InfluenzaPhase 1/2NCT00921947

Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults

A Phase 1/2 study testing VAX102 in people with Influenza, run by VaxInnate Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population. 2. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: VAX102
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Aug 2009
Phase: Phase 1/2
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 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Adult men or women aged 18 to 49 years inclusive.
Able and willing to provide written informed consent to participate.
Healthy, as determined by medical history, physical examination, and vital signs.
Willing to receive the unlicensed (VAX102) vaccine given as an i.m. or s.c. injection.
Willing to provide multiple blood specimens collected by venipuncture.
Females should avoid becoming pregnant during the course of the study
Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of the first and preceding receipt of the second (booster) vaccination.
Must exhibit comprehension of the study requirements; expressed availability for the required study period and expect to reside in the study area during the entire study period, and ability to attend scheduled visits.

Who cannot join

Persons under 18 years old or 50 years or older.
Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease.
Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination.
Persons who have had a prior serious reaction to influenza vaccine.
Persons with a history of anaphylactic-type reaction to injected vaccines.
Persons with a history of drug or chemical abuse in the year preceding the study.

Show all 10Show fewer

Persons who received an influenza vaccine for the current influenza season or those who plan to receive an influenza vaccine while participating in the study.
Persons who received any other vaccine within one week prior to enrollment (may delay enrollment).
Persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment).
Persons currently participating in another research study involving any study medications (medicines or vaccines).

Trial locations and contacts

1 site in 1 country.

United States1 site

Jean Brown Research
Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: A Phase II, Randomized, Open-Label Study to Evaluate the Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) in Healthy Adults

To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population.
To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked immunosorbent assay (ELISA) in a healthy adult population.

Conditions: Influenza
Being tested: VAX102
Keywords: influenza vaccine, M2e, Universal 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.

VAX102Biological
Also called STF2.4xM2e
Universal M2e influenza vaccine

Study groups in NCT00921947
Study group	Role	What they receive
VAX102 IM	Experimental	VAX102 given as 1 µg intramuscular (i.m.) Receives: Biological: VAX102
VAX102 SC	Experimental	VAX102 given as a 2 µg subcutaneous (s.c.) dose Receives: Biological: VAX102

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Solicited local and general symptoms experienced within 7 days after vaccination 1.
Measured: 0 to 7 days after vaccination
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Solicited local and general symptoms experienced within 14 days after vaccination 2
Measured: 14 days after vaccination

Secondary outcomes (1)

Anti-M2e Serum Antibody Concentration
Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.
Measured: 42 days (+/- 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Aug 2009

First posted17 Jun 2009 (estimated)
Study startJun 2009
Primary completionJul 2009
Study completionAug 2009

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.
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: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00921947
Sponsor's protocol ID: VAX102-09
Status last verified: Aug 2011
First submitted: 15 Jun 2009
Last updated: 24 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Open-Label Study to Evaluate the Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) in Healthy Adults
ClinicalTrials.gov ID: NCT00921947
Acronym / sponsor ID: VAX102-09
Conditions: Influenza
Keywords: influenza vaccine, M2e, Universal influenza vaccine
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: VaxInnate CorporationIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Jul 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 17 Jun 2009 (estimated)
Results: Posted 22 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population.
To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked immunosorbent assay (ELISA) in a healthy adult population.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
VAX102 IM	Experimental	Biological: VAX102VAX102 given as 1 µg intramuscular (i.m.)
VAX102 SC	Experimental	Biological: VAX102VAX102 given as a 2 µg subcutaneous (s.c.) dose

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Adult men or women aged 18 to 49 years inclusive.
Able and willing to provide written informed consent to participate.
Healthy, as determined by medical history, physical examination, and vital signs.
Willing to receive the unlicensed (VAX102) vaccine given as an i.m. or s.c. injection.
Willing to provide multiple blood specimens collected by venipuncture.

Key exclusion criteria (10 listed)

Persons under 18 years old or 50 years or older.
Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease.
Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination.
Persons who have had a prior serious reaction to influenza vaccine.
Persons with a history of anaphylactic-type reaction to injected vaccines.

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
VAX102Also: STF2.4xM2eUniversal M2e influenza vaccine	Biological	VAX102 IM, VAX102 SC

Primary outcome

Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Time frame: 0 to 7 days after vaccination
Solicited local and general symptoms experienced within 7 days after vaccination 1.
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Time frame: 14 days after vaccination
Solicited local and general symptoms experienced within 14 days after vaccination 2

1 secondary outcome

Anti-M2e Serum Antibody Concentration
Time frame: 42 days (+/- 2)

Results and safety

Results posted to the registry on 22 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VAX102 IM	30	30
VAX102 SC	30	30

Primary outcome: Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)

Time frame: 0 to 7 days after vaccination. Number. Unit: participants

Measure	VAX102 1.0 µg i.m. n = 30	VAX102 2.0 µg s.c. n = 30
Redness	0	13
Swelling	2	3
Bruising	0	0
Arm Pain	23	21
Headache	5	3
Fatigue	4	4
Joint Pain	4	3
Muscle Aches	13	10

Population analysed: The population analyzed included all participants receiving at least 1 dose of the vaccine.

Primary outcome: Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)

Time frame: 14 days after vaccination. Number. Unit: participants

Measure	VAX102 1.0 µg i.m. n = 28	VAX102 2.0 µg s.c. n = 30
Redness	0	0
Swelling	0	0
Bruising	0	0
Arm pain	0	0
Headache	0	0
Fatigue	0	1
Joint Pain	0	0
Muscle Aches	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 42 days following vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VAX102 IM	1 of 28 (3.6%)	0 of 28 (0%)	Not reported
VAX102 SC	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 N Taylor, MD study director

VaxInnate Corporation

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 VAX102 in people with Influenza, run by VaxInnate Corporation 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 10 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 24 Aug 2011. 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. 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?

Yes. Results are posted in the registry (first posted 22 Aug 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 Symptoms Post Vaccination 1 (Day 0) (time frame: 0 to 7 days after vaccination). The study lists 2 primary outcomes in all. 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 NCT00921947.

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 24 Aug 2011.