Trial of the Safety and Immunogenicity of an Oral, Replicating Ad26 Vectored HIV-1 Vaccine
|ClinicalTrials.gov Identifier: NCT02366013|
Recruitment Status : Completed
First Posted : February 19, 2015
Last Update Posted : November 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV||Biological: rcAd26.MOS1.HIV-Env 1x10^8 vp Biological: rcAd26.MOS1.HIV-Env 1x10^9 vp Biological: rcAd26.MOS1.HIV-Env 1x10^10 vp Biological: rcAd26.MOS1.HIV-Env 1x10^11 vp||Phase 1|
This study is a phase I dose-escalation randomized, double blind, placebo-controlled study designed to evaluate the safety and immunogenicity of rcAd26.MOS1.HIV-Env, an oral replicating adenovirus 26 vector vaccine in healthy HIV-1 uninfected adults. The vaccine will be administered orally at a single time point (Day 0) at one of four dose levels depending on study group: 1 x 10^8 virus particles (vp), 1 x 10^9 vp, 1 x 10^10 vp and 1 x 10^11 vp. Volunteers will be randomized to vaccine: placebo in a 5:1 ratio in each group.
Volunteers will be screened up to 56 days before vaccination and will be followed for 12 months after vaccination.
Because the vaccine is replication competent, volunteers will be housed in an isolation unit from day -2 through day 9. Household contacts will also be enrolled and tested for possible transmission.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1 Clinical Trial of the Safety and Immunogenicity of an Oral, Replicating Adenovirus 26 Vector Vaccine for HIV-1 (rcAd26.MOS1.HIV-Env) in Healthy HIV-1-uninfected Adults|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Group 1
1 dose of rcAd26.MOS1.HIV-Env 1x10^8 vp or placebo
Biological: rcAd26.MOS1.HIV-Env 1x10^8 vp
1 oral capsule, 1x10^8 vp/capsule or 1 placebo capsule; 5:1 vaccine:placebo
Experimental: Group 2
1 dose of rcAd26.MOS1.HIV-Env 1x10^9 vp or placebo
Biological: rcAd26.MOS1.HIV-Env 1x10^9 vp
10 oral capsules, 1x10^8 vp/capsule or 10 placebo capsules; 5:1 vaccine:placebo
Experimental: Group 3
1 dose of rcAd26.MOS1.HIV-Env 1x10^10 vp or placebo
Biological: rcAd26.MOS1.HIV-Env 1x10^10 vp
1 oral capsule, 1x10^10 vp/capsule or 1 placebo capsule; 5:1 vaccine:placebo
Experimental: Group 4
1 dose of rcAd26.MOS1.HIV-Env 1x10^11 vp or placebo
Biological: rcAd26.MOS1.HIV-Env 1x10^11 vp
10 oral capsules, 1x10^10 vp/capsule or 10 placebo capsules; 5:1 vaccine:placebo
- Safety and tolerability as measured by number of volunteers reporting the following: [ Time Frame: 4 Months post-vaccination ]
- Any adverse events within 4 months following vaccination (SAEs within 12 months following vaccination)
- Moderate or greater unsolicited adverse events related to study product (i.e., suspected adverse reactions) within 4 weeks post-vaccination
- Moderate or greater solicited reactions within 9 days post-vaccination
- Proportion (95%CI) of volunteers per dose group with positive shedding responses and mean response per group with 95% CI. [ Time Frame: 28 days ]o Rectal/oral shedding: real-time PCR for rcAd26.MOS1.HIV-Env at 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 17, 21, 7, 12, 21, and 28 days after vaccination.
- Proportion of volunteers per dose group with positive immunological responses and mean response (e.g. GMT) per group with 95% CI. [ Time Frame: 12 Months ]
- Cellular immunogenicity: Env-specific ELISPOT responses at 4 weeks after vaccination.
- Humoral immunogenicity: Env-specific binding antibody titers at 4 weeks after vaccination.
- Durability of responses: immunogenicity assays at 4, 8 and 12 months after vaccination.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366013
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||John Treanor, MD||University of Rochester|
|Study Chair:||Kathryn Stephenson, MD, MPH||Beth Israel Deaconess Medical Center|