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Trial record 33 of 112 for:    mf59

Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus 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: NCT03497845
Recruitment Status : Active, not recruiting
First Posted : April 13, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Biomedical Advanced Research and Development Authority

Brief Summary:

The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains.

The study is designed to evaluate the safety and immunogenicity of vaccination strategies with homologous or antigenically distant heterologous H5 influenza virus vaccines administered with AS03 or MF59 adjuvant.


Condition or disease Intervention/treatment Phase
Influenza A Virus, H5N1 Subtype Biological: VN Biological: IN Biological: dk/BANG Biological: gf/WA Biological: bhg/QL Biological: AS03 adjuvant Biological: MF59 adjuvant Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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 Homologous and Heterologous Prime-Boost Vaccination Strategies With Stockpiled Inactivated Monovalent Influenza A(H5) Vaccines Administered Intramuscularly With Either AS03 or MF59® as Adjuvant
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : September 2, 2019
Estimated Study Completion Date : September 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: a VN with AS03 Adjuvant, then gf/WA with AS03 Adjuvant
Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1, Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2, Day 42).
Biological: VN
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/Vietnam/1203/2004 vaccine antigen strain H5N1

Biological: gf/WA
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8

Biological: AS03 adjuvant
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Experimental: b IN with AS03 Adjuvant, then gf/WA with AS03 Adjuvant
Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1, Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2, Day 42).
Biological: IN
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/Indonesia/05/2005 vaccine antigen strain H5N1

Biological: gf/WA
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8

Biological: AS03 adjuvant
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Experimental: c dk/BANG with AS03 Adjuvant, then gf/WA with AS03 Adjuvant
Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1, Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2, Day 42).
Biological: dk/BANG
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/duck/Bangladesh/19097/2013 vaccine antigen strain H5N1

Biological: gf/WA
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8

Biological: AS03 adjuvant
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Experimental: d gf/WA with AS03 Adjuvant, then IN with AS03 Adjuvant
Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1, Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2, Day 42).
Biological: IN
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/Indonesia/05/2005 vaccine antigen strain H5N1

Biological: gf/WA
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8

Biological: AS03 adjuvant
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Experimental: e dk/BANG with AS03 Adjuvant, then bhg/QL with AS03 Adjuvant
Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 , Day 1; Dose 2, Day 42), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).
Biological: dk/BANG
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/duck/Bangladesh/19097/2013 vaccine antigen strain H5N1

Biological: bhg/QL
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/barheaded goose/Qinghai Lake/1A/2005 vaccine antigen strain H5N1

Biological: AS03 adjuvant
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Experimental: f gf/WA with AS03 Adjuvant, then bhg/QL with AS03 Adjuvant
Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1, Day 1; Dose 2, Day 42), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)
Biological: gf/WA
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8

Biological: bhg/QL
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/barheaded goose/Qinghai Lake/1A/2005 vaccine antigen strain H5N1

Biological: AS03 adjuvant
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Experimental: g VN with MF59 Adjuvant, then gf/WA with MF59 Adjuvant
Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1, Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2, Day 42).
Biological: VN
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/Vietnam/1203/2004 vaccine antigen strain H5N1

Biological: gf/WA
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8

Biological: MF59 adjuvant
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Experimental: h IN with MF59 Adjuvant, then gf/WA with MF59 Adjuvant
Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1, Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2, Day 42).
Biological: IN
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/Indonesia/05/2005 vaccine antigen strain H5N1

Biological: gf/WA
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8

Biological: MF59 adjuvant
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Experimental: i dk/BANG with MF59 Adjuvant, then gf/WA with MF59 Adjuvant
Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1, Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2, Day 42).
Biological: dk/BANG
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/duck/Bangladesh/19097/2013 vaccine antigen strain H5N1

Biological: gf/WA
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8

Biological: MF59 adjuvant
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Experimental: j gf/WA with MF59 Adjuvant, then IN with MF59 Adjuvant
Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1, Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2, Day 42).
Biological: IN
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/Indonesia/05/2005 vaccine antigen strain H5N1

Biological: gf/WA
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8

Biological: MF59 adjuvant
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Experimental: k dk/BANG with MF59 Adjuvant, then bhg/QL with MF59 Adjuvant
Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant, followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant.
Biological: dk/BANG
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/duck/Bangladesh/19097/2013 vaccine antigen strain H5N1

Biological: bhg/QL
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/barheaded goose/Qinghai Lake/1A/2005 vaccine antigen strain H5N1

Biological: MF59 adjuvant
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Experimental: l gf/WA with MF59 Adjuvant, then bhg/QL with MF59 Adjuvant
Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1, Day 1; Dose 2, Day 42), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
Biological: gf/WA
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8

Biological: bhg/QL
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other Name: A/barheaded goose/Qinghai Lake/1A/2005 vaccine antigen strain H5N1

Biological: MF59 adjuvant
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose




Primary Outcome Measures :
  1. Number of local and systemic adverse reactions to 2-dose H5 influenza vaccination series [ Time Frame: 8 days post-vaccination ]
    Safety of 2-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited local and systemic reactogenicity symptoms

  2. Number of local and systemic adverse reactions to 3-dose H5 influenza vaccination series [ Time Frame: 8 days post-vaccination ]
    Safety of 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited local and systemic reactogenicity symptoms

  3. Immunogenicity against vaccine strains following 2-dose H5 influenza vaccination series [ Time Frame: Day 43 ]
    Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)

  4. Immunogenicity against vaccine strains following 3-dose H5 influenza vaccination series [ Time Frame: Day 163 ]
    Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Is a male or nonpregnant female 18 to 49 years of age, inclusive, on Day 1 (first vaccination).
  2. Will avoid nonstudy vaccinations until 21 days after the last vaccination.
  3. Provides written informed consent prior to the initiation of any study-related procedures.
  4. Has a stable health status, as established by physical examination, vital sign measurements, and medical history.
  5. Has access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
  6. Is able to understand and comply with planned study procedures.
  7. Lives a reasonable distance from the site to be able to travel to and from the site for follow-up visits and agrees to go to the site for evaluation in the case of an adverse event.
  8. Agrees to stay in contact with the site for the duration of the study, has no current plans to move from the study area, and provides updated contact information as necessary.

Exclusion Criteria:

  1. Has a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol-9, thimerosal, or chicken protein), or allergy to squalene-based adjuvants or has had severe reactions following previous immunizations with contemporary influenza virus vaccines.
  2. A woman who has a positive urine pregnancy test prior to vaccination in this study or a woman who is breastfeeding.
  3. A female of childbearing potential (a) who refuses to use an acceptable method of birth control (b) from Day 1 (first vaccination) to end-of-study visit and, if sexually active, who has not used a reliable birth control method for at least 2 months prior to Day 1 (first vaccination).

    1. Female of childbearing potential is defined as post-onset menarche and premenopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: menopausal >1 year, tubal ligation >1 year, bilateral salpingo-oophorectomy, or hysterectomy.
    2. Adequate contraception is defined as a contraceptive method with 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 Day 1 (first vaccination), and this male is the sole partner for that subject (The information on the male sterility can come from the site personnel's review of the subject's medical records or interview with the subject 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. Is immunosuppressed as a result of an underlying illness or treatment, or anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months prior to Day 1 (first vaccination).
  5. Has an active neoplastic disease or a history of any hematologic malignancy. A subject with superficial skin cancer who does not require intervention other than local excision is not excluded.
  6. Has long-term use (≥14 consecutive days) of glucocorticoids including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within 1 month prior to screening. (Low-dose [≤800 mcg/day of beclomethasone dipropionate or equivalent] inhaled and topical steroids are allowed).
  7. Has a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis.
  8. Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
  9. Has a neurological or psychiatric diagnosis, which, although stable, is judged by the investigator to render the potential subject unable or unlikely to comply with the protocol or to provide accurate safety reports.
  10. Has received immunoglobulin or other blood product (with the exception of Rho[D] immune globulin) within the 3 months prior to Day 1 (first vaccination).
  11. Has received any live vaccine within 4 weeks or inactivated vaccines within 2 weeks prior to Day 1 (first vaccination). This includes seasonal influenza vaccines.
  12. Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. This includes potentially immune-mediated medical conditions such as Guillain-Barré syndrome, narcolepsy, current or history of autoimmune or chronic inflammatory disease.
  13. Has a first-degree relative with narcolepsy.
  14. Has an acute illness, including body temperature greater than 100.4°F, at screening, immediately prior to each vaccination or, per subject report, within 3 days prior to each vaccination. Subjects with an acute illness can be rescheduled for a vaccination as long as the vaccination visit is within the visit window. Note that subjects may return for randomization following resolution of the acute illness as long as recruitment remains open and subjects are within 14 days of signing consent.
  15. Has a Grade 2 or greater (by US Food and Drug Administration toxicity grade) safety laboratory value at screening.
  16. Has received an experimental agent (vaccine, biologic, device, blood product, or medication) within 1 month prior to Day 1 (first vaccination) in this study or plans receipt of an experimental agent during the study period.
  17. Is participating or plans to participate in another interventional clinical study (either active or follow-up phase) during the study period.
  18. Has received an influenza H5 vaccine in the past or has a history of H5 influenza infection prior to enrollment.
  19. Has known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
  20. Has a history of alcohol or drug abuse within 5 years prior to Day 1 (first vaccination).
  21. Has a body mass index >35 kg/m2.
  22. Has any condition that would, in the opinion of the investigator, place him or her at an unacceptable risk of injury or render him or her unable to meet the requirements of the protocol (including site of injection reactogenicity assessments).
  23. Is a first-degree relative of any person working on this study: site or sponsor.

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): NCT03497845


Locations
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United States, California
Optimal Research
San Diego, California, United States, 92108
United States, Illinois
Optimal Research
Peoria, Illinois, United States, 61614
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
United States, Kentucky
Central Kentucky Research Associates Inc
Lexington, Kentucky, United States, 40509
United States, Maryland
Optimal Research
Rockville, Maryland, United States, 20850
United States, New York
Rochester Clinical Research, Inc
Rochester, New York, United States, 14609
Sponsors and Collaborators
Biomedical Advanced Research and Development Authority

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Responsible Party: Biomedical Advanced Research and Development Authority
ClinicalTrials.gov Identifier: NCT03497845     History of Changes
Other Study ID Numbers: BP-I-16-005
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
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:
vaccine
adjuvant
Influenza in Birds
MF59
AS03

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