Smallpox Vaccine Clinical Trial
Official title:
Immune Responses to Vaccinia Virus Vaccination
| Verified date | March 15, 2016 |
| Source | National Institutes of Health Clinical Center (CC) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 69 |
| Est. completion date | March 15, 2016 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
- 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Frey SE, Couch RB, Tacket CO, Treanor JJ, Wolff M, Newman FK, Atmar RL, Edelman R, Nolan CM, Belshe RB; National Institute of Allergy and Infectious Diseases Smallpox Vaccine Study Group. Clinical responses to undiluted and diluted smallpox vaccine. N Engl J Med. 2002 Apr 25;346(17):1265-74. Epub 2002 Mar 28. — View Citation
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. Epub 2002 Mar 28. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 vi... | Upon review of all data |