Combination Study With MVA BN and Dryvax
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of MVA-BN in a Dose Response Regimen Followed by Administration of Dryvax in Healthy Adult Volunteers
2 other identifiers
interventional
91
1 country
1
Brief Summary
The overall goals of this study are to expand the available data on the safety and immunogenicity of MVA-BN in vaccinia-naive adults and to determine the optimum dose of MVA-BN to induce immune responses and attenuate Dryvax take reactions. Participants will include 90 healthy volunteers, ages 18-32 years. Participants will be randomly assigned to 1 of 6 study groups (groups A-F). Participants will be involved in study related procedures for up to 2 years. During this time, volunteers will return periodically for blood draws to check immune responses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2004
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 10, 2004
CompletedFirst Posted
Study publicly available on registry
May 11, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedDecember 19, 2014
September 1, 2008
3.3 years
May 10, 2004
December 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events and side effects to the vaccines.
Reactogenicity will be evaluated for a 2-week period post-vaccination at each time point and for the duration of study.
Secondary Outcomes (1)
Immunogenicity testing of antibody and cellular responses to the vaccines.
Visit days 0, 14, 28, 42, 56, 112, 140, 182, 365, and 730.
Study Arms (6)
E
EXPERIMENTALSubject will receive an SC dose of MVA 1x10\^8 on day 0 and day 28. On day 112 subjects will receive a dose of placebo by scarification.
D
ACTIVE COMPARATORSubject will receive a SC dose of placebo on day 0 and day 28. On day 112 subjects will receive a dose of Dryvax® by scarification.
C
EXPERIMENTALSubject will receive a SC dose of MVA 1x10\^8 on day 0 and day 28. On day 112 subjects will receive a dose of Dryvax® by scarification.
B
EXPERIMENTALSubjects will receive a SC dose of MVA 5x10\^7 on day 0 and day 28. On day 112 subjects will receive a dose of Dryvax® by scarification.
A
EXPERIMENTALSubjects will receive a SC dose of MVA 2x10\^7 on day 0 and day 28. On day 112 subjects will receive a dose of Dryvax® by scarification.
F
EXPERIMENTALSubject will receive an IM dose of MVA 1x10\^8 on day 0 and day 28. On day 112 subjects will receive a dose of Dryvax® by scarification.
Interventions
Dryvax®: 0.25 mL of vaccine will be administered by the standard route of scarification using a bifurcated needle on day 112 for Groups A, B, C, D and F.
Imvamune/MVA-BN 1x10\^8 will be administered intramuscularly to Group F on day 0 and day 28.
Group E will receive sterile saline placebo for injection via scarification on day 112.
Eligibility Criteria
You may qualify if:
- Ages 18-32.
- Never received smallpox vaccination.
- Read, signed and dated informed consent document.
- Availability for follow-up for the planned duration of the study two years after first immunization.
- Acceptable medical history by screening evaluation and limited physical examination.
- For women, negative serum pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to vaccination.
- If the volunteer is female and of child bearing potential, she agrees to use acceptable contraception, and not become pregnant for at least 56 days after the last vaccination. A woman is considered of child bearing potential unless post-menopausal or surgically sterilized. \[Acceptable contraception methods are restricted to effective intrauterine devices (IUDs) or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination.\] Women who are not sexually active must agree to use one of the acceptable contraception methods if they are of childbearing potential.
- Negative ELISA for HIV.
- ALT\<1.25 times institutional upper limit of normal.
- Negative hepatitis B surface antigen and negative antibody to hepatitis C virus.
- Negative urine glucose by dipstick or urinalysis.
- Adequate renal function defined as a serum creatinine less than or equal to 1.4mg/dL for males and less than or equal to 1.2mg/dL for females; urine protein \< 30 mg/dL or none or trace proteinuria (by urinalysis or dipstick); and a calculated creatine clearance greater than or equal to 80 mL/min. based on the following formulas:
- Males \[(140-age in years) X weight in kg\]/(72 X serum creatinine)
- Females 0.85X\[(140-age in years) X weight in kg\]/(72 X serum creatinine)
- ECG without clinical significance (e.g., all kinds of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV-node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, or 2 premature ventricular contractions (PVC) in a row, or ST elevation consistent with ischemia)
- +1 more criteria
You may not qualify if:
- History of immunodeficiency.
- Typical vaccinia scar.
- Known or suspected history of smallpox vaccination.
- Military service prior to 1989 or after January 2003.
- Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
- Malignancy, including squamous cell skin cancer or basal cell skin cancer at vaccination site or history of skin cancer at the vaccination site.
- Active autoimmune disease. Persons with vitiligo or thyroid disease on thyroid replacement are not excluded.
- History of keloid formation.
- History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor.
- History of an immediate family member (father, mother, brother or sister) who has had onset of ischemic heart disease before age 50 years.
- 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 for Estimating Your 10-Year Risk of Having a Heart Attack, located at the following URL: http://hin.nhlbi.nih.gov/atpiii/calculator.asp. NOTE: This criterion applies only to volunteers 20 years of age and older.
- Abnormal troponin I.
- Use of immunosuppressive medication. Corticosteroid nasal sprays are permissible. Persons who have used topical steroid can be enrolled after their therapy is completed.
- Medical or psychiatric condition or occupational responsibilities that preclude volunteer compliance with the protocol.
- Any history of "illegal" injection drug use.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Louis University
St Louis, Missouri, 63110, United States
Related Publications (1)
Elizaga ML, Vasan S, Marovich MA, Sato AH, Lawrence DN, Chaitman BR, Frey SE, Keefer MC; MVA Cardiac Safety Working Group. Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review. PLoS One. 2013;8(1):e54407. doi: 10.1371/journal.pone.0054407. Epub 2013 Jan 17.
PMID: 23349878RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2004
First Posted
May 11, 2004
Study Start
May 1, 2004
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
December 19, 2014
Record last verified: 2008-09