Pandemic InfluenzaPhase 1NCT00532792

A/H5N1 Dose Ranging Study With Adjuvant Patch

A Phase 1 study testing A/H5N1 in people with Pandemic Influenza, run by Intercell USA, Inc. at 5 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 501 participants
Where: 5 sitesUnited States
Study dates: Aug 2007to Jun 2008
Phase: Phase 1
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 within 24 hours of each vaccination with understanding (through Informed Consent process) to not become pregnant and 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

Laboratory abnormalities [as determined by the Toxicity Grading Scale (grade 1 4)] at laboratory 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 34Show fewer

Participated in research involving investigational product within 45 days before planned date of first 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 first vaccination
Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd
Ever received cholera toxin or vaccine (e.g. Orochol™, Dukoral™)
History of travelers' diarrhea in the last two years
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 illness
Previous vaccination with a pandemic candidate 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 first vaccination
Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to first vaccination
Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, 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(s)
Active skin allergy
Signs of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, or active contact dermatitis, or a history of keloid formation
Hirsute (significant amount of hair) at vaccination area(s)
Artificial tanning (UV radiation) over the duration of the study including the screening period
Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatologic monitoring of the vaccination site(s)
Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination
Suspicion of or recent history of (within one year of planned vaccination) 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 Guillain Barré syndrome) in the six weeks following a previous influenza vaccination
Medical history of achlorhydria
Employee of the investigational site
History of employment in bird or poultry industries or considerable exposure to birds (e.g. poultry or bird veterinarians, bird breeders, poultry butchers and/or cullers, etc.)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Quintiles Phase One Services
Kansas City, Kansas, 66211
Miami Research Associates
Miami, Florida, 33143
Jean Brown Research
Salt Lake City, Utah, 84124
Northwest Kinetics
Tacoma, Washington, 98418
Solano Clinical Research
Vallejo, California, 94589

Other trials in United States

About this study

Official title: A Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Administered With and Without an Adjuvant Patch in Healthy Adults

This is a Phase 1/2, randomized, observer-blind, placebo-controlled clinical trial. A maximum of 500 eligible subjects in 10 groups will be enrolled, randomized and vaccinated in this study. Subjects will receive an intramuscular injection of either the influenza A/H5N1 (low, medium or high dose) or placebo on Day 0 and Day 21 with or without a patch. This study will be performed in two parts.

In Part 1, an initial safety evaluation will be performed in 100 randomized subjects. A Safety Review Committee (SRC)will review all safety data, including laboratory values, through the Day 7 visit, and compare those data against Stopping Criteria. If the treatments are considered safe, Part 2 of the study will be initiated and a second vaccination will be administered to subjects in Part 1 on Day 21.

In Part 2, the remaining 400 subjects will be randomized, treated, and will follow the same visit structure and protocol-defined requirements as subjects in Part 1, without the additional laboratory safety measurements. An SRC review will also be performed of all safety data through the Day 28 visit for subjects participating in Part 1.

Conditions: Pandemic Influenza
Being tested: A/H5N1, Placebo
Keywords: Avian, Pandemic, Influenza, A/H5N1
Medical subject headings: Influenza, Human

What participants receive

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

A/H5N1Biological
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
A/H5N1Biological
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
A/H5N1Biological
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
A/H5N1Biological
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
A/H5N1Biological
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
A/H5N1Biological
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
A/H5N1Biological
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
A/H5N1Biological
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
A/H5N1Biological
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
PlaceboBiological
Placebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21

Study groups in NCT00532792
Study group	Role	What they receive
Group 1	Experimental	Not described Receives: Biological: A/H5N1
Group 2	Experimental	Not described Receives: Biological: A/H5N1
Group 3	Experimental	Not described Receives: Biological: A/H5N1
Group 4	Experimental	Not described Receives: Biological: A/H5N1
Group 5	Experimental	Not described Receives: Biological: A/H5N1
Group 6	Experimental	Not described Receives: Biological: A/H5N1
Group 7	Experimental	Not described Receives: Biological: A/H5N1
Group 8	Experimental	Not described Receives: Biological: A/H5N1
Group 9	Experimental	Not described Receives: Biological: A/H5N1
Group 10	Placebo comparator	Not described Receives: Biological: Placebo

What is being measured

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

Safety of Intramuscular A/H5N1 with and without the LT adjuvant patch
Measured: 6 months

Secondary outcomes (1)

Demonstration of adjuvant effect and evaluation of immunogenicity
Measured: Day 42

Timeline

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

Aug 2007Jun 2008

First posted20 Sep 2007 (estimated)
Study startAug 2007
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 501 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00532792
Sponsor's protocol ID: PLA101
Other IDs: HHSSO100200700031C
Status last verified: Jan 2012
First submitted: 19 Sep 2007
Last updated: 14 Mar 2012
Results posted: No
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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Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Administered With and Without an Adjuvant Patch in Healthy Adults
ClinicalTrials.gov ID: NCT00532792
Acronym / sponsor ID: PLA101
Conditions: Pandemic Influenza
Keywords: Avian, Pandemic, Influenza, A/H5N1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 501 participants (actual)
Lead sponsor: Intercell USA, Inc.Industry (pharma, biotech, devices)
Collaborators: Department of Health and Human Services
Study start: Aug 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 20 Sep 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
Group 1	Experimental	Biological: A/H5N1
Group 2	Experimental	Biological: A/H5N1
Group 3	Experimental	Biological: A/H5N1
Group 4	Experimental	Biological: A/H5N1
Group 5	Experimental	Biological: A/H5N1
Group 6	Experimental	Biological: A/H5N1
Group 7	Experimental	Biological: A/H5N1
Group 8	Experimental	Biological: A/H5N1
Group 9	Experimental	Biological: A/H5N1
Group 10	Placebo comparator	Biological: Placebo

Who may qualify

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

Key inclusion criteria (3 listed)

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 within 24 hours of each vaccination with understanding (through Informed Consent process) to not become pregnant and 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 (34 listed)

Laboratory abnormalities [as determined by the Toxicity Grading Scale (grade 1 4)] at laboratory 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/H5N1Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21	Biological	Group 1
A/H5N1Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21	Biological	Group 2
A/H5N1Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21	Biological	Group 3
A/H5N1Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21	Biological	Group 4
A/H5N1Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21	Biological	Group 5
A/H5N1Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21	Biological	Group 6
A/H5N1High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21	Biological	Group 7
A/H5N1High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21	Biological	Group 8
A/H5N1High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21	Biological	Group 9
PlaceboPlacebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21	Biological	Group 10

Primary outcome

Safety of Intramuscular A/H5N1 with and without the LT adjuvant patch
Time frame: 6 months

1 secondary outcome

Demonstration of adjuvant effect and evaluation of immunogenicity
Time frame: Day 42

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 14 Mar 2012.

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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.

Philip Leese, MD principal investigator

Quintiles Phase One Services

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing A/H5N1 in people with Pandemic Influenza, run by Intercell USA, Inc. at 5 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 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 14 Mar 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 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 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.

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?

Safety of Intramuscular A/H5N1 with and without the LT adjuvant patch (time frame: 6 months). 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 NCT00532792.

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 14 Mar 2012.