Pandemic InfluenzaPhase 2NCT00908687

A/H5N1/LT Dose Ranging Study

A Phase 2 study testing A/H5N1 and LT Adjuvant Patch in people with Pandemic Influenza, run by Intercell USA, Inc. at 6 sites in United States.

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

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Pandemic Influenza
What is being tested?: A/H5N1 and LT Adjuvant Patch
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 6 sitesUnited States
Study dates: May 2009to Jul 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 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male or females 18 to 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 within 24 hours of vaccination with understanding (through informed Consent process) to not become pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide) and IUD

Who cannot join

Clinically significant laboratory abnormalities at screening
Abnormalities at physical examination [as determined by the Toxicity Grading Scale (grade 1-4)]
Known allergies to any component of the vaccine
Known egg protein allergy
Known allergies to adhesives
Known disturbance of coagulation

Show all 33Show fewer

Participated in research involving investigational product within 45 days before planned date of vaccination
Donated or received blood or blood products such as plasma within the past 45 days
Received any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to planned date of vaccination
Ever received investigational enterotoxigenic E. coli, or LT (R192G) or NasalFlu, Berna Biotech Ltd
Ever received cholera toxin or vaccine (e.g. Orochol, Dukoral)
History of abdominal surgery (excluding C-Section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent acute gastrointestinal (GI) illness
Previous vaccination with a pandemic vaccine or previous proven contact with A/H5N1 wild type virus (contact with an individual with laboratory-confirmed A/H5N1 infection or contact with an animal which died as a result of A/H5N1 infection)
Recent or regular use of oral, topical or injected steroid medications within 45 days prior to vaccination
Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to vaccination
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 (significant amount of hair) at vaccination area
Artificial tanning (UV radiation) over the duration of the study including the screening period
Visible tattoos or marks (tattoos/scars) at the vaccination area that would prevent appropriate dermatologic monitoring of the vaccination site
Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination
Suspicion of or recent history (within one year of planned vaccination) of alcohol or substance abuse
Women who are pregnant or breastfeeding
Acute illness at screening or at baseline
Ever had a serious reaction to prior influenza vaccination
Developed a neurological disorder (such as Guillian Barré syndrome) in the six weeks following a previous influenza vaccination
Medical history of achlorhydria
Employee of the investigational site or sponsor
History of employment in bird or poultry industries or considerable exposure to birds (e.g. poultry or avian veterinarians, bird breeders, poultry butchers and/or culler, etc.)

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Advanced Clinical Research Institute
Anaheim, California, 92801
Johnson County Clinical Trials
Lenexa, Kansas, 66219
Miami Research Associates
Miami, Florida, 33143
Jean Brown Research
Salt Lake City, Utah, 84124
Accelovance
South Bend, Indiana, 46601
Solano Clinical Research
Vallejo, California, 94589

Other trials in United States

About this study

Official title: A Randomized Blinded, LT Dose-ranging Study to Assess the Immunogenicity and Safety of Different Doses of LT Adjuvant Patch Administered in Conjunction With Different Doses of Inactivated Influenza A/H5N1 Vaccine in Healthy Adults

This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).

Conditions: Pandemic Influenza
Being tested: A/H5N1, LT Adjuvant Patch

What participants receive

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

A/H5N1Biological
A/H5N1 Low Dose
A/H5N1Biological
A/H5N1 High Dose
LT Adjuvant PatchBiological
LT Adjuvant Patch Low Dose
LT Adjuvant PatchBiological
LT Adjuvant Patch High Dose

Study groups in NCT00908687
Study group	Role	What they receive
Group 1: 30 µg HA, no LT patch	Experimental	A/H5N1 Vaccine 30 µg HA i.m. on Day 0 Receives: Biological: A/H5N1
Group 2: 30 µg HA + 50 µg LT patch	Experimental	A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 Receives: Biological: A/H5N1; Biological: LT Adjuvant Patch
Group 3: 30 µg HA + 100 µg LT patch	Experimental	A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 Receives: Biological: A/H5N1; Biological: LT Adjuvant Patch
Group 4: 45 µg HA, no LT patch	Experimental	A/H5N1 Vaccine 45 µg HA i.m. on Day 0 Receives: Biological: A/H5N1
Group 5: 45 µg HA + 50 µg LT patch	Experimental	A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 Receives: Biological: A/H5N1; Biological: LT Adjuvant Patch
Group 6: 45 µg HA + 100 µg LT patch	Experimental	A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 Receives: Biological: A/H5N1; Biological: LT Adjuvant Patch

What is being measured

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

Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28.
Seroconversion is defined as either 1) baseline HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40. FDA/EMEA criterion for seroconversion was to meet or exceed 40%. FDA/EMEA criterion for seroprotection was to meet or exceed 70%.
Measured: Day 28

Secondary outcomes (2)

Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch
Measured: 6 months
Evaluate Treatment Group HI Responses Against US FDA Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (May 2007) and EMA CPMP/BWP/214/96 Criteria for Immunogenicity
Measured: Day 28

Timeline

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

May 2009Jul 2011

First posted27 May 2009 (estimated)
Study startMay 2009
Primary completionJan 2010
Study completionJul 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.
Other trials for Pandemic 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00908687
Sponsor's protocol ID: PLA201
Other IDs: HHSO100200700031C
Status last verified: Dec 2021
First submitted: 22 May 2009
Last updated: 10 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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All Pandemic Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Blinded, LT Dose-ranging Study to Assess the Immunogenicity and Safety of Different Doses of LT Adjuvant Patch Administered in Conjunction With Different Doses of Inactivated Influenza A/H5N1 Vaccine in Healthy Adults
ClinicalTrials.gov ID: NCT00908687
Acronym / sponsor ID: PLA201
Conditions: Pandemic Influenza
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: Intercell USA, Inc.Industry (pharma, biotech, devices)
Collaborators: Department of Health and Human Services
Study start: May 2009
Primary completion: Jan 2010 (actual)
Study completion: Jul 2011 (actual)
First posted: 27 May 2009 (estimated)
Results: Posted 13 Mar 2014

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Group 1: 30 µg HA, no LT patch	Experimental	Biological: A/H5N1A/H5N1 Vaccine 30 µg HA i.m. on Day 0
Group 2: 30 µg HA + 50 µg LT patch	Experimental	Biological: A/H5N1, Biological: LT Adjuvant PatchA/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
Group 3: 30 µg HA + 100 µg LT patch	Experimental	Biological: A/H5N1, Biological: LT Adjuvant PatchA/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
Group 4: 45 µg HA, no LT patch	Experimental	Biological: A/H5N1A/H5N1 Vaccine 45 µg HA i.m. on Day 0
Group 5: 45 µg HA + 50 µg LT patch	Experimental	Biological: A/H5N1, Biological: LT Adjuvant PatchA/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
Group 6: 45 µg HA + 100 µg LT patch	Experimental	Biological: A/H5N1, Biological: LT Adjuvant PatchA/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0

Who may qualify

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

Key inclusion criteria (3 listed)

Healthy adult male or females 18 to 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 within 24 hours of vaccination with understanding (through informed Consent process) to not become pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide) and IUD

Key exclusion criteria (33 listed)

Clinically significant laboratory abnormalities at screening
Abnormalities at physical examination [as determined by the Toxicity Grading Scale (grade 1-4)]
Known allergies to any component of the vaccine
Known egg protein allergy
Known allergies to adhesives

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
A/H5N1A/H5N1 Low Dose	Biological	Group 1: 30 µg HA, no LT patch, Group 2: 30 µg HA + 50 µg LT patch, Group 3: 30 µg HA + 100 µg LT patch
A/H5N1A/H5N1 High Dose	Biological	Group 4: 45 µg HA, no LT patch, Group 5: 45 µg HA + 50 µg LT patch, Group 6: 45 µg HA + 100 µg LT patch
LT Adjuvant PatchLT Adjuvant Patch Low Dose	Biological	Group 2: 30 µg HA + 50 µg LT patch, Group 5: 45 µg HA + 50 µg LT patch
LT Adjuvant PatchLT Adjuvant Patch High Dose	Biological	Group 3: 30 µg HA + 100 µg LT patch, Group 6: 45 µg HA + 100 µg LT patch

Primary outcome

Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28.
Time frame: Day 28
Seroconversion is defined as either 1) baseline HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40. FDA/EMEA criterion for seroconversion was to meet or exceed 40%. FDA/EMEA criterion for seroprotection was to meet or exceed 70%.

2 secondary outcomes

Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch
Time frame: 6 months
Evaluate Treatment Group HI Responses Against US FDA Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (May 2007) and EMA CPMP/BWP/214/96 Criteria for Immunogenicity
Time frame: Day 28

Results and safety

Results posted to the registry on 13 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: 30 µg HA, no LT Patch	50	49
Group 2: 30 µg HA + 50 µg LT Patch	100	99
Group 3: 30 µg HA + 100 µg LT Patch	102	99
Group 4: 45 µg HA, no LT Patch	50	47
Group 5: 45 µg HA + 50 µg LT Patch	98	94
Group 6: 45 µg HA + 100 µg LT Patch	100	94

Primary outcome: Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28.

Time frame: Day 28. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Group 1: 30 µg HA, no LT Patch n = 49	Group 2: 30 µg HA + 50 µg LT Patch n = 98	Group 3: 30 µg HA + 100 µg LT Patch n = 101	Group 4: 45 µg HA, no LT Patch n = 50	Group 5: 45 µg HA + 50 µg LT Patch n = 96	Group 6: 45 µg HA + 100 µg LT Patch n = 94
HI Seroconversion Rates	35.4 (22.2 to 50.5)	47.4 (37.2 to 57.8)	37.6 (28.2 to 47.8)	53.1 (38.3 to 67.5)	50.5 (40.1 to 61.0)	50.0 (39.5 to 60.5)
HI Seroprotection Rates	35.4 (22.2 to 50.5)	47.4 (37.2 to 57.8)	37.6 (28.2 to 47.8)	55.1 (40.2 to 69.3)	53.7 (43.2 to 64.0)	50.0 (39.5 to 60.5)

Population analysed: Primary Immunogenicity Evaluable Population (PIEP): all subjects who were consented, randomized, received the assigned treatment, had HI assay results at all the following time points: baseline (Day 0), Day 21 and Day 28, and did not have any major protocol deviations

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: 30 µg HA, no LT Patch	0 of 50 (0%)	31 of 50 (62%)	Not reported
Group 2: 30 µg HA + 50 µg LT Patch	0 of 100 (0%)	86 of 100 (86%)	Not reported
Group 3: 30 µg HA + 100 µg LT Patch	1 of 102 (1%)	86 of 102 (84.3%)	Not reported
Group 4: 45 µg HA, no LT Patch	0 of 50 (0%)	36 of 50 (72%)	Not reported
Group 5: 45 µg HA + 50 µg LT Patch	1 of 98 (1%)	87 of 98 (88.8%)	Not reported
Group 6: 45 µg HA + 100 µg LT Patch	1 of 100 (1%)	85 of 100 (85%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
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.

Eric Sheldon, MD principal investigator

Miami Research Associates

6 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 A/H5N1 and LT Adjuvant Patch in people with Pandemic Influenza, run by Intercell USA, Inc. at 6 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 3 inclusion and 33 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 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 13 Mar 2014). 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?

Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28. (time frame: Day 28). 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 NCT00908687.

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 Dec 2021.