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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Influenza A Virus, H5N1 Subtype
- Sponsor
- Biomedical Advanced Research and Development Authority
- Enrollment
- 720
- Locations
- 4
- Primary Endpoint
- Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Is a male or nonpregnant female 18 to 49 years of age, inclusive, on Day 1 (first vaccination).
- •Will avoid nonstudy vaccinations until 21 days after the last vaccination.
- •Provides written informed consent prior to the initiation of any study-related procedures.
- •Has a stable health status, as established by physical examination, vital sign measurements, and medical history.
- •Has access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
- •Is able to understand and comply with planned study procedures.
- •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.
- •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
- •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.
- •A woman who has a positive urine pregnancy test prior to vaccination in this study or a woman who is breastfeeding.
- •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).
- •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.
- •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).
- •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).
- •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.
- •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).
- •Has a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis.
- •Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
Outcomes
Primary Outcomes
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
Time Frame: 8 days post-vaccination
Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited local reactogenicity symptoms. Subjects in A-D and G-J did not receive 3 doses
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
Time Frame: 8 days post-vaccination
Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited systemic reactogenicity symptoms Subjects in A-D and G-J did not receive 3 doses
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series
Time Frame: Day 43
Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series
Time Frame: Day 163
Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)