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

NCT ID: NCT02680002

Last Updated: 2020-08-31

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

422 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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A/Vietnam/H5N1 Influenza Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

7.5 mcg H5N1 (stored as monobulk)

Intervention Type BIOLOGICAL

MF59 (stored as monobulk)

Intervention Type OTHER

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

Group Type EXPERIMENTAL

15 mcg H5N1 (stored as monobulk)

Intervention Type BIOLOGICAL

MF59 (stored as monobulk)

Intervention Type OTHER

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

Group Type EXPERIMENTAL

7.5 mcg H5N1 (stored as monobulk)

Intervention Type BIOLOGICAL

MF59

Intervention Type OTHER

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

Group Type EXPERIMENTAL

15 mcg H5N1 (stored as monobulk)

Intervention Type BIOLOGICAL

MF59

Intervention Type OTHER

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

Group Type EXPERIMENTAL

90 mcg H5N1 (stored as monobulk)

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

90 mcg H5N1 (stored in vials)

Intervention Type BIOLOGICAL

Interventions

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7.5 mcg H5N1 (stored as monobulk)

Intervention Type BIOLOGICAL

15 mcg H5N1 (stored as monobulk)

Intervention Type BIOLOGICAL

90 mcg H5N1 (stored as monobulk)

Intervention Type BIOLOGICAL

90 mcg H5N1 (stored in vials)

Intervention Type BIOLOGICAL

MF59

Intervention Type OTHER

MF59 (stored as monobulk)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PPD Development, LP

INDUSTRY

Sponsor Role collaborator

Biomedical Advanced Research and Development Authority

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radiant Research, Inc.

Atlanta, Georgia, United States

Site Status

Clinical Research Advantage, Inc./Ridge Family Practice

Council Bluffs, Iowa, United States

Site Status

Johnson County Clin-Trials, Inc.

Lenexa, Kansas, United States

Site Status

Central Kentucky Researcch Associates, Inc.

Lexington, Kentucky, United States

Site Status

Radiant Research, Inc.

Edina, Minnesota, United States

Site Status

Rochester Clinical Research, Inc.

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30553570 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/30553570

Safety and immunogenicity of influenza A(H5N1) vaccine stored up to twelve years in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS)

Other Identifiers

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BARDA CSN 15-0001

Identifier Type: -

Identifier Source: org_study_id

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