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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