First-in-human Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine fH1/DSP-0546LP
A Single Center, Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1 Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine "fH1/DSP-0546LP" After Intramuscular (IM) Administrations in Healthy Adults
3 other identifiers
interventional
144
1 country
1
Brief Summary
This study is a single center, randomized, double-blind, placebo-controlled, dose-finding, FIH, Phase 1 study to assess the safety, tolerability, and immunogenicity of the adjuvanted Universal Influenza Vaccine (fH1/DSP-0546LP) after IM administrations in healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2024
CompletedFirst Posted
Study publicly available on registry
June 14, 2024
CompletedStudy Start
First participant enrolled
June 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedApril 17, 2026
April 1, 2026
1.8 years
April 29, 2024
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Incidence of solicited local adverse events (AEs) during a 7-day follow-up period after each administration.
Solicited local AEs: pain, redness, swelling, induration, warmth, and pruritus at injection site
7 days after each administration
Incidence of solicited systemic AEs during a 7-day follow-up period after each administration.
Solicited systemic AEs: feverishness, chills, myalgia, fatigue, headache, nausea, arthralgia, malaise, and body temperature (measured axillary)
7 days after each administration
Incidence of unsolicited AEs from the first administration to 4 weeks after the second administration.
Clinical observations, clinical laboratory values and vital signs
From the first administration to 4 weeks after the second administration.
Incidence of serious adverse events (SAEs), AEs leading to study discontinuation, and adverse events of special interest throughout the study period.
From the first administration to 52-week follow-up after the second administration
Secondary Outcomes (3)
Percentage of subjects with increased immunoglobulin (Ig) G response to long alpha helix (LAH) after administration of fH1/DSP-0546LP.
From the day of the first administration to 52-week follow-up after the second administration
Percentage of subjects with increased neuraminidase inhibition antibody titer after administration of fH1/DSP-0546LP.
From the day of the first administration to 1 week after the second administration.
Seroconversion rate (SCR) of hemagglutination inhibition (HAI) antibody titers after administration of fH1/DSP-0546LP.
From the day of the first administration to 1 week after the second administration.
Study Arms (12)
combination of fH1 2 ug and DSP-0546LP 2.5 ug
EXPERIMENTALThe study vaccine (fH1 2 ug and DSP-0546LP 2.5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
combination of fH1 8 ug and DSP-0546LP 2.5 ug
EXPERIMENTALThe study vaccine (fH1 8 ug and DSP-0546LP 2.5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
combination of fH1 2 ug and DSP-0546LP 5 ug
EXPERIMENTALThe study vaccine (fH1 2 ug and DSP-0546LP 5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
combination of fH1 8 ug and DSP-0546LP 5 ug
EXPERIMENTALThe study vaccine (fH1 8 ug and DSP-0546LP 5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
combination of fH1 2 ug and DSP-0546LP 10 ug
EXPERIMENTALThe study vaccine (fH1 2 ug and DSP-0546LP 10 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
combination of fH1 8 ug and DSP-0546LP 10 ug
EXPERIMENTALThe study vaccine (fH1 8 ug and DSP-0546LP 10 ug) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
fH1 2 ug
EXPERIMENTALThe study vaccine (fH1 2 ug) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
fH1 8 ug
EXPERIMENTALThe study vaccine (fH1 8 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
DSP-0546LP 2.5 ug
EXPERIMENTALThe study vaccine (DSP-0546LP 2.5 ug) will be administered IM into the deltoid muscle of the non-dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
DSP-0546LP 5 ug
EXPERIMENTALThe study vaccine (DSP-0546LP 5 ug) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
DSP-0546LP 10 ug
EXPERIMENTALThe study vaccine (DSP-0546LP 10 ug) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
Placebo
PLACEBO COMPARATORThe study vaccine (placebo) will be administered IM into the deltoid muscle of the non- dominant upper arm whenever possible. Subjects will receive 2 administrations at 3-week intervals.
Interventions
2 administrations at 3-week intervals.
2 administrations at 3-week intervals.
2 administrations at 3-week intervals.
2 administrations at 3-week intervals.
2 administrations at 3-week intervals.
Eligibility Criteria
You may qualify if:
- Healthy adult male or female subject between 18 and 40 years of age at the time of informed consent.
- Subject who is fully informed of and understands the objectives, procedures, anticipated side effects of the vaccine and risks of the study and who voluntarily provides written consent to participate in the study.
- Subject's body weight is equal to or more than 50 kg, and body mass index is at least 18 kg/m2 but no more than 30 kg/m2 at screening.
- Subject willing and able to comply with the study requirements, including laboratory tests and reporting symptoms.
- A male subject with a female partner of childbearing potential must agree to use adequate and reliable contraception (e.g., using condom or have had vasectomy with proven sterility for male and using contraceptive agents, diaphragm, intrauterine devices (IUDs), or bilateral tubal ligation for female partner) from informed consent until at least 30 days after last administration of the study vaccine.
- A female subject is eligible for this study if she is neither pregnant nor breastfeeding and 1 of the following:
- Of non childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year).
- Of childbearing potential but has been and agrees to continue practicing highly effective contraception from informed consent until at least 30 days after the last administration. Highly effective methods of contraception include 1 or more of the following:
- a female subject who is abstinent or have a sexual relationship with sole female partner;
- male partner who is sterile (vasectomized) prior to the female subject's entry into the study and is the sole sexual partner for the female subject;
- hormonal (oral, intravaginal, transdermal, implantable or injectable), which is associated with inhibition of ovulation;
- an intrauterine hormone-releasing system;
- an intrauterine device with a documented failure rate of \< 1%;
- bilateral tubal occlusion.
- A female subject who is premenopausal and of childbearing potential must have a negative urine pregnancy-test result at screening, on Days 1 and 22.
- +1 more criteria
You may not qualify if:
- Subject with a history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematological, respiratory, psychiatric or neurologic disease, and who is considered ineligible for the study by the Principal Investigator (PI) or sub Investigator.
- Subject with other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior that may increase the risk of study participation or, in the Investigator's judgement, make the subject inappropriate for the study.
- Subject immunocompromised with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Subject with a history or evidence of autoimmune disease or known immunodeficiency of any cause or severe allergy.
- Subject who receives chronic treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, within 60 days before the Screening Visit or planned receipt throughout the study. If systemic corticosteroids have been administered short term (\< 14 days) for treatment of an acute illness, subjects should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before first administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- Subject with a history of severe adverse reaction associated with a vaccine and/or a known or suspected allergic reaction (e.g., anaphylaxis) or hypersensitivity to any component of the investigational product including egg protein.
- Subject with a history of substance abuse or drug abuse. If there is any doubt about the correctness of the information provided by the subject (history) or observation of a behavior that raises concerns about drug use, drug screening will be conducted at the Screening Visit or prior to first administration.
- Subject with a positive serology (hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antigen/antibody) at screening.
- Subject with any clinically significant abnormal clinical laboratory value (hematology, serum chemistry, urinalysis, coagulation) determined by the PI or sub-Investigator at screening.
- Subject with a history of excessive alcohol consumption (defined as drinking at least 21 units of alcohol beverage per week for a man and 14 units of alcohol beverage per week for a woman) within 6 months of the Screening Visit. Following common drinks contain 1 unit of alcohol: 300 ml beer \[4% alcohol by volume (ABV)\], 100 ml of wine (12% ABV), 30 ml of spirits (40% ABV).
- Subject who drinks large quantities of caffeinated beverages (coffee, tea, green tea, cola, tonic drink, etc) (approximately 1.8 L daily or more).
- Subject with a history of tobacco (including electronic cigarette) dependency or subject who smokes ≥ 20 cigarettes daily (excluding subject who stopped smoking more than 2 years ago).
- Subject who has received seasonal flu vaccine within a year prior to the Screening Visit.
- Subject who has experienced significant blood loss or donated blood (≥ 400 mL) within 90 days prior to the first administration or donated 200 mL of blood or more within 30 days prior to the first administration; has donated blood components within 14 days prior to the first administration.
- Subject who has received blood/plasma products or immunoglobulins within 6 months prior to the Screening Visit.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Vaccinology
Ghent, Corneel Heymanslaan 10, 9000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Subjects, Investigator staff, assessors, clinical operations personnel, data analysts, and personnel at central laboratories will remain blinded to the identity of the treatment from the time of randomization until clinical database lock and study unblinding.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2024
First Posted
June 14, 2024
Study Start
June 26, 2024
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
April 17, 2026
Record last verified: 2026-04