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Trial record 25 of 112 for:    mf59

Panblok H7 Vaccine Adjuvanted With AS03 or MF59

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03283319
Recruitment Status : Completed
First Posted : September 14, 2017
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Rho, Inc.
Information provided by (Responsible Party):
Biomedical Advanced Research and Development Authority

Brief Summary:
The main purpose of this study is to assess the safety and ability of a Panblok H7 influenza vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated by 28 days. Three different antigen dose levels of Panblok H7 will be tested.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: 3.75 ug Panblok H7 Biological: 7.5 ug Panblok H7 Biological: 15 ug Panblok H7 Biological: MF59 Biological: AS03 Phase 2

Detailed Description:
This is a randomized, double-blinded, phase 2 study to assess safety and immunogenicity of Panblok H7 vaccine at three antigen dose levels (3.75, 7.5, and 15 μg) adjuvanted with AS03 or MF59. The main purpose of this study is to assess the safety and ability of the recombinant Panblok H7 influenza vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated by 28 days in healthy males and nonpregnant females, aged 18 to 49 years, inclusive. The expected study duration is approximately 13.5 months per participant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to one of the six treatment groups at Day 1 and will receive the assigned dose of antigen and adjuvant on Day 1 and Day 29.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double-Blinded, Phase 2 Study to Assess Safety and Immunogenicity of Panblok H7 Vaccine at Three Antigen Dose Levels Adjuvanted With AS03® or MF59®
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: 3.75 ug Panblok H7 plus AS03
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 plus AS03
Biological: 3.75 ug Panblok H7
0.5 mL recombinant Panblok H7 influenza vaccine antigen 15 ug/mL.

Biological: AS03
0.5 mL AS03 (42.4 mg squalene/mL ) adjuvant.

Experimental: 7.5 ug Panblok H7 plus AS03
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with AS03
Biological: 7.5 ug Panblok H7
Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 30 ug/mL.

Biological: AS03
0.5 mL AS03 (42.4 mg squalene/mL ) adjuvant.

Experimental: 15 ug Panblok H7 plus AS03
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with AS03
Biological: 15 ug Panblok H7
Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 60 ug/mL.

Biological: AS03
0.5 mL AS03 (42.4 mg squalene/mL ) adjuvant.

Experimental: 3.75 ug Panblok H7 plus MF59
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 adjuvanted with MF59
Biological: 3.75 ug Panblok H7
0.5 mL recombinant Panblok H7 influenza vaccine antigen 15 ug/mL.

Biological: MF59
0.5 mL MF59 (39 mg squalene/mL ) adjuvant.

Experimental: 7.5 ug Panblok H7 plus MF59
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with MF59
Biological: 7.5 ug Panblok H7
Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 30 ug/mL.

Biological: MF59
0.5 mL MF59 (39 mg squalene/mL ) adjuvant.

Experimental: 15 ug Panblok H7 plus MF59
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with MF59
Biological: 15 ug Panblok H7
Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 60 ug/mL.

Biological: MF59
0.5 mL MF59 (39 mg squalene/mL ) adjuvant.




Primary Outcome Measures :
  1. Solicited local and systemic reactogenicity symptoms [ Time Frame: : Day 1-8, Day 29-36' (within 8 days of each vaccination, inclusive of the vaccination day) ]
    The number of occurrences of solicited local and systemic reactions occurring within 8 days of each vaccination, including the day of vaccination. Solicited local reactions at the vaccine injection site include redness, swelling, and pain. Solicited systemic reactions include fever, myalgia (muscle pain), arthralgia (joint pain), fatigue, headache, nausea, vomiting, diarrhea, and chills.

  2. Seroprotection based on serum hemagglutination-inhibition (HAI) antibody titers . [ Time Frame: Day 50 ]
    The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.


Secondary Outcome Measures :
  1. Treatment-emergent serious adverse events (AEs). [ Time Frame: Day 1 through Day 394 ]
    The number of occurrences of serious adverse events occurring in study participants post-vaccination.

  2. Treatment-emergent medically attended adverse events (MAAEs). [ Time Frame: Day 1 through Day 394 ]
    The number of occurrences of adverse events that require a visit to medical personnel, including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason occurring in study participants post-vaccination.

  3. Treatment-emergent potentially immune mediated medical conditions (PIMMCs). [ Time Frame: Day 1 through Day 394 ]
    The number of occurrences of medical conditions that are potentially immune mediated occurring in participants post-vaccination

  4. Treatment-emergent unsolicited AEs. [ Time Frame: Day 1 through Day 50 ]
    The number of occurrences of unsolicited adverse events (i.e. adverse events not included in the solicited local and systemic adverse event list) that occur in participants post-vaccination.

  5. Serum HAI antibody titers [ Time Frame: Screening and Days 29, 50, 121, and 212. ]
    Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.

  6. Serum microneutralization antibody titers [ Time Frame: Screening, Days 29, 50, 121, and 212. ]
    Serum microneutralization (MN) antibody titers against the H7 antigen (protein) contained in the vaccine. A higher MN titer means a better immune response to the vaccine.

  7. Seroprotection based on serum HAI antibody titers [ Time Frame: Screening and Days 29, 121, and 212 ]
    The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.

  8. Seroconversion based on serum HAI antibody titers [ Time Frame: Days 29, 50, 121, and 212 ]
    Outcome measure description: The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer <1:10 and a post-vaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.

  9. Seroconversion based on serum MN antibody titers [ Time Frame: Days 29, 50, 121, and 212 ]
    The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer <1:10 and a post-vaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer.



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:

  1. Male or nonpregnant female 18 to 49 years of age, inclusive, at the time of the first study vaccination.
  2. Provide written informed consent prior to the initiation of any study-related procedures.
  3. Are able to understand and comply with planned study procedures.
  4. Have a stable health status based on site investigator's clinical judgment, as established by physical examination, vital signs, and medical history.
  5. Have access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
  6. Agree to stay in contact with the study site for the duration of the study, have no current plans to move from the study area, and agree to provide updated contact information as necessary.

Exclusion Criteria:

  1. Have had a prior severe reaction to any influenza vaccine or have a known allergy to squalene-based adjuvants.
  2. Women who are pregnant or breast feeding. Women of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours prior to each vaccination.

    Women of childbearing potential are defined as postmenarcheal and premenopausal females capable of becoming pregnant. This does not include females who meet any of the following conditions: menopausal >12 months, tubal ligation >12 months, bilateral salpingo-oophorectomy, or hysterectomy.

  3. Women of childbearing potential who refuse to use an acceptable method of birth control from screening to Day 50 (Visit 7) or, if sexually active with a male partner, who have not used a reliable birth control method during the 2 months prior to screening.

    Adequate contraception is defined as a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example: abstinence from penile-vaginal intercourse; oral contraceptives, either combined or progestogen alone; injectable progestogen; implants of etonogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or intrauterine system; male partner sterilization at least 6 months prior to the female participant's Screening Visit, and this male is the sole partner for that participant (the information on the male partner's sterility can come from the site personnel's review of the participant medical records or interview with the participant on her medical history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).

  4. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months, or plans to receive immunosuppressive therapy/cytotoxic treatment during study participation.
  5. Have an active neoplastic disease or a history of any hematologic malignancy. However, participants with superficial skin cancer who do not require intervention other than local excision are not excluded.
  6. Have long-term use (≥14 consecutive days) of glucocorticoids including oral or parenteral prednisone or prednisone equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 µg/day of beclomethasone dipropionate or equivalent) within 1 month prior to screening in this study. However, participants on low-dose inhaled steroids (≤800 µg/day of beclomethasone dipropionate or equivalent) or topical steroids are not excluded.
  7. History of schizophrenia, bipolar disease, psychosis, or severe personality disorder.
  8. History of hospitalization for psychiatric illness, attempted suicide, or having been deemed a danger to self or others within the past 10 years.
  9. Have received immunoglobulin or other blood product (with the exception of Rho[D] immune globulin) within the 3 months prior to screening in this study.
  10. Have received any live vaccines within 4 weeks or inactivated or recombinant protein vaccines within 2 weeks prior to screening in this study or plan to receive such vaccines (including seasonal influenza vaccines) from screening through 21 days following the second dose of the study vaccine (Screening Visit through Day 50).
  11. Have an acute or chronic medical condition that, in the opinion of the site investigator, would render vaccination unsafe or would interfere with the evaluation of responses. This includes all PIMMCs such as Guillain Barré syndrome, narcolepsy, and current or history of autoimmune or chronic inflammatory disease.
  12. Have an acute illness, including body temperature greater than 100.4°F, at screening, immediately prior to each vaccination or, per participant report, within 3 days prior to each vaccination in this study.
  13. Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to screening in this study or expect to receive an experimental agent during the study period.
  14. Are participating or plan to participate in another interventional clinical trial (either active or follow up phase) during the study period.
  15. Participated in an A(H7) influenza vaccine study in the past or have a history of A(H7) influenza infection prior to vaccination in this study.
  16. Have known human immunodeficiency virus, hepatitis B, or hepatitis C infection (based on medical history).
  17. Have a history of alcohol or drug abuse in the last 5 years.
  18. Have a body mass index >35 kg/m2.
  19. Have a first degree relative with narcolepsy.
  20. Have any laboratory test result or clinical findings (including vital signs) that singly or in combination are likely to unfavorably alter the risk-benefit of participation or to confound study safety or immunogenicity results. participants cannot be rescreened based on abnormal laboratory test results.
  21. Alanine aminotransferase (AST) >2 times the upper limit of normal (ULN), or bilirubin >1.5 times the ULN unless isolated Gilbert's syndrome. participants cannot be rescreened based on abnormal laboratory test results.

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): NCT03283319


Locations
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United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, New York
Rochester Clinical Research, Inc
Rochester, New York, United States, 14609
Sponsors and Collaborators
Biomedical Advanced Research and Development Authority
Rho, Inc.
Investigators
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Principal Investigator: Mark Adams, MD Central Kentucky Research
Principal Investigator: Matthew Davis, MD Rochester Clinical Research, Inc
Principal Investigator: Carlos Fierro, MD Johnson County Clin-Trials
Principal Investigator: Terry Poling, MD Heartland Research Associates

Publications:
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Responsible Party: Biomedical Advanced Research and Development Authority
ClinicalTrials.gov Identifier: NCT03283319     History of Changes
Other Study ID Numbers: BP-I-17-002
HHSO100201400004I ( Other Grant/Funding Number: BARDA )
TO# HHSO10033001T ( Other Grant/Funding Number: BARDA )
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biomedical Advanced Research and Development Authority:
MF59
Influenza
human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
AS03
Adjuvants
Immunologic

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