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®
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Influenza, Human
- Sponsor
- Biomedical Advanced Research and Development Authority
- Enrollment
- 366
- Locations
- 4
- Primary Endpoint
- Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant MF59
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or nonpregnant female 18 to 49 years of age, inclusive, at the time of the first study vaccination.
- •Provide written informed consent prior to the initiation of any study-related procedures.
- •Are able to understand and comply with planned study procedures.
- •Have a stable health status based on site investigator's clinical judgment, as established by physical examination, vital signs, and medical history.
- •Have access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
- •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
- •Have had a prior severe reaction to any influenza vaccine or have a known allergy to squalene-based adjuvants.
- •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.
- •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).
- •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.
- •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.
- •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.
- •History of schizophrenia, bipolar disease, psychosis, or severe personality disorder.
- •History of hospitalization for psychiatric illness, attempted suicide, or having been deemed a danger to self or others within the past 10 years.
Outcomes
Primary Outcomes
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant MF59
Time Frame: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited local reactions at the injection site: erythema/redness, induration/swelling, and pain
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
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.
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
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.
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant AS03
Time Frame: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited systemic reactions include fever, myalgia (muscle pain), arthralgia (joint pain), fatigue, headache, nausea, vomiting, diarrhea, and chills.
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant MF59
Time Frame: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited systemic reactions include fever, myalgia (muscle pain), arthralgia (joint pain), fatigue, headache, nausea, vomiting, diarrhea, and chills.
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
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.
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant AS03
Time Frame: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited local reactions at the injection site: erythema/redness, induration/swelling, and pain
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
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 Outcomes
- Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant MF59(Day 1 through Day 394)
- Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant AS03(Day 1 through Day 53, which is the upper window of the Day 50 visit)
- Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03(Day 29, Day 50, Day 121, Day 212)
- Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant AS03(Day 1 through Day 394)
- Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59(Day 50)
- Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant MF59(Day 1 through Day 394)
- Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant AS03(Day 1 through Day 394)
- Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant MF59(Day 1 through Day 50)
- Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59(Day 50)
- Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59(Day 29, Day 50, Day 121, Day 212)
- Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03(Day 29, Day 50, Day 121, Day 212)
- Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03(Screening and Days 29, 50, 121 and 212)
- Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant AS03(Day 1 through Day 394)
- Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant MF59(Day 1 through Day 394)
- Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03(Screening, Day 29, Day 121, Day 212)
- Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03(Days 29, 50, 121, and 212)
- Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59(Day 29, Day 50, Day 121, Day 212)
- Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59(Screening and Days 29, 50, 121 and 212)
- Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03(Day 50)
- Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03(Day 50)
- Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03(Screening, Day 29, Day 121, Day 212)
- Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59(Screening, Day 29, Day 121, Day 212)
- Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59(Day 29, Day 50, Day 121, Day 212)
- Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03(Screening and Days 29, 50, 121 and 212)
- Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03(Day 50)
- Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59(Screening, Day 29, Day 121, Day 212)
- Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59(Day 50)
- Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03(Day 29, Day 50, Day 121, Day 212)
- Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59(Screening and Days 29, 50, 121 and 212)
- Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59(Day 29, Day 50, Day 121, Day 212)