Phase I Trial of DAR-901

Dartmouth Health

Status and phase: Completed; Phase 1

Conditions: Tuberculosis

Treatments: Biological: Sterile saline; Biological: BCG; Biological: DAR-901

Study type: Interventional

Funder types: Other

Identifiers

NCT02063555

DAR-901-MDES

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 3 patient groups, including a placebo group

DAR-901

Experimental group

Description:

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

Treatment:

Biological: DAR-901

BCG

Active Comparator group

Description:

Intradermal injection of 0.1 mL saline at 0 mos, 2 mos, intradermal injection of 0.1 mL BCG at 4 mos

Treatment:

Biological: BCG

Sterile saline

Placebo Comparator group

Description:

Intradermal injection of 0.1 mL sterile saline at 0, 2 and 4 mos

Treatment:

Biological: Sterile saline