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

Status unconfirmed · Not applicable

Conditions studied: Primary Immune Deficiency Diseases

In brief

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.

Key facts

Study ID

NCT01617122

Run by

University of South Florida

People needed

200

Starts

1995-10-01

Expected to finish

2015-12-01

Last updated by the study team

2012-07-17

Who can join

Age: 2 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• University of South Florida — St. Petersburg, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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