- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02680002
Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant
August 14, 2020 updated by: Biomedical Advanced Research and Development Authority
Randomized, Double-Blinded, Phase 2 Study to Assess Safety & Immunogenicity of Stored Inactivated Monovalent Influenza A/Vietnam/H5N1 Virus Vaccine Administered Intramuscularly at Different Dose Levels Given With & Without Stored MF59® Adjuvant
The main purpose of this study is to assess the usability of long-term stored H5N1 antigen and adjuvant.
The study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine when administered with or without MF59® adjuvant.
Study Overview
Status
Completed
Conditions
Detailed Description
This study is a randomized, double-blinded, Phase 2 study to assess the safety and immunogenicity of 2 doses of long-term stored inactivated monovalent influenza A/Vietnam/H5N1 virus vaccine administered intramuscularly with or without MF59 adjuvant in healthy males and nonpregnant females, aged 18 to 49 years, inclusive.
This study is designed to assist in stockpile management and will assess the usability of long-term stored H5N1 antigen (ie, stored >10 years) and adjuvant (ie, stored >5 years).
Study Type
Interventional
Enrollment (Actual)
422
Phase
- 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
-
-
Georgia
-
Atlanta, Georgia, United States, 30328
- Radiant Research, Inc.
-
-
Iowa
-
Council Bluffs, Iowa, United States, 51503
- Clinical Research Advantage, Inc./Ridge Family Practice
-
-
Kansas
-
Lenexa, Kansas, United States, 66219
- Johnson County Clin-Trials, Inc.
-
-
Kentucky
-
Lexington, Kentucky, United States, 40509
- Central Kentucky Researcch Associates, Inc.
-
-
Minnesota
-
Edina, Minnesota, United States, 55435
- Radiant Research, Inc.
-
-
New York
-
Rochester, New York, United States, 14609
- Rochester Clinical Research, Inc.
-
-
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
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or nonpregnant female
- Provide written informed consent prior to study-related procedures
- Stable health status
- Access to consistent and reliable means of telephone contact
- Able to understand and comply with planned study procedures
- Agree to stay in contact with site, and no plans to move from study area for study duration
Exclusion Criteria:
- Allergic to eggs, other vaccine components, or squalene-based adjuvants
- Women with positive pregnancy test within 24 hours of vaccination, or are breastfeeding
- Females of childbearing potential who refuse acceptable birth control, if sexually active, have not used birth control for 2 months prior to study entry
- Have immunosuppression or use anticancer chemotherapy or radiation therapy within preceding 36 months
- Have an active neoplastic disease or history of hematologic malignancy
- Have long term use (≥14 consecutive days) of glucocorticoids (>20 mg/day) or high-dose inhaled steroids (>800 mcg/day) within preceding 6 months
- Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis
- Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to self or others within past 10 years
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long-term as monobulk inactivated
|
|
Experimental: 15 mcg H5N1 (monobulk) Plus MF59 (monobulk)
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long-term as monobulk MF59 adjuvant
|
|
Experimental: 7.5 mcg H5N1 (monobulk) Plus MF59 (vials)
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant
|
|
Experimental: 15 mcg H5N1 (monobulk) Plus MF59 (vials)
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant
|
|
Experimental: 90 mcg H5N1 (monobulk) without MF59
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
|
Experimental: 90 mcg H5N1 (vials) without MF59
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Time Frame: Days 0 to 7
|
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
|
Days 0 to 7
|
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Time Frame: Days 21 to 28
|
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 28) following Dose 2
|
Days 21 to 28
|
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Time Frame: Days 0 to 7
|
Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
|
Days 0 to 7
|
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Time Frame: Days 21 to 28
|
Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 29) following Dose 2
|
Days 21 to 28
|
Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Time Frame: Days 0 to 7
|
Number of participants with mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 0 to 7) following Dose 1
|
Days 0 to 7
|
Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Time Frame: Days 21 to 28
|
Number of participants with of mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 21 to 28) following Dose 2
|
Days 21 to 28
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody
Time Frame: 21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days)
|
Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group
|
21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI)
Time Frame: First vaccination through 13 months
|
Number of participants with vaccine-associated serious adverse events (SAE) or adverse event of special interests (AESI) and occurence of AESIs or AEs leading to study withdrawal
|
First vaccination through 13 months
|
Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal.
Time Frame: First vaccination through approximately 13 months after first vaccination
|
Number of participants with adverse events of special interest (AESI) or adverse events (AE) leading to study withdrawal.
|
First vaccination through approximately 13 months after first vaccination
|
Number of Participants With Unsolicited Adverse Events (AE)
Time Frame: Day 0 (Visit 1) through Day 201 (Visit 8)
|
Number of participants with unsolicited adverse events (AE) through Visit 8 (Day 201)
|
Day 0 (Visit 1) through Day 201 (Visit 8)
|
Frequency of Unsolicited Adverse Events (AE)
Time Frame: 21 days following each vaccination (Days 0-21, >21 Days)
|
Frequency of unsolicited adverse events (AE) for 21 days following Dose 1 (Days 0-21) and after Dose 2 (>21 Days)
|
21 days following each vaccination (Days 0-21, >21 Days)
|
Occurrence of Clinical Safety Laboratory AEs
Time Frame: 7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42)
|
Occurrence of clinical safety laboratory AEs at 7 and 21 days after each vaccination
|
7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42)
|
GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies
Time Frame: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 201 (Visit 8)
|
Overall GMTs of HAI antibodies at baseline (Day 0) and Days 21, 28 and 201
|
Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 201 (Visit 8)
|
GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies
Time Frame: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 42 (Visit 7), Day 201 (Visit 8)
|
GMT of serum MN antibodies at baseline (Day 0) and Days 21, 28, 42 and 201
|
Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 42 (Visit 7), Day 201 (Visit 8)
|
Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40
Time Frame: Days 0 (Visit 1), 21 (Visit 4, +1day), 28 (Visit 6, +1 day), 42 (Visit 7, plus or minus 3 days), and 201 (Visit 8, plus or minus 7 days)
|
Proportion of participants achieving a serum HAI titer of at least 1:40 against the A/Vietnam/H5N1 antigen
|
Days 0 (Visit 1), 21 (Visit 4, +1day), 28 (Visit 6, +1 day), 42 (Visit 7, plus or minus 3 days), and 201 (Visit 8, plus or minus 7 days)
|
Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies
Time Frame: Days 21, 28, 42, and 201
|
Defined as proportion of subjects achieving either a prevaccination HAI titer of <1:10 and postvaccination titer of at least 1:40 or a prevaccination HAI titer of at least 1:10 and a 4-fold or greater increase of HAI postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline HAI titer is undetectable, it will be assigned a vaue of half the lower limit of detection.
|
Days 21, 28, 42, and 201
|
Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies
Time Frame: Days 21, 28, 42, and 201
|
Defined as proportion of subjects achieving either a prevaccination MN titer of <1:10 and postvaccination titer of at least 1:40 or a prevaccination MN titer of at least 1:10 and a 4-fold or greater increase of MN postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline MN titer is undetectable, it will be assigned a vaue of half the lower limit of detection.
|
Days 21, 28, 42, and 201
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2016
Primary Completion (Actual)
May 13, 2016
Study Completion (Actual)
March 31, 2017
Study Registration Dates
First Submitted
January 26, 2016
First Submitted That Met QC Criteria
February 8, 2016
First Posted (Estimate)
February 11, 2016
Study Record Updates
Last Update Posted (Actual)
August 31, 2020
Last Update Submitted That Met QC Criteria
August 14, 2020
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BARDA CSN 15-0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The study results will be posted on publicly available clinical trial registers.
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.
Clinical Trials on A/Vietnam/H5N1 Influenza Virus
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza A Virus, H5N1 Subtype | Influenza A Virus | Influenzavirus A | H5N1 Virus | OrthomyxovirdaeUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza A Virus, H5N1 Subtype | Influenza A Virus | Influenzavirus A | Orthomyxoviridae | H5N1 VirusUnited States
-
National Institute of Allergy and Infectious Diseases...Emory UniversityCompletedInfluenza A Virus, H5N1 SubtypeUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
IDRIDefense Advanced Research Projects Agency; MedicagoCompletedInfluenza A Subtype H5N1 InfectionUnited States
-
Medigen Biotechnology CorporationCompletedAvian Influenza | Bird Flu | Influenza A(H5N1)Taiwan
-
Institute of Vaccines and Medical Biologicals,...Department of Health and Human Services; Institut Pasteur; PATH; World Health OrganizationCompletedInfluenza A Subtype H5N1 InfectionVietnam
-
SeqirusNovartis VaccinesCompletedInfluenza | Influenza, Human | Influenza A Virus, H5N1 Subtype | Flu, Human | Flu, AvianAustralia, Germany, Italy
-
Gamaleya Research Institute of Epidemiology and...CompletedInfluenza A | Influenza A Virus Infection | Influenza Epidemic | Influenza H5N1Russian Federation
-
South East Asia Infectious Disease Clinical Research...University of Oxford; Wellcome TrustCompleted
Clinical Trials on 7.5 mcg H5N1 (stored as monobulk)
-
Institute of Vaccines and Medical Biologicals,...Department of Health and Human Services; Institut Pasteur; PATH; World Health OrganizationCompletedInfluenza A Subtype H5N1 InfectionVietnam