Reverse Genetic H9N2 Influenza Vaccine Study in Adults | NCT01320696

NCT01320696

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine	Biological	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.)

Exclusion Criteria:

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)
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

Contacts/Locations Module

Name	Affiliation	Role
Barbara Izay, MD	Baxter Innovations GmbH	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Accelovance		Huntsville	Alabama	35802	United States
Accelovance

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25355797	Derived	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.

IPD Sharing Statement Module

No data available

No data is available for this block.

Of the 353 enrolled participants, 275 met inclusion criteria and were randomized to treatment.

Arm/Group Information

ID	Title	Description
FG000	3.75 µg	Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
FG001	7.5 µg	Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
FG002	15 µg	Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
FG003	30 µg	Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
FG004	45 µg	Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00056 subjects FG00155 subjects FG00254 subjects FG00355 subjects FG00455 subjects
Vaccinated Vacc. 1		FG00056 subjects FG00155 subjects FG00254 subjects FG00355 subjects FG004
Vaccinated Vacc. 2		FG00053 subjects FG00153 subjects FG00254 subjects FG00355 subjects FG004
COMPLETED		FG00051 subjects FG00151 subjects FG00251 subjects FG00350 subjects FG004
NOT COMPLETED		FG0005 subjects FG0014 subjects FG0023 subjects FG0035 subjects FG004

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	3.75 µg	Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
BG001	7.5 µg	Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Posted

Count of Participants

Participants

21 days after 2nd vaccination

ID	Title	Description
OG000	3.75 µg	Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
OG001	7.5 µg	Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
OG002	15 µg

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	3.75 µg	Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Injection Site Reactions	General disorders			After 1st vaccination

More Info Module

Certain Agreements

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

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D007251	Influenza, Human

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

EG0009 affected56 at risk
EG00111 affected55 at risk
EG00220 affected54 at risk
EG00318 affected55 at risk
EG00426 affected55 at risk

OG0048.1(6.6 to 9.9)

OG00419.8(15.5 to 25.3)

OG00444.1(32.4 to 60.1)

OG00467.4(51.1 to 88.8)

OG0045.1(4.0 to 6.6)

OG0045.5(4.3 to 7.2)