- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00439803
A Clinical Trial of an Alphavirus Replicon Vaccine for Cytomegalovirus (CMV) (CMV)
A Single-Site, Phase 1, Double-Blind, Safety and Immunogenicity Trial of an Alphavirus Replicon Vaccine Expressing Cytomegalovirus Genes (AVX601) in Healthy Volunteers
AVX601, a bivalent alphavirus replicon vaccine expressing three CMV proteins (gB, pp65 and IE1) is a candidate vaccine against cytomegalovirus (CMV).
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Center for Clinical Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Between 18 and 45 years of age, inclusive
- Good general health without significant physical examination findings or clinically significant abnormal laboratory results
- Available to participate for the entire study period of approximately 12 months
- 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
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
- 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
- Willingness to participate in the study as evidenced by signed informed consent obtained before screening
Exclusion Criteria:
- Venous access deemed inadequate for the phlebotomy demands of the study
- Women who are breast feeding
- In female subjects, a positive urine pregnancy test at screening or on the day of any vaccine injection
- Receipt of any vaccine within 30 days prior to enrollment
- Use of any investigational agent within 30 days prior to enrollment
- Receipt of immunoglobulin or blood products within 60 days prior to enrollment
- Use of cytotoxic medications within 6 months prior to enrollment
- 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)
- History of serious adverse reactions to any vaccine, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema or abdominal pain
- History of immunodeficiency or autoimmune disease
- History of diabetes mellitus
- History of splenectomy
- 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)
- 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.
- History of medical, occupational or family problems as a result of alcohol or illicit drug use during the past 12 months
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: T4
|
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route
|
Active Comparator: T1
|
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route
|
Placebo Comparator: C1
|
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
3 doses of placebo given at T=0, 8, 24 weeks via the SC route
|
Active Comparator: T2
|
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route
|
Placebo Comparator: C2
|
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
3 doses of placebo given at T=0, 8, 24 weeks via the SC route
|
Active Comparator: T3
|
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route
|
Placebo Comparator: C3
|
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route
|
Placebo Comparator: C4
|
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
3 doses of placebo given at T=0, 8, 24 weeks via the SC route
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
evaluate safety of AVX601 based on teh frequency of Grade 2,3,or 4 systemic reactogenicity events
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
evaluate the immunogenicity of AVX601 in healthy volunteers after 3 doses of vaccine
Time Frame: 15 months
|
15 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert A Olmsted, Ph.D., AlphaVax, Inc.
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVX601-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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