Official Title
A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥18 Years Previously Fully Vaccinated With mRNA COVID-19 Vaccine
Brief Summary

The objective of this study is to evaluate the immunogenicity and safety of SCTV01E inparticipants aged ≥18 years and previously fully immunized with mRNA COVID-19 vaccine.

Detailed Description

The study is a randomized, double-blind, and positive-controlled Phase II booster study.
It will evaluate the immunogenicity and safety of SCTV01E as booster compared with
Comirnaty. The study is a randomized, double-blind, and positive-controlled Phase II
booster study. It will evaluate the immunogenicity and safety of SCTV01E as booster
compared with Comirnaty (the COVID-19 vaccine from Pfizer-BioNTech).

Unknown status
COVID-19
SARS-CoV-2 Infection

Biological: SCTV01E

D0; intramuscular injection

Biological: Comirnaty

D0; intramuscular injection

Biological: SCTV01E

D180; intramuscular injection

Biological: Comirnaty

D180; intramuscular injection

Eligibility Criteria

Inclusion Criteria:

1. Male or female aged ≥18 years old when signing ICF;

2. Participants who were fully vaccinated with 2 doses of mRNA COVID-19 vaccine
(Comirnaty from Pfizer or mRNA-1273 from Moderna) and the interval between the last
dose and this study vaccination is ≥3 months and ≤12 months.

3. The participant can sign the written ICF (by applying his / her signature or
fingerprint "for illiterate subject"), and can fully understand the trial procedure,
the risk of participating in the trial, and other interventions that can be selected
if they do not participate in the trial;

4. The participant and/or his entrusted person have the ability to read, understand,
and fill in record cards;

5. Healthy participants or participants with pre-existing medical conditions who are in
stable condition. The "pre-existing medical conditions" include but not limited to
hypertension, diabetes, chronic cholecystitis and cholelithiasis, chronic gastritis
that meet the described criteria. A stable medical condition is defined as disease
not requiring significant change in therapy or no need for hospitalization as a
consequence of worsening disease state for at least 3 months prior to enrollment;

6. Fertile men and women of childbearing potential voluntarily agree to take effective
contraceptive measures from signing ICF to 6 months after the 1st study vaccination;
the pregnancy test results of women of childbearing potential are negative on
screening.

Exclusion Criteria:

1. Previously diagnosed with COVID-19;

2. A positive result of nucleic acid test for SARS-CoV-2 during the screening period;

3. Presence of fever within 3 days before the study vaccination;

4. A history of infection or disease related to severe acute respiratory syndrome
(SARS), Middle East respiratory syndrome (MERS), or other disease corresponding use
of immunosuppressants;

5. A history of allergic reactions to any vaccine or drug, such as allergy, urticaria,
severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;

6. A medical or family history of seizure, epilepsy, encephalopathy and psychosis;

7. Immunocompromised patients suffering from immunodeficiency diseases, important organ
diseases, immune diseases (including Guillain-Barre Syndrome [GBS], systemic lupus
erythematosus, rheumatoid arthritis, asplenia or splenectomy caused by any
circumstances, and other immune diseases that may have an impact on immune response
in the investigator's opinion), etc.;

8. Long-term use of immunosuppressant therapy or immunomodulatory drugs for ≥14 days
within the first six months prior to enrollment. Whereas short-term (≤14 days) use
of oral, inhaled and topical steroids are allowed;

9. Patients on antituberculosis therapy;

10. Presence of severe or uncontrollable cardiovascular diseases, or severe or
uncontrollable disorders related to endocrine system, blood and lymphatic system,
liver and kidney, respiratory system, metabolic and skeletal systems, or
malignancies (skin basal cell carcinoma and carcinoma in-situ of cervix are
exceptions and will not be excluded), such as severe heart failure, severe pulmonary
heart disease, unstable angina, liver failure, or uremia;

11. Contraindications for intramuscular injection or intravenous blood sampling,
including thrombocytopenia and other blood coagulation disorders;

12. Participants who received any immunoglobulin or blood products in the previous 3
months before enrollment, or plan to receive similar products during the study;

13. Participants who received other investigational drugs within 1 month before the
study vaccination;

14. Participants who is at the acute state of disease, such as acute onset of chronic
heart failure, acute sore throat, hypertensive encephalopathy, acute pneumonia,
acute renal insufficiency, acute cholecystitis;

15. Participants received other drugs or vaccines used to prevent COVID-19, but
participants previously received Comirnaty from Pfizer or mRNA-1273 from Moderna
will not be excluded;

16. Participants vaccinated with influenza vaccine within 14 days or with other vaccines
within 28 days before the study vaccination;

17. Those who donated blood or had blood loss (≥450 mL) within 3 months before the
vaccination or plan to donate blood during the study period;

18. Those who are pregnant or breast-feeding or plan to be pregnant during the study
period;

19. Those who plan to donate ovum or sperms during the study period;

20. Those who cannot follow the trial procedures, or cannot cooperate to complete the
study due to planned relocation or long-term outing;

21. Those unsuitable for participating in the clinical trial as determined by the
investigator because of other abnormalities that are likely to confuse the study
results, or non-conformance with the maximal benefits of the participants;

22. Those who are tested positive for HIV in terms of serology.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Locations

Not Provided

Contacts

Zibin Luo
+86 13751891764
zibin_luo@sinocelltech.com

Yu Sun
+86 13816901291
yu_sun@sinocelltech.com

Not Provided

Sinocelltech Ltd.
NCT Number
Keywords
Covid-19
SARS-CoV-2 infection
Vaccine
MeSH Terms
COVID-19