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Evaluation and Treatment of Ocular Complications of Vaccinia Vaccination: Suitability of NP-016 Vaccinia Immune Globulin (VIG) for Sight-Threatening Conditions [VIG31] Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Evaluation and Treatment of Ocular Complications of Vaccinia Vaccination: Suitability of NP-016 Vaccinia Immune Globulin (VIG) for Sight-Threatening Conditions [VIG31] conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Evaluation and Treatment of Ocular Complications of Vaccinia Vaccination: Suitability of NP-016 Vaccinia Immune Globulin (VIG) for Sight-Threatening Conditions [VIG31] Clinical research trials and Evaluation and Treatment of Ocular Complications of Vaccinia Vaccination: Suitability of NP-016 Vaccinia Immune Globulin (VIG) for Sight-Threatening Conditions [VIG31] health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Evaluation and Treatment of Ocular Complications of Vaccinia Vaccination: Suitability of NP-016 Vaccinia Immune Globulin (VIG) for Sight-Threatening Conditions [VIG31]. Evaluation and Treatment of Ocular Complications of Vaccinia Vaccination: Suitability of NP-016 Vaccinia Immune Globulin (VIG) for Sight-Threatening Conditions [VIG31] Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Evaluation and Treatment of Ocular Complications of Vaccinia Vaccination: Suitability of NP-016 Vaccinia Immune Globulin (VIG) for Sight-Threatening Conditions [VIG31] clinical trial. Human subjects often get the best healthcare available for their Evaluation and Treatment of Ocular Complications of Vaccinia Vaccination: Suitability of NP-016 Vaccinia Immune Globulin (VIG) for Sight-Threatening Conditions [VIG31] condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Evaluation and Treatment of Ocular Complications of Vaccinia Vaccination: Suitability of NP-016 Vaccinia Immune Globulin (VIG) for Sight-Threatening Conditions [VIG31]  Evaluation and Treatment of Ocular Complications of Vaccinia Vaccination: Suitability of NP-016 Vaccinia Immune Globulin (VIG) for Sight-Threatening Conditions [VIG31]
Evaluation and Treatment of Ocular Complications of Vaccinia Vaccination: Suitability of NP-016 Vaccinia Immune Globulin (VIG) for Sight-Threatening Conditions [VIG31]
For Condition:
Status: Recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: 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 Orthopoxvirus. Following centuries of attempts to control the smallpox virus, Edward Jenner determined in 1776 that a normally harmless cowpox infection would render humans immune from the dreaded disease. Smallpox was thought to be eradicated worldwide during the 1970's and is still considered extinct in nature. However, some smallpox cultures have been retained in the laboratories of several countries and may pose a potential threat if used as a biological weapon. This has recently led to programs where mass-inoculations with vaccinia have been initiated throughout the U.S. Vaccination against smallpox using vaccinia can result in complications. Reactions are rarely serious or life threatening, but one of the most common serious complications occur in and around the eye. This occurs when a person transfers vaccinia viruses by touch from their primary inoculation site to their own eyes (auto-inoculation). Accidental exposure can also occur in the laboratory or by contact with a vaccinated person. Ocular involvement may be confined to the lids or conjunctiva but may easily be transferred to the cornea. Keratitis can result in scarring that could have a severe and permanent impact on vision. Even when the cornea is not affected, extensive lesions on the lid or other ocular tissues can lead to additional sight-threatening complications. While all participants will be provided standard-of-care antiviral treatments for ocular complications, there is clinical uncertainty as to whether NP-016 Vaccinia Immune Globulin (VIG) will decrease or increase corneal scarring. This study is a randomized, placebo-controlled trial to investigate the impact of intravenous NP-016 Vaccinia Immune Globulinon corneal scarring in participants with ocular complications of vaccinia infection. Further knowledge about the biologic mechanisms of complications associated with vaccinia vaccination and rapid diagnostic tests may lead to more effective forms of therapy.
Details: 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 Orthopoxvirus. Following centuries of attempts to control the smallpox virus, Edward Jenner determined in 1776 that a normally harmless cowpox infection would render humans immune from the dreaded disease. Smallpox was thought to be eradicated worldwide during the 1970's and is still considered extinct in nature. However, some smallpox cultures have been retained in the laboratories of several countries and may pose a potential threat if used as a biological weapon. This has recently led to programs where mass-inoculations with vaccinia have been initiated throughout the U.S. Vaccination against smallpox using vaccinia can result in complications. Reactions are rarely serious or life threatening, but one of the most common serious complications occur in and around the eye. This occurs when a person transfers vaccinia viruses by touch from their primary inoculation site to their own eyes (auto-inoculation). Accidental exposure can also occur in the laboratory or by contact with a vaccinated person. Ocular involvement may be confined to the lids or conjunctiva but may easily be transferred to the cornea. Keratitis can result in scarring that could have a severe and permanent impact on vision. Even when the cornea is not affected, extensive lesions on the lid or other ocular tissues can lead to additional sight-threatening complications. While all participants will be provided standard-of-care antiviral treatments for ocular complications, there is clinical uncertainty as to whether NP-016 Vaccinia Immune Globulin (VIG) will decrease or increase corneal scarring. This study is a randomized, placebo-controlled trial to investigate the impact of intravenous NP-016 Vaccinia Immune Globulinon corneal scarring in participants with ocular complications of vaccinia infection. Further knowledge about the biologic mechanisms of complications associated with vaccinia vaccination and rapid diagnostic tests may lead to more effective forms of therapy.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: To be eligible to enroll in this study, a prospective participant must satisfy all of the following inclusion criteria: 1. 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. 2. 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. 3. Have signs and symptoms consistent with ocular vaccinia. 4. To be eligible for randomization at the time of enrollment (or at any time during the study if the participant was not randomized at enrollment) the participant must have ocular features consistent with of any one or more of the following: Keratitis- corneal ulcer, stromal haze or infiltrate at any level of severity. Severe Conjunctivitis- at least one of these: membrane, ulceration/epithelial breakdown, focal lesion. Mild or Severe Blepharitis- pustules involving at least 1/3 of lid margin, edema and hyperemia. EXCLUSION CRITERIA: To be randomized to the VIG/placebo treatment, a proposed participant must not satisfy the following exclusion criteria: 1. Children with body weight less than 10 kg. 2. Have a known severe reaction to the IV or IM administration of human immunoglobulin. 3. Have a known IgA deficiency or other immune deficiency. 4. 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 VIG. 5. Is already receiving VIG. 6. Pregnant women, unless an approved, specific additional consent statement attesting to awareness of the unknown risk of VIG therapy during pregnancy is understood and signed by the participant. 7. Have orbital cellulites.
Total Enrollment: 200
Location and Contact Information:
National Eye Institute (NEI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 040157; 04-EI-0157
Study Start Date: April 19, 2004
Record last reviewed: March 17, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081835
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Evaluation and Treatment of Ocular Complications of Vaccinia Vaccination: Suitability of NP-016 Vaccinia Immune Globulin (VIG) for Sight-Threatening Conditions [VIG31]
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