Tuberculosis InfectionPhase 2NCT01689831
Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)
A Phase 2 study testing To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard. and Reactivity of Aplisol compared to reference standard PPD-S2. in people with Tuberculosis Infection, run by JHP Pharmaceuticals LLC at 1 site in United States.
Trial summary
Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2). 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?
- To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard. and Reactivity of Aplisol compared to reference standard PPD-S2.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2012
- 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 accepted if medical records cannot be obtained.
- 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 preparation or the readings of the injections
- Comprehension of the study requirements; expressed availability for the required study period, including readings at the nominal time points of 48 and 72 hours
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 the past
- Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is uncertain of his/her BCG vaccination status
- Presence of conditions that may suppress TST reactivity
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
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: Dose Comparison Study of Tuberculin Purified Protein Derivative (PPD)With Standard Tuberculin Purified Protein Derivative.
Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).
Read the detailed description
JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new Tuberculin PPD drug substance to the standard PPD-S2.
- Conditions
- Tuberculosis Infection
- Being tested
- To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard., Reactivity of Aplisol compared to reference standard PPD-S2.
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.Biological
Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.
Reactivity of Aplisol compared to reference standard PPD-S2.Biological
Also called Reference standard PPD-S2.
Reference standard PPD-S2 formulated to contain different dose concentrations.
| Study group | Role | What they receive |
|---|---|---|
| Aplisol, potency determination | Experimental | To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard. Receives: Biological: To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.; Biological: Reactivity of Aplisol compared to reference standard PPD-S2. |
| Reference standard PPD-S2, reference | Active comparator | Reactivity of Aplisol compared to reference standard PPD-S2. Receives: Biological: To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.; Biological: Reactivity of Aplisol compared to reference standard PPD-S2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm the potency of Aplisol equipotent to PPD-S2.
Measured: 72 hours
Secondary outcomes (1)
Assess tolerability of Aplisol with new tuberculin PPD
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 posted21 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (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
- 168 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
- NCT01689831
- Sponsor's protocol ID
- JHP - 42023
- Status last verified
- Sep 2012
- First submitted
- 3 Jul 2012
- Last updated
- 21 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Comparison Study of Tuberculin Purified Protein Derivative (PPD)With Standard Tuberculin Purified Protein Derivative.
- ClinicalTrials.gov ID
- NCT01689831
- Acronym / sponsor ID
- JHP - 42023
- Conditions
- Tuberculosis Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- JHP Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- May 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 Sep 2012 (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.
Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).
Detailed description
JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new Tuberculin PPD drug substance to the standard PPD-S2.
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, potency determination | Experimental | Biological: To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard., Biological: Reactivity of Aplisol compared to reference standard PPD-S2.To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard. |
| Reference standard PPD-S2, reference | Active comparator | Biological: To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard., Biological: Reactivity of Aplisol compared to reference standard PPD-S2.Reactivity of Aplisol compared to reference standard PPD-S2. |
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 accepted if medical records cannot be obtained.
- 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 preparation or the readings of the injections
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 the past
- Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is uncertain of his/her BCG vaccination status
- 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 confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2. | Biological | Aplisol, potency determination, Reference standard PPD-S2, reference |
| Reactivity of Aplisol compared to reference standard PPD-S2.Also: Reference standard PPD-S2.Reference standard PPD-S2 formulated to contain different dose concentrations. | Biological | Aplisol, potency determination, Reference standard PPD-S2, reference |
Primary outcome
Confirm the potency of Aplisol equipotent to PPD-S2.
Time frame: 72 hours
1 secondary outcome
Assess tolerability of Aplisol with new tuberculin PPD
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 21 Sep 2012.
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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.
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 To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard. and Reactivity of Aplisol compared to reference standard PPD-S2. 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 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 21 Sep 2012. 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 Cyndy Hughes (919-876-9300, Cyndy.Hughes@INCResearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm the potency of Aplisol equipotent to PPD-S2. (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 21 Sep 2012.