Protocol Number: 03-I-0151

Title:

Evaluation and Treatment of Persons with Serious Complications Associated with Vaccinia Vaccination

Number:

03-I-0151

Summary:

This study will evaluate people with complications associated with vaccinia (smallpox) vaccination. Vaccinia inoculation has been used for more than 100 years as the vaccination against smallpox. Some people, however, can develop serious or even life-threatening complications from the vaccine. This study will evaluate these individuals in order to learn more about:

- how to diagnose and treat complications of vaccinia virus;

- how the virus causes these complications; and,

- how the body fights the virus and whether the attempt to fight the virus contributes to the complications.

- Anyone who has received smallpox inoculation (except children who weigh less than 10 kilograms, or 22 pounds) or was exposed to someone who was recently vaccinated, and has an illness that is likely due to the vaccination may be eligible for this study. The illness has to have started within 30 days of vaccination or exposure.

Complications of smallpox vaccination include:

- inadvertent inoculation - spread of the vaccine virus from the vaccination site by direct contact to a distant site or to another person, with the development of skin or eye lesions;

- generalized vaccinia - spread of the vaccine virus from the vaccination site by the bloodstream few or multiple distant sites;

- erythema multiforme - development of a specific rash (often with a bulls-eye appearance)

- eczema vaccinatum - development of extensive skin lesions in people who may have had eczema in the past or who currently have eczema;

- progressive vaccinia - progressively enlarging ulcers at the site of the initial vaccination or at distant sites; and,

- postvaccinal encephalitis - development of an altered level of alertness, or new onset of weakness in one or more parts of the body.

- Other complications from smallpox vaccination, including myocarditis, may also be considered for this study.

Participants will undergo some or all of the following tests and procedures:

- history of the current illness and physical examination;

- blood tests to study the immune system and look for signs of infection with vaccinia virus or other organisms;

- study of DNA (hereditary material) to see if differences in certain genes are associated with differences in immune responses to the vaccine;

- photographs of skin lesions or other physical findings ;

- skin and throat swabs;

- skin biopsy (surgical removal of a small tissue sample) to look for vaccinia virus or other causes of the illness; and,

- x-rays, computerized tomography (CT) scans, magnetic resonance imaging (MRI) scans, and lumbar punctures (spinal taps)

Some patients may receive treatment for their illness. Medications include vaccinia immune globulin (pooled antibodies to the virus) or cidofovir (a medicine that inhibits the virus). NIH will provide treatment of the acute illness, but patients will be referred back to their regular doctor for any chronic health problems that result from smallpox vaccination.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Age range: All ages

1. Patients must:

(a) have received vaccinia vaccination AND have a syndrome compatible with complications of vaccination that began within 30 days of vaccination, or

(b) have been exposed to a person vaccinated with vaccinia who has skin lesions AND the patient (contact) now has skin lesions likely containing vaccinia that began within 30 days of exposure to the vaccinee, or

(c) have lesions consistent with vaccinia AND have a syndrome compatible with complications of vaccinia.

These complications include: inadvertent inoculation (including ophthalmic vaccinia), eczema vaccinatum, progressive vaccinia, postvaccinal encephalitis, generalized vaccinia, severe erythema multiforme, and other complications strongly suspected to be due to vaccinia.

These complications include:

-inadvertent inoculation (including ophthalmic vaccinia)

-eczema vaccinatum

-progressive vaccinia

-postvaccinal encephalitis

-generalized vaccinia

-severe erythema multiforme

-other complications strongly suspected to be due to vaccinia

2. The patient must be considered safe to transfer to the NIH Clinical Center in the opinion of the referring and accepting/NIH physician.

3. Patients must be willing to have their blood samples and CSF (when obtained for medically indicated reasons) stored for future research

4. Patients with a suspected or confirmed case of postvaccinal encephalitis will also require a Durable Power of Attorney for Health Care.

EXCLUSION CRITERIA:

1. Children younger than two years old.

Special Instructions:

Currently Not Provided

Keywords:

Small Pox

Variola

Orthopoxvirus

Recruitment Keyword(s):

None

Condition(s):

Smallpox

Vaccines

Investigational Drug(s):

Cidofovir

VIG IV

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Engler RJ, Kenner J, Leung DY. Smallpox vaccination: Risk considerations for patients with atopic dermatitis. J Allergy Clin Immunol. 2002 Sep;110(3):357-65. PMID: 12209080

Frey SE, Couch RB, Tacket CO, Treanor JJ, Wolff M, Newman FK, Atmar RL, Edelman R, Nolan CM, Belshe RB. Clinical responses to undiluted and diluted smallpox vaccine. N Engl J Med. 2002 Apr 25;346(17):1265-74. PMID: 11923490

Kesson AM, Ferguson JK, Rawlinson WD, Cunningham AL. Progressive vaccinia treated with ribavirin and vaccinia immune globulin. Clin Infect Dis. 1997 Oct;25(4):911-4. PMID: 9356807

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