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Phase I Trial of DAR-901

Primary Purpose

Tuberculosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

DAR-901

BCG

Sterile saline

About this trial

This is an interventional prevention trial for Tuberculosis focused on measuring Tuberculosis, BCG, HIV, TB Vaccines

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

DAR-901

BCG

Sterile saline

Arm 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

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

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

Outcomes

Primary Outcome Measures

Safety

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

Secondary Outcome Measures

Immunogenicity

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

Full Information

NCT ID

NCT02063555

First Posted

February 13, 2014

Last Updated

August 1, 2016

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Aeras

1. Study Identification

Unique Protocol Identification Number

NCT02063555

Brief Title

Phase I Trial of DAR-901

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Aeras

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis

Keywords

Tuberculosis, BCG, HIV, TB Vaccines

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DAR-901

Arm Type

Experimental

Arm 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

Arm Title

BCG

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sterile saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

DAR-901

Intervention Type

Biological

Intervention Name(s)

BCG

Intervention Type

Biological

Intervention Name(s)

Sterile saline

Primary Outcome Measure Information:

Title

Safety

Description

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

Time Frame

10 months

Secondary Outcome Measure Information:

Title

Immunogenicity

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles F. von Reyn, MD

Organizational Affiliation

Dartmouth College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dartmouth-Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31120957

Citation

Masonou T, Hokey DA, Lahey T, Halliday A, Berrocal-Almanza LC, Wieland-Alter WF, Arbeit RD, Lalvani A, von Reyn CF. CD4+ T cell cytokine responses to the DAR-901 booster vaccine in BCG-primed adults: A randomized, placebo-controlled trial. PLoS One. 2019 May 23;14(5):e0217091. doi: 10.1371/journal.pone.0217091. eCollection 2019.

Results Reference

derived

PubMed Identifier

29685114

Citation

Craig SR, Lahey T, Dixit A, Fordham von Reyn C. Altruism, Scepticism, and collective decision-making in foreign-born U.S. residents in a tuberculosis vaccine trial. BMC Public Health. 2018 Apr 23;18(1):535. doi: 10.1186/s12889-018-5460-3.

Results Reference

derived

PubMed Identifier

28498853

Citation

von Reyn CF, Lahey T, Arbeit RD, Landry B, Kailani L, Adams LV, Haynes BC, Mackenzie T, Wieland-Alter W, Connor RI, Tvaroha S, Hokey DA, Ginsberg AM, Waddell R. Safety and immunogenicity of an inactivated whole cell tuberculosis vaccine booster in adults primed with BCG: A randomized, controlled trial of DAR-901. PLoS One. 2017 May 12;12(5):e0175215. doi: 10.1371/journal.pone.0175215. eCollection 2017.

Results Reference

derived

Learn more about this trial

Phase I Trial of DAR-901

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