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

University of South Florida

Status: Unknown

Conditions: Primary Immune Deficiency Diseases

Treatments: Biological: Bacteriophage OX174

Study type: Interventional

Funder types: Other

Identifiers

NCT01617122

ACH 03-0120

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 2 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Bacteriophage

Experimental group

Description:

Subjects receive bacteriophage vaccinations and blood draws

Treatment:

Biological: Bacteriophage OX174