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HealthyPhase 1/2NCT01353534

Open-label Study to Assess Immunogenicity and Safety of a Vaccine Enhancement Patch When Administered With 2 Doses of H5N1 Vaccine

A Phase 1/2 study testing A/H5N1 Antigen and Vaccine Enhancement Patch in people with Healthy, run by Intercell USA, Inc. at 5 sites in 2 countries.

Completed

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

Official record
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Trial summary

Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will receive 15µg A/H5N1 by IM alone. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
A/H5N1 Antigen and Vaccine Enhancement Patch
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
5 sitesin 2 countries
Study dates
May 2011to Oct 2012
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 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult males or females 18-49 years of age (inclusive)
  • signed Informed Consent
  • Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and at all in-clinic visits with understanding to not become pregnant over the duration of the study.

Who cannot join

  • Clinically significant laboratory abnormalities at screening
  • abnormalities at physical examination
  • known allergies to any component of the A/H5N1 antigen
  • known egg protein allergy
  • known allergies to adhesives
  • known coagulation disorders
Show all 34Show fewer
  • use of any anticoagulant medication within 30 days prior to vaccination or planned usage during the study period
  • participated in research involving investigational product within 30 days before planned date of vaccination or planned participation during study period
  • donated or received blood or blood products such as plasma within the three months before planned date of vaccination or planned donation or use during the study period
  • received or planned receipt of seasonal influenza vaccine during the study period
  • received any licensed vaccines within 2 weeks (inactivated vaccines) or 4 weeks (live vaccines) prior to planned date of vaccination
  • planned receipt of any licensed vaccine during the first 42 days on study
  • previous or planned vaccination with any vaccine containing an oil in water emulsion adjuvant
  • previous or planned vaccination with pandemic vaccine against A/H5N1 or previous proven contact with A/H5N1 wild type virus
  • ever received investigational enterotoxigenic E. coli LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd. Ever received cholera toxin or vaccine
  • Recent or regular use of oral, topical or injected steroid medications within 30 days prior to vaccination or planned use during the study period.
  • Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to vaccination or planned use during the study period
  • Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, and end-stage renal disease, as determined by the Investigator
  • positive serology for HIV-1, HIV-2, HBsAg, or HCV
  • history of severe atopy
  • medical history of acute or chronic skin disease at vaccination area
  • active skin allergy
  • signs of acute skin infection, sunburn or skin abnormalities at the vaccination area including fungal infections, severe acne, active contact dermatitis, or a history of keloid formation
  • hirsute at vaccination area
  • artificial tanning over the duration of the study including the screening period
  • visible tattoos or marks at the vaccination area that would prevent appropriate dermatologic monitoring of the vaccination site
  • fever greater than or equal to 38.0°C at the time of planned vaccination
  • suspicion of or recent history of alcohol or substance abuse
  • women who are pregnant or breastfeeding
  • acute illness at screening or at the time of planned vaccination
  • ever had a serious reaction to prior influenza vaccination
  • developed a neurological disorder following a previous influenza vaccination or have any acute and evolving neurological disorder
  • employee of the investigational site or sponsor
  • history of employment in bird or poultry industries or considerable exposure to birds

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Austria3 sites

  • Privatklinik Leech

    Graz, Graz, 8010

  • Medizinische Universität Wien

    Vienna, State of Vienna, 1090

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Belgium2 sites

  • Antwerp University - Campus Drie Eiken

    Antwerp, Antwerp, 2610

  • University Hospital Ghent

    Ghent, Ghent, 9000

Other trials in Belgium

About this study

Official title: A Phase 1/2, Randomized, Open-Label, Study to Assess the Immunogenicity and Safety of a Vaccine Enhancement Patch (VEP) When Administered With Two Doses of Intramuscular Inactivated Influenza H5N1 Vaccine in Healthy Adults

Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered IM but followed by the topical application of a VEP at the vaccination site. Group 4 will receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application of a VEP at the vaccination site.

The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)

Conditions
Healthy
Being tested
A/H5N1 Antigen, Vaccine Enhancement Patch
Keywords
Immunogenicity and Safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A/H5N1 AntigenBiological

    A/H5N1 Antigen

  • Vaccine Enhancement PatchDrug

    Vaccine Enhancement Patch

Study groups in NCT01353534
Study groupRoleWhat they receive
Group 1Experimental3.8 mcg with AS03 adjuvant at D0 and 21
Receives: Biological: A/H5N1 Antigen
Group 2Experimental15 mcg at D0 and 21
Receives: Biological: A/H5N1 Antigen
Group 3Experimental15 mcg + 50 mcg VEP at D0 and 21
Receives: Biological: A/H5N1 Antigen; Drug: Vaccine Enhancement Patch
Group 4Experimental30 mcg + 50 mcg VEP at D0
Receives: Biological: A/H5N1 Antigen; Drug: Vaccine Enhancement Patch

What is being measured

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

  1. Evaluate hemagglutination inhibition (HI) immune responses

    Evaluate hemagglutination inhibition (HI) immune responses to two doses of 15μg A/H5N1 achieved in the antigen plus VEP group versus the antigen alone group (Group 3 vs. Group 2) at Day 42 using standard serological parameters (Geometric Mean Titer [GMT], Geometric Mean Fold Ratio [GMFR], seroconversion and seroprotection).

    Measured: Day 42

Secondary outcomes (2)

  1. Safety of 15µg and 30µg IM A/H5N1 antigen administered with the 50µg VEP

    Comprehensive assessment of solicited and non-solicited local (vaccination site) and systemic adverse events (AEs) Safety follow-up through six months after last vaccination

    Measured: 8 months

  2. Characterize HI immune responses

    Characterize HI immune responses in the 15µg A/H5N1 antigen alone group (Group 2) and the 15µg A/H5N1 antigen plus VEP group (Group 3) to determine if levels meet or exceed EMA CPMP/BWP/214/96 criteria for immunogenicity:

    • The percent of subjects achieving seroconversion for HI antibody titer should meet or exceed 40%
    • The percent of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70%
    • GMT increase > 2.5

    Measured: 8 months

Timeline

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

  1. First posted13 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2011
  4. Study completionOct 2012

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01353534
Sponsor's protocol ID
IC82-102
Status last verified
Oct 2012
First submitted
12 May 2011
Last updated
18 Oct 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing A/H5N1 Antigen and Vaccine Enhancement Patch in people with Healthy, run by Intercell USA, Inc. at 5 sites in 2 countries.

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 3 inclusion and 34 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 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Austria, Belgium. 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?

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 hemagglutination inhibition (HI) immune responses (time frame: Day 42). 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 NCT01353534.

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 18 Oct 2012.

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