Protocol Number: 03-I-0090

Title:

Immune Responses to Vaccinia Virus Vaccination

Number:

03-I-0090

Summary:

This study will examine how people's immune systems respond to inoculation with vaccinia virus -the standard vaccine used to protect against smallpox-and how these responses correlate with symptoms they develop after receiving the vaccine.

People 18 years of age and older who are scheduled to receive smallpox vaccination as a routine part of their employment (e.g., laboratory worker, health care worker, or emergency response worker) may be eligible for this study. They may or may not have been vaccinated previously. In addition, individuals who were vaccinated against smallpox at least 6 months before starting the study may participate as control subjects. All candidates will be screened with a brief medical history and physical examination.

Participants in the following vaccination categories will undergo the procedures described for their group:

Vaccine Recipient - Frequent Follow-up

Participants will come to the NIH Clinical Center every 2 to 3 days for a total of 7 visits over a 2-week period. At each visit, starting the day of vaccination, they will have the following procedures:

- Brief skin examination, possibly with photographs of skin lesions;

- Throat and skin swabs for vaccinia virus culture;

- Blood draw (about 8 teaspoonfuls).

Additional blood samples will be collected 1 month after vaccination and again within a year after vaccination. The blood will be analyzed for the immune response to the vaccine, genetic differences that might influence differences in immune response, and the presence of vaccinia virus.

Participants will fill out a diary card every day for 3 weeks after vaccination to record any symptoms. Individuals who develop symptoms lasting more than 2 weeks, such as persistent or new skin lesions, will return to the clinic for additional skin exams and blood tests. Individuals who develop vaccine side effects may have a urine culture for vaccinia virus.

Vaccine Recipient - Infrequent Follow-up

Participants will come to the NIH Clinical Center for blood tests on the day of vaccination, 4 weeks after vaccination, and once again within a year after vaccination. At each visit, 6 teaspoonfuls of blood will be drawn. This group will also include individuals who have been vaccinated within 8 months of entering the study and are not currently receiving the vaccine, but for whom blood samples are not available.

Control Group - Vaccinated at Least 6 Months Before Entering the Study

Participants will come to the NIH Clinical Center for blood tests every 2 to 3 days for 2 weeks, then at 1 month after the first blood draw, and again within a year of the first blood draw. About 8 teaspoonfuls of blood will be drawn at each visit.

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): Children

Eligibility Criteria:

INCLUSION CRITERIA:

18 years of age or older

Both males and females

Patients will be checked on day 0 and those with a hemoglobin of greater than or equal to12 g/dL will have blood drawn as described in the protocol. Patients with a hemoglobin of 11-11.9 will have a 50% reduction in the amount of blood drawn after the first visit from 40 ml per visit to 20 ml per visit. Patients with a hemoglobin less than 11 g/dL will be terminated from the study and referred for medical follow-up.

Able to sign the consent form and be willing to comply with study procedures.

Must be a laboratory worker, health care worker, or emergency response worker who is receiving smallpox vaccination as a routine part of employment. Persons who were previously vaccinated at least 8 months ago are eligible.

EXCLUSION CRITERIA:

Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety.

Special Instructions:

Currently Not Provided

Keywords:

Smallpox

Variola

Orthopoxvirus

Virus

Immunogenicity

Recruitment Keyword(s):

Smallpox Vaccine

Condition(s):

Smallpox Vaccine

Investigational Drug(s):

None

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):

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

Frey SE, Newman FK, Cruz J, Shelton WB, Tennant JM, Polach T, Rothman AL, Kennedy JS, Wolff M, Belshe RB, Ennis FA. Dose-related effects of smallpox vaccine. N Engl J Med. 2002 Apr 25;346(17):1275-80.

Mathew A, Ennis FA, Rothman AL. Transient decreases in human T cell proliferative responses following vaccinia immunization. Clin Immunol. 2000 Aug;96(2):100-7. PMID: 10900157

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 01/13/2009