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LeprosyPhase 1NCT01920750

Leprosy Skin Test Antigens Phase 1

A Phase 1 study testing MLCwA, MLSA-LAM and Mock Antigen in people with Leprosy, run by National Institute of Allergy and Infectious Diseases (NIAID).

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

This is a small Phase I trial to evaluate the safety of the use as skin test antigens of the immunologically active proteins from the soluble/cytosol and insoluble cell wall of Mycobacterium leprae. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Leprosy
What is being tested?
MLCwA, MLSA-LAM and Mock Antigen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Jan 1989to Feb 1999
Phase
Phase 1
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 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Born in the United States (less chance of previous exposure to tuberculosis or leprosy)
  • Healthy individuals who are free of any evidence of leprosy or tuberculosis by established clinical examinations
  • Between the ages of 18 and 40 years old
  • Females of child-bearing age (defined from the period of menarche to menopause, usually between the ages of 15 to 45), certified as not pregnant (as determined by a pregnancy test performed within 7 days prior to admission into the study)
  • Agreement to participate in the study after verbal explanation by the physician and nurses and signing of an informed consent form.
  • Weight greater than 100 lbs. (female) and.140 lbs. (male)
  • No known hypersensitivities or allergies
  • Negative tuberculin skin test (as determined by skin tests performed 3 weeks prior to study entry)

Who cannot join

  • Pregnant or lactating females
  • Oral corticosteroid treatment
  • Chronic illness
  • Immunosuppressive condition
  • Tuberculosis
  • Leprosy
Show all 10Show fewer
  • Age <18 or >40
  • Weight <100 lbs. (female) or <140 lbs. (male)
  • Positive tuberculin skin test
  • Extensive travel (2-3 trips/year) in leprosy/tuberculosis endemic regions

About this study

Official title: Phase I Study to Evaluate New Leprosy Skin Test Antigens: MLSA-LAM and MLCwA

This is a small Phase I trial to evaluate the safety of the use as skin test antigens of the immunologically active proteins from the soluble/cytosol and insoluble cell wall of Mycobacterium leprae. The overall objective is to generate new leprosy skin-test antigens, equivalent to tuberculin-PPD in the tuberculosis context, to be used (I) for the early diagnosis of leprosy; and (ii) as epidemiological tools to measure the incidence of disease. Evaluating new leprosy skin test antigens may provide a better way to diagnose leprosy in its early stages of infection. With the early administration of drug therapy, infected individuals can then be cured of this disease before nerve damage occurs or nodules (lepromas) start to develop on the skin. Ten healthy, leprosy-unexposed, tuberculin-negative volunteers, 18-40 years old, from within the staff of the Mycobacteria Research Laboratories, Department of Microbiology, Colorado State University, Fort Collins, Colorado, will be selected.

Read the detailed description

This is a small Phase I trial to evaluate the safety of the use as skin test antigens of the immunologically active proteins from the soluble/cytosol and insoluble cell wall of Mycobacterium leprae. The overall objective is to generate new leprosy skin-test antigens, equivalent to tuberculin-PPD in the tuberculosis context, to be used (I) for the early diagnosis of leprosy; and (ii) as epidemiological tools to measure the incidence of disease. Evaluating new leprosy skin test antigens may provide a better way to diagnose leprosy in its early stages of infection. With the early administration of drug therapy, infected individuals can then be cured of this disease before nerve damage occurs or nodules (lepromas) start to develop on the skin. Ten healthy, leprosy-unexposed, tuberculin-negative volunteers, ages 18-40 years old, from within the staff of the Mycobacteria Research Laboratories, Department of Microbiology, Colorado State University, Fort Collins, Colorado, will be selected for this study. The volunteers will be recruited by direct contact after placing notices in the Department of Microbiology at Colorado State University. There are approximately 40 faculty/staff/students in this population and all are routinely tested (PPD skin-testing or chest X-ray) by the staff at the Hartshorn Health Service Center in the context of the Department's tuberculosis research. Five individuals will be selected for testing MLSA-LAM and five will receive MLCwA. Each will receive single 0.1 ml intracutaneous injections of three titrated doses (1, 10 and 25 )lg/ml) of the skin-test antigen, one of mock antigen (i.e., physiological saline), and one of control antigen (the product now in use; Rees MLSA, 10 )lg), divided equally between the subject's two arms. Results will be recorded at 15 min, 48 h, 72 h, and 28 days post-injection. The test dose will be administered with a sterile1 ml syringe calibrated in tenths and fitted with a sterile, one-half inch, 26 or 27 gauge needle. The rubber stopper of the vial will be wiped with a sterile piece of cotton moistened with alcohol and allowed to dry.It is expected that all concentrations of the two leprosy skin test antigens will evoke similar negative responses. If so, all three concentrations will be used for subsequent studies. This protocol is linked to study 98-202.

Conditions
Leprosy
Being tested
MLCwA, MLSA-LAM, Mock Antigen
Keywords
Leprosy, skin test, MLSA-LAM, MLCwA, diagnosis, Protocol 98-202
Medical subject headings
Leprosy, Disease

What participants receive

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

  • MLCwABiological

    Antigen MLSA-LAM is a pellet extracted 3x followed by removal of SDS by column chromatography. Contains many of the same proteins

  • MLSA-LAMBiological

    Antigen MLSA-LAM is derived from M. leprae extract following sonication and centrifugation, leaving the cytosol (MLSA). Contains soluble protein antigens of M. leprae

  • Mock AntigenOther

    Physiological saline

Study groups in NCT01920750
Study groupRoleWhat they receive
Group 2Experimental5 subjects will receive d single 0.1 ml intracutaneous injections of 3 titrated doses (1, 10, and 25 grams/ml) of MLCwA and one of mock antigen equally in two arms
Receives: Biological: MLCwA; Biological: MLSA-LAM; Other: Mock Antigen
Group 1Experimental5 subjects received single 0.1 ml intracutaneous injections of 3 titrated doses (1, 10, and 25 grams/ml) of MLSA-LAM and one of mock antigen equally in two arms
Receives: Biological: MLCwA; Biological: MLSA-LAM; Other: Mock Antigen

What is being measured

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

  1. Range of concentration (1, 10, and 25 micrograms/ml) responses in the two leprosy skin test antigens in the control and mock antigens

    Measured: Up to 28 days post injection

  2. Incidence of leprosy

    Measured: Up to 28 days post injection

Timeline

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

  1. First posted12 Aug 2013 (estimated)
  2. Study startJan 1989
  3. Primary completionFeb 1999
  4. Study completionFeb 1999

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 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01920750
Sponsor's protocol ID
98-011
Status last verified
Aug 2013
First submitted
25 Jul 2013
Last updated
25 Jul 2014
Results posted
No

Publications

  • Rivoire BL, Groathouse NA, TerLouw S, Neupane KD, Ranjit C, Sapkota BR, Khadge S, Kunwar CB, Macdonald M, Hawksworth R, Thapa MB, Hagge DA, Tibbals M, Smith C, Dube T, She D, Wolff M, Zhou E, Makhene M, Mason R, Sizemore C, Brennan PJ. Safety and efficacy assessment of two new leprosy skin test antigens: randomized double blind clinical study. PLoS Negl Trop Dis. 2014 May 29;8(5):e2811. doi: 10.1371/journal.pntd.0002811. eCollection 2014.

    PubMed 24874401

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MLCwA, MLSA-LAM and Mock Antigen in people with Leprosy, run by National Institute of Allergy and Infectious Diseases (NIAID).

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 8 inclusion and 10 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 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Range of concentration (1, 10, and 25 micrograms/ml) responses in the two leprosy skin test antigens in the control and mock antigens (time frame: Up to 28 days post injection). The study lists 2 primary outcomes in all. 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 NCT01920750, which also lists 1 linked publication.

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 25 Jul 2014.

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