Smallpox Vaccine Adverse Reaction Clinical Trial
Official title:
Vaccinia Vaccine (ACAM2000) for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)
| Verified date | March 2024 |
| Source | Emergent BioSolutions |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | February 14, 2012 |
| Est. primary completion date | February 14, 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cangene Plasma Resources, Mid-Florida | Altamonte Springs | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Emergent BioSolutions | Centers for Disease Control and Prevention |
United States,
Russell PK. Vaccines in civilian defense against bioterrorism. Emerg Infect Dis. 1999 Jul-Aug;5(4):531-3. doi: 10.3201/eid0504.990413. No abstract available. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration | Days 0 to 90 post-vaccination |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02443623 -
VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
|
Phase 4 |