NVX-CoV2515 / Novavax - LARVOL DELTA

Immunogenicity and Safety of Heterologous Omicron BA.1 and Bivalent SARS-CoV-2 Recombinant Spike Protein Booster Vaccines: A Phase 3 Randomized Clinical Trial. (PubMed, J Infect Dis) - P3 | "NVX-CoV2515 elicited a superior neutralizing antibody response against the Omicron BA.1 subvariant as compared with NVX-CoV2373 when administered as a fourth dose. Safety data were consistent with the established safety profile of NVX-CoV2373."

Clinical • Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines (clinicaltrials.gov) - P3 | N=1340 | Completed | Sponsor: Novavax | Active, not recruiting ➔ Completed

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

Immunogenicity and safety of heterologous Omicron BA.1 and bivalent SARS-CoV-2 recombinant spike protein booster vaccines: a phase 3, randomized, clinical trial. (PubMed, J Infect Dis) - "NVX-CoV2515 elicited a superior neutralizing antibody response against the Omicron BA.1 subvariant compared with NVX-CoV2373 when administered as a fourth dose. Safety data were consistent with the established safety profile of NVX-CoV2373."

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

Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines (clinicaltrials.gov) - P3 | N=1340 | Active, not recruiting | Sponsor: Novavax | Trial completion date: Jul 2023 ➔ Feb 2024

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

Efficacy of mRNA-1273 and Novavax ancestral or BA.1 spike booster vaccines against SARS-CoV-2 BA.5 infection in non-human primates. (PubMed, Sci Immunol) - "Here, we compared the efficacy of three booster vaccines against Omicron BA.5 challenge in rhesus macaques: mRNA-1273, the Novavax ancestral spike protein vaccine (NVX-CoV2373), or Omicron BA.1 spike protein version (NVX-CoV2515). The protection against SARS-CoV-2 BA.5 infection in the upper respiratory airways correlated with binding, neutralizing, and ADNP activities of the serum antibody. These data have important implications for COVID-19 vaccine development, as vaccines that lower nasopharyngeal virus may help to reduce transmission."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8

Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines (clinicaltrials.gov) - P3 | N=1340 | Active, not recruiting | Sponsor: Novavax | N=2090 ➔ 1340

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

"We in no way have all the data. NVX-CoV2373 v mRNA BA.5 for BA.2.75? NVX-CoV2515 v mRNA BA.5 for BA.2.75? NVX-CoV2540 v mRNA BA.5 vs BA.2.75? NVX-CoV2540 v mRNA BA.5 for BA.5? And so on..." (@n6mac41717)

Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines (clinicaltrials.gov) - P3 | N=2090 | Active, not recruiting | Sponsor: Novavax | N=1340 ➔ 2090

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

Phase 3 Booster Study for the SARS-CoV-2 rS Vaccines (clinicaltrials.gov) - P3 | N=1340 | Active, not recruiting | Sponsor: Novavax | Not yet recruiting ➔ Active, not recruiting

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

Phase 3 Booster Study for the SARS-CoV-2 rS Vaccines (clinicaltrials.gov) - P3 | N=1340 | Not yet recruiting | Sponsor: Novavax | N=980 ➔ 1340

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

Phase 3 Boosting Study for the SARS-CoV-2 rS Vaccine (clinicaltrials.gov) - P3 | N=980 | Not yet recruiting | Sponsor: Novavax

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