HVTN 110
Status:Ongoing
Phase:I
Principal Investigator(s):Sean Bennet
Objective:Study to test different combinations of 3 experimental HIV vaccines. Two of the study vaccines are given as a pill that people will swallow, and contain a live, weakened virus called adenovirus trype 4. The third vaccine is given as an injection. The study tests the safety of the combinations, and the immune responses of the body to the different combinations.
*Trial is in follow-up*
Last updated February 27, 2021
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Vaccine A
Receive Ad4-mgag three times at 0,2,and 6 months with a boost at 8months
Biological: Ad4-mgag
A live replication-competent Adenovirus type-4 vector encoding a mosaic HIV Gag antigen, delivered orally by enteric-coated capsules.
Biological: AIDSVAX B/E
300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein adsorbed onto 600 mcg of aluminum hydroxide gel adjuvant, administered intramuscularly (IM).
Mode of DeliveryGel, Intramuscular
ARMsExperimental
DescriptionExperimental: Vaccine B
Receive Ad4-EnvC150 three times at 0,2,and 6 months with a boost at 8 months
Biological: Ad4-EnvC150
A live replication-competent Adenovirus type-4 vector encoding an HIV clade C Env protein (gp150 1086.C), delivered orally by enteric-coated capsules.
Biological: AIDSVAX B/E
300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein adsorbed onto 600 mcg of aluminum hydroxide gel adjuvant, administered intramuscularly (IM).
Mode of DeliveryGel, Intramuscular
ARMsExperimental
DescriptionExperimental: Vaccine A & B
Receive both Ad4-mgag and Ad4-EnvC150 three times at 0,2,and 6 months with a boost at 8 months
Biological: Ad4-mgag
A live replication-competent Adenovirus type-4 vector encoding a mosaic HIV Gag antigen, delivered orally by enteric-coated capsules.
Biological: Ad4-EnvC150
A live replication-competent Adenovirus type-4 vector encoding an HIV clade C Env protein (gp150 1086.C), delivered orally by enteric-coated capsules.
Biological: AIDSVAX B/E
300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein adsorbed onto 600 mcg of aluminum hydroxide gel adjuvant, administered intramuscularly (IM).
Mode of DeliveryGel, Intramuscular
ARMsExperimental
DescriptionExperimental: Vaccine A & B (previously received study vaccine)
People who have previously had a study vaccine: Receive both Ad4-mgag and Ad4-EnvC150 three times at 0,2,and 6 months with a boost at 8 months
Biological: Ad4-mgag
A live replication-competent Adenovirus type-4 vector encoding a mosaic HIV Gag antigen, delivered orally by enteric-coated capsules.
Biological: Ad4-EnvC150
A live replication-competent Adenovirus type-4 vector encoding an HIV clade C Env protein (gp150 1086.C), delivered orally by enteric-coated capsules.
Biological: AIDSVAX B/E
300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein adsorbed onto 600 mcg of aluminum hydroxide gel adjuvant, administered intramuscularly (IM).
Mode of DeliveryGel, Intramuscular
ARMsExperimental
Official Code:
NCT02771730
Trial Sponsors:
Emergent BioSolutions, NIAID
Start Date
End Date
March 3, 2015
February 8, 2019
Enrollment:60
Age range:
18 Years ↔
49 Years
Population:Cisgender Men, Cisgender Women