Phase I Trial of DAR-901

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

DAR-901

Intervention Type BIOLOGICAL

BCG

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

Group Type ACTIVE_COMPARATOR

BCG

Intervention Type BIOLOGICAL

Sterile saline

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

Group Type PLACEBO_COMPARATOR

Sterile saline

Intervention Type BIOLOGICAL

Interventions

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DAR-901

Intervention Type BIOLOGICAL

BCG

Intervention Type BIOLOGICAL

Sterile saline

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)