Suspended

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

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What is being tested

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.

+ To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.

Biological
Who is being recruted

Latent Infection+6

+ Actinomycetales Infections

+ Bacterial Infections and Mycoses

From 18 to 60 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 2
Interventional
Study Start: May 2012
See protocol details

Summary

Principal SponsorJHP Pharmaceuticals LLC
Study ContactCyndy HughesMore contacts
Last updated: September 21, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01689831
Principal SponsorJHP Pharmaceuticals LLC
Study ContactCyndy HughesMore contacts
Last updated: September 21, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

168 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Latent InfectionActinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsInfectionsMycobacterium InfectionsTuberculosisGram-Positive Bacterial InfectionsLatent Tuberculosis

Criteria

6 inclusion criteria required to participate
Comprehension of the study requirements; expressed availability for the required study period, including readings at the nominal time points of 48 and 72 hours
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
Generally healthy, as determined by medical history and targeted physical examination, if indicated
Give written informed consent to participate
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5 exclusion criteria prevent from participating
History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in the past
Presence of conditions that may suppress TST reactivity
Prior PPD test within the past 30 days
Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.

Group II

Active Comparator
Reactivity of Aplisol compared to reference standard PPD-S2.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

The University of Texas Health Science Center at Tyler

Tyler, United StatesOpen The University of Texas Health Science Center at Tyler in Google Maps
SuspendedOne Study Center