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

Respiratory Tract Infections Clinical Trial

Official title:

A Phase 2, Randomized, Study to Evaluate Safety and Immunogenicity of One or Two Heterologous Booster Vaccinations With an MF59-adjuvanted, Cell Culture-derived H5N6 Influenza Vaccine in Adults Primed With MF59-adjuvanted, Cell Culture-derived H5N1 Influenza Vaccine or Unprimed

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05422326
• Other study ID #: V89_18E1
• Status: Completed
• Phase: Phase 2
• Start date: July 18, 2022
• Est. completion date: March 24, 2023

Study information

• Verified date: August 2023
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: March 24, 2023
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Influenza, Human
• Orthomyxoviridae Infections
• Respiratory Tract Diseases
• Respiratory Tract Infections
• RNA Virus Infections
• Virus Diseases

Intervention

Biological:
• aH5N6c on Day 1
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N6 vaccine (aH5N6c) for intramuscular (IM) administration, containing 7.5 µg H5N6 hemagglutinin (HA) (A/Guangdong/18SF020/2018 (H5N6)-like) + 0.25 mL MF59 (approximately 0.5 mL total volume)
• aH5N6c on Day 22
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N6 vaccine (aH5N6c) for intramuscular (IM) administration, containing 7.5 µg H5N6 HA (A/Guangdong/18SF020/2018 (H5N6)-like) + 0.25 mL MF59 (approximately 0.5 mL total volume) given 3 weeks after the first aH5N6c vaccination
• Placebo on Day 22
Saline placebo (sterile, 0.5 mL) given 3 weeks after the aH5N6c vaccination

Locations

Country	Name	City	State
United States	Great Lakes Clinical Trials LLC	Chicago	Illinois
United States	Innovative Research of West Florida, Inc.	Clearwater	Florida
United States	Aventiv Research	Columbus	Ohio
United States	Optimal Research, LLC	Huntsville	Alabama
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	Optimal Research, LLC	Melbourne	Florida
United States	Clinical Research Consulting, LLC	Milford	Connecticut
United States	PMG Research of Raleigh	Raleigh	North Carolina
United States	Rochester Clinical Research, Inc	Rochester	New York
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	J. Lewis Research, Inc/Foothill Family Clinic North	Salt Lake City	Utah
United States	J. Lewis Research, Inc/Foothill Family Clinic South	Salt Lake City	Utah
United States	Biogenics Research Institute	San Antonio	Texas
United States	California Research Foundation	San Diego	California
United States	J. Lewis Research, Inc/Jordan River Family Medicine	South Jordan	Utah
United States	Clinical Research Consortium Arizona	Tempe	Arizona
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	AccellaCare	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N6 strain	GMT pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2	Day 1, Day 8, Day 22, Day 43
Primary	Geometric Mean Fold Increase (GMFI) of HI antibodies against H5N6 strain	GMFI 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2 compared to pre-vaccination (Day 1)	Day 1, Day 8, Day 22, Day 43
Primary	Percentage of subjects with HI titers =1:40 against H5N6 strain	Pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2	Day 1, Day 8, Day 22, Day 43
Primary	Percentage of subjects with seroconversion against H5N6 strain	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	Day 8, Day 22, Day 43
Secondary	GMT of HI antibodies against H5N1 strain	GMT pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2	Day 1, Day 8, Day 22, Day 43, Day 202
Secondary	GMFI of HI antibodies against H5N1 strain	GMFI 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2 compared to pre-vaccination (Day 1)	Day 1, Day 8, Day 22, Day 43, Day 202
Secondary	Percentage of subjects with HI titers =1:40 against H5N1 strain	Pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2	Day 1, Day 8, Day 22, Day 43, Day 202
Secondary	Percentage of subjects with seroconversion against H5N1 strain	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	Day 8, Day 22, Day 43, Day 202
Secondary	GMT of HI antibodies against H5N6 strain	GMT 6 months post-vaccination 2	Day 202
Secondary	GMFI of HI antibodies against H5N6 strain	GMFI 6 months post-vaccination 2 compared to pre-vaccination (Day 1)	Day 1, Day 202
Secondary	Percentage of subjects with HI titers =1:40 against H5N6 strain	6 months post-vaccination 2	Day 202
Secondary	Percentage of subjects with seroconversion against H5N6 strain	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	Day 202
Secondary	Frequency and severity of solicited local and systemic adverse events (AEs)	For 7 days following each vaccination	Day 1 through Day 7 and Day 22 through Day 28
Secondary	Frequency and severity of unsolicited AEs	For 3 weeks following each vaccination	Day 1 through Day 43
Secondary	Frequency and severity of serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI) and medically attended AEs (MAAEs)	From vaccination until study completion	Day 1 through Day 202