A PhaseⅡ Study to Evaluate the Safety & Immunogenicity of SARS-CoV-2 Alpha/Beta/Delta/Omicron Variants COVID-19 Vaccine

Summary

This study is a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the safety and immunogenicity of SCTV01E in population of different ages who have been vaccinated against COVID-19. A total of 750 participants ≥3 years old who have received the recommended dose and immunization procedure of domestically approved COVID-19 vaccines will be enrolled, including 250 participants ≥18 years old (group A), 250 participants aged 12-17 years old (group B), and 250 participants aged 3-11 years old (group C). The study will be carried out gradually according to the age of the participants from older to younger. Considering that SCTV01E in this study is the first clinical study in participants under 18 years old, 15 sentinel participants will be assigned to group B and 30 sentinel participants will be assigned to group C (including 15 aged 6-11 years old and 15 aged 3-5 years old). The Primary end points are 1. The incidence and severity of solicited adverse events on days 0-7 after inoculation with SCTV01E. 2. IgG total antibody concentrations (ELISA) against SARS-CoV-2 prototype strains and neutralizing antibodies titer (Live virus neutraliztion antibody test) against SARS-CoV-2 Omicron variant at 28 days post-vaccination.

Timeline

Start

2023-01-05

Primary completion

2024-01-15

Completion

2024-01-15

Publications

• Background Tuekprakhon A, Nutalai R, Dijokaite-Guraliuc A, Zhou D, Ginn HM, Selvaraj M, Liu C, Mentzer AJ, Supasa P, Duyvesteyn HME, Das R, Skelly D, Ritter TG, Amini A, Bibi S, Adele S, Johnson SA, Constantinides B, Webster H, Temperton N, Klenerman P, Barnes E, Dunachie SJ, Crook D, Pollard AJ, Lambe T, Goulder P, Paterson NG, Williams MA, Hall DR; OPTIC Consortium; ISARIC4C Consortium; Fry EE, Huo J, Mongkolsapaya J, Ren J, Stuart DI, Screaton GR. Antibody escape of SARS-CoV-2 Omicron BA.4 and BA.5 from vaccine and BA.1 serum. Cell. 2022 Jul 7;185(14):2422-2433.e13. doi: 10.1016/j.cell.2022.06.005. Epub 2022 Jun 9.
• Background WHO Coronavirus (COVID-19) Dashboard [EB/OL]. [2022-10-21]. https://covid19.who.int.
• Background COVID-19 vaccine tracker and landscape [EB/OL]. [2022-10-21]. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines.
• Background WHO-COVID19 Vaccine Tracker [EB/OL]. [2022-10-21]. https://covid19.trackvaccines.org/agency/who/.
• Background 健康界. 中国疾控中心：新冠疫苗"加强针"仍免费接种；国务院联防联控机制：力争年底前完成3至11岁人群新冠疫苗接种|疫苗|接种|新闻|表示|人群|-健康界[EB/OL]. [2022-10-21]. https://www.cn-healthcare.com/articlewm/20211031/content-1279647.html.
• Background FDA. Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age [EB/OL]. [2022-10-21]. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children.
• Background EverdayHEALTH-NEWS. BA.4 and BA.5 Omicron Subvariants Are Now Dominant in the U.S.[EB/OL]. [2022-10-21]. https://www.everydayhealth.com/coronavirus/ba4-and-ba5-have-become-dominant-omicron-subvariants-in-the-us/.

Drugs

Indications