This study is a Phase 3 trial designed to check the safety and immune response to a new Omicron JN.1 COVID-19 vaccine. Study researchers will give a single dose of this vaccine, called NVX-CoV2705, to approximately 120 participants. This includes adults aged 65 and older, and individuals aged 12 to 64 who have existing health conditions that put them at high risk for severe COVID-19. All participants must have received a previous COVID-19 vaccine at least 90 days before joining this study. Study researchers will be closely monitoring participants for their immune response for 28 days and collecting safety data for 180 days after vaccination.
This is a Phase 3, open-label, single arm study to evaluate the safety and immunogenicity of a single dose of an Omicron JN.1 subvariant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M® (NVX-CoV2705) in participants ≥ 65 years of age and participants 12 through 64 years of age who have at least one underlying condition that puts them at high risk for severe outcomes from coronavirus disease 2019 (COVID 19) previously vaccinated with a COVID-19 vaccine ≥ 90 days prior to study vaccination. The goal will be to enroll a similar number of participants in the 2 age cohorts (≥ 65 years and 12 through 64 years) and in the 12 through 64 years age cohort, an effort will be made to enroll a similar number of participants in the 2 age subcohorts (12 through 17 years and 18 through 64 years). Approximately 120 participants, approximately 60 participants in each age cohort and approximately 30 participants in each age subcohort, will be enrolled to receive a single dose of NVX-CoV2705 on Day 0 and remain on study for immunogenicity until Day 28 and safety data collection through 180 days post-vaccination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
Intramuscular (deltoid) injection at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant.
Investigational Site Number US404
Phoenix, Arizona, United States
Investigational Site Number US395
Melrose Park, Illinois, United States
Investigational Site Number US406
Lenexa, Kansas, United States
Pseudovirus neutralization (ID50) of Omicron JN.1 subvariant vaccine expressed as GMFR
Pseudovirus neutralization (ID50) GMFR for the Omicron JN.1 subvariant at Day 28 following study vaccination.
Time frame: Day 28
Pseudovirus neutralization (ID50) of Omicron JN.1 subvariant vaccine expressed as GMT
Pseudovirus neutralization (ID50) GMTs for the Omicron JN.1 subvariant at Day 28 following study vaccination.
Time frame: Day 28
Pseudovirus neutralization (ID50) of Omicron JN.1 subvariant vaccine expressed as SRR
SRRs in ID50 titers for the Omicron JN.1 subvariant assessed at Day 28 following study vaccination.
Time frame: Day 28
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Number of participants reported solicited local and systemic adverse events (AEs)
Time frame: Day 28
Number of Participants Reported any unsolicited AEs and MAAEs
Incidence, severity, and relationship of any unsolicited AEs and MAAEs through 28 days after vaccination.
Time frame: Day 28
Number of Participants Reported MAAEs Attributed to Study Vaccine, Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
• Incidence and severity of treatment-related MAAEs, AESIs (predefined list, including PIMMCs and myocarditis and/or pericarditis), and SAEs through Day 180/EoS.
Time frame: Day 180
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676
Investigational Site Number US294
Lafayette, Louisiana, United States
Investigational Site Number US407
Southfield, Michigan, United States
Investigational Site Number US326
Omaha, Nebraska, United States
Investigational Site Number US381
Cincinnati, Ohio, United States
Investigational Site Number US047
Austin, Texas, United States
Investigational Site Number US073
Tomball, Texas, United States
Investigational Site Number US391
Pleasant View, Utah, United States