Phase I Trial of DAR-901

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Collaborator:
Aeras
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT02063555
First received: February 13, 2014
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Tuberculosis
Biological: DAR-901
Biological: BCG
Biological: Sterile saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Safety [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
    Subjects will be followed for both systemic side effects and injection site reactions


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Cellular and humoral responses to the vaccine antigen will be tested at baseline and after each of 3 doses of vaccine


Estimated Enrollment: 77
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Inactivated Mycobacterium obuense
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02063555

Contacts
Contact: Charles F. von Reyn, MD 603 650 7167 fvr@dartmouth.edu
Contact: Timothy Lahey, MD 603 650 8840 timothy.lahey@dartmouth.edu

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Brenda Haynes, RN    603-650-5250    brenda.haynes@hitchcock.org   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Aeras
Investigators
Principal Investigator: Charles F. von Reyn, MD Geisel School of Medicine at Dartmouth
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02063555     History of Changes
Other Study ID Numbers: DAR-901-MDES
Study First Received: February 13, 2014
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration
United States: Dartmouth Committee for the Protection of Human Subjects

Keywords provided by Dartmouth-Hitchcock Medical Center:
Tuberculosis
BCG
HIV
TB Vaccines

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

ClinicalTrials.gov processed this record on September 11, 2014