Evaluate Bacteriophage as a Useful Immunogen in Patients... | NCT01617122

Studies
Evaluate Bacteriophage as a Useful Immunogen in Patients With Primary Immune Deficiency Diseases (PIDD)

NCT01617122

Sponsor

University of South Florida

Status

Unknown status

Last Update Posted

Jul 17, 2012Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Primary Immune Deficiency Diseases

Interventions

Bacteriophage OX174

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1995

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Aug 5, 2010

First Submission Date that Met QC Criteria

Jun 8, 2012

First Posted Date

Jun 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2012

Last Update Posted Date

Jul 17, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This protocol is designed to ascertain whether the bacteriophage 0X174 neoantigen is safe and effective as an antigen used in the evaluation of primary and secondary immune responses. Bacteriophage 0X174 is given intravenously 2 billion PFU/Kg of body weight; small blood specimens of 3-5 ml (about 1 teaspoon) are collected after 15 minutes, 7 days, 14 days, and 28 days. Blood is collected at intervals following the administration of the bacteriophage and the number of phage/ml is determined by the agar overlay method using suspension of E. coli C and serially diluted patient's serum. Phage-specific IgG and IgM are measured by neutralization assay. Capacity of switch from IgM to IgG is determined.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bacteriophage	Experimental	Subjects receive bacteriophage vaccinations and blood draws	Biological: Bacteriophage OX174

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bacteriophage OX174	Biological	Give first dose of bacteriophage (2 x 109 PFU/kg body weight (0.02 ml/kg)) at visit one. Obtain labs prior to vaccine, 15 minutes, 1 week, 2 weeks, and 4 weeks after vaccine. 6 weeks after 1st vaccine, obtain blood, give 2nd dose of bacteriophage, obtain labs 15 minutes, 1 week, 2 weeks, and 4 weeks after vaccine. Selected patients may receive a tertiary vaccine.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evidence of capacity of switch from IgM to IgG.	Blood samples are obtained after each immunizition of Bacteriophage.	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subject/parent or guardian willing to sign consent and adhere to study schedule
known or suspected primary immune deficiency

Exclusion Criteria:

pregnancy
breastfeeding
unwilling to sign consent or adhere to study schedule
< 2 yrs of age or > 85 yrs of age
previous reaction to vaccine

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carla Duff, RN BSN CCRP	Contact	727-553-3515		cduff@health.usf.edu
Amy Kramer	Contact	727-553-1258		akramer@health.usf.edu

Overall Officials

Name	Affiliation	Role
John W Sleasman, MD	University of South Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of South Florida	Recruiting	St. Petersburg	Florida	33701	United States

Condition Browse Module

MeSH Terms

ID	Term
D000081207	Primary Immunodeficiency Diseases
D000084063	Reinfection

Ancestor Terms

ID	Term
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided