MedTrace Logo

Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults

NCT06602531 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2026-04-03

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and immune responses of three different dose levels a self-amplifying RNA pandemic influenza vaccine (ARCT-2304) in adults. The key objectives of the study are:

* To evaluate safety and reactogenicity of different dose levels of the ARCT-2304 vaccine
* To describe the Immune responses of different dose levels of the ARCT-2304 vaccine as measured by hemagglutination inhibition (HAI) and neuraminidase enzyme-linked lectin (ELLA) antibody responses

Researchers will compare the results with licensed influenza vaccines to select the most optimal dose level and schedule for vaccine administration in terms of safety and immunogenicity for further development of the vaccine.

Participants will receive 2 doses of the ARCT-2304 vaccine or 1 dose of licensed influenza vaccine and 1 dose of placebo.

They will be asked:

* to complete a daily diary for 7 days after each vaccination, answering questions how they have been feeling on that day.
* to provide blood samples at each visit in the clinic
* to comply with all study visits and procedures (e.g., be available for planned telephone contacts and unscheduled clinic visits, if required)

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

ARCT-2304

Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.

BIOLOGICAL

Control vaccine (licensed seasonal influenza vaccine) younger adults

Each participant will receive one intramuscular (IM) dose into the deltoid muscle.

BIOLOGICAL

Control vaccine (licensed seasonal influenza vaccine) older adults

Each participant will receive one intramuscular (IM) dose into the deltoid muscle.

OTHER

Placebo Vaccine

Each participant will receive one intramuscular (IM) dose into the deltoid muscle.

Sponsors & Collaborators

Principal Investigators

  • Clinical Program Director · Arcturus Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2025-06-13
Completion
2025-12-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06602531 on ClinicalTrials.gov