COVID-19Phase 1/2NCT05043285
The Safety and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Vaccinated With Inactivated COVID-19 Vaccine.
A Phase 1/2 study testing SCTV01C in people with COVID-19 and SARS-CoV-2 Infection, run by Sinocelltech Ltd. at 1 site in United Arab Emirates.
Trial summary
The objective of this study is to evaluate the safety, tolerability, and immunogenicity of SCTV01C in healthy population aged ≥18 years previously vaccinated with inactivated COVID-19 vaccine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- SCTV01C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 22 Dec 2021to 1 Jan 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
- Phase I:
- Participants are eligible to be included in the study only if the following conditions are met:
- Male or female aged ≥18 years old when signing ICF;
- Participants that were fully vaccinated with inactivated anti-SARS-CoV-2 vaccine, and the last dose is ≥6 months away from the vaccination of this study.
- Participants that can sign written ICF and voluntarily participate in the trial, 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;
- Ability to read, understand, and fill in record cards;
Show all 16Show fewer
- Those who are clinically judged to be healthy, the results of physical examination, vital signs and laboratory tests during the screening period are normal, or although beyond the normal reference range, they are judged by investigators to be of no clinical significance;
- Fertile men and women of childbearing age voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the study vaccination; the pregnancy test results of women of childbearing age are negative on screening.
- Phase II:
- Participants are eligible to be included in the study only if the following conditions are met:
- Male or female aged ≥18 years old when signing ICF;
- Participants that were fully vaccinated with inactivated anti-SARS-CoV-2 vaccine, and the last dose is ≥6 months away from the vaccination of this study.
- Participants that can sign written ICF and voluntarily participate in the trial, 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;
- Ability to read, understand, and fill in record cards;
- 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;
- Fertile men and women of childbearing age voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the study vaccination; the pregnancy test results of women of childbearing age are negative on screening.
Who cannot join
- Phase I:
- A participant who conforms to any of the following criteria should not be enrolled in the study:
- Previous diagnosis of COVID-19;
- High-risk populations (such as medical workers, close contacts of patients with COVID-19 infection, etc.) who are more likely to be infected with SARS-Cov-2;
- Presence of fever within 3 days before the study vaccination;
- A history of infection or disease related to severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or corresponding immunosuppressants;
Show all 47Show fewer
- 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 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.;
- Long-term use of immunosuppressant therapy or immunomodulatory drugs for ≥14 days within the first six months prior to enrollment, or plan to use immunosuppressant therapy or immunomodulatory drugs within two years after enrollment. Whereas short-term (≤14 days) use of oral, inhaled and topical steroids are allowed.
- Patients on antituberculosis therapy;
- Previously or currently suffering from clinically significant cardiovascular diseases, or clinically significant disorders related to respiratory system, liver and kidney, gastrointestinal system, endocrine system, blood and lymphatic system, metabolic and skeletal systems, or malignancies, that may affect the study assessment, or cause risks during the study vaccination, or interfere with the data interpretation as determined by the investigator;
- 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 investigational drugs within 1 month before the study vaccination;
- 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;
- Participants received other drug used for prevention of COVID-19 (exception for previous inactivated vaccine the participant received) ;
- Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination;
- 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;
- Those who are pregnant or breast-feeding;
- Those who plan to donate ovum or sperms during the study period;
- Those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing;
- 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;
- Those who are tested positive for hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis or HIV in terms of serology.
- Phase II:
- A participant who conforms to any of the following criteria should not be enrolled in the study:
- Previous diagnosis of COVID-19;
- Presence of fever within 3 days before the study vaccination;
- A history of infection or disease related to severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or corresponding immunosuppressants;
- 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 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.;
- Long-term use of immunosuppressant therapy or immunomodulatory drugs for ≥14 days within the first six months prior to enrollment, or plan to use immunosuppressant therapy or immunomodulatory drugs within two years after enrollment. Whereas short-term (≤14 days) use of oral, inhaled and topical steroids are allowed.
- Patients on antituberculosis therapy;
- 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) , such as severe heart failure, severe pulmonary heart disease, unstable angina, liver failure, or uremia;
- 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 investigational drugs within 1 month before the study vaccination;
- 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;
- Participants received other drug used for prevention of COVID-19 (exception for previous inactivated vaccine the participant received) ;
- Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination;
- 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;
- Those who are pregnant or breast-feeding;
- Those who plan to donate ovum or sperms during the study period;
- Those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing;
- 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;
- Those who are tested positive for HIV in terms of serology.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Al Kuwait Hospital (Al Baraha Hospital)
Dubai
+971 4 271 0000, albaraha-hospital@moh.gov.ae
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Vaccinated With Inactivated Vaccine Against COVID-19.
The objective of this study is to evaluate the safety, tolerability, and immunogenicity of SCTV01C in healthy population aged ≥18 years previously vaccinated with inactivated COVID-19 vaccine.
Read the detailed description
This is a Phase I/II, multicenter, randomized, double-blinded trial designed to evaluate the safety, tolerability, and immunogenicity of SCTV01C in healthy population aged ≥18 years previously vaccinated with inactivated COVID-19 vaccine.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- SCTV01C, Placebo
- Keywords
- COVID-19, SARS-CoV-2, 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.
SCTV01CBiological
intramuscular injection
PlaceboOther
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 20 µg dose, 18-59 years of age (phase 1/2) | Experimental | Not described Receives: Biological: SCTV01C |
| 20 µg dose, ≥60 years of age (phase 1/2) | Experimental | Not described Receives: Biological: SCTV01C |
| 40 µg dose, 18-59 years of age (phase 1/2) | Experimental | Not described Receives: Biological: SCTV01C |
| 40 µg dose, ≥60 years of age (phase 1/2) | Experimental | Not described Receives: Biological: SCTV01C |
| Placebo, 18-55 years of age (phase 1/2) | Placebo comparator | Not described Receives: Other: Placebo |
| Placebo, ≥60 years of age (phase 1/2) | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse reactions in phase 1
Measured: Day 0 to Day 7 after the study vaccination
GMT and GMI of specific IgG total antibodies (ELISA method) against Alpha (B.1.1.7), Beta (B.1.351), and Delta (B.1.617.2) variants of SARS-CoV-2 in phase 2
Measured: Day 14 after the study vaccination
GMT and GMI of neutralizing antibodies titers in phase 2
Measured: Day 14 after the study vaccination
Incidence and severity of solicited AEs in phase 2
Measured: Day 0 to Day 7 after the study vaccination
Secondary outcomes (10)
Incidence and severity of solicited adverse events in phase 1
Measured: Day 0 to Day 7 after the study vaccination
Incidence and severity of all unsolicited adverse events in phase 1
Measured: Day 0 to Day 28 after the study vaccination
Incidence and severity of laboratory abnormalities related adverse events in phase 1
Measured: Day 3 after the study vaccination
Incidence and severity of serious adverse events (SAEs), adverse events of special interest (AESIs) and medically attended adverse events (MAAEs) in phase 1
Measured: Within 365 days after the study vaccination
GMT and GMI of specific IgG total antibodies against Alpha (B.1.1.7), Beta (B.1.351), and Delta (B 1.617.2) variants of SARS-CoV-2 in phase 1
Measured: Day 14 after the study vaccination
GMT and GMI of eutralizing antibodies titers for Delta (B.1.617.2) variant of SARS-CoV-2 in phase 1
Measured: Day 14 after the study vaccination
GMT and GMI of specific total IgG antibodies against Alpha (B.1.1.7), Beta (B.1.351), and Delta (B.1.617.2) variants of SARS-CoV-2 in phase 2
Measured: Day 28, Day 90, Day 180, Day 365 after the study vaccination
GMT and GMI of neutralizing antibodies titers for Delta (B.1.617.2) variant of SARS-CoV-2 in phase 2
Measured: Day 28, Day 90, Day 180, Day 365 after the study vaccination
Incidence and severity of unsolicited adverse events in phase 2
Measured: Day 0 to Day 28 after the study vaccination
Incidence and severity of SAEs, AESIs and MAAEs in phase 2
Measured: Within 365 days after the study vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start22 Dec 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- This is a randomized, double-blind, placebo-controlled phase I/II clinical trial to evaluate the safety, tolerability and immunogenicity of SCTV01C (A Bivalent Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Variants) in healthy population aged ≥18 years previously vaccinated with inactivated vaccine against COVID-19. In the study, participants receive 20 µg dose or placebo, 40 µg dose or placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yang Wang, Ph.D., Study director, Sinocelltech Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043285
- Sponsor's protocol ID
- SCTV01C-01-1
- Status last verified
- Dec 2021
- First submitted
- 12 Sep 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Vaccinated With Inactivated Vaccine Against COVID-19.
- ClinicalTrials.gov ID
- NCT05043285
- Acronym / sponsor ID
- SCTV01C-01-1
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Keywords
- COVID-19, SARS-CoV-2, Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 14 Sep 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.
The objective of this study is to evaluate the safety, tolerability, and immunogenicity of SCTV01C in healthy population aged ≥18 years previously vaccinated with inactivated COVID-19 vaccine.
Detailed description
This is a Phase I/II, multicenter, randomized, double-blinded trial designed to evaluate the safety, tolerability, and immunogenicity of SCTV01C in healthy population aged ≥18 years previously vaccinated with inactivated COVID-19 vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- This is a randomized, double-blind, placebo-controlled phase I/II clinical trial to evaluate the safety, tolerability and immunogenicity of SCTV01C (A Bivalent Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Variants) in healthy population aged ≥18 years previously vaccinated with inactivated vaccine against COVID-19. In the study, participants receive 20 µg dose or placebo, 40 µg dose or placebo.
| Arm | Type | Receives |
|---|---|---|
| 20 µg dose, 18-59 years of age (phase 1/2) | Experimental | Biological: SCTV01C |
| 20 µg dose, ≥60 years of age (phase 1/2) | Experimental | Biological: SCTV01C |
| 40 µg dose, 18-59 years of age (phase 1/2) | Experimental | Biological: SCTV01C |
| 40 µg dose, ≥60 years of age (phase 1/2) | Experimental | Biological: SCTV01C |
| Placebo, 18-55 years of age (phase 1/2) | Placebo comparator | Other: Placebo |
| Placebo, ≥60 years of age (phase 1/2) | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participants are eligible to be included in the study only if the following conditions are met:
- Male or female aged ≥18 years old when signing ICF;
- Participants that were fully vaccinated with inactivated anti-SARS-CoV-2 vaccine, and the last dose is ≥6 months away from the vaccination of this study.
- Participants that can sign written ICF and voluntarily participate in the trial, 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;
- Ability to read, understand, and fill in record cards;
Key exclusion criteria (47 listed)
- A participant who conforms to any of the following criteria should not be enrolled in the study:
- Previous diagnosis of COVID-19;
- High-risk populations (such as medical workers, close contacts of patients with COVID-19 infection, etc.) who are more likely to be infected with SARS-Cov-2;
- Presence of fever within 3 days before the study vaccination;
- A history of infection or disease related to severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or corresponding immunosuppressants;
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 |
|---|---|---|
| SCTV01Cintramuscular injection | Biological | 20 µg dose, 18-59 years of age (phase 1/2), 20 µg dose, ≥60 years of age (phase 1/2), 40 µg dose, 18-59 years of age (phase 1/2), 40 µg dose, ≥60 years of age (phase 1/2) |
| PlaceboIntramuscular injection | Other | Placebo, 18-55 years of age (phase 1/2), Placebo, ≥60 years of age (phase 1/2) |
Primary outcome
Incidence and severity of adverse reactions in phase 1
Time frame: Day 0 to Day 7 after the study vaccination
GMT and GMI of specific IgG total antibodies (ELISA method) against Alpha (B.1.1.7), Beta (B.1.351), and Delta (B.1.617.2) variants of SARS-CoV-2 in phase 2
Time frame: Day 14 after the study vaccination
GMT and GMI of neutralizing antibodies titers in phase 2
Time frame: Day 14 after the study vaccination
Incidence and severity of solicited AEs in phase 2
Time frame: Day 0 to Day 7 after the study vaccination
10 secondary outcomes
Incidence and severity of solicited adverse events in phase 1
Time frame: Day 0 to Day 7 after the study vaccination
Incidence and severity of all unsolicited adverse events in phase 1
Time frame: Day 0 to Day 28 after the study vaccination
Incidence and severity of laboratory abnormalities related adverse events in phase 1
Time frame: Day 3 after the study vaccination
Incidence and severity of serious adverse events (SAEs), adverse events of special interest (AESIs) and medically attended adverse events (MAAEs) in phase 1
Time frame: Within 365 days after the study vaccination
GMT and GMI of specific IgG total antibodies against Alpha (B.1.1.7), Beta (B.1.351), and Delta (B 1.617.2) variants of SARS-CoV-2 in phase 1
Time frame: Day 14 after the study vaccination
GMT and GMI of eutralizing antibodies titers for Delta (B.1.617.2) variant of SARS-CoV-2 in phase 1
Time frame: Day 14 after the study vaccination
GMT and GMI of specific total IgG antibodies against Alpha (B.1.1.7), Beta (B.1.351), and Delta (B.1.617.2) variants of SARS-CoV-2 in phase 2
Time frame: Day 28, Day 90, Day 180, Day 365 after the study vaccination
GMT and GMI of neutralizing antibodies titers for Delta (B.1.617.2) variant of SARS-CoV-2 in phase 2
Time frame: Day 28, Day 90, Day 180, Day 365 after the study vaccination
Incidence and severity of unsolicited adverse events in phase 2
Time frame: Day 0 to Day 28 after the study vaccination
Incidence and severity of SAEs, AESIs and MAAEs in phase 2
Time frame: Within 365 days after the study vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Yang Wang, Ph.D. study director
Sinocelltech Ltd.
1 site 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 in people with COVID-19 and SARS-CoV-2 Infection, run by Sinocelltech Ltd. at 1 site in United Arab Emirates.
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 16 inclusion and 47 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: status not confirmed, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Zhong, M.D. (+86 13810917207 ext. 9026, bo_zhong@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse reactions in phase 1 (time frame: Day 0 to Day 7 after the study vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2022.