Immune Responses to Smallpox Vaccination

This study is currently recruiting participants.
Verified May 2013 by National Institutes of Health Clinical Center (CC)
Information provided by:
National Institutes of Health Clinical Center (CC) Identifier:
First received: May 15, 2006
Last updated: March 14, 2014
Last verified: May 2013

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.

Smallpox Vaccine

Study Type: Observational
Official Title: Immune Responses to Vaccinia Virus Vaccination

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 340
Study Start Date: February 2003
Detailed Description:

Vaccinia virus is used to vaccinate persons to prevent disease with smallpox. Limited information is available regarding cellular immune responses to vaccinia virus. We will obtain blood from vaccinated persons and measure immune responses in vitro to the virus and correlate these findings with symptoms from vaccination. Elucidation of these responses might help to predict side effects associated with vaccination, and suggest new therapies to reduce these side effects.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

    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.


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

  Contacts and Locations
Please refer to this study by its identifier: NCT00325975

Contact: Carla D Williams, R.N. (301) 443-9460
Contact: Jeffrey I Cohen, M.D.

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
Principal Investigator: Jeffrey I Cohen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00325975     History of Changes
Other Study ID Numbers: 030090, 03-I-0090
Study First Received: May 15, 2006
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Smallpox Vaccine

Additional relevant MeSH terms:
Poxviridae Infections
DNA Virus Infections
Virus Diseases processed this record on April 17, 2014