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InfluenzaPhase 1/2NCT01320696

Reverse Genetic H9N2 Influenza Vaccine Study in Adults

A Phase 1/2 study testing Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine in people with Influenza, run by Alachua Government Services, 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

The purpose of the study is to identify the optimal dose level of a reverse genetic (RG) reassortant H9N2 pandemic influenza vaccine for further product development. 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?
Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
353 participants
Where
5 sitesUnited States
Study dates
Mar 2011to May 2012
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

  • Subject is 18 to 49 years of age, inclusive, on the day of screening
  • Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to study entry
  • Subject is generally healthy, as determined by the investigator's clinical judgement through collection of medical history and performance of a physical examination
  • Subject is physically and mentally capable of participating in the study as determined by the investigator
  • Subject agrees to keep a daily record of symptoms for the duration of the study
  • If female of childbearing potential, subject presents with a negative urine pregnancy test within 24 hours prior to first vaccination and agrees to employ adequate birth control measures for the duration of the study. For the purposes of this study at least one of the following types of US Food and Drug Administration (FDA) approved birth control measures shall be applied through completion of the Day 181 study visit:
  • Hormonal types of birth control (such as implants or birth control pills) or an intrauterine device
  • A barrier type of birth control measure (i.e. condoms, diaphragms, cervical caps, etc.)

Who cannot join

  • Subject has a history of exposure to H9N2 influenza virus or a history of vaccination with an H9N2 influenza vaccine
  • Subject is at potential occupational risk of contracting H9N2 influenza infection (e.g. poultry workers)
  • Subject currently suffers from or has a history of a significant (requiring hospitalization or change in intervention in past 6 months)neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder such as but not limited to: multiple sclerosis, lupus, Guillain-Barre syndrome as determined by the investigator
  • Subject has a body temperature of >= 100.4 degrees Fahrenheit (>= 38.0 degrees Celsius) on the day of vaccination, by oral measurement. [NOTE: Subjects meeting this exclusion criterion may be rescheduled for vaccination and study entry at a later date provided: 1) body temperature measured orally has decreased to < 100.4 degrees Fahrenheit (< 38.0 degrees Celsius); 2) all other inclusion/exclusion criteria are met; 3) the rescheduled date is no more than 14 days past the initial screening assessments and date; and 4) the study site is still enrolling subjects and randomization is not closed]
  • Subject has a Body Mass Index (BMI) >= 35
  • Subject has hypertension at screening that is graded as greater than Stage 1 (defined as a systolic pressure > 159 or diastolic pressure > 99 while seated and at rest (measurement shall be repeated twice before subject is excluded)
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  • Subject has clinically significant abnormal laboratory values at screening as determined by the investigator
  • Subject tests positive for Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAgs) or Hepatitis C Virus (HCV)
  • Subject has any medically diagnosed or suspected immune deficient condition based on medical history and physical examination as determined by the investigator
  • Subject has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (> 800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs (use of inhaled and nasal steroids will be permitted)
  • Subject has a history of severe (required immediate medical life threatening treatment and/or hospitalization) allergic reactions or anaphylaxis as determined by the investigator
  • Subject has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating as determined by the investigator
  • Subject has received any blood products (e.g. blood transfusion or immunoglobulins) within 90 days prior to study entry
  • Subject has donated one or more units of blood (approximately 450 mL) or plasma within 30 days prior to study entry
  • Subject has received any live vaccine within 4 weeks or an inactivated vaccine or a subunit vaccine within 2 weeks prior to vaccination in this study
  • Subject has a functional or surgical asplenia
  • Subject has a positive urine drug screen (unless the subject is currently prescribed the drug detected by a licensed health care provider and the continued administration of the drug would not otherwise exclude the subject from participation)
  • Subject has a known or suspected problem with alcohol or drug abuse as determined by the investigator
  • Subject is currently enrolled or has participated in another clinical study involving an investigational products (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study
  • Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e. children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
  • If female, subject is pregnant or lactating at the time of study enrollment
  • Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Accelovance

    Huntsville, Alabama, 35802

  • Accelovance

    Melbourne, Florida, 32935

  • Accelovance

    Peoria, Illinois, 61602

  • Accelovance

    Rockville, Maryland, 20850

  • Accelovance

    South Bend, Indiana, 46601

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Multi-center, Phase 1/2 Study to Assess Safety and Immunogenicity of Five Dose Levels of a Reverse Genetic (RG) Reassortant H9N2 Pandemic Influenza Vaccine in Healthy Subjects Aged 18 to 49 Years

The purpose of the study is to identify the optimal dose level of a reverse genetic (RG) reassortant H9N2 pandemic influenza vaccine for further product development.

Conditions
Influenza
Being tested
Reverse Genetic (RG) reassortant A/H9N2 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.

  • Reverse Genetic (RG) reassortant A/H9N2 influenza vaccineBiological

    Two intramuscular vaccinations; 5 dose groups: 3.75 µg, 7.5 µg, 15 µg, 30 µg or 45 µg HA antigen (strain A/H9N2/chicken/Hong Kong/G9/97; non-adjuvanted formulation

Study groups in NCT01320696
Study groupRoleWhat they receive
Cohort 1Experimental50 subjects will be randomized 1:1:1:1:1 to 5 dose groups (10 subjects per treatment group) to receive 2 intramuscular injections of RG reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
Receives: Biological: Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine
Cohort 2ExperimentalAfter a safety data review of the first 50 subjects, a further 225 subjects will be randomized 1:1:1:1:1 to 5 dose groups and will receive 2 intramuscular injections of RG reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
Receives: Biological: Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine

What is being measured

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

  1. Number of Subjects With a Hemagglutination Inhibition (HI) Antibody Response to the Vaccine Strain (A/H9N2/Chicken/Hong Kong/G9/97) Associated With Seroconversion 21 Days After the Second Vaccination

    Measured: 21 days after 2nd vaccination

  2. Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the Second Vaccination

    Measured: 21 days after 2nd vaccination

  3. Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity

    Measured: 7 days after 1st and 2nd vaccination

Secondary outcomes (13)

  1. Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the First Vaccination

    Measured: 21 days after 1st vaccination

  2. Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20

    Measured: 21 days after 1st and 2nd vaccination

  3. Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2

    Measured: 21 days after 1st and 2nd vaccination

  4. Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays

    Measured: 21 days after 1st and 2nd vaccination

  5. Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays

    Measured: 21 days after 1st and 2nd vaccination

  6. Number of Subjects With Seroconversion (as Defined for the Primary Immunogenicity Endpoint) Measured by HI Assay 21 Days After the First Vaccination as Compared to Baseline

    Measured: 21 days after 1st vaccination

  7. Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline

    Measured: 21 days after 1st and 2nd vaccination

  8. Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination

    Measured: 21 days after 1st and 2nd vaccination

  9. Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays

    Measured: 180 days after 1st vaccination

  10. Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays

    Measured: 180 days after 1st vaccination

  11. Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays

    Measured: 180 days after 1st vaccination

  12. Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination

    Measured: 7 days after 1st and 2nd vaccination

  13. Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period

    Measured: Through study completion by all subjects, an average of 181 days (+/- 14 days)

Timeline

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

  1. First posted22 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionJun 2011
  4. Study completionMay 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01320696
Sponsor's protocol ID
831001
Status last verified
Feb 2023
First submitted
21 Mar 2011
Last updated
16 Feb 2023
Data monitoring committee
Yes

Publications

  • Aichinger G, Grohmann-Izay B, van der Velden MV, Fritsch S, Koska M, Portsmouth D, Hart MK, El-Amin W, Kistner O, Barrett PN. Phase I/II randomized double-blind study of the safety and immunogenicity of a nonadjuvanted vero cell culture-derived whole-virus H9N2 influenza vaccine in healthy adults. Clin Vaccine Immunol. 2015 Jan;22(1):46-55. doi: 10.1128/CVI.00275-14. Epub 2014 Oct 29.

    PubMed 25355797

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine in people with Influenza, run by Alachua Government Services, 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 8 inclusion and 22 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 16 Feb 2023. 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. 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 16 Feb 2023). 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 Subjects With a Hemagglutination Inhibition (HI) Antibody Response to the Vaccine Strain (A/H9N2/Chicken/Hong Kong/G9/97) Associated With Seroconversion 21 Days After the Second Vaccination (time frame: 21 days after 2nd vaccination). The study lists 3 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 NCT01320696, which also lists 1 linked publication.

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 16 Feb 2023.

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