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

Phase 2

• Conditions: Tuberculosis Infection
• Interventions: 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.

• Registration Number: NCT01689831
• Lead Sponsor: JHP Pharmaceuticals LLC

Brief Summary

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-03
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-18
• Last Update Submitted: 2012-09-18
• Study First Posted: 2012-09-21
• Last Update Posted: 2012-09-21
• Primary Completion: 2012-10
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aplisol, potency determination	To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.	To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
Aplisol, potency determination	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	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.
Reference standard PPD-S2, reference	Reactivity of Aplisol compared to reference standard PPD-S2.	Reactivity of Aplisol compared to reference standard PPD-S2.

Primary Outcome Measures

Name	Time	Method
Confirm the potency of Aplisol equipotent to PPD-S2.	72 hours

Secondary Outcome Measures

Name	Time	Method
Assess tolerability of Aplisol with new tuberculin PPD	72 hours

Trial Locations

Locations (1)

The University of Texas Health Science Center at Tyler; 🇺🇸 Tyler, Texas, United States