Tuberculosis InfectionPhase 203NCT01798095
Equivalence Study of Specificity of PPD
A Phase 2 study testing Aplisol@ PPD material and Reference Standard in people with Tuberculosis Infection, run by JHP Pharmaceuticals LLC at 1 site in United States.
Trial summary
Determine if investigational products and reference standard produce similar responses. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis Infection
- What is being tested?
- Aplisol@ PPD material and Reference Standard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jul 2013
- Phase
- Phase 2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or nonpregnant females, age 18 to 70 years
- Negligible risk of manifesting a positive PPD test as evidenced by:
- Prior history of negative PPD test or interferon gamma release assay (IGRA) within 14 months before Screening
- No history of Bacillus Calmette- Guérin vaccination; or if vaccination status is uncertain, was born in the US and did not live outside the US as a child
- No history of Mtb or Mtb therapy (including isoniazid, rifampin, ethambutol, pyrazinamide, or streptomycin)
- No history of infection with atypical mycobacteria, including suspicious chest roentgenogram
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- No history of high risk medical conditions (eg, HIV infection or other immunosuppressive conditions, severe chronic renal disease [as evidenced by a creatinine clearance < 30 ml/min], poorly controlled diabetes mellitus, silicosis, intravenous drug use, or alcohol abuse)
- No known close contact to a confirmed Mtb case (family or social setting)
- No history of living or travelling in India, China, Sub-Saharan Africa, or Southeast Asia in the past 6 months
- No exposure (other than casual) to high-risk environments for Mtb exposure (eg, prisons, homeless shelters); healthcare workers are allowed
Who cannot join
- Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
- History of anaphylactic type reaction or other severe reaction to PPD in the past, including a history of blistering or sloughing
- Presence of conditions that may suppress TST reactivity, including:
- Protocol No. JHP-Aplisol-03 Confidential 04 May 2012 Page 8 of 38
- Acute viral infections, including measles, mumps, chicken pox, human immunodeficiency virus (HIV1, HIV2). Mild viral syndromes are allowed.
- Acute bacterial infections including typhoid fever, brucellosis, typhus, leprosy, or pertussis
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- Acute systemic fungal infection
- Live virus vaccinations within the past 6 weeks, including measles, mumps, polio, varicella, or FluMist®
- Metabolic derangements (eg, poorly controlled diabetes, Cushing syndrome, chronic renal failure [as evidenced by a creatinine clearance < 30 ml/min])
Trial locations and contacts
1 site in 1 country.
Arlene Lund, B.Sc. contact
United States1 site
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
Joe Santor, Pharm. D., 903-877-7632, clin.res@uthct.edu
David Griffith, M.D.
About this study
Official title: A Randomized, Double-blind, Equivalence Study of the Specificity of Tuberculin Purified Protein Derivative (PPD) (Aplisol®) in Comparison With a Reference Standard
Determine if investigational products and reference standard produce similar responses.
Read the detailed description
Primary:
To determine if the 2 investigational products (Aplisol formulated from the new Tuberculin PPD drug substance and the reference standard PPD-S2) produce qualitatively similar responses (positive or negative) in subjects who are uninfected with M. tuberculosis (Mtb) or other mycobacteria.
Secondary:
- To determine if the 2 investigational products have equivalent specificity for detecting subjects currently or previously infected with Mtb;
- To assess the tolerability of the investigational products in terms of the local and systemic reactogenicity events.
- Conditions
- Tuberculosis Infection
- Being tested
- Aplisol@ PPD material, Reference Standard
- Keywords
- TB, Aplisol
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aplisol@ PPD materialBiological
Also called Aplisol@
Determine equivalency of materials
Reference StandardBiological
Also called US Reference Standard
Reference standard material for comparison to newly produced materials.
| Study group | Role | What they receive |
|---|---|---|
| Aplisol | Experimental | To confirm the response of PPD materials Receives: Biological: Aplisol@ PPD material; Biological: Reference Standard |
| PPD Standard | Active comparator | Determine equivalent specificity for new material compared to standard material. Receives: Biological: Aplisol@ PPD material; Biological: Reference Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of similarity in responses
To determine if the 2 investigational products (Aplisol formulated from the new Tuberculin PPD drug substance and the reference standard PPD-S2) produce qualitatively similar responses (positive or negative) in subjects who are uninfected with M. tuberculosis (Mtb) or other mycobacteria.Skin test responses will be used to determine product similarity in responses.
Measured: 72 hours
Secondary outcomes (1)
Determine equivalent specificity
To determine if the 2 investigational products have equivalent specificity for detecting subjects currently or previously infected with Mtb; 2) To assess the tolerability of the investigational products in terms of the localand systemic reactogenicity events. Skin responses to new PPD and reference standard will be monitored to determine equivalent specificity.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JHP Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798095
- Sponsor's protocol ID
- JHP-03
- Acronym
- 03
- Status last verified
- Feb 2013
- First submitted
- 31 Jan 2013
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Equivalence Study of the Specificity of Tuberculin Purified Protein Derivative (PPD) (Aplisol®) in Comparison With a Reference Standard
- ClinicalTrials.gov ID
- NCT01798095
- Acronym / sponsor ID
- 03 / JHP-03
- Conditions
- Tuberculosis Infection
- Keywords
- TB, Aplisol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- JHP Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- Feb 2013
- Primary completion
- May 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine if investigational products and reference standard produce similar responses.
Detailed description
Primary:
To determine if the 2 investigational products (Aplisol formulated from the new Tuberculin PPD drug substance and the reference standard PPD-S2) produce qualitatively similar responses (positive or negative) in subjects who are uninfected with M. tuberculosis (Mtb) or other mycobacteria.
Secondary:
- To determine if the 2 investigational products have equivalent specificity for detecting subjects currently or previously infected with Mtb;
- To assess the tolerability of the investigational products in terms of the local and systemic reactogenicity events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aplisol | Experimental | Biological: Aplisol@ PPD material, Biological: Reference StandardTo confirm the response of PPD materials |
| PPD Standard | Active comparator | Biological: Aplisol@ PPD material, Biological: Reference StandardDetermine equivalent specificity for new material compared to standard material. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Males or nonpregnant females, age 18 to 70 years
Key exclusion criteria (9 listed)
- Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
- Protocol No. JHP-Aplisol-03 Confidential 04 May 2012 Page 8 of 38
- Acute viral infections, including measles, mumps, chicken pox, human immunodeficiency virus (HIV1, HIV2). Mild viral syndromes are allowed.
- Acute bacterial infections including typhoid fever, brucellosis, typhus, leprosy, or pertussis
- Acute systemic fungal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aplisol@ PPD materialAlso: Aplisol@Determine equivalency of materials | Biological | Aplisol, PPD Standard |
| Reference StandardAlso: US Reference StandardReference standard material for comparison to newly produced materials. | Biological | Aplisol, PPD Standard |
Primary outcome
Determination of similarity in responses
Time frame: 72 hours
To determine if the 2 investigational products (Aplisol formulated from the new Tuberculin PPD drug substance and the reference standard PPD-S2) produce qualitatively similar responses (positive or negative) in subjects who are uninfected with M. tuberculosis (Mtb) or other mycobacteria.Skin test responses will be used to determine product similarity in responses.
1 secondary outcome
Determine equivalent specificity
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene Lund, B.Sc. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aplisol@ PPD material and Reference Standard in people with Tuberculosis Infection, run by JHP Pharmaceuticals LLC at 1 site in United States.
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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Feb 2013. 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 United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arlene Lund, B.Sc. (919-985-3220), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of similarity in responses (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2013; AzTrials last refreshed its copy on 6 Nov 2026.