P-1438. A Safety and Immunogenicity Study of Novavax's COVID-Influenza Combination and Stand-alone Influenza Vaccines in Adults 65 years and Older

TL;DR

This study evaluates the safety and immune response of a combined and standalone influenza vaccine in older adults.

Contribution

The paper presents new safety and immunogenicity data for a combined COVID-19 and influenza vaccine in adults aged 65 and older.

Findings

CIC and tNIV showed acceptable safety profiles with mostly mild to moderate side effects.

Immunogenicity assessments showed neutralizing antibody responses to influenza and SARS-CoV-2 JN.1 strain.

No serious adverse events like myocarditis or death were reported in the CIC or tNIV groups.

Abstract

Using its recombinant protein nanoparticle and Matrix-M® adjuvant technology platform, Novavax has developed both a COVID-19 Influenza Combination vaccine (CIC) and a trivalent nanoparticle influenza hemagglutinin vaccine (tNIV). Here, we report on an ongoing, randomized, observer-blinded trial (CIC-E-301) to evaluate the safety and immunogenicity of these vaccines in adults ≥ 65 years. In CIC-E-301, CIC is compared to Novavax's 2024-2025 COVID-19 vaccine targeting JN.1 (NVX-CoV2705) and Fluzone® High-Dose; tNIV is compared to Fluzone High-Dose.Table 1Demographics and Baseline Characteristics for CIC-E-301 – Safety Analysis SetTable 2Summary of Solicited Local Injection Site Adverse Events within 7 Days of Vaccination for CIC-E-301 – Local Reactogenicity Analysis Set

Demographics and Baseline Characteristics for CIC-E-301 – Safety Analysis Set

Summary of Solicited Local Injection Site Adverse Events within 7 Days of Vaccination for CIC-E-301 – Local Reactogenicity Analysis Set

A total of 1985 participants in Australia and New Zealand received a single dose of either CIC, NVX-CoV2705, tNIV, or Fluzone High-Dose in a 3:2:1:3 ratio, respectively. The tolerability and safety of CIC and tNIV were evaluated by assessing reactogenicity for 7 days post dose and unsolicited adverse events (AEs) through Day 28. Immunogenicity was also assessed, with sera collected 28 days post dose and analyzed for vaccine-homologous influenza A and B strain neutralizing antibody (NAb) responses and influenza hemagglutination inhibiting antibodies, and for SARS-CoV-2 NAb responses to the JN.1 strain of SARS-CoV-2. Analyses of data are descriptive, with no prespecified statistical hypotheses.Table 3Summary of Solicited Systemic Adverse Events within 7 Days of Vaccination for CIC-E-301 – Systemic Reactogenicity Analysis SetTable 4Overall Summary of Unsolicited Adverse Events through Day 28 for CIC-E-301 – Safety Analysis Set

Summary of Solicited Systemic Adverse Events within 7 Days of Vaccination for CIC-E-301 – Systemic Reactogenicity Analysis Set

Overall Summary of Unsolicited Adverse Events through Day 28 for CIC-E-301 – Safety Analysis Set

Demographic and baseline characteristics were balanced across the vaccine groups. Overall, the median age of participants was 71 years, 54.5% male/ 45.5% female, 91.2% White, with median time since last COVID-19 vaccination of 46.7 weeks.

A single dose of CIC or tNIV had an acceptable safety and tolerability profile. Solicited local and systemic reactogenicity AEs, respectively, were reported more frequently following CIC (66.7%, 42.3%) and tNIV (64.8%, 44.0%) than NVX-CoV2705 (36.4%, 31.5%) and Fluzone High-Dose (48.7%, 36.2%). Most reactogenicity events in the CIC and tNIV recipients were Grade 1 (∼1% Grade 3) including local tenderness and pain, muscle pain, and fatigue. Unsolicited TEAEs, including related and/or severe TEAEs, MAAEs, and SAEs (reported for 0.5% - 1.4%) were noted at similar frequencies across the vaccine groups.

There were no AESIs reported for CIC or NVX-CoV2705, 1 (0.5%) for tNIV, and 3 (0.5%) for Fluzone High-Dose. There were no events of myocarditis/pericarditis or death.

Chijioke Bennett, MD, MPH, MBA, Novavax, Inc.: employee|Novavax, Inc.: Stocks/Bonds (Public Company) Katherine Smith, M.D., Novavax, Inc.: employee|Novavax, Inc.: Stocks/Bonds (Public Company) Wayne Woo, MS, Novavax, Inc: Employee|Novavax, Inc: Stocks/Bonds (Public Company) Susan Neal, n/a, Novavax Inc.: employee|Novavax Inc.: Stocks/Bonds (Public Company) Joyce S. Plested, n/a, Novavax, Inc.: employee|Novavax, Inc.: Stocks/Bonds (Public Company) Tim Vincent, n/a, Novavax, Inc.: employee|Novavax, Inc.: Stocks/Bonds (Public Company) Mingzhu Zhu, n/a, Novavax, Inc.: employee|Novavax, Inc.: Stocks/Bonds (Public Company) Shane Cloney-Clark, n/a, Novavax, Inc.: employee|Novavax, Inc.: Stocks/Bonds (Public Company) Bridget Riviers, Ph.D., Novavax, Inc: Employee|Novavax, Inc: Stocks/Bonds (Public Company) Miranda R. Cai, PhD, Novavax, Inc.: employee|Novavax, Inc.: Stocks/Bonds (Public Company) Pratyusha Kajipet, M.S., Novavax: employee|Novavax: Stocks/Bonds (Public Company) Zhaohui Cai, PhD, Novavax, Inc.: employee|Novavax, Inc.: Stocks/Bonds (Public Company) Iksung Cho, MS, Novavax, Inc.: employee|Novavax, Inc.: Stocks/Bonds (Public Company) Raburn M. Mallory, M.D., Novavax: I am an employee of Novavax|Novavax: Stocks/Bonds (Public Company) Robert Walker, M.D., Novavax, Inc.: employee|Novavax, Inc.: Stocks/Bonds (Public Company)

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