Smallpox Vaccine Adverse Reaction
Conditions
Brief summary
The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).
Interventions
BIOLOGICALACAM2000
Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.
Sponsors
Centers for Disease Control and Prevention
Emergent BioSolutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed written informed consent. * Age 18 - 65 years. * Normal and healthy as determined by medical history, physical exam, vital signs and clinical laboratory tests at screening visit. * Subject must meet all required subject suitability criteria that pertain to normal Source Plasma donors. * Subject must have been previously immunized for smallpox, at ≥1 year prior to commencement of screening assessments for the VA-006 trial, and vaccination history must be confirmed by oral or written history AND the presence of a visible pathognomonic smallpox vaccination scar. * Female subjects of childbearing potential must use at least one of the following means of birth control documented by a physician's letter: * Surgical sterilization * Hormonal (oral/injectable/implant) for at least 30 days prior to vaccination * Intrauterine device (IUD) inserted at least 7 days prior to vaccination. * Female subjects who are not using one of the methods of birth control listed above must be documented as postmenopausal, which is defined as not having a menstrual period for longer than 12 months and having a serum follicle-stimulating hormone (FSH) level ≥ 40 mIU/mL.
Exclusion criteria
* History of severe adverse event(s) from previous participation in the VA-001 or VA-005 trials or any other smallpox vaccination program/study. * Subject, household contact, or other close/intimate contact: * with eczema, history of eczema, exfoliative skin conditions, wounds, burns, or other skin conditions at the Investigator's discretion. * with a history of immunodeficiencies (see section 7.1.2 of the protocol). * who received radiotherapy or chemotherapy, adrenocorticotropic hormone (ACTH), corticosteroids, or immunosuppressive drugs. * with eye disease treated with topical steroids. * with known or suspected disorders of immunoglobulin synthesis. * with leukemia, lymphomas of any type, melanoma, or other malignant neoplasms affecting the bone marrow or lymphatic systems. * with a history of adverse reactions to smallpox (vaccinia) vaccine. * has recently been diagnosed with cancer and who will be undergoing chemotherapy or radiation therapy during the vaccination healing time. * is a transplant recipient (except for corneal transplant). * is pregnant, planning pregnancy or breast feeding (female subjects must have negative serum pregnancy test at screening and negative urine pregnancy test prior to vaccination). * Household or other close/intimate contact(s) under the age of 12 months. * History of allergies to latex, phenol, any of the antibiotics listed in the vaccine content, or any other component of ACAM2000 or its diluent * Severely or morbidly obese or higher obesity classification (BMI ≥ 35). * Subjects with abnormal EKG and/or cardiac Troponin levels at screening. * Subjects with cancer or kidney disease (except kidney stones). * Subject has 3 or more of the following risk factors: * High blood pressure diagnosed by a doctor * High blood cholesterol diagnosed by a doctor * Diabetes or high blood sugar diagnosed by a doctor * A first degree relative (for example, mother, father, brother, sister) who had a heart condition before the age of 50 * Currently smokes cigarettes * Cardiovascular disease or heart condition diagnosed by a doctor at any time in the past, with or without symptoms, including: * Arrhythmia * Syncope * Previous myocardial infarction * Angina * Coronary artery disease * Congestive heart failure * Cardiomyopathy * Stroke or transient ischemic attack * Chest pain or shortness of breath with activity (such as walking up stairs) * Other heart conditions being treated by a physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration | Days 0 to 90 post-vaccination |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaccination This study was a single arm study. All eligible subjects received ACAM2000.
ACAM2000: Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Vaccination |
|---|---|
| Age | 47 years STANDARD_DEVIATION 9.1 |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 15 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration
Time frame: Days 0 to 90 post-vaccination
Population: Post-vaccination adverse events were assessed in the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAM200 Vaccination Dose | Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration | Vaccination complications | 52 percentage of participants |
| ACAM200 Vaccination Dose | Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration | Headache | 8 percentage of participants |
| ACAM200 Vaccination Dose | Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration | injection site scab | 4 percentage of participants |