First-in-human Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Univ… (NCT06460064) | Clinical Trial Compass
CompletedPhase 1
First-in-human Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine fH1/DSP-0546LP
Belgium144 participantsStarted 2024-06-26
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of solicited local adverse events (AEs) during a 7-day follow-up period after each administration.
Timeframe: 7 days after each administration
2
Incidence of solicited systemic AEs during a 7-day follow-up period after each administration.
Timeframe: 7 days after each administration
3
Incidence of unsolicited AEs from the first administration to 4 weeks after the second administration.
Timeframe: From the first administration to 4 weeks after the second administration.
4
Incidence of serious adverse events (SAEs), AEs leading to study discontinuation, and adverse events of special interest throughout the study period.
Timeframe: From the first administration to 52-week follow-up after the second administration
. 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:
Exclusion criteria
. 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.