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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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ClinicalTrials.gov Identifier: NCT02680002
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Biomedical Advanced Research and Development Authority

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.

Condition or disease Intervention/treatment Phase
A/Vietnam/H5N1 Influenza Virus Biological: 7.5 mcg H5N1 (stored as monobulk) Biological: 15 mcg H5N1 (stored as monobulk) Biological: 90 mcg H5N1 (stored as monobulk) Biological: 90 mcg H5N1 (stored in vials) Other: MF59 Other: MF59 (stored as monobulk) Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : March 2016
Actual Primary Completion Date : May 13, 2016
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine


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
Biological: 7.5 mcg H5N1 (stored as monobulk)
Other: MF59 (stored as monobulk)
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
Biological: 15 mcg H5N1 (stored as monobulk)
Other: MF59 (stored as monobulk)
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
Biological: 7.5 mcg H5N1 (stored as monobulk)
Other: MF59
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
Biological: 15 mcg H5N1 (stored as monobulk)
Other: MF59
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
Biological: 90 mcg H5N1 (stored as monobulk)
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
Biological: 90 mcg H5N1 (stored in vials)



Primary Outcome Measures :
  1. Number of occurences of mild, moderate, or severe solicited local and systemic reactogenicity symptoms [ Time Frame: Days 0 up to Day 42 ]
    Occurence of mild, moderate, or severe solicited local and systemic reactogenicity symptoms

  2. Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody [ Time Frame: 21 days after receipt of second dose of vaccine (Day 42) ]
    Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group


Secondary Outcome Measures :
  1. Occurence of vaccine-associated serious adverse events (SAE) or adverse event of special interests (AESI) [ Time Frame: first vaccination through 13 months ]
    Occurence of vaccine-associated serious adverse events (SAE) or adverse event of special interests (AESI) and occurence of AESIs or AEs leading to study withdrawal

  2. Frequency and severity of unsolicited adverse events (AE) [ Time Frame: 21 days following each vaccination (Days 0-21; Days 21-42) ]
    Frequency and severity of unsolicited adverse events (AE) for 21 days following each vaccination

  3. 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

  4. GMT of serum microneutralization (MN) antibodies [ Time Frame: Days 0, 21, 28, 42, and 201 ]
  5. Serum HAI titer of at least 1:40 [ Time Frame: Days 0, 21, 28, 42, and 201 ]
    Proportion of subjects achieving a serum HAI titer of at least 1:40 against the A/Vietnam/H5N1 antigen

  6. Seroconversion rate (SCR) [ Time Frame: Days 21, 28, 42, and 201 ]
    Defined as proportion of subjects achieving either a prevaccination HAI or MN titer of <1:10 and postvaccination titer of at least 1:40 or a prevaccination HAI or MN titer of at least 1:10 and a 4-fold or greater increase of HAI or MN postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline HAI or MN titer is undetectable, it will be assigned a vaue of half the lower limit of detection

  7. Occurrence of vital sign abnormalities [ Time Frame: 30 minutes post-vaccination on Day 1 and Day 21 ]
  8. GMT of serum HAI antibodies [ Time Frame: Days 0, 21, 28, and 201 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680002


Locations
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United States, Georgia
Radiant Research, Inc.
Atlanta, Georgia, United States, 30328
United States, Iowa
Clinical Research Advantage, Inc./Ridge Family Practice
Council Bluffs, Iowa, United States, 51503
United States, Kansas
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, United States, 66219
United States, Kentucky
Central Kentucky Researcch Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, Minnesota
Radiant Research, Inc.
Edina, Minnesota, United States, 55435
United States, New York
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
Sponsors and Collaborators
Biomedical Advanced Research and Development Authority
PPD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biomedical Advanced Research and Development Authority
ClinicalTrials.gov Identifier: NCT02680002     History of Changes
Other Study ID Numbers: BARDA CSN 15-0001
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study results will be posted on publicly available clinical trial registers.

Additional relevant MeSH terms:
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Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
MF59 oil emulsion
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic