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

NCT05652543 | Completed Phase 2 DMC

• 1 other identifier: SCTV01E-01-CHN-1
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

COVID-19 Pandemic

Keywords

COVID-19 Pandemic, Vaccine

Outcome Measures

Primary Outcomes (3)

• Safety endpoint: Incidence and severity of Solicited Adverse Events

  The incidence and severity of solicited adverse events on days 0-7 after inoculation with SCTV01E;

  Day 0~Day 7

• Immunogenicity endpoint 1: IgG total antibody concentration (ELISA)

  IgG total antibody (ELISA) concentrations against SARS-CoV-2 prototype strains at 28 days post-vaccination and serum response rates (Geometric mean concentration \[GMC\], VOC/VOI based on epidemic variations can be tested);

  Day 28

• Immunogenicity endpoint 2: Neutralizing antibody titer against SARS-CoV-2 Omicron variants (live virus neutralization test)

  Geometric mean titer (GMT) and serum response rates at 28 days post-vaccination for neutralizing antibodies against SARS-CoV-2 Omicron variants (live virus neutralization test). VOC/VOI based on epidemic variations can be tested;

  Day 28

Secondary Outcomes (5)

• Safety endpoint 1: Incidence and severity of Unsolicited Adverse Events

  Day 0~Day 28

• Safety endpoint 2: Incidence and severity of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

  Day 0~Day 180

• Immunogenicity endpoint 1: IgG total antibody concentration (ELISA)

  Day 0~Day 180

• Immunogenicity endpoint 2: Neutralizing antibody titer against SARS-CoV-2 Omicron variants (live virus neutralization test)

  Day 0~Day 180

• Immunogenicity endpoint 3: T cell Response

  Day 0~Day 90

Study Arms (2)

Vaccine group

EXPERIMENTAL

Participants ≥3 years old who have received the recommended dose and immunization procedure of domestically approved COVID-19 vaccine will receive vaccine (SCTV01E).

Biological: SCTV01E

Placebo group

PLACEBO COMPARATOR

Participants ≥3 years old who have received the recommended dose and immunization procedure of domestically approved COVID-19 vaccine will receive placebo (normal saline)

Biological: Placebo (normal saline)

Interventions

SCTV01E BIOLOGICAL

Participants will be vaccinated with SCTV01E on Day 0, and safety and immunogenicity will be monitored for 180 days after vaccination.

Vaccine group

Placebo (normal saline) BIOLOGICAL

Participants will be vaccinated with Placebo (normal saline) on Day 0, and safety and immunogenicity will be monitored for 180 days after vaccination.

Placebo group

Eligibility Criteria

• Age: 3 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The age when signing ICF should meet the requirements of the scheme (Group A ≥18 years old; Group B 12-17 years old; Group C, 3-11 years old) male or female;
• Have previously received the recommended dose and immunization procedures of COVID-19 vaccine approved for domestic market, and the interval between signing ICF and receiving the last dose of COVID-19 vaccine is 6-24 months;
• Subject and/or guardian or client of both parties are able to sign a written ICF and voluntarily participate in the trial, fully understand the trial procedure, the risks of participating in the trial and the alternative interventions available to non-participants;
• The subject and/or the guardian or client of both parties can read, understand and fill in the diary card;
• Fertile men and women of childbearing age voluntarily agree to take effective contraceptive measures from signing the ICF to 180 days after receiving the trial vaccine; Pregnancy tests for women of childbearing age during the screening period were negative.

You may not qualify if:

• Fever (\> 14 years of age, axillary temperature ≥37.3℃; ≤14 years old, axillary temperature ≥37.5℃);
• SARS-CoV-2 nucleic acid test was positive during the screening period;
• Previous history of allergy to any vaccine or drug, such as: allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, angioneurotic edema, etc.;
• Those who have a history of immune deficiency diseases, major organ diseases, immune diseases \[including Guillain-Barre syndrome (GBS), systemic lupus erythematosus, rheumatoid arthritis, asthenia or splenectomy caused by any circumstances, and other immune diseases that researchers believe may have an impact on the immune response\], etc.;
• Currently suffering from severe or uncontrollable cardiovascular diseases, endocrine diseases, diseases of the blood and lymphatic systems, diseases of the liver and kidney, diseases of the respiratory system, diseases of the metabolic and skeletal systems or malignancies (other than basal cell carcinoma of the skin and carcinoma in situ of the cervix), such as severe heart failure, severe pulmonary heart disease, unstable angina, liver failure or uremia;
• The subjects are in an acute state of disease, such as acute onset of chronic heart failure, acute sore throat, hypertensive encephalopathy, acute pneumonia, acute renal insufficiency, acute cholecystitis, etc.;
• Anti-tuberculosis therapy is being used;
• Influenza vaccine within 14 days prior to vaccination or another type of vaccine within 28 days prior to vaccination;
• Use of immunosuppressant or immunomodulatory drugs for ≥14 days in the 6 months before enrollment, but short-term use of oral, inhaled and topical steroid hormones (≤14 days) is allowed;
• are pregnant or breastfeeding or plan to become pregnant during the study period;
• HIV-positive patients;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (4)

Lianshui County Center for Disease Control and Prevention

Lianshui, Jiangsu, 223400, China

Location

Jiangsu Center for Disease Control and Prevention

Nanjing, Jiangsu, 210003, China

Location

Taizhou Vaccine Clinical Research Center

Taizhou, Jiangsu, 225316, China

Location

Dazhu County Center for Disease Control and Prevention

Dazhou, Sichuan, 635100, China

Location

Related Publications (7)

• 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.

  PMID: 35772405 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/.

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

SCTV01C vaccine; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Zhu Fengcai

  Jiangsu Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants ≥3 years old who has received the recommended dose and immunization procedure of domestically approved COVID-19 vaccine, Participants in each group (including the first 15 participants in Group A and sentry participants in groups B and C) will be randomly inoculated with either SCTV01E or placebo (normal saline) according to 4:1, i.e. 200 participants in each group will receive SCTV01E and 50 participants will receive placebo (normal saline).

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 15, 2022
• Study Start: January 5, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)