NCT02366013

Brief Summary

This is a dose escalation study to test the safety and immunogenicity of an oral HIV-1 vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 hiv

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

1.4 years

First QC Date

February 4, 2015

Last Update Submit

November 18, 2016

Conditions

HIV

Keywords

HIVHIV PreventionHIV VaccineHealthy

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability as measured by number of volunteers reporting the following:

    * 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

    4 Months post-vaccination

Secondary Outcomes (2)

  • Proportion (95%CI) of volunteers per dose group with positive shedding responses and mean response per group with 95% CI.

    28 days

  • Proportion of volunteers per dose group with positive immunological responses and mean response (e.g. GMT) per group with 95% CI.

    12 Months

Study Arms (4)

Group 1

EXPERIMENTAL

1 dose of rcAd26.MOS1.HIV-Env 1x10\^8 vp or placebo

Biological: rcAd26.MOS1.HIV-Env 1x10^8 vp

Group 2

EXPERIMENTAL

1 dose of rcAd26.MOS1.HIV-Env 1x10\^9 vp or placebo

Biological: rcAd26.MOS1.HIV-Env 1x10^9 vp

Group 3

EXPERIMENTAL

1 dose of rcAd26.MOS1.HIV-Env 1x10\^10 vp or placebo

Biological: rcAd26.MOS1.HIV-Env 1x10^10 vp

Group 4

EXPERIMENTAL

1 dose of rcAd26.MOS1.HIV-Env 1x10\^11 vp or placebo

Biological: rcAd26.MOS1.HIV-Env 1x10^11 vp

Interventions

rcAd26.MOS1.HIV-Env 1x10^8 vpBIOLOGICAL

1 oral capsule, 1x10\^8 vp/capsule or 1 placebo capsule; 5:1 vaccine:placebo

Group 1
rcAd26.MOS1.HIV-Env 1x10^9 vpBIOLOGICAL

10 oral capsules, 1x10\^8 vp/capsule or 10 placebo capsules; 5:1 vaccine:placebo

Group 2
rcAd26.MOS1.HIV-Env 1x10^10 vpBIOLOGICAL

1 oral capsule, 1x10\^10 vp/capsule or 1 placebo capsule; 5:1 vaccine:placebo

Group 3
rcAd26.MOS1.HIV-Env 1x10^11 vpBIOLOGICAL

10 oral capsules, 1x10\^10 vp/capsule or 10 placebo capsules; 5:1 vaccine:placebo

Group 4

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40 years old.
  • Ability and willingness to provide informed consent.
  • Complete an assessment of understanding
  • Available for the duration of the trial, including willingness to be kept in an isolation facility
  • From Day 10 through 4 months following vaccination must reside alone or with no more than 2 adults (age 18-60) and no minors under age 18
  • Good general health as shown by medical history, physical exam, and screening
  • Willing to undergo HIV testing and willing to receive risk reduction counseling
  • All female volunteers must be willing to undergo urine pregnancy tests
  • Sexually active males must be willing to use an effective method of contraception until at least 4 months after vaccination
  • Women of child bearing potential commit to use an effective method of contraception when sexually active with males for 4 months after vaccination
  • Willing to forgo donations of blood or any other tissues during the study and, for those who test HIV positive due to trial vaccination (vaccine-induced HIV seroreactivity), until the anti-HIV antibody titers become undetectable
  • Low risk for HIV infection and willing to maintain low-risk behavior for the trial duration

You may not qualify if:

  • Confirmed HIV-1 or HIV-2 infection; confirmed HCV, HBV, or syphilis infection
  • Current or planned participation in another clinical trial of an experimental agent during the study period
  • Pregnant or lactating
  • Significant acute or chronic disease, including inflammatory bowel disease or other chronic gastrointestinal disease, immunodeficiency syndrome, or condition requiring immunosuppressant medications
  • Use of anticancer, antituberculosis or other medications considered significant by the investigator within the previous 6 months
  • Receipt of live-attenuated vaccine within the previous 60 days or planned receipt within 60 days after vaccination with Investigational Product (within 14 days for live attenuated influenza vaccine \[LAIV\]); or receipt of other vaccine (e.g., influenza, pneumococcal), allergy treatment with antigen injections or tuberculin skin test within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product
  • Receipt of blood transfusion or blood-derived products within the previous 3 months
  • Receipt of HIV vaccine(s) in a prior HIV vaccine trial.
  • Previous severe local or systemic reactions to vaccination
  • History of splenectomy
  • History of seizure in the last 3 years
  • Known autoimmune disease
  • Asthma other than mild, well-controlled asthma.
  • Diabetes mellitus type 1 or type 2
  • Thyroidectomy, or thyroid disease requiring medication during the last 12 months
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • Stephenson KE, Keefer MC, Bunce CA, Frances D, Abbink P, Maxfield LF, Neubauer GH, Nkolola J, Peter L, Lane C, Park H, Verlinde C, Lombardo A, Yallop C, Havenga M, Fast P, Treanor J, Barouch DH. First-in-human randomized controlled trial of an oral, replicating adenovirus 26 vector vaccine for HIV-1. PLoS One. 2018 Nov 14;13(11):e0205139. doi: 10.1371/journal.pone.0205139. eCollection 2018.

    PMID: 30427829DERIVED

Study Officials

  • John Treanor, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

  • Kathryn Stephenson, MD, MPH

    Beth Israel Deaconess Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 19, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

US(1)