NCT02063555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 2, 2016

Status Verified

August 1, 2016

Enrollment Period

2.1 years

First QC Date

February 13, 2014

Last Update Submit

August 1, 2016

Conditions

Tuberculosis

Keywords

TuberculosisBCGHIVTB Vaccines

Outcome Measures

Primary Outcomes (1)

  • Safety

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

    10 months

Secondary Outcomes (1)

  • Immunogenicity

    10 months

Study Arms (3)

DAR-901

EXPERIMENTAL

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

Biological: DAR-901

BCG

ACTIVE COMPARATOR

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

Biological: BCG

Sterile saline

PLACEBO COMPARATOR

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

Biological: Sterile saline

Interventions

DAR-901BIOLOGICAL
DAR-901
BCGBIOLOGICAL
BCG
Sterile salineBIOLOGICAL
Sterile saline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects: age 18-65, prior BCG vaccine (scar)
  • HIV negative subjects: negative ELISA for HIV (48 subjects with negative IGRA, 8 subjects with positive IGRA)
  • HIV positive subjects: positive ELISA for HIV, on ART (13 subjects with negative IGRA, 8 subjects with positive IGRA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (3)

  • 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.

    PMID: 31120957DERIVED

  • 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.

    PMID: 29685114DERIVED

  • 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.

    PMID: 28498853DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Charles F. von Reyn, MD

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 14, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

August 2, 2016

Record last verified: 2016-08

Locations

US(1)