Status:
COMPLETED
Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Smallpox
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
Imvamune (licensed name of MVA being developed as a smallpox vaccine) has been tested in over 2,000 individuals and is on path for licensure. This study will be a Phase II to evaluate three different ...
Detailed Description
This is a Phase II, randomized, open-label immunogenicity and safety study of different immunization schedules and delivery systems (syringe and needle vs. the Stratis™) in healthy, vaccinia-naïve adu...
Eligibility Criteria
Inclusion
- 18 to 40 years of age, inclusive.
- Read, signed, and dated informed consent document.
- Available for follow-up for the planned duration of the study (six 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 or urine pregnancy test at screening and within 24 hours prior to vaccination.
- If the subject is female and of childbearing potential\*, she agrees to practice abstinence\*\* or use acceptable contraception\*\*\* through 56 days after the last vaccination in order to avoid pregnancy:
- \* a woman is considered of childbearing potential unless post-menopausal (\>/= 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
- \*\*No sexual intercourse with men (vaginal penetration by a penis, coitus)
- \*\*\*Acceptable contraception methods are restricted to effective devices (IUDs, NuvaRing®) or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, condoms with spermicidal agents, monogamous relationship with a vasectomized partner who has been vasectomized for 6 months or more prior to study entry, or successful Essure placement with documented confirmation test at least 3 months after the procedure, and any other FDA-approved contraceptive method
- Negative test for HIV.
- Alanine Aminotransferase (ALT) \<1.25 times the central lab upper limit of normal.
- Negative hepatitis B surface antigen and negative antibody to hepatitis C virus.
- Negative urine glucose and negative or trace urine protein by dipstick or urinalysis.
- Adequate renal function (defined as a serum creatinine not exceeding the central lab's upper limit of normal).
- Electrocardiogram (ECG) with no clinically significant abnormalities\*
- \* e.g., complete left or right bundle branch block, incomplete left bundle branch block or sustained ventricular arrhythmia, or two PVC's in a row, or ST elevation consistent with ischemia)
- Acceptable hematology parameters:
- Hemoglobin (Hgb) equal or above the lower limit of central lab normal (sex-specific);
- White Blood Cell (WBC) \> 3,800 and \< 10,900/mm\^3;
- Platelets \>/=120,000/mm\^3
- Body mass index \>/=18.5-\< 35.
- Be able to understand and comply with planned study procedures.
Exclusion
- History of immunodeficiency.
- Typical vaccinia scar.
- Known or suspected history of smallpox vaccination including MVA alone or as a vector, as well as other investigational smallpox vaccines.
- Military service prior to 1991 or after January 2003.
- Known or suspected significant underlying illness 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. 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\*
- \*Subjects with a not clinically relevant heart murmur, i.e., without any pathological ECG/arrhythmias or under treatment are not excluded.
- Systolic blood pressure \>/= 150mmHg or diastolic blood pressure \>/= 100mmHg.
- 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 (NCEP) risk assessment tool\*
- \*NOTE that this criterion applies only to subjects 20 years of age and older AND only if at least one of the following apply:
- have smoked a cigarette in the past month, and/or
- have hypertension (defined as systolic blood pressure \>140 mm Hg) or are on antihypertensive medication, and/or
- 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
- URL for NCEP risk assessment tool: http://cvdrisk.nhlbi.nih.gov/calculator.asp (if a subject has an HDL of greater than 100mg/dl please enter 100 in the tool)
- High-dose corticosteroid use for greater than 2 weeks duration within three months prior to vaccination or current use of immunosuppressive medication:
- \>5 mg prednisone or equivalent is considered high dose and immunosuppressive
- Corticosteroid nasal sprays for allergic rhinitis are permissible
- Persons who are using a topical steroid for mild uncomplicated dermatitis such as poison ivy or contact dermatitis may be enrolled the day after their therapy is completed
- Inhaled steroids for asthma are not permissible
- Oral/parenteral corticosteroids given for non-chronic conditions not expected to recur are permissible if the length of therapy was \</= 14 days with completion at least 30 days prior to enrollment.
- 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 subject's participation in the study.
- Receipt of blood products or immunoglobulin, including Rhogam, within six months prior to vaccination.
- Donation of a unit of blood within 56 days prior to vaccination or planned donation prior to 28-days following the last vaccination.
- Pregnant or breastfeeding women.
- Active exfoliative skin disorders/conditions, current varicella zoster virus infection, or any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn greater than 2×2 cm.
- Any condition that, in the opinion of the investigator, might interfere with assessing the study objectives.
- Known allergy to egg, aminoglycoside (including gentamicin) or chicken.
- Study personnel.
- Allergic reaction to any vaccine.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
435 Patients enrolled
Trial Details
Trial ID
NCT01827371
Start Date
June 1 2013
End Date
April 1 2015
Last Update
September 7 2016
Active Locations (6)
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1
Emory Vaccine Center - The Hope Clinic
Decatur, Georgia, United States, 30030-1705
2
University of Iowa - Vaccine Research and Education Unit
Iowa City, Iowa, United States, 52242-2600
3
University of Maryland Medical System - General Clinical Research Center (GCRC)
Baltimore, Maryland, United States, 21201-1544
4
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, United States, 63104-1015