Phase I Trial of DAR-901
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/3/2016 |
| Start Date: | February 2014 |
| End Date: | June 2016 |
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
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.
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.
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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