A/H5N1/LT Dose Ranging Study

December 9, 2021 updated by: Intercell USA, Inc.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1: 30 µg HA, no LT patch
A/H5N1 Vaccine 30 µg HA i.m. on Day 0
Biological: A/H5N1
A/H5N1 Low Dose
Biological: A/H5N1
A/H5N1 High Dose
Experimental: Group 2: 30 µg HA + 50 µg LT patch
A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
Biological: A/H5N1
A/H5N1 Low Dose
Biological: A/H5N1
A/H5N1 High Dose
Biological: LT Adjuvant Patch
LT Adjuvant Patch Low Dose
Biological: LT Adjuvant Patch
LT Adjuvant Patch High Dose
Experimental: Group 3: 30 µg HA + 100 µg LT patch
A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
Biological: A/H5N1
A/H5N1 Low Dose
Biological: A/H5N1
A/H5N1 High Dose
Biological: LT Adjuvant Patch
LT Adjuvant Patch Low Dose
Biological: LT Adjuvant Patch
LT Adjuvant Patch High Dose
Experimental: Group 4: 45 µg HA, no LT patch
A/H5N1 Vaccine 45 µg HA i.m. on Day 0
Biological: A/H5N1
A/H5N1 Low Dose
Biological: A/H5N1
A/H5N1 High Dose
Experimental: Group 5: 45 µg HA + 50 µg LT patch
A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
Biological: A/H5N1
A/H5N1 Low Dose
Biological: A/H5N1
A/H5N1 High Dose
Biological: LT Adjuvant Patch
LT Adjuvant Patch Low Dose
Biological: LT Adjuvant Patch
LT Adjuvant Patch High Dose
Experimental: Group 6: 45 µg HA + 100 µg LT patch
A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
Biological: A/H5N1
A/H5N1 Low Dose
Biological: A/H5N1
A/H5N1 High Dose
Biological: LT Adjuvant Patch
LT Adjuvant Patch Low Dose
Biological: LT Adjuvant Patch
LT Adjuvant Patch High Dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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%.
Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch
Time Frame: 6 months
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
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intercell USA, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Department of Health and Human Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PLA201
  • HHSO100200700031C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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