NCT00081835

Evaluation and Treatment of Eye Complications of Vaccinia Vaccination

Completed Phase 2 Last updated 2 July 2017

What this trial tests

Phase 2 trial testing NP-016 Vaccine Immune Globulin (IV-VIG) in Vaccinia in 400 participants. Completed in 15 August 2007.

Timeline

19 April 2004

15 August 2007

Quick facts

Lead sponsor	National Eye Institute (NEI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	400
Start date	19 April 2004
Estimated completion	15 August 2007
Sites	1 location across United States

Drugs / interventions tested

• NP-016 Vaccine Immune Globulin (IV-VIG) — full drug profile →

Conditions studied

• Vaccinia — all drugs for Vaccinia →

Sponsor

National Eye Institute (NEI)

Who can join

1 and older, any sex, with Vaccinia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.