Phase I Trial of DAR-901

Overview

This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative and HIV positive adults previously vaccinated with BCG. The goals of the trial are to determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at different dose levels, ranging from 0.1 to 1 mg.

Full Title of Study: “A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose, Dose-Ranging Study of the Safety and Immunogenicity of DAR-901, a Killed, Non-Tuberculous Mycobacterial Vaccine, in HIV-negative and HIV-positive Adults Who Have Previously Received BCG”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2016

Interventions

  • Biological: DAR-901
  • Biological: BCG
  • Biological: Sterile saline

Arms, Groups and Cohorts

  • Experimental: DAR-901
    • Intradermal administration at 0, 2 and 4 months Three dose groups in dose escalation: 0.1 mg, 0.3 mg and 1.0 mg, all constituted in 0.1 mL
  • Active Comparator: BCG
    • Intradermal injection of 0.1 mL saline at 0 mos, 2 mos, intradermal injection of 0.1 mL BCG at 4 mos
  • Placebo Comparator: Sterile saline
    • Intradermal injection of 0.1 mL sterile saline at 0, 2 and 4 mos

Clinical Trial Outcome Measures

Primary Measures

  • Safety
    • Time Frame: 10 months
    • Subjects will be followed for both systemic side effects and injection site reactions

Secondary Measures

  • Immunogenicity
    • Time Frame: 10 months
    • Cellular and humoral responses to the vaccine antigen will be tested at baseline and after each of 3 doses of vaccine

Participating in This Clinical Trial

Inclusion Criteria

All subjects: age 18-65, prior BCG vaccine (scar) 56 HIV negative subjects: negative ELISA for HIV (48 subjects with negative IGRA, 8 subjects with positive IGRA) 21 HIV positive subjects: positive ELISA for HIV, on ART (13 subjects with negative IGRA, 8 subjects with positive IGRA) Exclusion Criteria:

pregnancy, positive serology for hepatitis B or C, active tuberculosis immunosuppression, severe medical illness -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dartmouth-Hitchcock Medical Center
  • Collaborator
    • Aeras
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Charles F. von Reyn, MD, Principal Investigator, Dartmouth College

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