19-I-0069
Status:Ongoing
Phase:I
Principal Investigator(s):Mark Connors
Objective:Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy VolunteersResearchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection. Researchers want to see if all the vaccines help fight HIV and if the adenoviruses are contagious.Last updated September 16, 2022
Prevention Option(s):HIV Vaccine
Study Design:Open label
Arms and Assigned Interventions
DescriptionBiological: Ad4-Env150KN
10^8 vp doses of Ad4-Env150KN formulated as a liquid for intranasal administration.
Biological: VRC-HIVRGP096-00-VP (Trimer 4571) with alum
500-mcg dose of protein boost vaccine formulated for intramuscular administration.
Mode of DeliveryIntramuscular, Spray
ARMsExperimental
DescriptionBiological: Ad4-Env145NFL
10^8 vp doses of Ad4-Env145NFL formulated as a liquid for intranasal administration.
Biological: VRC-HIVRGP096-00-VP (Trimer 4571) with alum
500-mcg dose of protein boost vaccine formulated for intramuscular administration.
Mode of DeliveryIntramuscular, Spray
ARMsExperimental
DescriptionBiological: Ad4-Env145NFL
10^8 vp doses of Ad4-Env145NFL formulated as a liquid for intranasal administration.
Biological: VRC-HIVRGP096-00-VP (Trimer 4571) with alum
500-mcg dose of protein boost vaccine formulated for intramuscular administration.
Mode of DeliveryIntramuscular, Spray
ARMsActive Comparator
DescriptionBiological: Ad4-Env150KN
10^8 vp doses of Ad4-Env150KN formulated as a liquid for intranasal administration.
Biological: VRC-HIVRGP096-00-VP (Trimer 4571) with alum
500-mcg dose of protein boost vaccine formulated for intramuscular administration.
Mode of DeliveryIntramuscular, Spray
ARMsActive Comparator
Official Code:
NCT03878121
Trial Sponsors:
NIAID
Start Date
End Date
April 17, 2019
April 15, 2024
Enrollment:300
Age range:
18 Years ↔
65 Years
Population:Cisgender Men, Cisgender Women