Population Genetics Analysis Program: Immunity to Vaccines/Infections (NIAID/NIH)

The study examines the role of candidate human immune response gene polymorphisms (and their receptors, expression and function) and variations in immune response, among 1,000 active duty members of the military who were recently vaccinated with ACAM2000 or Dryvax Smallpox vaccine. In addition to the phenotype and genotype data available through dbGaP, extensive clinical data are available through NIAID's ImmPort data portal; information to map the the data available in dbGaP to the data available in ImmPort is provided in the dataset pht005302.v1.p1 of the current study, dbGaP phs001057.v1.p1.]]>
Inclusion Criteria: Written informed consent. Age range of 18 through 40 years old. Subject is in good health. If subject has any medical conditions, they must be stable - where stable is defined as not requiring either a significant change in therapy or a hospitalization in the last 12 weeks. Subject has received one and only one dose of smallpox vaccine more than one month ago but within the last 4 years. Subject recalls having had a "good take" from the smallpox vaccine leaving a sore or lesion as an expected vaccine reaction that may or may not have left a scar where the vaccine was given. Subject is able to follow study procedures. Subject agrees NOT to donate blood in the next 56 days. Exclusion Criteria: Subject has donated blood within the last 56 days. Subject has a known or suspected immunodeficiency or is receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids (e.g. for cancer, HIV, or autoimmune disease. Subject has received systemic corticosteroids for treatment of an acute illness in the last 30 days. Subject has a serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigators opinion precludes the subject from participating in the study. Subject has received any blood products, including immunoglobulin, within 6 months of study enrollment. Subject is excluded if they ever contracted a rash or some other disease as a result of direct exposure to another person's smallpox vaccination reaction. Subject has any medical condition that would, in the opinion of the investigator, interfere with the evaluation of the study objectives. Subject previously participated in this particular study. ]]>