NCT07079670

Safety and Immunogenicity of NVX-CoV2705

A Phase 3 Open-Label, Single-Arm Study to Evaluate the Safety and Immunogenicity of an Omicron JN.1 Subvariant SARS-CoV-2 rS Vaccine Adjuvanted With Matrix-M

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 676 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	NVX-CoV2705	Intramuscular (deltoid) injection at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant.

Timeline

• Start date: 2025-10-09
• Primary completion: 2026-04-16
• Completion: 2026-06-16
• First posted: 2025-07-23
• Last updated: 2026-02-13

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study