NCT06409663

A Strain Change Study for SARS-CoV-2 rS Vaccines

A Phase 3 Open-Label, Single-Arm Study to Evaluate the Safety and Immunogenicity of a JN.1 Subvariant SARS CoV-2 rS Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Severe Acute Respiratory Syndrome Coronavirus 2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	NVX-CoV2705 Vaccine	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.

Timeline

• Start date: 2024-10-14
• Primary completion: 2024-10-15
• Completion: 2025-04-17
• First posted: 2024-05-10
• Last updated: 2025-07-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study