Phase I Trial of DAR-901

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02063555
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : August 2, 2016
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: DAR-901 Biological: BCG Biological: Sterile saline Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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 Start Date : February 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Biological: DAR-901
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
Biological: BCG
Placebo Comparator: Sterile saline
Intradermal injection of 0.1 mL sterile saline at 0, 2 and 4 mos
Biological: Sterile saline

Primary Outcome Measures :
  1. Safety [ Time Frame: 10 months ]
    Subjects will be followed for both systemic side effects and injection site reactions

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02063555

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Principal Investigator: Charles F. von Reyn, MD Dartmouth College

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT02063555     History of Changes
Other Study ID Numbers: DAR-901-MDES
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: August 2016

Keywords provided by Dartmouth-Hitchcock Medical Center:
TB Vaccines

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections