InfluenzaPhase 1/2AVX502-003NCT00706732
A Safety and Immunogenicity Trial in Adults 65 Years of Age or Over to Prevent Influenza
A Phase 1/2 study testing AVX502 in people with Influenza, run by AlphaVax, Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety of the vaccine and the immune response to the vaccine in healthy adult volunteers 65 years of age or older. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in the arm on two occasions over… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- AVX502
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Mar 2009
- Phase
- Phase 1/2
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years of age or older
- Good general health without significant physical examination findings or clinically significant abnormal laboratory results
- Available to participate for entire study period
- Acceptable laboratory parameters
- Willingness to have blood stored for up to 10 years for use in additional assays to evaluate immune responses to influenza or the alphavirus vector if such assays become available
- Willingness to refrain from donating blood while participating in the study
- Willingness to delay receipt of 2008-2009 licensed influenza vaccination until after completing study visit 6 procedures (study week 8)
- Signed inform consent obtained before screening and before enrollment
Who cannot join
- Venous access deemed inadequate for th phlebotomy demands of the study
- Receipt of any other vaccine within 30 days prior to enrollment
- Use of any investigational agent within 30 days prior to enrollment
- Receipt of immunoglobulin or other 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)
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- History of serious adverse reactions to any vaccines, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, or abdominal pain
- History of autoimmune disease or 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 or to understand informed consent. 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 particpant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for further participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Site, Phase I/II, Double Blinded, Safety and Immunogenicity Trial of an Alphavirus Replicon Vaccine Expressing Influenza A/Wyoming/03/2003 Hemagglutinin (AVX502) in Adult Volunteers 65 Years of Age or Older
The objective of this study is to evaluate the safety of the vaccine and the immune response to the vaccine in healthy adult volunteers 65 years of age or older. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in the arm on two occasions over one month. The study will last approximately 10 months and will have a total of 7 visits.
- Conditions
- Influenza
- Being tested
- AVX502, Placebo
- Keywords
- Influenza, Flu, A/Wyoming/03/2003, Alphavirus
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVX502Biological
2 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route
AVX502Biological
2 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route
PlaceboBiological
2 doses of placebo given at T=0 and T=4 weeks via the IM route
PlaceboBiological
2 doses of placebo given at T=0 and T=4 weeks via the SC route
| Study group | Role | What they receive |
|---|---|---|
| T1 | Active comparator | Not described Receives: Biological: AVX502 |
| T2 | Active comparator | Not described Receives: Biological: AVX502 |
| C1 | Placebo comparator | Not described Receives: Biological: Placebo |
| C2 | 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 the safety of AVX502 in healthy adult volunteers 65 years of age or older via the frequency of systemic reactogenicity events, local vaccine reactions and Adverse Events
Measured: 28 weeks
Secondary outcomes (1)
Evaluate the immunogenicity of AVX502 in healthy adult volunteers 65 years of age and older via serum antibody concentration
Measured: 4 weeks after second dose of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlphaVax, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Olmsted, Ph.D., Principal investigator, AlphaVax, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706732
- Sponsor's protocol ID
- AVX502-003
- Acronym
- AVX502-003
- Status last verified
- Jul 2012
- First submitted
- 26 Jun 2008
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Site, Phase I/II, Double Blinded, Safety and Immunogenicity Trial of an Alphavirus Replicon Vaccine Expressing Influenza A/Wyoming/03/2003 Hemagglutinin (AVX502) in Adult Volunteers 65 Years of Age or Older
- ClinicalTrials.gov ID
- NCT00706732
- Acronym / sponsor ID
- AVX502-003 / AVX502-003
- Conditions
- Influenza
- Keywords
- Influenza, Flu, A/Wyoming/03/2003, Alphavirus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AlphaVax, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 30 Jun 2008 (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.
The objective of this study is to evaluate the safety of the vaccine and the immune response to the vaccine in healthy adult volunteers 65 years of age or older. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in the arm on two occasions over one month. The study will last approximately 10 months and will have a total of 7 visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T1 | Active comparator | Biological: AVX502 |
| T2 | Active comparator | Biological: AVX502 |
| C1 | Placebo comparator | Biological: Placebo |
| C2 | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Age 65 years of age or older
- Good general health without significant physical examination findings or clinically significant abnormal laboratory results
- Available to participate for entire study period
- Acceptable laboratory parameters
- Willingness to have blood stored for up to 10 years for use in additional assays to evaluate immune responses to influenza or the alphavirus vector if such assays become available
Key exclusion criteria (12 listed)
- Venous access deemed inadequate for th phlebotomy demands of the study
- Receipt of any other vaccine within 30 days prior to enrollment
- Use of any investigational agent within 30 days prior to enrollment
- Receipt of immunoglobulin or other blood products within 60 days prior to enrollment
- Use of cytotoxic medications within 6 months 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 |
|---|---|---|
| AVX5022 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route | Biological | T1 |
| AVX5022 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route | Biological | T2 |
| Placebo2 doses of placebo given at T=0 and T=4 weeks via the IM route | Biological | C1 |
| Placebo2 doses of placebo given at T=0 and T=4 weeks via the SC route | Biological | C2 |
Primary outcome
Evaluate the safety of AVX502 in healthy adult volunteers 65 years of age or older via the frequency of systemic reactogenicity events, local vaccine reactions and Adverse Events
Time frame: 28 weeks
1 secondary outcome
Evaluate the immunogenicity of AVX502 in healthy adult volunteers 65 years of age and older via serum antibody concentration
Time frame: 4 weeks after second dose of vaccine
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 12 Jul 2012.
- AlphaVax, Inc.Link provided by the sponsor.
- Johnson County Clin-TrialsLink 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 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 1/2 study testing AVX502 in people with Influenza, 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 8 inclusion and 12 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 12 Jul 2012. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 the safety of AVX502 in healthy adult volunteers 65 years of age or older via the frequency of systemic reactogenicity events, local vaccine reactions and Adverse Events (time frame: 28 weeks). 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 12 Jul 2012.