InfluenzaPhase 1/2NCT00440362
A Phase 1/2 Clinical Trial of an Alphavirus Replicon Vaccine for Influenza
A Phase 1/2 study testing AVX502 in people with Influenza, run by AlphaVax, Inc. at 1 site in United States.
Trial summary
AVX502, an alphavirus replicon vaccine expressing an influenza HA protein, is a candidate vaccine against influenza. 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 18-40 years of age. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy 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
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2007
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 40 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 4 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: 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 influenza 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 influenza vaccine within 12 months prior to enrollment;
- Receipt of any other vaccine within 30 days prior to enrollment;
- Use of any investigational agent within 30 days prior to enrollment;
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- 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);
- Presence of any factor that places the individual at increased risk for severe complications from influenza;
- History of serious adverse reactions to any vaccine, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema or abdominal pain;
- History of autoimmune disease;
- 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.
About this study
Official title: A Single-Site, Phase 1/2, Double-Blind, Safety and Immunogenicity Trial of an Alphavirus Replicon Vaccine Expressing Influenza A/Wyoming/03/2003 Hemagglutinin (AVX502) in Healthy Volunteers
AVX502, an alphavirus replicon vaccine expressing an influenza HA protein, is a candidate vaccine against influenza.
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 18-40 years of age. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in each arm on one or two occasions over 2 months. The study will last 4 months and will have a total of 8 visits.
Read the detailed description
This is a randomized, double-blind, placebo-controlled Phase 1/2 study of the safety and immunogenicity of AVX502 vaccine at two dosage levels and two routes of administration in healthy volunteers conducted at a single research center. A total of 216 participants will be enrolled. Participants will be randomized to receive active vaccine at one of two dosage levels or placebo in a 4:4:1 ratio. Within each active dosage level or placebo subgroup, participants will be randomized to receive their injections by either IM or SC injection in a 1:1 ratio, and will also be randomized to receive either 1 injection (at Week 0) or 2 injections (1 at each of two visits at Weeks 0 and 8) in a 1:1 ratio. Vaccine will be administered by a study nurse in an outpatient setting and all participants will be followed for 4 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 HA by ELISA and hemagglutination inhibition assays and to the vaccine vector by a VRP neutralization assay) and peripheral blood mononuclear cells (PMBC) (for measurement of cellular immune responses to HA peptides).
- 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
1 dose at 2e8 IU given at t=0 via IM route
AVX502Biological
1 dose at 2e7 IU given at T=0 via the IM route
AVX502Biological
1 dose at 2e7 IU given at t=0 via the SC route
AVX502Biological
1 dose at 2e8 IU given at T=0 via the SC route
AVX502Biological
2 doses at 2e7 IU given at T=0 and 8 weeks via the IM route
AVX502Biological
2 doses at 2e8 IU given at T=0 and 8 weeks via the IM route
AVX502Biological
2 doses of 2e7 IU given at t=0 and 8 weeks via the SC route
AVX502Biological
2 doses at 2e8 IU given at T=0 and 8 weeks via the SC route
PlaceboBiological
1 dose of placebo given at T=0 via the IM route
PlaceboBiological
1 dose of placebo given at T=0 via the SC route
PlaceboBiological
2 doses of placebo given at T=0 and 8 weeks via the IM route
PlaceboBiological
2 doses of placebo given at T=0 and 8 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 |
| T3 | Active comparator | Not described Receives: Biological: AVX502 |
| T4 | Active comparator | Not described Receives: Biological: AVX502 |
| T5 | Active comparator | Not described Receives: Biological: AVX502 |
| T6 | Active comparator | Not described Receives: Biological: AVX502 |
| T7 | Active comparator | Not described Receives: Biological: AVX502 |
| T8 | Active comparator | Not described Receives: Biological: AVX502 |
| C1 | Placebo comparator | Not described Receives: Biological: Placebo |
| C2 | Placebo comparator | Not described Receives: Biological: Placebo |
| C3 | Placebo comparator | Not described Receives: Biological: Placebo |
| 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 AVX502 in healthy volunteers via frequency of Grade 2-4 systemic reactogenicity events, grade 3 or 4 local vaccine reactions and all AE's
Measured: 16 weeks
Secondary outcomes (1)
Evaluate immunogenicity of AVX502 in healthy volunteers via serum antibody concentration
Measured: 4 weeks post first 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 posted27 Feb 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2007
- Study completionSep 2007
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 216 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
- NCT00440362
- Sponsor's protocol ID
- AVX502-002
- 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 1/2, Double-Blind, Safety and Immunogenicity Trial of an Alphavirus Replicon Vaccine Expressing Influenza A/Wyoming/03/2003 Hemagglutinin (AVX502) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00440362
- Acronym / sponsor ID
- AVX502-002
- Conditions
- Influenza
- Keywords
- Influenza, Flu, A/Wyoming/03/2003, Alphavirus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- AlphaVax, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 27 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.
AVX502, an alphavirus replicon vaccine expressing an influenza HA protein, is a candidate vaccine against influenza.
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 18-40 years of age. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in each arm on one or two occasions over 2 months. The study will last 4 months and will have a total of 8 visits.
Detailed description
This is a randomized, double-blind, placebo-controlled Phase 1/2 study of the safety and immunogenicity of AVX502 vaccine at two dosage levels and two routes of administration in healthy volunteers conducted at a single research center. A total of 216 participants will be enrolled. Participants will be randomized to receive active vaccine at one of two dosage levels or placebo in a 4:4:1 ratio. Within each active dosage level or placebo subgroup, participants will be randomized to receive their injections by either IM or SC injection in a 1:1 ratio, and will also be randomized to receive either 1 injection (at Week 0) or 2 injections (1 at each of two visits at Weeks 0 and 8) in a 1:1 ratio. Vaccine will be administered by a study nurse in an outpatient setting and all participants will be followed for 4 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 HA by ELISA and hemagglutination inhibition assays and to the vaccine vector by a VRP neutralization assay) and peripheral blood mononuclear cells (PMBC) (for measurement of cellular immune responses to HA peptides).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| T1 | Active comparator | Biological: AVX502 |
| T2 | Active comparator | Biological: AVX502 |
| T3 | Active comparator | Biological: AVX502 |
| T4 | Active comparator | Biological: AVX502 |
| T5 | Active comparator | Biological: AVX502 |
| T6 | Active comparator | Biological: AVX502 |
| T7 | Active comparator | Biological: AVX502 |
| T8 | Active comparator | Biological: AVX502 |
| C1 | Placebo comparator | Biological: Placebo |
| C2 | Placebo comparator | Biological: Placebo |
| C3 | Placebo comparator | Biological: Placebo |
| C4 | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Between 18 and 40 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 4 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: 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;
Key exclusion criteria (17 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 influenza vaccine within 12 months prior to enrollment;
- Receipt of any other vaccine 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 |
|---|---|---|
| AVX5021 dose at 2e8 IU given at t=0 via IM route | Biological | T2 |
| AVX5021 dose at 2e7 IU given at T=0 via the IM route | Biological | T1 |
| AVX5021 dose at 2e7 IU given at t=0 via the SC route | Biological | T3 |
| AVX5021 dose at 2e8 IU given at T=0 via the SC route | Biological | T4 |
| AVX5022 doses at 2e7 IU given at T=0 and 8 weeks via the IM route | Biological | T5 |
| AVX5022 doses at 2e8 IU given at T=0 and 8 weeks via the IM route | Biological | T6 |
| AVX5022 doses of 2e7 IU given at t=0 and 8 weeks via the SC route | Biological | T7 |
| AVX5022 doses at 2e8 IU given at T=0 and 8 weeks via the SC route | Biological | T8 |
| Placebo1 dose of placebo given at T=0 via the IM route | Biological | C1 |
| Placebo1 dose of placebo given at T=0 via the SC route | Biological | C2 |
| Placebo2 doses of placebo given at T=0 and 8 weeks via the IM route | Biological | C3 |
| Placebo2 doses of placebo given at T=0 and 8 weeks via the SC route | Biological | C4 |
Primary outcome
Evaluate safety of AVX502 in healthy volunteers via frequency of Grade 2-4 systemic reactogenicity events, grade 3 or 4 local vaccine reactions and all AE's
Time frame: 16 weeks
1 secondary outcome
Evaluate immunogenicity of AVX502 in healthy volunteers via serum antibody concentration
Time frame: 4 weeks post first 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 10 Nov 2008.
- 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 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 1/2 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 7 inclusion and 17 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 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 safety of AVX502 in healthy volunteers via frequency of Grade 2-4 systemic reactogenicity events, grade 3 or 4 local vaccine reactions and all AE's (time frame: 16 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 10 Nov 2008.