Clinical trial NCT05901636: A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults
Official title: A Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of a Universal Influenza (Uniflu) Vaccine With INFLUENZA G1 mHA in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza Prevention
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2023-06-13
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to evaluate safety/ reactogenicity of INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), with or without Al(OH)3 adjuvant, in healthy adults greater than or equal to (\>=) 18 to less than or equal to (\<=) 45 years of age.


Eligibility criteria: Inclusion Criteria:

* Must be healthy as confirmed by medical history, physical examination, vital signs, and clinical laboratory tests performed at screening
* Contraceptive (birth control) use by female participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies. Before randomization, participants who were born female must be either: a) not of childbearing potential; b) of childbearing potential and practicing a highly effective method of contraception and agreeing to remain on such a method of contraception from signing the informed consent until 3 months after the last dose of study vaccine. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. Highly effective methods for this study include: hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion/ligation procedures, vasectomized partner (the vasectomized partner should be the sole partner for that participant), and sexual abstinence
* All female participants of childbearing potential must: a) have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening; b) have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
* Must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the US FDA toxicity scale the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator

Exclusion Criteria:

* Contraindication to IM injections and blood draws, example, bleeding disorders
* Clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (\>=) 38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
* History of severe allergic reaction (for example, anaphylaxis) or other serious adverse reactions to vaccines or vaccine excipients (specifically the excipients of the study vaccine\[s\])
* Abnormal function of the immune system resulting from: a) clinical conditions (example, autoimmune disease or immunodeficiency) or their treatments expected to have an impact on the immune response elicited by the study vaccine; b) chronic or recurrent use of systemic corticosteroids within 2 months before administration of study vaccine and during the study; c) administration of antineoplastic and immunomodulating agents or radiotherapy expected to have an impact on the immune response elicited by the study vaccine within 6 months before administration of study vaccine and during the study
* History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
* Received treatment with immunoglobulins (including monoclonal antibodies) expected to impact the vaccine-induced immune response in the 2 months or blood products in the 3 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study.
* Received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine, or received an investigational biological product within 3 months or 5 half-lives, whichever is longer, before the planned study intervention, or is currently enrolled or plans to participate in another investigational study or observational clinical study during the course of this study
* Pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study vaccine. Oocyte donation is prohibited while enrolled in this study
* Received or plans to receive: licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccination\[s\]; other licensed (not live) vaccines (not including seasonal influenza vaccines) - within 14 days before or after planned administration of the first or subsequent study vaccination\[s\]; seasonal influenza vaccines - within 4 months before planned administration of the first study vaccination until the end of the study (that is, any individual who requires a seasonal influenza vaccination for occupational or other reasons will be excluded)
* Has received a pandemic influenza vaccine (other than Hemagglutinin Type 1 and Neuraminidase Type 1 \[H1N1\]) in a previous pandemic influenza vaccine study at any time prior to randomization

Primary outcomes:
measure: Number of Participants with Solicited Local Adverse Events (AEs) at 7 Days Post-vaccination 1
timeFrame: 7 Days after vaccination 1 on Day 1 (Day 8)
measure: Number of Participants with Solicited Local AEs at 7 Days Post-vaccination 2
timeFrame: 7 Days after vaccination 2 on Day 57 (Day 64)
measure: Number of Participants with Solicited Local AEs by Severity at 7 Days Post-vaccination 1
timeFrame: 7 Days after vaccination 1 on Day 1 (Day 8)
measure: Number of Participants with Solicited Local AEs by Severity at 7 Days Post-vaccination 2
timeFrame: 7 Days after vaccination 2 on Day 57 (Day 64)
measure: Duration of Solicited Local AEs at 7 Days Post-vaccination 1
timeFrame: 7 Days after vaccination 1 on Day 1 (Day 8)
measure: Duration of Solicited Local AEs at 7 Days Post-vaccination 2
timeFrame: 7 Days after vaccination 2 on Day 57 (Day 64)
measure: Number of Participants with Solicited Systemic AEs at 7 Days Post-vaccination 1
timeFrame: 7 Days after vaccination 1 on Day 1 (Day 8)
measure: Number of Participants with Solicited Systemic AEs at 7 Days Post-vaccination 2
timeFrame: 7 Days after vaccination 2 on Day 57 (Day 64)
measure: Number of Participants with Solicited Systemic AEs by Severity at 7 Days Post-vaccination 1
timeFrame: 7 Days after vaccination 1 on Day 1 (Day 8)
measure: Number of Participants with Solicited Systemic AEs by Severity at 7 Days Post-vaccination 2
timeFrame: 7 Days after vaccination 2 on Day 57 (Day 64)
measure: Duration of Solicited Systemic AEs at 7 Days Post-vaccination 1
timeFrame: 7 Days after vaccination 1 on Day 1 (Day 8)
measure: Duration of Solicited Systemic AEs at 7 Days Post-vaccination 2
timeFrame: 7 Days after vaccination 2 on Day 57 (Day 64)
measure: Number of Participants with Solicited Systemic AEs Related to Study Vaccine at 7 Days Post-vaccination 1
timeFrame: 7 Days after vaccination 1 on Day 1 (Day 8)
measure: Number of Participants with Solicited Systemic AEs Related to Study Vaccine at 7 Days Post-vaccination 2
timeFrame: 7 Days after vaccination 2 on Day 57 (Day 64)
measure: Number of Participants with Unsolicited AEs at 28 Days Post-vaccination 1
timeFrame: 28 Days after vaccination 1 on Day 1 (Day 29)
measure: Number of Participants with Unsolicited AEs at 28 Days Post-vaccination 2
timeFrame: 28 Days after vaccination 2 on Day 57 (Day 85)
measure: Number of Participants with Unsolicited AEs by Severity at 28 Days Post-vaccination 1
timeFrame: 28 Days after vaccination 1 on Day 1 (Day 29)
measure: Number of Participants with Unsolicited AEs by Severity at 28 Days Post-vaccination 2
timeFrame: 28 Days after vaccination 2 on Day 57 (Day 85)
measure: Duration of Unsolicited AEs at 28 Days Post-vaccination 1
timeFrame: 28 Days after vaccination 1 on Day 1 (Day 29)
measure: Duration of Unsolicited AEs at 28 Days Post-vaccination 2
timeFrame: 28 Days after vaccination 2 on Day 57 (Day 85)
measure: Number of Participants with Unsolicited AEs Related to Study Vaccine at 28 Days Post-vaccination 1
timeFrame: 28 Days after vaccination 1 on Day 1 (Day 29)
measure: Number of Participants with Unsolicited AEs Related to Study Vaccine at 28 Days Post-vaccination 2
timeFrame: 28 Days after vaccination 2 on Day 57 (Day 85)
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 365
measure: Number of Participants with Serious Adverse Events (SAEs) Related to Study Vaccine
timeFrame: Day 1 up to Day 365
Secondary outcomes:
measure: Quantification of Antibody Binding to Hemagglutinin (HA) Stem or Full-length Hemagglutinin as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
timeFrame: Days 1, 8, 29, 57, 64, 85, 238 and 365
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: Floridian Clinical Research LLC
state: Florida
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Metairie
country: United States
facility: Clinical Trials Managements, LLC
state: Louisiana
city: Cincinnati
country: United States
facility: CTI Clinical Trial and Consulting Services
state: Ohio
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: