COVID-19Phase 1/2NCT05148091

The Safety, Tolerability and Immunogenicity of COVID-19 Vaccine (SCTV01C) in Healthy, Unvaccinated Adults

A Phase 1/2 study testing SCTV01C, Adjuvant and Saline in people with COVID-19, run by Sinocelltech Ltd. at 5 sites in China.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: SCTV01C, Adjuvant and Saline
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 478 participants
Where: 5 sitesChina
Study dates: 1 Dec 2021to 4 Aug 2023
Phase: Phase 1/2
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged ≥18 years old when signing ICF;
No other anti-SARS-COV-2 vaccines (approved for marketing or registered study) have been previously administered;
Participants can sign written ICF and voluntarily participate in the study, and can fully understand the study procedure and the risk of participating in the study,
Participants should have the ability to read, understand and fill the vaccination record card (VRC);
Only for participants in Phase I : Those who are clinically judged to be healthy, the results of physical examination, vital signs and laboratory tests during the screening phase are normal;
Only for participants in Phase II: Healthy participants or participants with stable underlying diseases;
Fertile men and women of childbearing age voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after full vaccination; the pregnancy test results of women of childbearing age are negative on screening.

Who cannot join

Presence of fever within 72 h before vaccination (axillary temperature ≥ 37.3℃), or active tuberculosis, or in the acute phase of other diseases;
A history of severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or other coronavirus infections or illness or relevant
A history of allergic reactions to any vaccine or drug, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
A medical or family history of seizure, epilepsy, encephalopathy and psychosis;
Immunocompromised patients suffering or suffered from immunodeficiency diseases, important organ diseases, or immune diseases, etc.;
Long-term use of immunosuppressive or immunomodulatory drugs for 14 or more days within 6 months prior to study enrollment, or planned use of immunosuppressive or immunomodulatory drugs within 2 years after study enrollment. The use of inhaled and topical corticosteroid is permitted;

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For Phase I participants only: Previously or currently suffering from clinically significant cardiovascular diseases (except for the hypertension that can be controlled with drugs), or clinically significant disorders related to respiratory system, liver and kidney (except for light fatty liver), gastrointestinal system (except for chronic gastritis), endocrine system, blood and lymphatic system, metabolic and skeletal systems, or malignancies (except for skin basal cell carcinoma and carcinoma in-situ of cervix), that may affect the study assessment, or cause risks during the study vaccination, or interfere with the data interpretation as determined by the investigator; For Phase II participants only: 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 (except for skin basal cell carcinoma and carcinoma in-situ of cervix);
Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders;
Participants who received any immunoglobulin or blood products in the previous 3 months, or plan to receive similar products during the study;
Participants who received other intervention investigational drugs within 1 month before the vaccination (Except for the participants in the saline control group participating in the clinical study of COVID-19 vaccine);
Participants vaccinated with influenza vaccine within 14 days, or with other type of vaccines within 28 days before the vaccination;
Those who donated blood or had blood loss (≥450 mL) within 3 months before the first dose vaccination or plan to donate blood during the study period;
Those who are pregnant or breast-feeding;
Those who plan to donate ovum or sperms during the study period;
Those who cannot follow the study procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing;
Those unsuitable for participating in the clinical study 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;
For Phase I participants only: those who are tested positive for hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis or HIV in terms of etiology or serology; For Phase II participants only: those who are tested positive for HIV in terms of etiology or serology.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

China5 sites

Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, 100176
Hunan Provincial Center for Disease Control And Prevention
Changsha, Hunan, 410005
Anhui Provincial Hospital
Hefei, Anhui, 230001
PetroChina Central Hospital
Langfang, Hebei, 050011

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase Ⅰ/Ⅱ Clinical Study to Evaluate the Safety, Tolerability and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Unvaccinated Against COVID-19

SCTV01C-02-1 is a randomized, double-blind, placebo controlled Phase Ⅰ/Ⅱ clinical trial of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant bivalent trimeric S protein vaccine manufactured by Sinocelltech, Ltd. The purpose of this study is to evaluate the safety , tolerability and immunogenicity of the experimental vaccine in healthy adults aged ≥ 18 Years previously unvaccinated.

Read the detailed description

This study is a randomized, double-blind, multi-center, placebo-controlled phase Ⅰ/Ⅱ clinical trial in adults aged ≥ 18 years previously unvaccinated. The purpose of this study is to evaluate the safety , tolerability and immunogenicity of the experimental SARS-CoV-2 protein vaccine (SCTV01C). The experimental vaccine and adjuvant (one placebo) were both manufactured by Sinocelltech, Ltd., while the saline (the other placebo) was commercially purchased. A total of 752 participants will be enrolled, with 112 at phase Ⅰ, and 640 at phase Ⅱ. There will be two dosage levels (20μg and 40μg), and two age groups (18~59 years old and ≥ 60 years old ) at both Phase Ⅰ and Phase Ⅱ. All of participants will be assigned to receive two doses of experimental vaccine(20μg or 40μg) or placebo (Adjuvant or Saline) on the schedule of Day 0 and Day 28.

Conditions: COVID-19
Being tested: SCTV01C, Adjuvant, Saline
Medical subject headings: COVID-19

What participants receive

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

SCTV01CBiological
A Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Alpha and Beta Variants
AdjuvantOther
Also called SCT-VA02B
SCT-VA02B is the adjuvant of SCTV01C VACCINE applied as one of the control in the trial
SalineOther
Saline is used as the other control in the trial

Study groups in NCT05148091
Study group	Role	What they receive
18~59 yrs. low dosage (20 μg) - SCTV01C VACCINE	Experimental	20 participants in Phase I and 120 participants in Phase II at the age of 18~59 years old will receive two doses of low dosage (20 μg/0.5mL) SCTV01C VACCINE on Day 0 and Day 28 Receives: Biological: SCTV01C
18~59 yrs. low dosage (20 μg) - Adjuvant (SCT-VA02B )	Placebo comparator	4 participants in Phase I and 20 participants in Phase II at the age of 18~59 years old will receive two doses of study adjuvant (SCT-VA02B ,0.5mL) on Day 0 and Day 28 Receives: Other: Adjuvant
18~59 yrs. low dosage (20 μg) - Saline	Placebo comparator	4 participants in Phase I and 20 participants in Phase II at the age of 18~59 years old will receive two doses of saline (0.5mL) on Day 0 and Day 28 Receives: Other: Saline
≥60 yrs. low dosage (20 μg) - SCTV01C VACCINE	Experimental	20 participants in Phase I and 120 participants in Phase II at the age of ≥60 years old will receive two doses of low dosage (20 μg/0.5mL) SCTV01C VACCINE on Day 0 and Day 28 Receives: Biological: SCTV01C
≥60 yrs. low dosage (20 μg) - Adjuvant (SCT-VA02B )	Placebo comparator	4 participants in Phase I and 20 participants in Phase II at the age of ≥60 years old will receive two doses of study adjuvant (SCT-VA02B, 0.5mL) on Day 0 and Day 28 Receives: Other: Adjuvant
≥60 yrs. low dosage (20 μg) - Saline	Placebo comparator	4 participants in Phase I and 20 participants in Phase II at the age of ≥60 years old will receive two doses of saline (0.5mL) on Day 0 and Day 28 Receives: Other: Saline
18~59 yrs. high dosage (40 μg) - SCTV01C VACCINE	Experimental	20 participants in Phase I and 120 participants in Phase II at the age of 18~59 years old will receive two doses of high dosage (40 μg/0.5mL) SCTV01C VACCINE on Day 0 and Day 28 Receives: Biological: SCTV01C
18~59 yrs. high dosage (40 μg) - Adjuvant (SCT-VA02B )	Placebo comparator	4 participants in Phase I and 20 participants in Phase II at the age of 18~59 years old will receive two doses of study adjuvant (SCT-VA02B, 0.5mL) on Day 0 and Day 28 Receives: Other: Adjuvant
18~59 yrs. high dosage (40 μg) - Saline	Placebo comparator	4 participants in Phase I and 20 participants in Phase II at the age of 18~59 years old will receive two doses of saline (0.5mL) on Day 0 and Day 28 Receives: Other: Saline
≥60 yrs. high dosage (40 μg) - SCTV01C VACCINE	Experimental	20 participants in Phase I and 120 participants in Phase II at the age of ≥60 years old will receive two doses of high dosage (40 μg/0.5mL) SCTV01C VACCINE on Day 0 and Day 28 Receives: Biological: SCTV01C
≥60 yrs. high dosage (40 μg) - Adjuvant (SCT-VA02B )	Placebo comparator	4 participants in Phase I and 20 participants in Phase II at the age of ≥60 years old will receive two doses of study adjuvant (SCT-VA02B, 0.5mL) on Day 0 and Day 28 Receives: Other: Adjuvant
≥60 yrs. high dosage (40 μg) - Saline	Placebo comparator	4 participants in Phase I and 20 participants in Phase II at the age of ≥60 years old will receive two doses of saline (0.5mL) on Day 0 and Day 28 Receives: Other: Saline

What is being measured

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

Phase I: Incidence and severity of adverse reactions (ARs) from Day 0 to Day 7 days after each dose of vaccination.
Incidence and severity of adverse reactions occured from Day 0 to Day 7 after each dose of vaccination.
Measured: From Day 0 to Day 7 after each dose
Phase II: Geometric mean titers (GMT) and seroconversion rate of total IgG antibody (ELISA method) against the SARS-CoV-2 Alpha, Beta and Delta variants on Day 14 after the second dose of vaccination;
IgG GMT and seroconversion rate against the SARS-CoV-2 Alpha, Beta, Delta variants on Day 14 after the second dose of vaccination.
Measured: Day 14 after the second dose of vaccination
Phase II: GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 14 after the second dose of vaccination;
GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against Alpha and Beta variants of SARS-CoV-2 on Day 14 after the second dose of vaccination;
Measured: Day 14 after the second dose of vaccination
Phase II: GMT and seroconversion rate of neutralizing antibody (Pseudovirus neutralization assay) against the SARS-CoV-2 Alpha and Beta variants on Day 14 after the second dose of vaccination;
GMT and seroconversion rate of neutralizing antibody (Pseudovirus neutralization assay) against the SARS-CoV-2 Alpha and Beta variants on Day 14 after the second dose of vaccination;
Measured: Day 14 after the second dose of vaccination
Phase II: Incidence and severity of solicited AEs from Day 0 to Day 7 after each dose of vaccination;
Incidence and severity of solicited AEs from Day 0 to Day 7 after each dose of vaccination
Measured: Day 0 to Day 7 after each dose of vaccination

Secondary outcomes (15)

Phase I: GMT and seroconversion rate of total IgG antibody (ELISA method) against the Alpha, Beta, Delta variants SARS-CoV-2 and T4-Foldon on Day 28 after the first dose of vaccination;
GMT and seroconversion rate of total IgG antibody against the Alpha, Beta, Delta variants of SARS-CoV-2 and T4-Foldon on Day 28 after the first dose of vaccination
Measured: Day 28 after the first dose of vaccination
Phase I: GMT and seroconversion rate of total IgG antibody (ELISA method) against the Alpha, Beta, Delta variants of SARS-CoV-2 and T4-Foldon on Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
GMT and seroconversion rate of total IgG antibody against the Alpha, Beta, Delta variants of SARS-CoV-2 and T4-Foldon on Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination
Measured: Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Phase I: GMT and seroconversion rate of neutralizing antibody (Pseudovirus neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
GMT and seroconversion rate of neutralizing antibody (Pseudovirus neutralization assay) against the SARS-CoV-2 Alpha and Beta variants of SARS-CoV-2on Day 14, Day28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Measured: Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination
Phase I: GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Measured: Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination
Phase I: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations 14 days and 90 days after the second dose of study vaccination;
Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations 14 days and 90 days after the second dose of study vaccination;
Measured: Day 14 and Day 90 after the second dose of study vaccination
Phase I: Incidence and severity of solicited adverse events (AEs) from Day 0 to Day 7 days after each dose of vaccination;
Incidence and severity of solicited adverse events (AEs) from Day 0 to Day 7 days after each dose of vaccination.;
Measured: Day 0 to Day 7 days after each dose of vaccination
Phase I: Incidence and severity of all unsolicited AEs Day 0 to Day 28 after each dose of vaccination;
Incidence and severity of all unsolicited AEs Day 0 to Day 28 after each dose of vaccination;
Measured: Day 0 to Day 28 after each dose of vaccination
Phase I: Incidence and severity of laboratory abnormalities related AEs on Day 3 after each dose of vaccination;
Incidence and severity of laboratory abnormalities related AEs on Day 3 after each dose of vaccination;
Measured: Day 3 after each dose of vaccination
Phase I: Incidence and severity of serious adverse events (SAEs), adverse events of special interest (AESIs) and medically attended adverse events (MAAEs) within 365 days after each dose of vaccination;
Incidence and severity of serious adverse events (SAEs), adverse events of special interest (AESIs) and medically attended adverse events (MAAEs) within 365 days after each dose of vaccination;
Measured: within 365 days after each dose of vaccination
Phase II: Incidence and severity of all unsolicited AEs Day 0 to Day 28 after each dose of vaccination;
Incidence and severity of all unsolicited AEs Day 0 to Day 28 after each dose of vaccination;
Measured: Day 0 to Day 28 after each dose of vaccination
Phase II: Incidence and severity of SAEs, AESIs, MAAEs within 365 days after each dose of vaccination;
Incidence and severity of SAEs, AESIs, MAAEs within 365 days after each dose of vaccination;
Measured: within 365 days after each dose of vaccination
Phase II: GMT and seroconversion rate of total IgG antibodies (ELISA method) against the Alpha, Beta and Delta variants of SARS-CoV-2 on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
GMT and seroconversion rate of total IgG antibodies against the Alpha, Beta and Delta variants of SARS-CoV-2 on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Measured: Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination
Phase II: GMT of the neutralizing antibody titer (pseudoviral neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
GMT of the neutralizing antibody titer (pseudoviral neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Measured: Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination
Phase II: GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against the SARS-CoV-2 Alpha and Beta variants on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against the SARS-CoV-2 Alpha and Beta variants on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Measured: Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination
Phase II: GMT of neutralizing antibody titers (pseudoviral neutralization assay) on Day 14, Day 28, Day 90, Day 180 and D365 after the second vaccination for other variants, such as Delta, Lambda and Gamma, etc.
Phase II: GMT of neutralizing antibody titers (pseudoviral neutralization assay) on Day 14, Day 28, Day 90, Day 180 and D365 after the second vaccination for other variants, such as Delta, Lambda and Gamma, etc.
Measured: Day 14, Day 28, Day 90, Day 180 and D365 after the second vaccination

Timeline

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

1 Dec 20214 Aug 2023

First posted8 Dec 2021
Study start1 Dec 2021
Primary completion4 Aug 2023
Study completion4 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Sinocelltech Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 478 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05148091
Sponsor's protocol ID: SCTV01C-02-1
Status last verified: Aug 2023
First submitted: 16 Nov 2021
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

Wang G, Zhao K, Zhao X, Cui Y, He P, Zhang T, Wang Y, Shi R, Li Y, Wang Q, Ren Y, Chen Z, Zhao X, Xie Z, Liang Y, Tian Q, Pan J, Zhang C, Han Y, Dai Y, Ni S, Zhang Y, Yang X, Fu Y, Liu D, Li J, Zhang M, Hu Z, Xie L. Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants. Expert Rev Vaccines. 2025 Dec;24(1):128-137. doi: 10.1080/14760584.2025.2456231. Epub 2025 Jan 27.
PubMed 39834144
Wang G, Zhao K, Han J, Hu Z, Zhang T, Wang Y, Shi R, Li Y, Song Q, Du H, He P, Xu S, Yang X, Fu Y, Cui Y, Xie L. Safety and immunogenicity of a bivalent SARS-CoV-2 recombinant protein vaccine, SCTV01C in unvaccinated adults: A randomized, double-blinded, placebo-controlled, phase I clinical trial. J Infect. 2023 Feb;86(2):154-225. doi: 10.1016/j.jinf.2022.11.008. Epub 2022 Nov 17. No abstract available.
PubMed 36403700

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Phase Ⅰ/Ⅱ Clinical Study to Evaluate the Safety, Tolerability and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Unvaccinated Against COVID-19
ClinicalTrials.gov ID: NCT05148091
Acronym / sponsor ID: SCTV01C-02-1
Conditions: COVID-19
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 478 participants (actual)
Lead sponsor: Sinocelltech Ltd.Industry (pharma, biotech, devices)
Study start: 1 Dec 2021 (actual)
Primary completion: 4 Aug 2023 (actual)
Study completion: 4 Aug 2023 (actual)
First posted: 8 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 12

Arm	Type	Receives
18~59 yrs. low dosage (20 μg) - SCTV01C VACCINE	Experimental	Biological: SCTV01C20 participants in Phase I and 120 participants in Phase II at the age of 18~59 years old will receive two doses of low dosage (20 μg/0.5mL) SCTV01C VACCINE on Day 0 and Day 28
18~59 yrs. low dosage (20 μg) - Adjuvant (SCT-VA02B )	Placebo comparator	Other: Adjuvant4 participants in Phase I and 20 participants in Phase II at the age of 18~59 years old will receive two doses of study adjuvant (SCT-VA02B ,0.5mL) on Day 0 and Day 28
18~59 yrs. low dosage (20 μg) - Saline	Placebo comparator	Other: Saline4 participants in Phase I and 20 participants in Phase II at the age of 18~59 years old will receive two doses of saline (0.5mL) on Day 0 and Day 28
≥60 yrs. low dosage (20 μg) - SCTV01C VACCINE	Experimental	Biological: SCTV01C20 participants in Phase I and 120 participants in Phase II at the age of ≥60 years old will receive two doses of low dosage (20 μg/0.5mL) SCTV01C VACCINE on Day 0 and Day 28
≥60 yrs. low dosage (20 μg) - Adjuvant (SCT-VA02B )	Placebo comparator	Other: Adjuvant4 participants in Phase I and 20 participants in Phase II at the age of ≥60 years old will receive two doses of study adjuvant (SCT-VA02B, 0.5mL) on Day 0 and Day 28
≥60 yrs. low dosage (20 μg) - Saline	Placebo comparator	Other: Saline4 participants in Phase I and 20 participants in Phase II at the age of ≥60 years old will receive two doses of saline (0.5mL) on Day 0 and Day 28
18~59 yrs. high dosage (40 μg) - SCTV01C VACCINE	Experimental	Biological: SCTV01C20 participants in Phase I and 120 participants in Phase II at the age of 18~59 years old will receive two doses of high dosage (40 μg/0.5mL) SCTV01C VACCINE on Day 0 and Day 28
18~59 yrs. high dosage (40 μg) - Adjuvant (SCT-VA02B )	Placebo comparator	Other: Adjuvant4 participants in Phase I and 20 participants in Phase II at the age of 18~59 years old will receive two doses of study adjuvant (SCT-VA02B, 0.5mL) on Day 0 and Day 28
18~59 yrs. high dosage (40 μg) - Saline	Placebo comparator	Other: Saline4 participants in Phase I and 20 participants in Phase II at the age of 18~59 years old will receive two doses of saline (0.5mL) on Day 0 and Day 28
≥60 yrs. high dosage (40 μg) - SCTV01C VACCINE	Experimental	Biological: SCTV01C20 participants in Phase I and 120 participants in Phase II at the age of ≥60 years old will receive two doses of high dosage (40 μg/0.5mL) SCTV01C VACCINE on Day 0 and Day 28
≥60 yrs. high dosage (40 μg) - Adjuvant (SCT-VA02B )	Placebo comparator	Other: Adjuvant4 participants in Phase I and 20 participants in Phase II at the age of ≥60 years old will receive two doses of study adjuvant (SCT-VA02B, 0.5mL) on Day 0 and Day 28
≥60 yrs. high dosage (40 μg) - Saline	Placebo comparator	Other: Saline4 participants in Phase I and 20 participants in Phase II at the age of ≥60 years old will receive two doses of saline (0.5mL) on Day 0 and Day 28

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Aged ≥18 years old when signing ICF;
No other anti-SARS-COV-2 vaccines (approved for marketing or registered study) have been previously administered;
Participants can sign written ICF and voluntarily participate in the study, and can fully understand the study procedure and the risk of participating in the study,
Participants should have the ability to read, understand and fill the vaccination record card (VRC);
Only for participants in Phase I : Those who are clinically judged to be healthy, the results of physical examination, vital signs and laboratory tests during the screening phase are normal;

Key exclusion criteria (17 listed)

Presence of fever within 72 h before vaccination (axillary temperature ≥ 37.3℃), or active tuberculosis, or in the acute phase of other diseases;
A history of severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or other coronavirus infections or illness or relevant
A history of allergic reactions to any vaccine or drug, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
A medical or family history of seizure, epilepsy, encephalopathy and psychosis;
Immunocompromised patients suffering or suffered from immunodeficiency diseases, important organ diseases, or immune diseases, etc.;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SCTV01CA Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Alpha and Beta Variants	Biological	18~59 yrs. high dosage (40 μg) - SCTV01C VACCINE, 18~59 yrs. low dosage (20 μg) - SCTV01C VACCINE, ≥60 yrs. high dosage (40 μg) - SCTV01C VACCINE, ≥60 yrs. low dosage (20 μg) - SCTV01C VACCINE
AdjuvantAlso: SCT-VA02BSCT-VA02B is the adjuvant of SCTV01C VACCINE applied as one of the control in the trial	Other	18~59 yrs. high dosage (40 μg) - Adjuvant (SCT-VA02B ), 18~59 yrs. low dosage (20 μg) - Adjuvant (SCT-VA02B ), ≥60 yrs. high dosage (40 μg) - Adjuvant (SCT-VA02B ), ≥60 yrs. low dosage (20 μg) - Adjuvant (SCT-VA02B )
SalineSaline is used as the other control in the trial	Other	18~59 yrs. high dosage (40 μg) - Saline, 18~59 yrs. low dosage (20 μg) - Saline, ≥60 yrs. high dosage (40 μg) - Saline, ≥60 yrs. low dosage (20 μg) - Saline

Primary outcome

Phase I: Incidence and severity of adverse reactions (ARs) from Day 0 to Day 7 days after each dose of vaccination.
Time frame: From Day 0 to Day 7 after each dose
Incidence and severity of adverse reactions occured from Day 0 to Day 7 after each dose of vaccination.
Phase II: Geometric mean titers (GMT) and seroconversion rate of total IgG antibody (ELISA method) against the SARS-CoV-2 Alpha, Beta and Delta variants on Day 14 after the second dose of vaccination;
Time frame: Day 14 after the second dose of vaccination
IgG GMT and seroconversion rate against the SARS-CoV-2 Alpha, Beta, Delta variants on Day 14 after the second dose of vaccination.
Phase II: GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 14 after the second dose of vaccination;
Time frame: Day 14 after the second dose of vaccination
GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against Alpha and Beta variants of SARS-CoV-2 on Day 14 after the second dose of vaccination;
Phase II: GMT and seroconversion rate of neutralizing antibody (Pseudovirus neutralization assay) against the SARS-CoV-2 Alpha and Beta variants on Day 14 after the second dose of vaccination;
Time frame: Day 14 after the second dose of vaccination
GMT and seroconversion rate of neutralizing antibody (Pseudovirus neutralization assay) against the SARS-CoV-2 Alpha and Beta variants on Day 14 after the second dose of vaccination;
Phase II: Incidence and severity of solicited AEs from Day 0 to Day 7 after each dose of vaccination;
Time frame: Day 0 to Day 7 after each dose of vaccination
Incidence and severity of solicited AEs from Day 0 to Day 7 after each dose of vaccination

15 secondary outcomes

Phase I: GMT and seroconversion rate of total IgG antibody (ELISA method) against the Alpha, Beta, Delta variants SARS-CoV-2 and T4-Foldon on Day 28 after the first dose of vaccination;
Time frame: Day 28 after the first dose of vaccination
Phase I: GMT and seroconversion rate of total IgG antibody (ELISA method) against the Alpha, Beta, Delta variants of SARS-CoV-2 and T4-Foldon on Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Time frame: Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Phase I: GMT and seroconversion rate of neutralizing antibody (Pseudovirus neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Time frame: Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination
Phase I: GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Time frame: Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination
Phase I: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations 14 days and 90 days after the second dose of study vaccination;
Time frame: Day 14 and Day 90 after the second dose of study vaccination
Phase I: Incidence and severity of solicited adverse events (AEs) from Day 0 to Day 7 days after each dose of vaccination;
Time frame: Day 0 to Day 7 days after each dose of vaccination
Phase I: Incidence and severity of all unsolicited AEs Day 0 to Day 28 after each dose of vaccination;
Time frame: Day 0 to Day 28 after each dose of vaccination
Phase I: Incidence and severity of laboratory abnormalities related AEs on Day 3 after each dose of vaccination;
Time frame: Day 3 after each dose of vaccination
Phase I: Incidence and severity of serious adverse events (SAEs), adverse events of special interest (AESIs) and medically attended adverse events (MAAEs) within 365 days after each dose of vaccination;
Time frame: within 365 days after each dose of vaccination
Phase II: Incidence and severity of all unsolicited AEs Day 0 to Day 28 after each dose of vaccination;
Time frame: Day 0 to Day 28 after each dose of vaccination
Phase II: Incidence and severity of SAEs, AESIs, MAAEs within 365 days after each dose of vaccination;
Time frame: within 365 days after each dose of vaccination
Phase II: GMT and seroconversion rate of total IgG antibodies (ELISA method) against the Alpha, Beta and Delta variants of SARS-CoV-2 on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Time frame: Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination
Phase II: GMT of the neutralizing antibody titer (pseudoviral neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Time frame: Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination
Phase II: GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against the SARS-CoV-2 Alpha and Beta variants on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Time frame: Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination
Phase II: GMT of neutralizing antibody titers (pseudoviral neutralization assay) on Day 14, Day 28, Day 90, Day 180 and D365 after the second vaccination for other variants, such as Delta, Lambda and Gamma, etc.
Time frame: Day 14, Day 28, Day 90, Day 180 and D365 after the second vaccination

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
Derived from this study: PubMed 39834144Wang G, Zhao K, Zhao X, Cui Y, He P, Zhang T, Wang Y, Shi R, Li Y, Wang Q, Ren Y, Chen Z, Zhao X, Xie Z, Liang Y, Tian Q, Pan J, Zhang C, Han Y, Dai Y, Ni S, Zhang Y, Yang X, Fu Y, Liu D, Li J, Zhang M, Hu Z, Xie L. Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants. Expert Rev Vaccines. 2025 Dec;24(1):128-137. doi: 10.1080/14760584.2025.2456231. Epub 2025 Jan 27.
Derived from this study: PubMed 36403700Wang G, Zhao K, Han J, Hu Z, Zhang T, Wang Y, Shi R, Li Y, Song Q, Du H, He P, Xu S, Yang X, Fu Y, Cui Y, Xie L. Safety and immunogenicity of a bivalent SARS-CoV-2 recombinant protein vaccine, SCTV01C in unvaccinated adults: A randomized, double-blinded, placebo-controlled, phase I clinical trial. J Infect. 2023 Feb;86(2):154-225. doi: 10.1016/j.jinf.2022.11.008. Epub 2022 Nov 17. No abstract available.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yimin Cui, M.D. principal investigator

Peking University First Hospital

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SCTV01C, Adjuvant and Saline in people with COVID-19, run by Sinocelltech Ltd. at 5 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 7 inclusion and 17 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 5 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Phase I: Incidence and severity of adverse reactions (ARs) from Day 0 to Day 7 days after each dose of vaccination. (time frame: From Day 0 to Day 7 after each dose). The study lists 5 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 NCT05148091, which also lists 2 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.