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

To Evaluate Bacteriophage OX174 Antigen as a Useful Immunogen in Patients With Immune Deficiency

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01617122

Acronym

Bacteriophage

Enrollment

200

Registered

2012-06-12

Start date

1995-10-31

Completion date

2015-12-31

Last updated

2012-07-17

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

Conditions

Primary Immune Deficiency Diseases

Keywords

PID, PIDD, antibody deficiency, CVID, recurrent infections

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.

Interventions

BIOLOGICALBacteriophage 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactCarla Duff, RN BSN CCRP

cduff@health.usf.edu727-553-3515

Backup ContactAmy Kramer

akramer@health.usf.edu727-553-1258

Outcome results

None listed

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