Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard (PPD-S2)

NCT ID: NCT01798121

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-07-31

Brief Summary

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).

Conditions

Tuberculosis Identification.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: DOUBLE

Study Groups

Aplisol

To compare new PPD to reference standard material

Group Type: EXPERIMENTAL

To compare new PPD to reference standard material

Intervention Type: BIOLOGICAL

Aplisol@ will be compared to reference standard material

Reference standard

Intervention Type: BIOLOGICAL

Response of reference standard material compared to Aplisol@.

Reference standard

Response of standard material

Group Type: PLACEBO_COMPARATOR

To compare new PPD to reference standard material

Intervention Type: BIOLOGICAL

Aplisol@ will be compared to reference standard material

Interventions

To compare new PPD to reference standard material

Aplisol@ will be compared to reference standard material

Intervention Type: BIOLOGICAL

Reference standard

Response of reference standard material compared to Aplisol@.

Intervention Type: BIOLOGICAL

Other Intervention Names

Aplisol@; Tuberculin PPD Standard.

Eligibility Criteria

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 acc

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 prepar

6. Comprehension of the study requirements; expressed availability for the required study period, including readings at the nomina

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

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

5. Presence of conditions that may suppress TST reactivity -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

JHP Pharmaceuticals LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Arlene Lund, B.Sc.

Role: CONTACT

arlene.lund@incresearch.com

919-985-3220

Other Identifiers

JHP-Aplisol-02

Identifier Type: -

Identifier Source: org_study_id