NCT01320696

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
353

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
10.8 years until next milestone

Results Posted

Study results publicly available

February 16, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

March 21, 2011

Results QC Date

September 20, 2022

Last Update Submit

February 1, 2023

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

  • 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

    21 days after 2nd vaccination

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

    21 days after 2nd vaccination

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

    7 days after 1st and 2nd vaccination

Secondary Outcomes (13)

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

    21 days after 1st vaccination

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

    21 days after 1st and 2nd vaccination

  • 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

    21 days after 1st and 2nd vaccination

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

    21 days after 1st and 2nd vaccination

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

    21 days after 1st and 2nd vaccination

  • +8 more secondary outcomes

Study Arms (2)

Cohort 1

EXPERIMENTAL

50 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

Biological: Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine

Cohort 2

EXPERIMENTAL

After 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

Biological: Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine

Interventions

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

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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 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)
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Accelovance

Huntsville, Alabama, 35802, United States

Location

Accelovance

Melbourne, Florida, 32935, United States

Location

Accelovance

Peoria, Illinois, 61602, United States

Location

Accelovance

South Bend, Indiana, 46601, United States

Location

Accelovance

Rockville, Maryland, 20850, United States

Location

Related Publications (1)

  • 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.

    PMID: 25355797DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Wael El-Amin, M.D.
Organization
Resilience Inc.
Wael.el-amin@resilience.com
(240)885-1221

Study Officials

  • Barbara Izay, MD

    Baxter Innovations GmbH

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 22, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Study Completion

May 1, 2012

Last Updated

February 16, 2023

Results First Posted

February 16, 2023

Record last verified: 2023-02

Locations

US(5)