AzTrials
AzTrials

COVID-19 PandemicPhase 2SCTV01ENCT05652543

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

A Phase 2 study testing SCTV01E in people with COVID-19 Pandemic, run by Sinocelltech Ltd. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 3 to 120 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19 Pandemic
What is being tested?
SCTV01E
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
518 participants
Where
4 sitesChina
Study dates
5 Jan 2023to 15 Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 120 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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;
  • Healthy subjects or subjects with stable underlying diseases. Stable underlying diseases were defined as those who were in stable condition at least 3 months before inclusion in the study, had no significant change in treatment regimen and had not been admitted to hospital due to disease progression;
  • 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.

Who cannot join

  • 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.;
Show all 11Show fewer
  • 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;

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Dazhu County Center for Disease Control and Prevention

    Dazhou, Sichuan, 635100

  • Lianshui County Center for Disease Control and Prevention

    Lianshui, Jiangsu, 223400

  • Jiangsu Center for Disease Control and Prevention

    Nanjing, Jiangsu, 210003

  • Taizhou Vaccine Clinical Research Center

    Taizhou, Jiangsu, 225316

Other trials in China

About this study

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

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.

Read the detailed 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).

Being tested
SCTV01E, Placebo (normal saline)
Keywords
COVID-19 Pandemic, Vaccine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCTV01EBiological

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

  • 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.

Study groups in NCT05652543
Study groupRoleWhat they receive
Vaccine groupExperimentalParticipants ≥3 years old who have received the recommended dose and immunization procedure of domestically approved COVID-19 vaccine will receive vaccine (SCTV01E).
Receives: Biological: SCTV01E
Placebo groupPlacebo comparatorParticipants ≥3 years old who have received the recommended dose and immunization procedure of domestically approved COVID-19 vaccine will receive placebo (normal saline)
Receives: Biological: Placebo (normal saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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;

    Measured: Day 0~Day 7

  2. 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);

    Measured: Day 28

  3. 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;

    Measured: Day 28

Secondary outcomes (5)

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

    Incidence and severity of unsolicited adverse events on days 0-28 after inoculation with SCTV01E;

    Measured: Day 0~Day 28

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

    Incidence and severity of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 180 days of vaccination with SCTV01E.

    Measured: Day 0~Day 180

  3. Immunogenicity endpoint 1: IgG total antibody concentration (ELISA)

    GMC and serum response rates of total IgG antibody (ELISA) against the prototype strain of SARS-CoV-2 on days 7, 14, 90 and 180 after inoculation with SCTV01E (other VOC/VOI can be increased depending on the epidemic situation);

    Measured: Day 0~Day 180

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

    GMT and serum response rates for neutralizing antibodies against SARS-CoV-2 Omicron variant (live virus neutralization test) on days 7, 14, 90 and 180 after inoculation with SCTV01E (other VOC/VOI can be tested depending on the epidemic situation);

    Measured: Day 0~Day 180

  5. Immunogenicity endpoint 3: T cell Response

    Number of T cell subsets secreting IFN-γ (for Th1) and IL-4 (for Th2) on day 7 and day 90 after SCTV01E in subjects ≥18 years old.

    Measured: Day 0~Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2022
  2. Study start5 Jan 2023
  3. Primary completion15 Jan 2024
  4. Study completion15 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
518 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05652543
Sponsor's protocol ID
SCTV01E-01-CHN-1
Acronym
SCTV01E
Status last verified
Jan 2024
First submitted
12 Dec 2022
Last updated
8 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35772405

  • WHO Coronavirus (COVID-19) Dashboard [EB/OL]. [2022-10-21]. https://covid19.who.int.

  • 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.

  • WHO-COVID19 Vaccine Tracker [EB/OL]. [2022-10-21]. https://covid19.trackvaccines.org/agency/who/.

  • 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.

  • 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.

  • 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/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCTV01E in people with COVID-19 Pandemic, run by Sinocelltech Ltd. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety endpoint: Incidence and severity of Solicited Adverse Events (time frame: Day 0~Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05652543, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in