The present study aims to investigate the safety and immunogenicity of the Novavax JN.1 subvariant vaccine SARS-CoV-2 rS adjuvanted with Matrix-M (NVX CoV2705) in previously vaccinated adults. A descriptive comparison will be made with participants who received the prior authorized vaccine NVX-CoV2601 in an earlier study (2019nCoV-313).
This is a Phase 3, open-label, single arm study to evaluate the safety and immunogenicity of a single dose of a 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 previously vaccinated adults. Approximately 60 participants 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 up to 180 days post-vaccination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
60
All injections will be administered in a 0.5 mL injection volume at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant at each injection.
Foothills Research Center - CCT Research
Phoenix, Arizona, United States
Benchmark Research
Austin, Texas, United States
Incidence, duration, and severity of solicited local and systemic adverse events (AEs)
Incidence, duration, and severity of solicited local and systemic adverse events (AEs) for 7 days following vaccination.
Time frame: Day 7[ following 1st vaccination]
Incidence, severity, and relationship of any unsolicited AEs
Incidence, severity, and relationship of any unsolicited AEs through 28 days after vaccination.
Time frame: Day 28
Incidence and severity of treatment-related MAAEs, adverse events of special interest and serious adverse events interest (AESIs; predefined list, including PIMMCs, myocarditis and/or pericarditis), and serious adverse events (SAEs)
Incidence and severity of treatment-related MAAEs, adverse events of special interest and serious adverse events interest (AESIs; predefined list, including PIMMCs, myocarditis and/or pericarditis), and serious adverse events (SAEs) through day 180 or end of study (EoS).
Time frame: Day 180 or end of study (EoS).
Pseudovirus neutralization titers for the JN.1 subvariant expressed as GMTs
Pseudo virus neutralization antibody responses induced by NVX CoV2705 for the JN.1 subvariant at Day 28 following study vaccination.
Time frame: Day 0 to Day 28
Pseudovirus neutralization antibody responses against the JN.1 subvariant Expressed as GMFR
Pseudovirus neutralization antibody responses of ID50 titers for the JN.1 subvariant of time points (Day 28) from Baseline
Time frame: Day 0 to Day 28
Pseudovirus neutralization antibody responses against the JN.1 subvariant Expressed as SRRs
Pseudovirus neutralization antibody responses of ID50 titers for the JN.1 subvariant of time points (Day 28) from Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 28
Anti-S IgG antibody responses for the JN.1 subvariant Expressed as (GMEU)
immunoglobulin G (IgG) antibody responses for the JN.1 subvariant at relevant time points (Days 0 and 28).
Time frame: Day-0 (baseline) to Day 28.
Anti-S IgG antibody responses for the JN.1 subvariant Expressed as GMFR
immunoglobulin G (IgG) antibody responses for the JN.1 subvariant at relevant time points (Days 0 and 28).
Time frame: Frame: Day 0 and Day-28
Anti-S IgG antibody responses for the JN.1 subvariant Expressed as SRRs
Immunoglobulin G (IgG) antibody responses for the JN.1 subvariant at relevant time points (Days 0 and 28).
Time frame: Frame: Day 0 and Day 28