Áñez, G., et al. Safety and immunogenicity of four sequential doses of NVX-CoV2373 in adults and adolescents: A phase 3, randomized, placebo-controlled trial (PREVENT-19). Vaccine, 2025 Aug 13, 61:127362.
Áñez, G., et al. Safety and immunogenicity of four sequential doses of NVX-CoV2373 in adults and adolescents: A phase 3, randomized, placebo-controlled trial (PREVENT-19). Vaccine, 2025 Aug 13, 61:127362. PMID: 40479932
- This phase 3 trial evaluates the safety, immunogenicity, and durability of up to four doses of the NVX-CoV2373 COVID-19 vaccine in adults and adolescents. The vaccine is adjuvanted with Matrix-M®, a saponin-based adjuvant derived from QS-21, and its role in improving immune responses is highlighted.
- The findings demonstrate that additional booster doses significantly enhance immune responses, including neutralizing antibodies and binding antibody levels, which remain durable for at least eight months post-third dose. The immune responses elicited by the 3rd and 4th doses are non-inferior to those observed after the primary two-dose series, with evidence of cross-reactivity against Omicron subvariants such as BA.5 and BQ.1.1. The vaccine was well-tolerated, with no new safety signals identified with repeated dosing.
- NVX-CoV2373 is effective in eliciting strong, durable, and cross-reactive humoral immune responses in adults and adolescents, with additional booster doses enhancing immunity without introducing new safety concerns. These findings support continued use and updates of the vaccine to effectively combat circulating SARS-CoV-2 strains and emerging variants.
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