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AzTrials

TuberculosisPhase 2/3NCT00052195

Investigational Vaccine for the Prevention of Disseminated Tuberculosis in HIV Infected People

A Phase 2/3 study testing SRL-172 in people with Tuberculosis and HIV Infections, run by Dartmouth-Hitchcock Medical Center at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A significant number of HIV infected patients in Africa also have disseminated tuberculosis (infection throughout multiple organs). This type of tuberculosis is a significant cause of mortality in these patients. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tuberculosis, HIV Infections
What is being tested?
SRL-172
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,975 participants
Where
1 siteTanzania
Study dates
Sep 2001to May 2009
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • HIV infection
  • CD4 count more than 200 cells/mm3
  • BCG scar

Who cannot join

  • Active tuberculosis. Patients will be deferred from study enrollment until they show no signs of active disease.
  • Serious underlying disease (e.g., congestive heart failure, advanced cancer)
  • Life expectancy of less than 2 years
  • Pregnancy. Women who are pregnant may be eligible for the study after they give birth.

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

  • Muhimbili University College of Health Sciences

    Dar es Salaam

Other trials in Tanzania

About this study

Official title: DARDAR Health Project (Disseminated Tuberculosis and HIV Infection)

A significant number of HIV infected patients in Africa also have disseminated tuberculosis (infection throughout multiple organs). This type of tuberculosis is a significant cause of mortality in these patients. The purpose of this study is to evaluate the safety and effectiveness of a vaccine designed to prevent disseminated tuberculosis.

Read the detailed description

Disseminated infection with Mycobacterium tuberculosis (dMTB) has been documented in 10% to 25% of patients with HIV infection in Africa. Unlike pulmonary tuberculosis (pMTB), most cases of dMTB are not recognized and death ensues rapidly. Therefore, dMTB may be a more important cause of HIV-associated mortality than pMTB in developing countries. Mycobacterium vaccae (MV) is an investigational vaccine prepared by heat inactivation of a nontuberculous mycobacteria. MV immunization may reduce the risk of HIV-associated dMTB. The purpose of this study is to define risk factors for HIV-associated dMTB and to assess the safety and effectiveness of an MV vaccine for the prevention of HIV-associated pulmonary and disseminated tuberculosis.

HIV positive patients with prior BCG immunization and HIV negative controls will be entered in a 5-year study in Tanzania. Participants will be randomized to receive a 5-dose series of MV or placebo over 12 months, with a repeat skin test at Month 14. Baseline evaluation will include medical history, chest x-ray, skin tests with purified protein derivative (PPD), and blood tests to evaluate interferon-gamma production. Participants with PPD reactions greater than or equal to 5 mm will receive 6 months of prophylaxis with isoniazid. Participants will be followed every 3 months for 3 to 5 years to assess new pMTB (microbiologic or clinical diagnosis) or dMTB (microbiologic diagnosis). Potential risk factors for dMTB will also be assessed.

Being tested
SRL-172
Keywords
Mycobacterium vaccae, BCG, Disseminated tuberculosis, SRL-172, DAR-901
Medical subject headings
Tuberculosis, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SRL-172Biological

    5 doses of 0.1mL vaccine or placebo given intradermally over 12-months

Study groups in NCT00052195
Study groupRoleWhat they receive
BPlacebo comparatorNot described
Receives: Biological: SRL-172
AExperimentalNot described
Receives: Biological: SRL-172

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. safety and efficacy of a prime-boost immunization strategy for the prevention of HIV-associated dTB and pTB

    Measured: every six months

Secondary outcomes (1)

  1. Risk factors for HIV-associated dTB and relative contributions of primary infection, reinfection, and reactivation in its pathogenesis

    Measured: every six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 2001
  3. Primary completionDec 2008
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,975 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00052195
Sponsor's protocol ID
1R01AI045407-01A2
Other IDs
1R01AI045407-01A2, 3R01AI045407-02S1, 5R01AI045407-03, U01AI045407-06, U01AI045407-07, U01AI045407-08
Status last verified
Feb 2016
First submitted
24 Jan 2003
Last updated
19 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Mtei L, Matee M, Herfort O, Bakari M, Horsburgh CR, Waddell R, Cole BF, Vuola JM, Tvaroha S, Kreiswirth B, Pallangyo K, von Reyn CF. High rates of clinical and subclinical tuberculosis among HIV-infected ambulatory subjects in Tanzania. Clin Infect Dis. 2005 May 15;40(10):1500-7. doi: 10.1086/429825. Epub 2005 Apr 12.

    PubMed 15844073

  • von Reyn CF, Mtei L, Arbeit RD, Waddell R, Cole B, Mackenzie T, Matee M, Bakari M, Tvaroha S, Adams LV, Horsburgh CR, Pallangyo K; DarDar Study Group. Prevention of tuberculosis in Bacille Calmette-Guerin-primed, HIV-infected adults boosted with an inactivated whole-cell mycobacterial vaccine. AIDS. 2010 Mar 13;24(5):675-85. doi: 10.1097/QAD.0b013e3283350f1b.

    PubMed 20118767

  • Lahey T, Arbeit RD, Bakari M, Horsburgh CR, Matee M, Waddell R, Mtei L, Vuola JM, Pallangyo K, von Reyn CF. Immunogenicity of a protective whole cell mycobacterial vaccine in HIV-infected adults: a phase III study in Tanzania. Vaccine. 2010 Nov 10;28(48):7652-8. doi: 10.1016/j.vaccine.2010.09.041. Epub 2010 Sep 25.

    PubMed 20875492

  • Lahey T, Czechura T, Crabtree S, Arbeit RD, Matee M, Horsburgh CR, MacKenzie T, Bakari M, Pallangyo K, von Reyn CF. Greater preexisting interferon gamma responses to mycobacterial antigens and lower bacillary load during HIV-associated tuberculosis. J Infect Dis. 2013 Nov 15;208(10):1629-33. doi: 10.1093/infdis/jit396. Epub 2013 Aug 1.

    PubMed 23908490

  • Lahey T, Mackenzie T, Arbeit RD, Bakari M, Mtei L, Matee M, Maro I, Horsburgh CR, Pallangyo K, von Reyn CF. Recurrent tuberculosis risk among HIV-infected adults in Tanzania with prior active tuberculosis. Clin Infect Dis. 2013 Jan;56(1):151-8. doi: 10.1093/cid/cis798. Epub 2012 Sep 12.

    PubMed 22972862

  • Lahey T, Mitchell BK, Arbeit RD, Sheth S, Matee M, Horsburgh CR, MacKenzie T, Mtei L, Bakari M, Vuola JM, Pallangyo K, von Reyn CF. Polyantigenic interferon-gamma responses are associated with protection from TB among HIV-infected adults with childhood BCG immunization. PLoS One. 2011;6(7):e22074. doi: 10.1371/journal.pone.0022074. Epub 2011 Jul 20.

    PubMed 21799772

  • von Reyn CF, Kimambo S, Mtei L, Arbeit RD, Maro I, Bakari M, Matee M, Lahey T, Adams LV, Black W, Mackenzie T, Lyimo J, Tvaroha S, Waddell R, Kreiswirth B, Horsburgh CR, Pallangyo K. Disseminated tuberculosis in human immunodeficiency virus infection: ineffective immunity, polyclonal disease and high mortality. Int J Tuberc Lung Dis. 2011 Aug;15(8):1087-92. doi: 10.5588/ijtld.10.0517.

    PubMed 21740673

  • Lahey T, Sheth S, Matee M, Arbeit R, Horsburgh CR, Mtei L, Mackenzie T, Bakari M, Vuola JM, Pallangyo K, von Reyn CF. Interferon gamma responses to mycobacterial antigens protect against subsequent HIV-associated tuberculosis. J Infect Dis. 2010 Oct 15;202(8):1265-72. doi: 10.1086/656332.

    PubMed 20812851

  • Lahey T, Matee M, Mtei L, Bakari M, Pallangyo K, von Reyn CF. Lymphocyte proliferation to mycobacterial antigens is detectable across a spectrum of HIV-associated tuberculosis. BMC Infect Dis. 2009 Feb 23;9:21. doi: 10.1186/1471-2334-9-21.

    PubMed 19236695

  • Munseri PJ, Talbot EA, Mtei L, Fordham von Reyn C. Completion of isoniazid preventive therapy among HIV-infected patients in Tanzania. Int J Tuberc Lung Dis. 2008 Sep;12(9):1037-41.

    PubMed 18713501

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SRL-172 in people with Tuberculosis and HIV Infections, run by Dartmouth-Hitchcock Medical Center at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety and efficacy of a prime-boost immunization strategy for the prevention of HIV-associated dTB and pTB (time frame: every six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00052195, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.

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