EuroNeut41
Status:Completed
Phase:I
Principal Investigator(s):
Objective:To assess the safety of three priming immunisations by nasal route followed by two booster immunisations by intramuscular route and to assess immunogenicity responses induced by the vaccine.
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionGroup 1 Nasal vaccine - Low-dose (20 µg in 40 µL) IM vaccine (200 µg in 400 µL)
Mode of DeliverySpray
ARMsExperimental
DescriptionGroup 2 Nasal vaccine - Mid-dose (100 µg in 200 µL) IM vaccine (200 µg in 400 µL)
Mode of DeliverySpray
ARMsExperimental
DescriptionGroup 3 Nasal vaccine - Full-dose (200 µg in 400 µL) IM vaccine (200 µg in 400 µL)
Mode of DeliverySpray
ARMsExperimental
DescriptionGroup 4 Nasal Placebo - 400 µL IM vaccine (200 µg in 400 µL)
Mode of DeliverySpray
ARMsExperimental
DescriptionGroup 5 Nasal placebo - 40 µL in Cohort 1 / 200 µL in Cohort 2 IM placebo (400 µL)
Mode of DeliverySpray
ARMsPlacebo Comparator
Official Code:
NCT01509144
Trial Sponsors:
European Commission, PX'Therapeutics
Start Date
End Date
January 1, 2012
October 31, 2013
Enrollment:48
Age range:
18 Years ↔
55 Years
Population:Cisgender Women