tetano
Editor, Senior Moderator
J Infect Dis
. 2024 Jul 25;230(1):e4-e16.
doi: 10.1093/infdis/jiad508. Immunogenicity and Safety of Heterologous Omicron BA.1 and Bivalent SARS-CoV-2 Recombinant Spike Protein Booster Vaccines: A Phase 3 Randomized Clinical Trial
Chijioke Bennett[SUP] 1 [/SUP], E Joy Rivers[SUP] 1 [/SUP], Wayne Woo[SUP] 1 [/SUP], Mark Bloch[SUP] 2 [/SUP], King Cheung[SUP] 3 [/SUP], Paul Griffin[SUP] 4 [/SUP], Rahul Mohan[SUP] 5 [/SUP], Sachin Deshmukh[SUP] 6 [/SUP], Mark Arya[SUP] 7 [/SUP], Oscar Cumming[SUP] 8 [/SUP], A Munro Neville[SUP] 9 [/SUP], Toni McCallum Pardey[SUP] 8 [/SUP], Joyce S Plested[SUP] 1 [/SUP], Shane Cloney-Clark[SUP] 1 [/SUP], Mingzhu Zhu[SUP] 1 [/SUP], Raj Kalkeri[SUP] 1 [/SUP], Nita Patel[SUP] 1 [/SUP], Agi Buchanan[SUP] 1 [/SUP], Alex Marcheschi[SUP] 1 [/SUP], Jennifer Swan[SUP] 1 [/SUP], Gale Smith[SUP] 1 [/SUP], Iksung Cho[SUP] 1 [/SUP], Gregory M Glenn[SUP] 1 [/SUP], Robert Walker[SUP] 1 [/SUP], Raburn M Mallory[SUP] 1 [/SUP]
Affiliations
Background: Mutations present in emerging SARS-CoV-2 variants permit evasion of neutralization with prototype vaccines. A novel Omicron BA.1 subvariant-specific vaccine (NVX-CoV2515) was tested alone or as a bivalent preparation with the prototype vaccine (NVX-CoV2373) to assess antibody responses to SARS-CoV-2.
Methods: Participants aged 18 to 64 years immunized with 3 doses of prototype mRNA vaccines were randomized 1:1:1 to receive a single dose of NVX-CoV2515, NVX-CoV2373, or the bivalent mixture in a phase 3 study investigating heterologous boosting with SARS-CoV-2 recombinant spike protein vaccines. Immunogenicity was measured 14 and 28 days after vaccination for the SARS-CoV-2 Omicron BA.1 sublineage and ancestral strain. Safety profiles of vaccines were assessed.
Results: Of participants who received trial vaccine (N = 829), those administered NVX-CoV2515 (n = 286) demonstrated a superior neutralizing antibody response to BA.1 vs NVX-CoV2373 (n = 274) at day 14 (geometric mean titer ratio, 1.6; 95% CI, 1.33-2.03). Seroresponse rates were 73.4% (91/124; 95% CI, 64.7-80.9) for NVX-CoV2515 vs 50.9% (59/116; 95% CI, 41.4-60.3) for NVX-CoV2373. All formulations were similarly well tolerated.
Conclusions: 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 trials registration: ClinicalTrials.gov (NCT05372588).
Keywords: NVX-CoV2373; SARS-CoV-2; neutralizing antibody; omicron BA.1; reactogenicity.
. 2024 Jul 25;230(1):e4-e16.
doi: 10.1093/infdis/jiad508. Immunogenicity and Safety of Heterologous Omicron BA.1 and Bivalent SARS-CoV-2 Recombinant Spike Protein Booster Vaccines: A Phase 3 Randomized Clinical Trial
Chijioke Bennett[SUP] 1 [/SUP], E Joy Rivers[SUP] 1 [/SUP], Wayne Woo[SUP] 1 [/SUP], Mark Bloch[SUP] 2 [/SUP], King Cheung[SUP] 3 [/SUP], Paul Griffin[SUP] 4 [/SUP], Rahul Mohan[SUP] 5 [/SUP], Sachin Deshmukh[SUP] 6 [/SUP], Mark Arya[SUP] 7 [/SUP], Oscar Cumming[SUP] 8 [/SUP], A Munro Neville[SUP] 9 [/SUP], Toni McCallum Pardey[SUP] 8 [/SUP], Joyce S Plested[SUP] 1 [/SUP], Shane Cloney-Clark[SUP] 1 [/SUP], Mingzhu Zhu[SUP] 1 [/SUP], Raj Kalkeri[SUP] 1 [/SUP], Nita Patel[SUP] 1 [/SUP], Agi Buchanan[SUP] 1 [/SUP], Alex Marcheschi[SUP] 1 [/SUP], Jennifer Swan[SUP] 1 [/SUP], Gale Smith[SUP] 1 [/SUP], Iksung Cho[SUP] 1 [/SUP], Gregory M Glenn[SUP] 1 [/SUP], Robert Walker[SUP] 1 [/SUP], Raburn M Mallory[SUP] 1 [/SUP]
Affiliations
- PMID: 39052718
- DOI: 10.1093/infdis/jiad508
Background: Mutations present in emerging SARS-CoV-2 variants permit evasion of neutralization with prototype vaccines. A novel Omicron BA.1 subvariant-specific vaccine (NVX-CoV2515) was tested alone or as a bivalent preparation with the prototype vaccine (NVX-CoV2373) to assess antibody responses to SARS-CoV-2.
Methods: Participants aged 18 to 64 years immunized with 3 doses of prototype mRNA vaccines were randomized 1:1:1 to receive a single dose of NVX-CoV2515, NVX-CoV2373, or the bivalent mixture in a phase 3 study investigating heterologous boosting with SARS-CoV-2 recombinant spike protein vaccines. Immunogenicity was measured 14 and 28 days after vaccination for the SARS-CoV-2 Omicron BA.1 sublineage and ancestral strain. Safety profiles of vaccines were assessed.
Results: Of participants who received trial vaccine (N = 829), those administered NVX-CoV2515 (n = 286) demonstrated a superior neutralizing antibody response to BA.1 vs NVX-CoV2373 (n = 274) at day 14 (geometric mean titer ratio, 1.6; 95% CI, 1.33-2.03). Seroresponse rates were 73.4% (91/124; 95% CI, 64.7-80.9) for NVX-CoV2515 vs 50.9% (59/116; 95% CI, 41.4-60.3) for NVX-CoV2373. All formulations were similarly well tolerated.
Conclusions: 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 trials registration: ClinicalTrials.gov (NCT05372588).
Keywords: NVX-CoV2373; SARS-CoV-2; neutralizing antibody; omicron BA.1; reactogenicity.