Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard (PPD-S2) (02)

JHP Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Tuberculosis Identification.

Treatments: Biological: Reference standard; Biological: To compare new PPD to reference standard material

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01798121

JHP-Aplisol-02

Details and patient eligibility

About

A study to determine bioequivalence of PPD material versus Reference Standard.

Full 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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

90 participants in 2 patient groups, including a placebo group

Aplisol

Experimental group

Description:

To compare new PPD to reference standard material

Treatment:

Biological: To compare new PPD to reference standard material

Biological: Reference standard

Reference standard

Placebo Comparator group

Description:

Response of standard material

Treatment:

Biological: To compare new PPD to reference standard material