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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05422326
Other study ID # V89_18E1
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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