Recruiting

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

Sponsor:

University of South Florida

Code:

NCT01617122

Conditions

Primary Immune Deficiency Diseases

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

Interventions

Bacteriophage OX174

Study Details

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.

Conditions

Primary Immune Deficiency Diseases

Study ID

NCT01617122

Start date

Oct, 1995

Status verified date

Jul, 2012

Completion date

Dec, 2015

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. pregnancy
2. breastfeeding
3. unwilling to sign consent or adhere to study schedule
4. < 2 yrs of age or > 85 yrs of age
5. previous reaction to vaccine

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Bacteriophage

Subjects receive bacteriophage vaccinations and blood draws

Interventions

Bacteriophage OX174

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.

Primary outcome measure

Evidence of capacity of switch from IgM to IgG. [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Carla Duff, RN BSN CCRP

727-553-3515 cduff@health.usf.edu

Amy Kramer

727-553-1258 akramer@health.usf.edu

Locations

University of South Florida

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Carla Duff, RN BSN CCRP

727-553-3515 cduff@health.usf.edu

Amy Kramer

727-553-1258 akramer@health.usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Jul 17, 2012

Last verified

Jul, 2012

Keywords

PID
PIDD
antibody deficiency
CVID
recurrent infections

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2012-07-17.