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Trial of the Safety and Immunogenicity of an Oral, Replicating Ad26 Vectored HIV-1 Vaccine

NCT02366013 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2016-11-21

No results posted yet for this study

Summary

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

Conditions

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

Sponsors & Collaborators

Principal Investigators

  • John Treanor, MD · University of Rochester

  • Kathryn Stephenson, MD, MPH · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02366013 on ClinicalTrials.gov