A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad35.RSV.FA2 Regimens Boosted With Ad26.RSV.FA2 in Healthy Adult Participants
Status:Completed
Phase:I
Principal Investigator(s):Crucell Holland BV
Objective:The purpose of this study is to assess the safety and tolerability of intramuscular homologous and heterologous prime-boost regimens of Ad35.RSV.FA2 (human adenovirus-vectored vaccine candidate) and Ad26.RSV.FA2 in healthy participants.
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionTwo subsequent Intramuscular injections of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on Day 1, Day 85 and an intramuscular injection of Ad26.RSV.FA2 (5x10^10 vp) on Day 169.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionIntramuscular injection of Ad35.RSV.FA2 (1x10^11 vp) on Day 1, an intramuscular injection of placebo control on Day 85 and an injection of Ad35.RSV.FA2 (1x10^11 vp) on Day 169.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionOne intramuscular injection of Ad35.RSV.FA2 (1x10^11 vp) on Day 1 and an intramuscular injection of placebo control on Day 85 and an intramuscular injection of Ad26.RSV.FA2 (5x10^10 vp) on Day 169.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionTwo subsequent intramuscular injections of placebo control on Day 1, Day 85 and an intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on Day 169.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT02440035
Trial Sponsors:
Crucell Holland BV
Start Date
End Date
April 11, 2015
June 11, 2016
Enrollment:48
Age range:
18 Years ↔
50 Years
Population:Cisgender Men, Cisgender Women