CompletedPhase 1

Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults

Australia139 participantsStarted 2024-01-22

Plain-language summary

This is a safety and Immunogenicity first-in-human dose-ranging study of self-amplifying RNA Seasonal Influenza Vaccine (ARCT-2138) in adults.

Who can participate

Age range18 Years – 85 Years

SexALL

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

✓. Individuals are male, female, or transgender adults 18 to 49 years of age or 65 to 85 years of age.
✓. Healthy participants or participants with pre-existing stable medical conditions. Pre-existing stable medical condition means a subject who: has full capacity of daily activity and no major medication modification; has not undergone surgical or minimally invasive intervention or had any hospitalization/emergency room visit for the specific medical condition within 3 months prior to Day 1.
✓. Participant or legally authorized representatives must freely provide documented informed consent prior to study procedures being performed.
✓. Individuals who have not received influenza vaccine within 6 months prior to enrollment.
✓. Individuals must agree to comply with all study visits and procedures (including blood tests, nasopharyngeal swabs, diary completion, receipt of telephone calls from the site, willingness to be available for Unscheduled Clinic Visits).
✓. Individuals of childbearing potential must be willing to adhere to contraceptive requirements.

Exclusion criteria

✕. Individuals with acute medical illness or febrile illness, including body temperature \>100.4°F (\>38.0°C) within 3 days prior to Randomization. These individuals may be offered the opportunity to enter the study after fever and illness has stabilized. Participants with suspected or confirmed influenza should be excluded and referred for medical care. Rescreening will be permitted for individuals who are presented with suspected influenza if another diagnosis is confirmed.
✕. Individuals with any medical, neurological, or psychiatric condition that, in the opinion of the investigator, could place the participant at an unacceptable risk of injury or render the participant unable to comply with all study procedures and achieve successful completion of the trial.
✕. Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any mRNA vaccine, influenza vaccine, or excipients.
✕. Individuals who have a positive pregnancy test at the Screening visit or Day 1 or who intend to become pregnant or breastfeed during the study.
✕. Individuals with a history of myocarditis, pericarditis, myopericarditis or cardiomyopathy.
✕. Individuals with a history of Guillain-Barré syndrome, encephalomyelitis, or transverse myelitis.
✕. Individuals with a known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular (I.M.) injection.
✕. Individuals with a history of congenital or acquired immunodeficiency.

What they're measuring

Percentage of participants reporting local Adverse Events

Timeframe: 14 Days following study vaccination

Percentage of participants reporting systemic Adverse Events

Timeframe: 14 Days following study vaccination

Percentage of participants reporting unsolicited Adverse Events

Timeframe: 29 Days following study vaccination

Percentage of participants reporting laboratory or vital signs abnormalities

Timeframe: 29 Days following study vaccination

Percentage of participants reporting serious adverse events, medically attended adverse events adverse events of special interest and adverse events leading early termination

Timeframe: 29 Days following study vaccination

Serum hemagglutination inhibition (HAI) antibody levels against the HA glycoprotein.

Timeframe: 29 days following study vaccination

Serum neuraminidase enzyme-linked lectin (ELLA) assay antibody levels against the NA glycoproteins.

Timeframe: 29 days following study vaccination

Trial details

NCT IDNCT06125691

SponsorArcturus Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-10

View on ClinicalTrials.gov More Influenza, Human trials

Who can participate

Age range18 Years – 85 Years

SexALL

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

✓. Individuals are male, female, or transgender adults 18 to 49 years of age or 65 to 85 years of age.
✓. Healthy participants or participants with pre-existing stable medical conditions. Pre-existing stable medical condition means a subject who: has full capacity of daily activity and no major medication modification; has not undergone surgical or minimally invasive intervention or had any hospitalization/emergency room visit for the specific medical condition within 3 months prior to Day 1.
✓. Participant or legally authorized representatives must freely provide documented informed consent prior to study procedures being performed.
✓. Individuals who have not received influenza vaccine within 6 months prior to enrollment.
✓. Individuals must agree to comply with all study visits and procedures (including blood tests, nasopharyngeal swabs, diary completion, receipt of telephone calls from the site, willingness to be available for Unscheduled Clinic Visits).
✓. Individuals of childbearing potential must be willing to adhere to contraceptive requirements.

Exclusion criteria

✕. Individuals with acute medical illness or febrile illness, including body temperature \>100.4°F (\>38.0°C) within 3 days prior to Randomization. These individuals may be offered the opportunity to enter the study after fever and illness has stabilized. Participants with suspected or confirmed influenza should be excluded and referred for medical care. Rescreening will be permitted for individuals who are presented with suspected influenza if another diagnosis is confirmed.
✕. Individuals with any medical, neurological, or psychiatric condition that, in the opinion of the investigator, could place the participant at an unacceptable risk of injury or render the participant unable to comply with all study procedures and achieve successful completion of the trial.
✕. Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any mRNA vaccine, influenza vaccine, or excipients.
✕. Individuals who have a positive pregnancy test at the Screening visit or Day 1 or who intend to become pregnant or breastfeed during the study.
✕. Individuals with a history of myocarditis, pericarditis, myopericarditis or cardiomyopathy.
✕. Individuals with a history of Guillain-Barré syndrome, encephalomyelitis, or transverse myelitis.
✕. Individuals with a known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular (I.M.) injection.
✕. Individuals with a history of congenital or acquired immunodeficiency.

What they're measuring

Percentage of participants reporting local Adverse Events

Timeframe: 14 Days following study vaccination

Percentage of participants reporting systemic Adverse Events

Timeframe: 14 Days following study vaccination

Percentage of participants reporting unsolicited Adverse Events

Timeframe: 29 Days following study vaccination

Percentage of participants reporting laboratory or vital signs abnormalities

Timeframe: 29 Days following study vaccination

Percentage of participants reporting serious adverse events, medically attended adverse events adverse events of special interest and adverse events leading early termination

Timeframe: 29 Days following study vaccination

Serum hemagglutination inhibition (HAI) antibody levels against the HA glycoprotein.

Timeframe: 29 days following study vaccination

Serum neuraminidase enzyme-linked lectin (ELLA) assay antibody levels against the NA glycoproteins.

Timeframe: 29 days following study vaccination