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 range18 Years – 40 Years
SexALL
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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.
✓. 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
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
. 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.