Phase I Trial of DAR-901

Phase 1CompletedNCT02063555

Dartmouth-Hitchcock Medical Center59 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Tuberculosis

Interventions

DAR-901BIOLOGICAL

BCGBIOLOGICAL

Sterile salineBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \-

Locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

Safety

Subjects will be followed for both systemic side effects and injection site reactions

Time frame: 10 months

Secondary Outcomes

Immunogenicity

Cellular and humoral responses to the vaccine antigen will be tested at baseline and after each of 3 doses of vaccine

Time frame: 10 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.