Cytomegalovirus InfectionsPhase 1CMVNCT00439803
A Clinical Trial of an Alphavirus Replicon Vaccine for Cytomegalovirus (CMV)
A Phase 1 study testing AVX601 in people with Cytomegalovirus Infections, run by AlphaVax, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- AVX601
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Center for Clinical Research
Cincinnati, Ohio, 45229
About this study
Official title: 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.
Read the detailed description
This is a randomized, double-blind, placebo-controlled Phase 1 study of the safety and immunogenicity of AVX601 vaccine at two dosage levels and two routes of administration in healthy volunteers conducted at a single research center. A total of 40 participants will be enrolled into two groups of 20 participants each. Within each group, participants will be randomized to receive the active vaccine by IM injection (N = 8) or SC injection (N = 8) or to receive a placebo by IM injection (N = 2) or SC injection (N = 2). Each participant will receive a total of six injections of vaccine or placebo, two at each visit at Weeks 0, 8 and 24, administered by a study nurse in an outpatient setting, and will be followed for 12 months after the first immunization. Safety data will include local and systemic reactogenicity after each dose of vaccine, collected in a systematic format using a subject memory aid and a standard grading scale, specific safety laboratory parameters and general AEs. Immunogenicity data will be obtained by collecting blood at defined time points before and after immunization and separating serum (for measurement of antibodies to CMV by ELISA and neutralization assays and to the vaccine vector by a VRP neutralization assay) and peripheral blood mononuclear cells (PMBC) (for measurement of cellular immune responses to CMV peptides).
- Conditions
- Cytomegalovirus Infections
- Being tested
- AVX601, Placebo
- Keywords
- CMV, cytomegalovirus, Alphavirus
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVX601Biological
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route
PlaceboBiological
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
AVX601Biological
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route
PlaceboBiological
3 doses of placebo given at T=0, 8, 24 weeks via the SC route
AVX601Biological
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route
AVX601Biological
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
AVX601Biological
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route
PlaceboBiological
3 doses of placebo given at T=0, 8, 24 weeks via the SC route
| Study group | Role | What they receive |
|---|---|---|
| T1 | Active comparator | Not described Receives: Biological: AVX601 |
| C1 | Placebo comparator | Not described Receives: Biological: Placebo |
| T2 | Active comparator | Not described Receives: Biological: AVX601 |
| C2 | Placebo comparator | Not described Receives: Biological: Placebo |
| T3 | Active comparator | Not described Receives: Biological: AVX601 |
| C3 | Placebo comparator | Not described Receives: Biological: AVX601 |
| T4 | Active comparator | Not described Receives: Biological: AVX601 |
| C4 | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate safety of AVX601 based on teh frequency of Grade 2,3,or 4 systemic reactogenicity events
Measured: 1 year
Secondary outcomes (1)
evaluate the immunogenicity of AVX601 in healthy volunteers after 3 doses of vaccine
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startApr 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlphaVax, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert A Olmsted, Ph.D., Principal investigator, AlphaVax, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439803
- Sponsor's protocol ID
- AVX601-001
- Acronym
- CMV
- Status last verified
- Nov 2008
- First submitted
- 23 Feb 2007
- Last updated
- 10 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Site, Phase 1, Double-Blind, Safety and Immunogenicity Trial of an Alphavirus Replicon Vaccine Expressing Cytomegalovirus Genes (AVX601) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00439803
- Acronym / sponsor ID
- CMV / AVX601-001
- Conditions
- Cytomegalovirus Infections
- Keywords
- CMV, cytomegalovirus, Alphavirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AlphaVax, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 26 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind, placebo-controlled Phase 1 study of the safety and immunogenicity of AVX601 vaccine at two dosage levels and two routes of administration in healthy volunteers conducted at a single research center. A total of 40 participants will be enrolled into two groups of 20 participants each. Within each group, participants will be randomized to receive the active vaccine by IM injection (N = 8) or SC injection (N = 8) or to receive a placebo by IM injection (N = 2) or SC injection (N = 2). Each participant will receive a total of six injections of vaccine or placebo, two at each visit at Weeks 0, 8 and 24, administered by a study nurse in an outpatient setting, and will be followed for 12 months after the first immunization. Safety data will include local and systemic reactogenicity after each dose of vaccine, collected in a systematic format using a subject memory aid and a standard grading scale, specific safety laboratory parameters and general AEs. Immunogenicity data will be obtained by collecting blood at defined time points before and after immunization and separating serum (for measurement of antibodies to CMV by ELISA and neutralization assays and to the vaccine vector by a VRP neutralization assay) and peripheral blood mononuclear cells (PMBC) (for measurement of cellular immune responses to CMV peptides).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| T1 | Active comparator | Biological: AVX601 |
| C1 | Placebo comparator | Biological: Placebo |
| T2 | Active comparator | Biological: AVX601 |
| C2 | Placebo comparator | Biological: Placebo |
| T3 | Active comparator | Biological: AVX601 |
| C3 | Placebo comparator | Biological: AVX601 |
| T4 | Active comparator | Biological: AVX601 |
| C4 | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVX6013 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route | Biological | T1 |
| Placebo3 doses of placebo given at T=0, 8, 24 weeks via the IM route | Biological | C1 |
| AVX6013 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route | Biological | T2 |
| Placebo3 doses of placebo given at T=0, 8, 24 weeks via the SC route | Biological | C2 |
| AVX6013 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route | Biological | T3 |
| AVX6013 doses of placebo given at T=0, 8, 24 weeks via the IM route | Biological | C3 |
| AVX6013 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route | Biological | T4 |
| Placebo3 doses of placebo given at T=0, 8, 24 weeks via the SC route | Biological | C4 |
Primary outcome
evaluate safety of AVX601 based on teh frequency of Grade 2,3,or 4 systemic reactogenicity events
Time frame: 1 year
1 secondary outcome
evaluate the immunogenicity of AVX601 in healthy volunteers after 3 doses of vaccine
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2008.
- AlphaVax Human Vaccines, Inc.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A Olmsted, Ph.D. principal investigator
AlphaVax, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVX601 in people with Cytomegalovirus Infections, run by AlphaVax, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate safety of AVX601 based on teh frequency of Grade 2,3,or 4 systemic reactogenicity events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2008.