Phase I Trial of DAR-901

Phase 1

Completed

• Conditions: Tuberculosis
• Interventions: Biological: Sterile saline; Biological: BCG; Biological: DAR-901

• Registration Number: NCT02063555
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-14
• Primary Completion: 2016-03
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sterile saline	Sterile saline	Intradermal injection of 0.1 mL sterile saline at 0, 2 and 4 mos
BCG	BCG	Intradermal injection of 0.1 mL saline at 0 mos, 2 mos, intradermal injection of 0.1 mL BCG at 4 mos
DAR-901	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

Primary Outcome Measures

Name	Time	Method
Safety	10 months	Subjects will be followed for both systemic side effects and injection site reactions

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States