Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513669
Status:
COMPLETED
Last Update Posted:
2013-03-15
First Post:
2007-08-08
Brief Title:
Phase Ib Trial of Two Virosome Formulated Malaria Vaccine Components PEV 301 PEV 302 in Tanzania
Sponsor:
Swiss Tropical Public Health Institute
Organization:
Swiss Tropical Public Health Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PMAL03
Brief Summary:
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
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 n8 will be injected with the vaccine combination and group AP n2 will be vaccinated with the placebocomparator Inflexal V 5 weeks later 8 children will be enrolled first and randomized in 2 groups Group CV n6 will be injected with the vaccine combination and group CP n2 will be vaccinated with comparator 1 week later the rest of the cohort n32 will be enrolled and randomized in 2 groups Group CV n26 will be injected with the vaccine combination and group CP n6 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
First 10 adult males will be enrolled and randomized in 2 groups Group AV n8 will be injected with the vaccine combination and group AP n2 will be vaccinated with the placebocomparator Inflexal V 5 weeks later 8 children will be enrolled first and randomized in 2 groups Group CV n6 will be injected with the vaccine combination and group CP n2 will be vaccinated with comparator 1 week later the rest of the cohort n32 will be enrolled and randomized in 2 groups Group CV n26 will be injected with the vaccine combination and group CP n6 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None