Tuberculosis Identification.Phase 202NCT01798121
Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard (PPD-S2)
A Phase 2 study testing To compare new PPD to reference standard material and Reference standard in people with Tuberculosis Identification., run by JHP Pharmaceuticals LLC.
Trial summary
A study to determine bioequivalence of PPD material versus Reference Standard. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis Identification.
- What is being tested?
- To compare new PPD to reference standard material and Reference standard
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- 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 60 years
- Documented PPD reactivity of 5 to 21 mm in the past, documented in a medical record. Self-reported PPD reactivity will be acc
- Give written informed consent to participate
- Generally healthy, as determined by medical history and targeted physical examination, if indicated
- Possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study prepar
- Comprehension of the study requirements; expressed availability for the required study period, including readings at the nomina
Who cannot join
- Prior PPD test within the past 30 days
- Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
- History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in
- Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is
- Presence of conditions that may suppress TST reactivity -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind, Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard Tuberculin Purified Protein Derivative (PPD-S2) for Detection of Tuberculosis in Subjects With a Confirmed Diagnosis of Tuberculosis.
A study to determine bioequivalence of PPD material versus Reference Standard.
Read the detailed description
This study is a multicenter, double-blind, active-controlled parallel-group study to determine the bioequivalence of newly produced PPD material versus PPD-S2 in the detection of male and female subjects with current or previously diagnosed intrathoracic Mtb infection, as documented by a positive culture for Mtb (preferred method), by their primary care or attending physician and/or by the subject's current or prior medical records (ie, sensitivity determination).
- Conditions
- Tuberculosis Identification.
- Being tested
- To compare new PPD to reference standard material, Reference standard
- Keywords
- PPD, Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To compare new PPD to reference standard materialBiological
Also called Aplisol@
Aplisol@ will be compared to reference standard material
Reference standardBiological
Also called Tuberculin PPD Standard.
Response of reference standard material compared to Aplisol@.
| Study group | Role | What they receive |
|---|---|---|
| Aplisol | Experimental | To compare new PPD to reference standard material Receives: Biological: To compare new PPD to reference standard material; Biological: Reference standard |
| Reference standard | Placebo comparator | Response of standard material Receives: Biological: To compare new PPD to reference standard material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare new PPD to Reference Standard
Determine bio-equivalence of material used in trial by means of dose response and reaction sizes in patients.
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 completionMar 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 Identification.Studies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 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
- NCT01798121
- Sponsor's protocol ID
- JHP-Aplisol-02
- Acronym
- 02
- 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 Tuberculin Purified Protein Derivative in Comparison With a Reference Standard Tuberculin Purified Protein Derivative (PPD-S2) for Detection of Tuberculosis in Subjects With a Confirmed Diagnosis of Tuberculosis.
- ClinicalTrials.gov ID
- NCT01798121
- Acronym / sponsor ID
- 02 / JHP-Aplisol-02
- Conditions
- Tuberculosis Identification.
- Keywords
- PPD, Tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- JHP Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- Feb 2013
- Primary completion
- Mar 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.
A study to determine bioequivalence of PPD material versus Reference Standard.
Detailed description
This study is a multicenter, double-blind, active-controlled parallel-group study to determine the bioequivalence of newly produced PPD material versus PPD-S2 in the detection of male and female subjects with current or previously diagnosed intrathoracic Mtb infection, as documented by a positive culture for Mtb (preferred method), by their primary care or attending physician and/or by the subject's current or prior medical records (ie, sensitivity determination).
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aplisol | Experimental | Biological: To compare new PPD to reference standard material, Biological: Reference standardTo compare new PPD to reference standard material |
| Reference standard | Placebo comparator | Biological: To compare new PPD to reference standard materialResponse of standard material |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males or nonpregnant females age 18 to 60 years
- Documented PPD reactivity of 5 to 21 mm in the past, documented in a medical record. Self-reported PPD reactivity will be acc
- Give written informed consent to participate
- Generally healthy, as determined by medical history and targeted physical examination, if indicated
- Possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study prepar
Key exclusion criteria (5 listed)
- Prior PPD test within the past 30 days
- Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
- History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in
- Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is
- Presence of conditions that may suppress TST reactivity -
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 |
|---|---|---|
| To compare new PPD to reference standard materialAlso: Aplisol@Aplisol@ will be compared to reference standard material | Biological | Aplisol, Reference standard |
| Reference standardAlso: Tuberculin PPD Standard.Response of reference standard material compared to Aplisol@. | Biological | Aplisol |
Primary outcome
Compare new PPD to Reference Standard
Time frame: 72 hours
Determine bio-equivalence of material used in trial by means of dose response and reaction sizes in patients.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing To compare new PPD to reference standard material and Reference standard in people with Tuberculosis Identification., run by JHP Pharmaceuticals LLC.
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 6 inclusion and 5 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.
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 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, arlene.lund@incresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare new PPD to Reference Standard (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.