EN | UA
EN | UA

Help Support

Back

Immunogenicity and safety of NVX-CoV2373 vaccine in healthy adults

covid-19_vaccine covid-19_vaccine
covid-19_vaccine covid-19_vaccine

An interim report of phase I/II randomized controlled trial was performed to explore safety and immunogenicity of NVX-CoV2373 vaccine in healthy adult patients.

See All

Key take away

In healthy adults, 2 doses of  NVX-CoV2373 administered with a 21-day interval induced robust anti-SARS-CoV-2 immune responses and exhibited acceptable safety and tolerability profile.

Background

An interim report of phase I/II randomized controlled trial was performed to explore safety and immunogenicity of NVX-CoV2373 vaccine in healthy adult patients.

Method

Healthy adults ≥ 20 years of age (n = 200) without a history/risk of COVID-19 infection and no previous exposure to any intervention were recruited. The participants were stratified by age (< 65 or ≥ 65 years) and were randomly given two doses of NVX-CoV2373 vaccine (n = 150) or placebo (n = 50) 21 days apart. The immunogenicity and safety evaluated by serum immunoglobulin G (IgG) levels against SARS-CoV-2 rS protein on day 36 were the major endpoints ascertained. At 4 weeks following the second dose, the primary data analysis was reported, ahead of 12-month follow-up completion.

Result

The occurrence of adverse events (AEs) in the NVX-CoV2373 and placebo arms during 7 days following each injection is depicted in Table 1:

Following each vaccination, injection site pain and tenderness were the most commonly reported AEs (regardless of age) in the NVX-CoV2373 arm. By day 36, robust immune responses were witnessed in the NVX-CoV2373 arm (n = 150) such as a seroconversion rate of 100% (97.6, 100) and IgG geometric mean fold rise of 259 (219, 306). No similar response was observed in the placebo (n = 49).

Conclusion

NVX-CoV2373 (recombinant SARS-CoV-2 nanoparticle vaccine) was safe, well-tolerated, and elicited promising anti-SARS-CoV-2 immune responses in healthy adults.

Source:

Vaccine

Article:

Safety and immunogenicity of NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults: Interim report of a phase I/II randomized controlled trial

Authors:

Taisei Masuda et al.

Comments (0)

You want to delete this comment? Please mention comment Invalid Text Content Text Content cannot me more than 1000 Something Went Wrong Cancel Confirm Confirm Delete Hide Replies View Replies View Replies en ru ua
Try: