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

A Randomized, Double-blind, Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard Tuberculin Purified Protein Derivative (PPD-S2) for Detection of Tuberculosis in Subjects With a Confirmed Diagnosis of Tuberculosis.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01798121

Acronym

Enrollment

Registered

2013-02-25

Start date

2013-02-28

Completion date

2013-07-31

Last updated

2013-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis Identification.

Keywords

PPD, Tuberculosis

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).

Interventions

BIOLOGICALTo compare new PPD to reference standard material

Aplisol@ will be compared to reference standard material

BIOLOGICALReference standard

Response of reference standard material compared to Aplisol@.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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 -

Design outcomes

Primary

Measure	Time frame	Description
Compare new PPD to Reference Standard	72 hours	Determine bio-equivalence of material used in trial by means of dose response and reaction sizes in patients.

Contacts

Primary ContactArlene Lund, B.Sc.

arlene.lund@incresearch.com919-985-3220

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026