL03)
|Falciparum Malaria||Biological: PEV 301& 302 in virosomes Biological: Inflexal V (active comparator)||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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|
- Safety (incidence of local and systemic adverse events) Humoral immunity [ Time Frame: 30 days post-injection ]
- Cell-mediated immunity [ Time Frame: 14 days post-injection ]
|Study Start Date:||January 2008|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513669
|Bagamoyo Research and Training Unit|
|Principal Investigator:||Blaise Genton, MD PhD||Swiss tropical institute, Ifakara Health Research and Development Center|