A Study to Evaluate Safety and Immunogenicity of One or Two Booster Vaccinations With H5N6 Influenza Vaccine in Adults Primed With H5N1 Influenza Vaccine or Unprimed
- Conditions
- Influenza in BirdsInfectionsVirus DiseasesOrthomyxoviridae InfectionsRNA Virus InfectionsInfluenza, HumanRespiratory Tract DiseasesRespiratory Tract Infections
- Interventions
- Biological: aH5N6c on Day 1Biological: Placebo on Day 22Biological: aH5N6c on Day 22
- Registration Number
- NCT05422326
- Lead Sponsor
- Seqirus
- Brief Summary
This is a Phase 2, randomized, multi-center study in approximately 300 adults who received 2 doses of aH5N1c or placebo in and completed the parent study V89_18 in the \<65 years of age cohort. The study investigates whether two priming doses of MF59-adjuvanted H5N1 cell culture-derived vaccine (aH5N1c) followed by one or two booster vaccinations with a MF59-adjuvanted H5N6 cell culture derived vaccine (aH5N6c) 3 weeks apart elicit immune responses to the antigens used for priming (H5N1) and boosting (H5N6) after first and second heterologous booster vaccination.
Eligible subjects, who received 2 doses of aH5N1c in the parent study V89_18 are randomized in a 1:1 ratio to receive either two aH5N6c vaccinations, 3 weeks apart (group 1) or an aH5N6c vaccination on Day 1 and saline placebo on Day 22 (group 2). Eligible subjects, who received placebo in the parent study will receive two aH5N6c vaccinations, 3 weeks apart (group 3). After the second vaccine administration, subjects are monitored for approximately 6 months for safety and antibody persistence. The total study duration will be approximately 7 months per subject.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- Subjects who received 2 doses of aH5N1c vaccine or placebo in and completed the parent study V89_18 in the <65 years of age cohort.
- Individuals who can comply with study procedures including follow-up.
- Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to study entry and who do not plan to do so until at least 30 days after the last study vaccination.
- Progressive, unstable or uncontrolled clinical conditions.
- Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- Abnormal function of the immune system.
- History of any medical condition considered an adverse event of special interest (AESI).
- Received immunoglobulins with immunomodulating effects or any blood products within 180 days prior to informed consent.
- Subjects, who received an influenza H5 vaccine other than in the V89_18 parent study or have a history of H5 influenza infection prior to enrollment.
- Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
- Individuals who received any other vaccines [except corona virus disease 2019 (COVID-19) vaccines] within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccination.
- Receipt of any COVID-19 vaccine within 7 days prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from study vaccination.
- Acute (severe) febrile illness.
- A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Placebo on Day 22 Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 and have been randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 Group 1 aH5N6c on Day 22 Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 and have been randomized to receive two aH5N6c vaccinations, 3 weeks apart Group 1 aH5N6c on Day 1 Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 and have been randomized to receive two aH5N6c vaccinations, 3 weeks apart Group 2 aH5N6c on Day 1 Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 and have been randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 Group 3 aH5N6c on Day 22 Eligible subjects who received placebo in the parent study V89_18 receive two aH5N6c vaccinations, 3 weeks apart. Group 3 aH5N6c on Day 1 Eligible subjects who received placebo in the parent study V89_18 receive two aH5N6c vaccinations, 3 weeks apart.
- Primary Outcome Measures
Name Time Method Percentage of subjects with seroconversion against H5N6 strain Day 8, Day 22, Day 43 Seroconversion 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2, defined as a ≥4-fold increase in HI titer post-vaccination in those with pre-vaccination titer ≥1:10, or a post-vaccination HI titer ≥1:40 for subjects with baseline titer \<1:10
Geometric Mean Fold Increase (GMFI) of HI antibodies against H5N6 strain Day 1, Day 8, Day 22, Day 43 GMFI 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2 compared to pre-vaccination (Day 1)
Percentage of subjects with HI titers ≥1:40 against H5N6 strain Day 1, Day 8, Day 22, Day 43 Pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2
Geometric Mean Titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N6 strain Day 1, Day 8, Day 22, Day 43 GMT pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2
- Secondary Outcome Measures
Name Time Method GMT of HI antibodies against H5N1 strain Day 1, Day 8, Day 22, Day 43, Day 202 GMT pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2
GMFI of HI antibodies against H5N1 strain Day 1, Day 8, Day 22, Day 43, Day 202 GMFI 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2 compared to pre-vaccination (Day 1)
Percentage of subjects with HI titers ≥1:40 against H5N1 strain Day 1, Day 8, Day 22, Day 43, Day 202 Pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2
Percentage of subjects with seroconversion against H5N1 strain Day 8, Day 22, Day 43, Day 202 Seroconversion 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2, defined as a ≥4-fold increase in HI titer post-vaccination in those with pre-vaccination titer ≥1:10, or a post-vaccination HI titer ≥1:40 for subjects with baseline titer \<1:10
Frequency and severity of serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI) and medically attended AEs (MAAEs) Day 1 through Day 202 From vaccination until study completion
GMT of HI antibodies against H5N6 strain Day 202 GMT 6 months post-vaccination 2
GMFI of HI antibodies against H5N6 strain Day 1, Day 202 GMFI 6 months post-vaccination 2 compared to pre-vaccination (Day 1)
Percentage of subjects with HI titers ≥1:40 against H5N6 strain Day 202 6 months post-vaccination 2
Percentage of subjects with seroconversion against H5N6 strain Day 202 Seroconversion 6 months post-vaccination 2, defined as a ≥4-fold increase in HI titer post-vaccination in those with pre-vaccination titer ≥1:10, or a post-vaccination HI titer ≥1:40 for subjects with baseline titer \<1:10
Frequency and severity of solicited local and systemic adverse events (AEs) Day 1 through Day 7 and Day 22 through Day 28 For 7 days following each vaccination
Frequency and severity of unsolicited AEs Day 1 through Day 43 For 3 weeks following each vaccination
Trial Locations
- Locations (17)
California Research Foundation
🇺🇸San Diego, California, United States
Great Lakes Clinical Trials LLC
🇺🇸Chicago, Illinois, United States
Biogenics Research Institute
🇺🇸San Antonio, Texas, United States
J. Lewis Research, Inc/Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Clinical Research Consortium Arizona
🇺🇸Tempe, Arizona, United States
Clinical Research Consulting, LLC
🇺🇸Milford, Connecticut, United States
Optimal Research, LLC
🇺🇸Melbourne, Florida, United States
Innovative Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
PMG Research of Raleigh
🇺🇸Raleigh, North Carolina, United States
AccellaCare
🇺🇸Winston-Salem, North Carolina, United States
Aventiv Research
🇺🇸Columbus, Ohio, United States
J. Lewis Research, Inc/Foothill Family Clinic North
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc/Jordan River Family Medicine
🇺🇸South Jordan, Utah, United States
The Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Rochester Clinical Research, Inc
🇺🇸Rochester, New York, United States