NVX-CoV2601 / Novavax - LARVOL DELTA

ARMOR Study: Immunogenicity and Safety of Recombinant Spike Protein Vaccine in Patients With Inflammatory Bowel Disease and Liver Transplant Recipients Comparable to Healthy Controls (ACG 2025) - "Twenty-one patients, 18 IBD and 3 liver transplant recipients, were enrolled in ARMOR and compared with 42 age/sex-matched healthy controls (Mean age 47.65, 60% males) (Table 1). In the ARMOR cohort, anti-spike IgG GMT increased significantly post-immunization (22,969 to 66,639 EU/mL at one month; 2.9-fold increase, p=0.001). Healthy controls showed an increase from 54,812 to 129,813 EU/mL (2.4-fold increase; p< 0.001)."

Clinical • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Novel Coronavirus Disease • Solid Organ Transplantation • Transplant Rejection • Transplantation

Detection of Anti-SARS-CoV-2 Mucosal Immunoglobulin A in Clinical Saliva Samples After a Dose of Novavax COVID-19 Vaccine. (PubMed, J Med Virol) - P3 | "These participants had previously received ≥ 2 mRNA-based COVID-19 vaccinations prior to enrollment and received a single intramuscular study dose of NVX-CoV2601 (XBB.1.5) or bivalent vaccine (NVX-CoV2601 + NVX-CoV2373 [Wuhan]). Furthermore, cross-reactivity by identification of anti-JN.1 and anti-Wuhan IgA was also observed. The detection of IgA in clinical mucosal samples using this assay will be a valuable tool in supporting vaccine development."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and safety of a monovalent Omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine in previously unvaccinated, SARS-CoV-2 seropositive participants: Primary day-28 analysis of a phase 2/3 open-label study. (PubMed, Vaccine) - P2/3 | "A single dose of NVX-CoV2601 in vaccine-naive participants with a history of SARS-CoV-2 infection elicited a robust neutralizing antibody response that was noninferior to that observed in vaccinated participants. The vaccine was well-tolerated. These data support the use of NVX-CoV2601 as a single dose, regardless of prior vaccination history."

Journal • P2/3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity, safety, and reactogenicity of concomitant administration of the novavax vaccine against Omicron XBB.1.5 (NVX-CoV2601) and a 20-valent pneumococcal conjugate vaccine in adults aged ≥60 years: A randomised, double-blind, placebo-controlled, non-inferiority trial. (PubMed, J Infect) - P4 | "Immunogenicity following co-administration of NVX-CoV2601 with PCV20 was non-inferior to administration of NVX-CoV2601 alone. Given the similar safety and reactogenicity profile, our findings may help to overcome concerns about concomitant vaccination and pave the way for combination vaccines."

Clinical • Head-to-Head • Journal • Infectious Disease • Novel Coronavirus Disease • Pneumococcal Infections • Respiratory Diseases

Safety and Immunogenicity of Omicron Protein Vaccines in mRNA-Vaccinated Adolescents: A Phase 3, Randomised Trial. (PubMed, J Infect) - "NVX-CoV2601 elicited more robust antibody responses to XBB.1.5 and ancestral virus, compared with a bivalent formulation. The safety profile within each group was consistent with NVX-CoV2373, which contains ancestral recombinant spike protein."

Journal • P3 data • Cardiovascular • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and safety of a monovalent omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose in US adults: interim analysis of a single-arm phase 2/3 study. (PubMed, Lancet Infect Dis) - P2/3 | "The coprimary endpoints were met, and NVX-CoV2601 was well tolerated. These interim data support NVX-CoV2601 use per guidance for XBB.1.5-directed COVID-19 vaccines and demonstrate the adaptability of this vaccine platform for updated SARS-CoV-2 spike proteins."

Journal • P2/3 data • Asthma • Cardiovascular • Fatigue • Hypertension • Immunology • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Pulmonary Disease • Respiratory Diseases

Interim analysis of SARS-CoV-2 vaccine NVX-CoV2601 as a heterologous booster dose. (PubMed, Lancet Infect Dis) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines (clinicaltrials.gov) - P2/3 | N=994 | Completed | Sponsor: Novavax | Active, not recruiting ➔ Completed | Trial completion date: Nov 2024 ➔ May 2024

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines (clinicaltrials.gov) - P3 | N=400 | Completed | Sponsor: Novavax | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SAFETY AND IMMUNOGENICITY OF PROTEIN-BASED OMICRON SUBVARIANT MONOVALENT AND BIVALENT SARS-COV-2 VACCINES IN ADOLESCENTS PREVIOUSLY VACCINATED WITH MRNA: A PHASE 3, RANDOMIZED, DOUBLE-BLINDED CLINICAL TRIAL (ESPID 2024) - "Both vaccines demonstrated robust immunogenicity, though NVX-CoV2601 elicited comparatively higher XBB.1.5-specific nAb titers (Figure) and IgG levels compared to bivalent vaccine, including among participants with ≥3 prior mRNA doses and those with evidence of prior COVID-19 infection. Regarding heterologous administration, the safety profile of both Novavax vaccines was consistent with the established safety profile of the ancestral-based Novavax monovalent vaccine. Ongoing analysis will provide additional insight into vaccine-mediated cross-protection to newly emerging SARS-CoV-2 variant strains."

Clinical • Late-breaking abstract • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines (clinicaltrials.gov) - P2/3 | N=994 | Active, not recruiting | Sponsor: Novavax | N=1980 ➔ 994

Enrollment change • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines (clinicaltrials.gov) - P3 | N=400 | Active, not recruiting | Sponsor: Novavax | Trial completion date: Mar 2024 ➔ Aug 2024

Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines (clinicaltrials.gov) - P2/3 | N=1980 | Active, not recruiting | Sponsor: Novavax | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines (clinicaltrials.gov) - P3 | N=400 | Active, not recruiting | Sponsor: Novavax | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines (clinicaltrials.gov) - P2/3 | N=1980 | Recruiting | Sponsor: Novavax | Not yet recruiting ➔ Recruiting | Trial completion date: May 2024 ➔ Nov 2024

Enrollment open • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adolescents Previously Vaccinated With mRNA COVID-19 Vaccines (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: Novavax

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases