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Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant

Primary Purpose

A/Vietnam/H5N1 Influenza Virus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
7.5 mcg H5N1 (stored as monobulk)
15 mcg H5N1 (stored as monobulk)
90 mcg H5N1 (stored as monobulk)
90 mcg H5N1 (stored in vials)
MF59
MF59 (stored as monobulk)
Sponsored by
Biomedical Advanced Research and Development Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for A/Vietnam/H5N1 Influenza Virus

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Radiant Research, Inc.
  • Clinical Research Advantage, Inc./Ridge Family Practice
  • Johnson County Clin-Trials, Inc.
  • Central Kentucky Researcch Associates, Inc.
  • Radiant Research, Inc.
  • Rochester Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)

15 mcg H5N1 (monobulk) Plus MF59 (monobulk)

7.5 mcg H5N1 (monobulk) Plus MF59 (vials)

15 mcg H5N1 (monobulk) Plus MF59 (vials)

90 mcg H5N1 (monobulk) without MF59

90 mcg H5N1 (vials) without MF59

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 28) following Dose 2
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.
Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
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.
Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 29) following Dose 2
Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Number of participants with mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 0 to 7) following Dose 1
Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
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
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody
Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group

Secondary Outcome Measures

Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI)
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
Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal.
Number of participants with adverse events of special interest (AESI) or adverse events (AE) leading to study withdrawal.
Number of Participants With Unsolicited Adverse Events (AE)
Number of participants with unsolicited adverse events (AE) through Visit 8 (Day 201)
Frequency of Unsolicited Adverse Events (AE)
Frequency of unsolicited adverse events (AE) for 21 days following Dose 1 (Days 0-21) and after Dose 2 (>21 Days)
Occurrence of Clinical Safety Laboratory AEs
Occurrence of clinical safety laboratory AEs at 7 and 21 days after each vaccination
GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies
Overall GMTs of HAI antibodies at baseline (Day 0) and Days 21, 28 and 201
GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies
GMT of serum MN antibodies at baseline (Day 0) and Days 21, 28, 42 and 201
Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40
Proportion of participants achieving a serum HAI titer of at least 1:40 against the A/Vietnam/H5N1 antigen
Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies
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.
Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies
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.

Full Information

First Posted
January 26, 2016
Last Updated
August 14, 2020
Sponsor
Biomedical Advanced Research and Development Authority
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT02680002
Brief Title
Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 13, 2016 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biomedical Advanced Research and Development Authority
Collaborators
PPD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
A/Vietnam/H5N1 Influenza Virus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
422 (Actual)

8. Arms, Groups, and Interventions

Arm Title
7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)
Arm Type
Experimental
Arm Description
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
Arm Title
15 mcg H5N1 (monobulk) Plus MF59 (monobulk)
Arm Type
Experimental
Arm Description
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
Arm Title
7.5 mcg H5N1 (monobulk) Plus MF59 (vials)
Arm Type
Experimental
Arm Description
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
Arm Title
15 mcg H5N1 (monobulk) Plus MF59 (vials)
Arm Type
Experimental
Arm Description
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
Arm Title
90 mcg H5N1 (monobulk) without MF59
Arm Type
Experimental
Arm Description
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
Arm Title
90 mcg H5N1 (vials) without MF59
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
7.5 mcg H5N1 (stored as monobulk)
Intervention Type
Biological
Intervention Name(s)
15 mcg H5N1 (stored as monobulk)
Intervention Type
Biological
Intervention Name(s)
90 mcg H5N1 (stored as monobulk)
Intervention Type
Biological
Intervention Name(s)
90 mcg H5N1 (stored in vials)
Intervention Type
Other
Intervention Name(s)
MF59
Intervention Type
Other
Intervention Name(s)
MF59 (stored as monobulk)
Primary Outcome Measure Information:
Title
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Description
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
Time Frame
Days 0 to 7
Title
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Description
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 28) following Dose 2
Time Frame
Days 21 to 28
Title
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.
Description
Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
Time Frame
Days 0 to 7
Title
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.
Description
Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 29) following Dose 2
Time Frame
Days 21 to 28
Title
Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Description
Number of participants with mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 0 to 7) following Dose 1
Time Frame
Days 0 to 7
Title
Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Description
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
Time Frame
Days 21 to 28
Title
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody
Description
Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group
Time Frame
21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days)
Secondary Outcome Measure Information:
Title
Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI)
Description
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
Time Frame
First vaccination through 13 months
Title
Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal.
Description
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
Title
Number of Participants With Unsolicited Adverse Events (AE)
Description
Number of participants with unsolicited adverse events (AE) through Visit 8 (Day 201)
Time Frame
Day 0 (Visit 1) through Day 201 (Visit 8)
Title
Frequency of Unsolicited Adverse Events (AE)
Description
Frequency of unsolicited adverse events (AE) for 21 days following Dose 1 (Days 0-21) and after Dose 2 (>21 Days)
Time Frame
21 days following each vaccination (Days 0-21, >21 Days)
Title
Occurrence of Clinical Safety Laboratory AEs
Description
Occurrence of clinical safety laboratory AEs at 7 and 21 days after each vaccination
Time Frame
7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42)
Title
GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies
Description
Overall GMTs of HAI antibodies at baseline (Day 0) and Days 21, 28 and 201
Time Frame
Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 201 (Visit 8)
Title
GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies
Description
GMT of serum MN antibodies at baseline (Day 0) and Days 21, 28, 42 and 201
Time Frame
Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 42 (Visit 7), Day 201 (Visit 8)
Title
Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40
Description
Proportion of participants achieving a serum HAI titer of at least 1:40 against the A/Vietnam/H5N1 antigen
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)
Title
Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies
Description
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.
Time Frame
Days 21, 28, 42, and 201
Title
Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies
Description
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.
Time Frame
Days 21, 28, 42, and 201

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Radiant Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Research Advantage, Inc./Ridge Family Practice
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
Johnson County Clin-Trials, Inc.
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Central Kentucky Researcch Associates, Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Radiant Research, Inc.
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study results will be posted on publicly available clinical trial registers.
Citations:
PubMed Identifier
30553570
Citation
Oshansky CM, Zhou J, Gao Y, Schweinle JE, Biscardi K, DeBeauchamp J, Pavetto C, Wollish A; BRITE Study Coordination Team; Webby RJ, Cioce V, Donis RO, Bright RA. Safety and immunogenicity of influenza A(H5N1) vaccine stored up to twelve years in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS). Vaccine. 2019 Jan 14;37(3):435-443. doi: 10.1016/j.vaccine.2018.11.069. Epub 2018 Dec 12.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/30553570
Description
Safety and immunogenicity of influenza A(H5N1) vaccine stored up to twelve years in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS)

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Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant

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