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Evaluation and Treatment of Eye Complications of Vaccinia Vaccination

NCT00081835 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2017-07-02

No results posted yet for this study

Summary

This study will evaluate patients with eye complications related to vaccination against smallpox to learn more about these conditions. Vaccinia vaccination has been used for more than 100 years for preventing smallpox. A small number of people who receive the vaccination (less than 1 in 1,000) develop complications, sometimes in their eyes. This usually results from the accidental transfer of the infection from the vaccination site to the face or eyes, perhaps by touching the vaccination area and then the face or eyelids before washing the hands. The study will also examine whether an experimental treatment called NP-016 vaccinia immune globulin can reduce corneal scarring that is sometimes associated with serious vaccinia complications and can impair vision.

Children and adults with keratitis, severe conjunctivitis, or blepharitis following exposure to vaccinia vaccination may be eligible for this study. Children must weigh at least 10 kg.

Participants undergo the following tests and procedures at enrollment, with some tests repeated at scheduled study visits:

1. Medical history and physical examination
2. Infectious disease consultation
3. Complete eye evaluation including:

* Fundus photography to examine the back of the eye - dilation of the pupils with eye drops to examine and photograph the back of the eye
* Slit lamp biomicroscopy - evaluation of the front part of the eye with a slit lamp microscope
* Eye pressure measurements
* Eye swab to look for vaccinia virus or other causes of disease
4. Blood tests
5. Photographs and documentation of eye and skin lesions
6. Vaccinia diagnostic tests, such as skin or mucosa scrapings; blood, throat, or urine cultures; and tissue biopsies, if needed

Patients begin treatment with standard medications for their eye disease, such as trifluridine (Viroptic® (Registered Trademark)) anti-viral eye drops. Patients whose condition becomes serious are offered additional treatment with intravenous (through a vein) infusions of either VIG or placebo (salt water solution with no active drug) and are randomly assigned to one or the other treatment group. All patients continue standard-of-care treatment as well.

Follow-up visits at the NIH eye clinic are scheduled as required by the patient's condition. Patients with mild complications who are taking only standard medications may need to be seen only 1 month after the initial visit and then 6 months and 12 months later. Patients with more serious conditions who qualify for VIG or placebo treatments may be seen daily for a week, then once a week for the rest of the first month, and then at 6 months and 12 months, unless more frequent treatment or observation is required.

Conditions

  • Vaccinia

Interventions

DRUG

NP-016 Vaccine Immune Globulin (IV-VIG)

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-19
Completion
2007-08-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00081835 on ClinicalTrials.gov