Status:
COMPLETED
Evaluation and Treatment of Eye Complications of Vaccinia Vaccination
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Vaccinia
Eligibility:
All Genders
1+ years
Phase:
PHASE2
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 pr...
Detailed Description
Vaccinia virus (a live but relatively weak relative of smallpox and cowpox) is used to vaccinate people against the development of smallpox (variola) resulting from an infection with the viral genus O...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- To be eligible to enroll in this study, a prospective participant must satisfy all of the following inclusion criteria:
- 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.
- EXCLUSION CRITERIA:
- To be randomized to the VIGIV/placebo treatment, a proposed participant must not satisfy the following exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
April 19 2004
Trial Type :
INTERVENTIONAL
End Date :
August 15 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00081835
Start Date
April 19 2004
End Date
August 15 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892