Safety, Tolerability and Immunogenicity Study of Different Vaccine Schedules With Ad26.Mos.HIV and Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults
Status:Completed
Phase:I
Principal Investigator(s):Crucell Holland BV Clinical Trial
Objective:The primary purpose of this study is to assess safety, tolerability of the different vaccine schedules (different regimen durations and different number of dose administrations) with Ad26.Mos.HIV and Clade C Glycoprotein (gp) 140 and to assess Envelope (Env)-binding Antibody (Ab) responses of the different vaccine schedules.
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48.
Mode of Delivery
ARMsExperimental
DescriptionParticipants will receive Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) at Week 0, 12 and 24.
Mode of Delivery
ARMsExperimental
DescriptionParticipants will receive Ad26.Mos.HIV vaccine at Week 0; followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) at Week 8 and 24.
Mode of Delivery
ARMsExperimental
Official Code:
NCT02685020
Trial Sponsors:
Crucell Holland BV Clinical Trial
Start Date
End Date
March 10, 2016
January 4, 2019
Enrollment:36
Age range:
18 Years ↔
50 Years
Population:Cisgender Men, Cisgender Women