IAVI 010
Status:Completed
Phase:II
Principal Investigator(s):Barry S. Peters & Walter Jaoko
Objective:To evaluate the safety and tolerability of plasmid DNA and recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen.
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Randomized
Arms and Assigned Interventions
DescriptionExperimental Groups A & B:
DNA (0.5mg) or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA (5x10^6 pfu) or Placebo at Months 5 and 8 delivered subcutaneously.
Mode of DeliveryIntramuscular, Subcutaneous
ARMs
DescriptionExperimental Groups C & D: DNA (0.5mg) or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA (5x10^7 pfu) or Placebo at Months 5 and 8 delivered subcutaneously.
Mode of DeliveryIntramuscular, Subcutaneous
ARMs
DescriptionExperimental Groups E & F: DNA (0.5mg) or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA (5x10^8 pfu) or Placebo at Months 5 and 8 delivered subcutaneously.
Mode of Delivery
ARMs
DescriptionExperimental Group G: DNA (0.5mg) or Placebo delivered intramuscularly at Months 0 and 1 followed Placebo at Months 5 and 8 delivered intramuscularly.
Mode of DeliveryIntramuscular, Subcutaneous
ARMs
DescriptionExperimental Groups C2/D2/E2 (Subgroups of C,D,E):
DNA (0.5mg) or Placebo delivered intramuscularly at Months 0 and 1 followed by MVA or Placebo at Months 5 and Month 12+ (volunteers offered second MVA/placebo more than 12 months (late boost) after their enrollment into their original treatment assignment) delivered ID, SC, or IM according to original randomization. Vaccine:Placebo = blinded ratio, maximum in C2/D2/E2 = 16.
Mode of Delivery
ARMs
Official Code:
NCT01371175
Trial Sponsors:
IAVI, Medical Research Council-Oxford, University of Nairobi
Start Date
End Date
April 30, 2003
May 31, 2005
Enrollment:115
Age range:
18 Years ↔
60 Years
Population:Cisgender Men, Cisgender Women