Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)

Tuberculosis Infection Clinical Trial

Official title:

Dose Comparison Study of Tuberculin Purified Protein Derivative (PPD)With Standard Tuberculin Purified Protein Derivative.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01689831
• Other study ID #: JHP - 42023
• Status: Recruiting
• Phase: Phase 2
• First received: July 3, 2012
• Last updated: September 18, 2012
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: September 2012
• Source: JHP Pharmaceuticals LLC
• Contact: Cyndy Hughes
• Phone: 919-876-9300
• Email: Cyndy.Hughes[@]INCResearch.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).

Description:

JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new Tuberculin PPD drug substance to the standard PPD-S2.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Males or nonpregnant females age 18 to 60 years

2. 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.

3. Give written informed consent to participate

4. Generally healthy, as determined by medical history and targeted physical examination, if indicated

5. 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

6. Comprehension of the study requirements; expressed availability for the required study period, including readings at the nominal time points of 48 and 72 hours

Exclusion Criteria:

1. Prior PPD test within the past 30 days

2. Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating

3. History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in the past

4. 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

5. Presence of conditions that may suppress TST reactivity

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis Infection

Intervention

Biological:
• 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.
• Reactivity of Aplisol compared to reference standard PPD-S2.
Reference standard PPD-S2 formulated to contain different dose concentrations.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Tyler	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
JHP Pharmaceuticals LLC	INC Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirm the potency of Aplisol equipotent to PPD-S2.		72 hours	No
Secondary	Assess tolerability of Aplisol with new tuberculin PPD		72 hours	No