Tuberculosis
Conditions
Keywords
Tuberculosis, BCG, HIV, TB Vaccines
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.
Interventions
Sponsors
Aeras
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 10 months | Subjects will be followed for both systemic side effects and injection site reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | 10 months | Cellular and humoral responses to the vaccine antigen will be tested at baseline and after each of 3 doses of vaccine |
Countries
United States
Outcome results
None listed