A PhaseⅡ Study to Evaluate the Safety & Immunogenicity of SARS-CoV-2 Alpha/Beta/Delta/Omicron Variants COVID-19 Vaccine — SCTV01E  

COVID-19 Pandemic Clinical Trial

Official title: Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant SARS-CoV-2 Alpha/Beta/Delta/Omicron Variants S Trimer Protein Vaccine (SCTV01E) in a Vaccinated Population

Status Completed

Clinical Trial 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.

Clinical Trial Description

Firstly, 250 participants will be randomly enrolled in group A, among which the first 15 participants will be observed for 7 days after receiving the study vaccine and assessed for safety by the DSMB. If the 15 participants do not meet the study suspension/termination criteria, 15 sentinel participants in group B will be enrolled. The sentinel participants in Group B will be observed for 7 days after receiving the study vaccine, and safety is assessed by the DSMB. If the sentinel participants in group B do not meet the study suspension/termination criteria, non-sentinel participants in Group B and 15 sentinel participants in Group C aged 6-11 years old will be enrolled at the same time. The 15 sentinel participants aged 6-11 years in group C will be observed for 7 days after receiving the study vaccine and assessed for safety by the DSMB. If the study suspension/termination criteria are not met, non-sentinel participants aged 6-11 years old in group C and 15 sentinel participants aged 3-5 years old in group C will be enrolled, and sentinel participants aged 3-5 years old in group C will be observed for 7 days after receiving the study vaccine. Safety will be assessed by the DSMB and non-sentinel participants aged 3-5 years old in Group C will be enrolled if study suspension/termination criteria are not met in sentinel participants aged 3-5 years old.

Participants in each group (including the first 15 participants in Group A and sentinel participants in groups B and C) will be randomly inoculated with either SCTV01E or placebo (normal saline) at a ratio of 4:1, i.e. 200 participants in each group will receive SCTV01E and 50 participants will receive placebo (normal saline).

Randomized stratification factors for group A are age (18-59 years vs. ≥60 years), past COVID-19 vaccination status (completion of baseline immunization vs. Completion of booster immunization), the last type of COVID-19 vaccine received (inactivated vs. other vaccines), and the duration of prior Informed consent form (ICF) signing (6-12 months vs. 12-24 months); Randomized stratification factor for group B are past COVID-19 vaccination (completion of baseline immunization vs. Completion of booster immunization), type of COVID-19 vaccine last received (inactivated vs. other vaccines) and time since ICF last received (6-12 months vs. 12-24 months); Random stratification factors for group C are age (3-5 years vs. 6-11 years), past COVID-19 vaccination (completion of baseline immunization vs. Completion of enhanced immunization), the last type of COVID-19 vaccine received (inactivated vs. other vaccines), and the duration of prior Informed consent form (ICF) signing (6-12 months vs. 12-24 months). ;

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

• NCT number: NCT05652543
• Study type: Interventional
• Source: Sinocelltech Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: January 5, 2023
• Completion date: January 15, 2024