This Phase I/II study is to characterize the safety and immunogenicity of 2 dose levels of AZD6489, an investigational RSV recombinant prefusion F protein VLP vaccine.
This Phase I/II clinical study will be conducted in the US at approximately 5 sites. The study is a randomized, double-blind, active-controlled study to characterize the safety and immunogenicity of a single dose of AZD6489 in adults ≥ 60 years of age. Two dose levels of AZD6489 will be assessed. Approximately 160 participants will be randomized and stratified by age group and previous receipt of RSV vaccine. Participants will be randomized/dosed to receive AZD6489, licensed RSV vaccine #1, or licensed RSV vaccine #2. The study is split into 2 cohorts based on the 2 dose levels of AZD6489 being studied. For each cohort, an initial sentinel group of 8 participants will be followed up for safety via a telephone or teleconference call, approximately 48 hours post-study intervention, and the safety data will be evaluated by the SRC in order to provide a recommendation to continue randomization and vaccination for the remaining participants in that cohort. An ESDR of all available safety data through 7 days post-vaccination of Cohort 1 will be conducted. Randomization of Cohort 2 will be allowed only after the ESDR of Cohort 1 participants has been completed and the results support that the safety profile is acceptable. This study includes 5 in-clinic study visits. The duration of each participant's involvement in the study will be approximately 12 months following the administration of study intervention. Safety will be assessed for the duration of the study. Blood will be taken for immunological and safety assessments as per SoA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
164
Participants will receive AZD6489 as a single intramuscular injection.
Participants will receive licensed RSV vaccine #1 as a single intramuscular injection.
Participants will receive licensed RSV vaccine #2 as a single intramuscular injection.
Research Site
Long Beach, California, United States
Research Site
Rolling Hills Estates, California, United States
Research Site
Chicago, Illinois, United States
Research Site
Lenexa, Kansas, United States
Incidence of immediate unsolicited adverse events (AEs)
To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines
Time frame: 30 minutes post-study intervention
Incidence of injection site and systemic solicited adverse reactions (ARs)
To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines
Time frame: Day 1 through 7 days post-study intervention
Incidence of unsolicited adverse events (AEs)
To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines
Time frame: Day 1 through 28 days post-study intervention
Incidence of serious adverse events (SAEs)
To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines
Time frame: Day 1 to Day 365
Incidence of adverse events of special interest (AESIs)
To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines
Time frame: Day 1 to Day 365
Incidence of medically attended adverse events (MAAEs)
To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines
Time frame: Day 1 to Day 365
RSV A nAb responses to AZD6489
To characterize the nAb responses to RSV A in serum following a single IM vaccination with AZD6489
Time frame: Day 29
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Research Site
Kansas City, Missouri, United States
Research Site
Omaha, Nebraska, United States