Evaluation and Treatment of Eye Complications of Vaccinia Vaccination

NCT00081835 | Completed Phase 2

• 2 other identifiers: 04015704-EI-0157
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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:

• 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
• Blood tests
• Photographs and documentation of eye and skin lesions
• Vaccinia diagnostic tests, such as skin or mucosa scrapings; blood, throat, or urine cultures; and tissue biopsies, if needed

Conditions

Vaccinia

Keywords

Smallpox; Cowpox; Corneal Ulcer; Keratitis; Immune Response, Vaccine; Cornea; Vaccinia; Vaccinia Immune Globulin (VIG); Conjunctivitis; Vaccinia Vaccination; Smallpox Vaccination

Interventions

NP-016 Vaccine Immune Globulin (IV-VIG) DRUG

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant, or their parent or guardian if younger than 18 years at enrollment, is able to understand and sign an approved consent form. Any minor participant with adequate reading and writing skills must also sign an assent using a form approved by the local Institutional Review Board or Independent Ethics Committee (IRB/IEC). Minors with verbal skills but without adequate reading and writing skills should have an acknowledgement signed by their parent or guardian to certify that verbal assent to participate was obtained.
• The participant must have received the vaccinia vaccination, been exposed to a person vaccinated with vaccinia who has skin lesions, or been exposed directly to accidental splash of the vaccine.
• Have signs and symptoms consistent with ocular vaccinia.
• To be eligible for randomization the participant must have corneal involvement defined as a keratitis with any abnormality of the epithelium, stroma, or endothelium consistent with vaccinia infection.

You may not qualify if:

• Children with body weight less than 10 kg.
• Have a known severe reaction to the IV or IM administration of human immunoglobulin.
• Have known severe acute allergic reactions to the non-active ingredients of polysorbate 80, maltose, or the trace amounts of TNBP or Triton X-100 used in the preparation of VIGIV.
• Has received VIGIV within 6 months prior to randomization.
• Pregnant women, unless an approved, specific additional consent statement attesting to awareness of the unknown risk of VIGIV therapy during pregnancy is understood and signed by the participant.
• Have orbital cellulites.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Ruben FL, Lane JM. Ocular vaccinia. An epidemiologic analysis of 348 cases. Arch Ophthalmol. 1970 Jul;84(1):45-8. doi: 10.1001/archopht.1970.00990040047012. No abstract available.

  PMID: 5423606 BACKGROUND

MeSH Terms

Conditions

Vaccinia; Smallpox; Cowpox; Corneal Ulcer; Keratitis; Corneal Diseases; Conjunctivitis

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Eye Infections; Eye Diseases; Conjunctival Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 22, 2004
• First Posted: April 22, 2004
• Study Start: April 19, 2004
• Study Completion: August 15, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-08-15

Locations

US (1)