Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally

Completed · Phase 2

Conditions studied: Smallpox

In brief

Due to recent concern of biowarfare and bioterrorism, the US government is making efforts to improve its ability to protect citizens against the smallpox virus. This study will evaluate safety of IMVAMUNE®, an investigational smallpox vaccine, and its ability to stimulate the immune system (the body's defense system). Two vaccine preparations have the same name but one is a liquid and one is a powder that has liquid added just before it is given. The vaccine that comes as a liquid will be injected (given as a shot) just under the skin (subcutaneously) or injected between the layers of the skin (intradermally). The powder formulation is only injected just under the skin. Approximately 495 adults, age 18 older born after 1971, which have not had smallpox vaccine before, may participate in the study for about 7 months.

Key facts

Study ID

NCT00914732

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

523

Starts

2010-02-01

Expected to finish

2011-04-01

Last updated by the study team

2021-02-03

Who can join

Age: 18 and older, up to 38. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Inclusion criteria that must be met prior to the initial vaccination:
• At least 18 years of age and born after 1971.
• Read, signed, and dated informed consent document.
• Available for follow-up for the planned duration of the study (6 months after last immunization).
• Acceptable medical history by screening evaluation and limited physical assessment.
• If the subject is female and of childbearing potential, negative serum pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to vaccination.
• If the subject is female and of childbearing potential, she agrees to use acceptable contraception, and not become pregnant for 28 days following the last vaccination:
• A woman is considered of childbearing potential unless post-menopausal (greater than or equal to 1 year) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy).
• Acceptable contraception methods are restricted to effective devices [intrauterine devices (IUD)s, NuvaRing®] or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, abstinence from sexual intercourse with men (vaginal penetration by a penis, coitus), and monogamous relationship with a vasectomized partner.
• Negative enzyme linked immunosorbent assay (ELISA) for human immunodeficiency virus (HIV).
• Alanine aminotransferase (ALT) <1.25 times institutional upper limit of normal.
• Negative hepatitis B surface antigen and negative antibody to hepatitis C virus.
• Negative urine glucose and urine protein <1 plus by dipstick or urinalysis.
• Adequate renal function is defined as a serum creatinine not exceeding the institution's upper limit of normal.
• Electrocardiogram (ECG) in absence of clinical significance (e.g., complete left or right bundle branch block, incomplete left bundle branch block or sustained ventricular arrhythmia, or 2 premature ventricular contraction's (PVC)'s in a row, or sympathetic tonus (ST) elevation consistent with ischemia).
• The following blood parameters:
• Hemoglobin equal or above the lower limit of institutional normal (sex-specific);
• White blood cells greater than 2,500 and less than 11,000/mm\^3;
• Platelets greater than or equal to 140,000/mm\^3.
• Weight: greater than or equal to 110 pounds.
• Inclusion Criteria that must be met prior to the second vaccination:
• Acceptable medical history.
• If the subject is female and of childbearing potential, negative urine or serum pregnancy test within 24 hours prior to vaccination.
• If the subject is female and of childbearing potential, she agrees to use acceptable contraception, and not become pregnant for 28 days following the last vaccination:
• A woman is considered of childbearing potential unless post-menopausal (greater than or equal to 1 year) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy).

You may not qualify if…

• Exclusion criteria that apply prior to the initial vaccination:
• History of immunodeficiency
• Typical vaccinia scar
• Known or suspected history of smallpox vaccination including Modified Vaccinia Ankara (MVA) alone or as a vector as well as other investigational smallpox vaccine
• Military service prior to 1991 or after January 2003
• Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease, diabetes mellitus, or moderate to severe kidney impairment
• Malignancy not including squamous cell skin cancer or basal cell skin cancer unless at the vaccination site or history of skin cancer at the vaccination site
• Active autoimmune disease
• a. Persons with vitiligo or thyroid disease (e.g., taking thyroid hormone replacement) are not excluded
• History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor
• Systolic blood pressure greater than or equal to 150 mmHg or diastolic blood pressure greater than or equal to 100 mmHg
• Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool (http://hp2010.nhlbihin.net/atpiii/calculator.asp)
• NOTE that this criterion applies only to subjects 20 years of age and older AND only if at least one of the following apply:
• a. have smoked a cigarette in the past month, and/or b. have hypertension (defined as systolic blood pressure >140 mm Hg) or are on antihypertensive medication, and/or c. have a family history of coronary heart disease in male first-degree relative (father or brother) <55 years of age or a female first-degree relative (mother or sister) <65 years of age
• High-dose steroid use for greater than 2 weeks duration within three months prior to vaccination and current use of immunosuppressive medication
• Corticosteroid nasal sprays are permissible
• Persons who are using a topical steroid can be enrolled after their therapy is completed
• Inhaled steroids for asthma are not permissible
• Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
• Any history of illegal injection drug use
• Receipt or planned receipt of inactivated vaccine from 14 days prior to the first vaccination through 14 days post second vaccination
• Receipt or planned receipt of any other live attenuated vaccine within 30 days prior to the first vaccination through 30 days post second vaccination
• Use of any other experimental agent within 30 days prior to vaccination and for the duration of the study
• Receipt of blood products or immunoglobulin within six months prior to vaccination
• Donation of a unit of blood within 56 days prior to vaccination and prior to Visit 6

Where it is running

• Emory Vaccine Center - The Hope Clinic — Decatur, Georgia, United States
• University of Iowa - Vaccine Research & Education Unit — Iowa City, Iowa, United States
• University of Maryland School of Medicine - Center for Vaccine Development - Baltimore — Baltimore, Maryland, United States
• Saint Louis University - Center for Vaccine Development — St Louis, Missouri, United States
• Vanderbilt University Hospital - Pediatric Clinical Research — Nashville, Tennessee, United States
• Baylor College of Medicine - Molecular Virology and Microbiology — Houston, Texas, United States
• Group Health Research Institute - Seattle — Seattle, Washington, United States
• The University of Washington - Virology Research Clinic — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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