InfluenzaPhase 2NCT00966238
Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults >= 65 Years of Age
A Phase 2 study testing VAX125 in people with Influenza, run by VaxInnate Corporation at 3 sites in United States.
Trial summary
A multi-center, open-label, escalating dose-ranging study to assess the safety, reactogenicity, and immunogenicity of four different VAX125 vaccine doses; 0.5 µg, 1.0 µg, 2.0 µg, or 3.0 µg, delivered i.m. as a single dose vaccination on Day 0. 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?
- VAX125
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2009to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult men or women aged 65 or older; female subjects must be post menopausal.
- Live in the community, independently or in an assisted living environment
- Based on the results of the Short Portable Mental Status Questionnaire (SPMSQ), be rated as normal or have no greater than mild severity dementia.
- As defined by the Canadian Study of Health and Aging Clinical Frailty Scale (CSHA-CFS), fitness ranging from very fit to mildly frail; Classes 1 to 5 of 7.
- Healthy volunteers, as determined by medical history, physical examination (PE), vital signs, and clinical safety laboratory examinations.
- Able to comprehend the study requirements, agree to its provisions, have the ability to adhere to the provisions of the study, and give written informed consent prior to study entry.
- Willing to receive the unlicensed (VAX125) vaccine given as an i.m. injection.
- Willing to provide multiple blood specimens collected by venipuncture.
Who cannot join
- Persons who in the opinion of the Investigator, have a psychiatric illness, a chronic illness (e.g., diabetes or liver or kidney disease), or who are taking a concomitant therapy or have any other condition that would interfere with the subject's participation in the study or interpretation of the study results.
- Persons having cancer or have received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
- Persons with impaired immune responsiveness (of any cause), including diabetes mellitus.
- Persons presently receiving or having a recent history of receiving (within the past six months) any medication or therapeutic modality that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, radiation therapy, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Inhaled and topical corticosteroids are allowed.
- Persons who have had a prior serious reaction to influenza vaccine.
- Persons with a history of anaphylactic-type reaction to injected vaccines.
Show all 13Show fewer
- Persons with a history of drug or chemical abuse in the year prior to screening.
- Persons currently participating in another research study involving study medications (drugs or vaccines) or who have participated within 30 days of vaccination.
- Persons who have received blood or blood products within eight weeks prior to vaccination or are planning to receive blood or blood products during the study period.
- Persons who have donated blood or blood products within eight weeks prior to vaccination or plan to donate at any time during the study.
- Persons with acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness as determined by the Investigator through medical history and physical examination. Vaccination can be delayed until the subject has recovered.
- Persons with significant cardiovascular disease e.g., New York Heart Associate (NYHA) Class 3 or 4 congestive heart failure; myocardial infarction within the past six months; unstable angina, coronary angioplasty within the past six months; uncontrolled ventricular cardiac arrhythmias; resting heart rate (HR) >100 beats per minute (bpm)
- Persons with a history of chronic obstructive pulmonary disease or history of other lung disease.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Coastal Carolina Research Center
Charleston, South Carolina, 29464
JCCT
Lanexa, Kansas, 66219
Univ of Rochester
Rochester, New York, 14642
About this study
Official title: A Phase II, Open-label, Escalating Dose-ranging Study to Evaluate the Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults ≥65 Years of Age
A multi-center, open-label, escalating dose-ranging study to assess the safety, reactogenicity, and immunogenicity of four different VAX125 vaccine doses; 0.5 µg, 1.0 µg, 2.0 µg, or 3.0 µg, delivered i.m. as a single dose vaccination on Day 0. Hypothesis: VAX125 is safe and immunogenic at one or more of the doses tested.
Read the detailed description
A total of 80 community-living adults who are ≥65 years of age will be enrolled across the four dose groups. Following vaccination, each subject will remain at the study site for at least 30 minutes to be observed for any immediate reactogenicity complaints associated with the Day 0 vaccination. Subjects will also be evaluated during clinic visits on Study Days 1, 7, 14, and 28 following vaccination. In addition, a safety follow-up telephone contact will occur on post vaccination Day 3.
There will be 20 subjects per dose group. Up to 3 study sites will enroll 6-10 subjects per dose group over a two-day enrollment period. Progression to the next higher dose group will take place only if the Safety Monitoring Committee (SMC) assessment of the 30 (+15) minutes, Day 0, and Day 1 post vaccination safety data; Day 3 telephone report: and the Day 0 and Day 1 serum C-reactive protein (CRP) results concludes that the lower dose was well tolerated.
- Conditions
- Influenza
- Being tested
- VAX125
- Keywords
- influenza, vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAX125Biological
STF2.HA1(SI) (VAX125), which is a recombinant fusion protein that consists of Salmonella typhimurium flagellin type 2 (STF2), a Toll-like receptor 5 (TLR5) ligand, fused at its C-terminus to the globular head domain of the hemagglutinin (HA) antigen of influenza A HA1 Solomon Islands (SI).
| Study group | Role | What they receive |
|---|---|---|
| VAX125 | Experimental | HA1 influenza vaccine Receives: Biological: VAX125 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Local and Systemic Immediate Reactogenicity Complaints
Measured: within 4 hours following vaccination
Secondary outcomes (1)
Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers
Measured: 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- VaxInnate Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Taylor, MD, Study director, VaxInnate Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966238
- Sponsor's protocol ID
- VAX125-02
- Status last verified
- Sep 2014
- First submitted
- 24 Aug 2009
- Last updated
- 2 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Taylor DN, Treanor JJ, Strout C, Johnson C, Fitzgerald T, Kavita U, Ozer K, Tussey L, Shaw A. Induction of a potent immune response in the elderly using the TLR-5 agonist, flagellin, with a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125, STF2.HA1 SI). Vaccine. 2011 Jul 12;29(31):4897-902. doi: 10.1016/j.vaccine.2011.05.001. Epub 2011 May 17.
PubMed 21596084
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Escalating Dose-ranging Study to Evaluate the Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults ≥65 Years of Age
- ClinicalTrials.gov ID
- NCT00966238
- Acronym / sponsor ID
- VAX125-02
- Conditions
- Influenza
- Keywords
- influenza, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- VaxInnate CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 26 Aug 2009 (estimated)
- Results
- Posted 14 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, open-label, escalating dose-ranging study to assess the safety, reactogenicity, and immunogenicity of four different VAX125 vaccine doses; 0.5 µg, 1.0 µg, 2.0 µg, or 3.0 µg, delivered i.m. as a single dose vaccination on Day 0. Hypothesis: VAX125 is safe and immunogenic at one or more of the doses tested.
Detailed description
A total of 80 community-living adults who are ≥65 years of age will be enrolled across the four dose groups. Following vaccination, each subject will remain at the study site for at least 30 minutes to be observed for any immediate reactogenicity complaints associated with the Day 0 vaccination. Subjects will also be evaluated during clinic visits on Study Days 1, 7, 14, and 28 following vaccination. In addition, a safety follow-up telephone contact will occur on post vaccination Day 3.
There will be 20 subjects per dose group. Up to 3 study sites will enroll 6-10 subjects per dose group over a two-day enrollment period. Progression to the next higher dose group will take place only if the Safety Monitoring Committee (SMC) assessment of the 30 (+15) minutes, Day 0, and Day 1 post vaccination safety data; Day 3 telephone report: and the Day 0 and Day 1 serum C-reactive protein (CRP) results concludes that the lower dose was well tolerated.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAX125 | Experimental | Biological: VAX125HA1 influenza vaccine |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Adult men or women aged 65 or older; female subjects must be post menopausal.
- Live in the community, independently or in an assisted living environment
- Based on the results of the Short Portable Mental Status Questionnaire (SPMSQ), be rated as normal or have no greater than mild severity dementia.
- As defined by the Canadian Study of Health and Aging Clinical Frailty Scale (CSHA-CFS), fitness ranging from very fit to mildly frail; Classes 1 to 5 of 7.
- Healthy volunteers, as determined by medical history, physical examination (PE), vital signs, and clinical safety laboratory examinations.
Key exclusion criteria (13 listed)
- Persons who in the opinion of the Investigator, have a psychiatric illness, a chronic illness (e.g., diabetes or liver or kidney disease), or who are taking a concomitant therapy or have any other condition that would interfere with the subject's participation in the study or interpretation of the study results.
- Persons having cancer or have received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
- Persons with impaired immune responsiveness (of any cause), including diabetes mellitus.
- Persons presently receiving or having a recent history of receiving (within the past six months) any medication or therapeutic modality that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, radiation therapy, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Inhaled and topical corticosteroids are allowed.
- Persons who have had a prior serious reaction to influenza vaccine.
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 |
|---|---|---|
| VAX125STF2.HA1(SI) (VAX125), which is a recombinant fusion protein that consists of Salmonella typhimurium flagellin type 2 (STF2), a Toll-like receptor 5 (TLR5) ligand, fused at its C-terminus to the globular head domain of the hemagglutinin (HA) antigen of influenza A HA1 Solomon Islands (SI). | Biological | VAX125 |
Primary outcome
Number of Participants With Local and Systemic Immediate Reactogenicity Complaints
Time frame: within 4 hours following vaccination
1 secondary outcome
Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers
Time frame: 28 days after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21596084Taylor DN, Treanor JJ, Strout C, Johnson C, Fitzgerald T, Kavita U, Ozer K, Tussey L, Shaw A. Induction of a potent immune response in the elderly using the TLR-5 agonist, flagellin, with a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125, STF2.HA1 SI). Vaccine. 2011 Jul 12;29(31):4897-902. doi: 10.1016/j.vaccine.2011.05.001. Epub 2011 May 17.
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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.
David Taylor, MD study director
VaxInnate Corporation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VAX125 in people with Influenza, run by VaxInnate Corporation at 3 sites 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 13 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 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 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?
Yes. Results are posted in the registry (first posted 14 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Local and Systemic Immediate Reactogenicity Complaints (time frame: within 4 hours following vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00966238, which also lists 1 linked publication.
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 2 Oct 2014.