A Clinical Trial of an Alphavirus Replicon Vaccine for Cytomegalovirus (CMV)
NCT ID: NCT00439803
Last Updated: 2008-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2007-04-30
2008-07-31
Brief Summary
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The objectives of this Phase 1 study are to test the safety of the vaccine and the immune response to the vaccine in healthy volunteers who have not previously been infected with CMV. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in each arm on three occasions over 6 months. The study will last 12 months and will have a total of 12 visits.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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T1
AVX601
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route
C1
Placebo
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
T2
AVX601
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route
C2
Placebo
3 doses of placebo given at T=0, 8, 24 weeks via the SC route
T3
AVX601
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route
C3
AVX601
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
T4
AVX601
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route
C4
Placebo
3 doses of placebo given at T=0, 8, 24 weeks via the SC route
Interventions
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AVX601
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route
Placebo
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
AVX601
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route
Placebo
3 doses of placebo given at T=0, 8, 24 weeks via the SC route
AVX601
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route
AVX601
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
AVX601
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route
Placebo
3 doses of placebo given at T=0, 8, 24 weeks via the SC route
Eligibility Criteria
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Inclusion Criteria
2. Good general health without significant physical examination findings or clinically significant abnormal laboratory results
3. Available to participate for the entire study period of approximately 12 months
4. For women of childbearing potential, a negative urine pregnancy test at screening and before each immunization, and agreement to consistently use contraception from 28 days prior to enrollment until the last protocol visit, for sexual activity that could lead to pregnancy
5. Acceptable laboratory parameters:
* negative CMV serology
* hemoglobin ≥ 11.2 g/dL for women, ≥ 12.8 g/dL for men
* white blood cell count 3,300 - 12,000 cells/mm3
* platelet count 125,000 - 550,000/mm3
* alanine aminotransferase (ALT) within normal range for study laboratory
* serum creatinine within normal range for study laboratory
* normal urine dipstick (negative glucose, negative hemoglobin, and negative or trace protein)
* negative hepatitis B virus (HBV) and hepatitis C virus (HCV) blood tests
* negative HIV blood test
6. Willingness to have blood stored for up to 10 years for use in additional assays to evaluate immune responses to CMV or the alphavirus vector if such assays become available
7. Willingness to participate in the study as evidenced by signed informed consent obtained before screening
Exclusion Criteria
2. Women who are breast feeding
3. In female subjects, a positive urine pregnancy test at screening or on the day of any vaccine injection
4. Receipt of any vaccine within 30 days prior to enrollment
5. Use of any investigational agent within 30 days prior to enrollment
6. Receipt of immunoglobulin or blood products within 60 days prior to enrollment
7. Use of cytotoxic medications within 6 months prior to enrollment
8. Use of systemic corticosteroids within 6 months prior to enrollment (except that participants who have completed a course of prednisone, at up to 20 mg per day for up to 7 days, at least 1 month prior to enrollment are eligible for enrollment)
9. History of serious adverse reactions to any vaccine, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema or abdominal pain
10. History of immunodeficiency or autoimmune disease
11. History of diabetes mellitus
12. History of splenectomy
13. History of malignancy within the last 3 years (except that participants with a diagnosis of basal cell carcinoma of the skin are eligible for enrollment)
14. Psychiatric condition that may interfere with the ability to comply with the protocol requirements. Specifically excluded are persons with history of psychosis within the past 3 years or history of suicidal attempt or gesture within the past 3 years.
15. History of medical, occupational or family problems as a result of alcohol or illicit drug use during the past 12 months
16. Any condition which leads the investigator to believe that the participant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for participation
18 Years
45 Years
ALL
Yes
Sponsors
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AlphaVax, Inc.
INDUSTRY
Responsible Party
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AlphaVax, Inc.
Principal Investigators
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Robert A Olmsted, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
AlphaVax, Inc.
Locations
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Cincinnati Center for Clinical Research
Cincinnati, Ohio, United States
Countries
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Related Links
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AlphaVax Human Vaccines, Inc.
Other Identifiers
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AVX601-001
Identifier Type: -
Identifier Source: org_study_id