COVID-19Phase 2NCT05522829
A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine SCTV01E-1 in Population Aged Above 18 Years
A Phase 2 study testing SCTV01E-1 on D0, SCTV01E-1 on D28 and SCTV01E-1 on D150 in people with COVID-19 and SARS-CoV-2 Infection, run by Sinocelltech Ltd..
Trial summary
The study is a randomized, double-blind Phase II study. It will evaluate the immunogenicity and safety of SCTV01E-1. Approximately 400 participants aged 18 years and older will be enrolled in this study. 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?
- SCTV01E-1 on D0, SCTV01E-1 on D28 and SCTV01E-1 on D150
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2022to 15 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years when signing ICF;
- For Cohort 1: Participants who have not been vaccinated with any COVID-19 vaccine; For Cohort 2: Participants who were fully vaccinated with 2 or 3 doses of inactivated COVID-19 vaccine and the interval between the last dose of previously vaccination and the 1st study vaccination is 3 to 24 months;
- Healthy participants or participants with pre-existing medical conditions that are in stable condition. The "pre-existing medical conditions" include but not limited to hypertension, diabetes, chronic cholecystitis and cholelithiasis, chronic gastritis, etc. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization as a consequence of worsening disease state for at least 3 months prior to study participation;
- The participant or his/her legal representative can sign written ICF, and can fully understand the trial procedure, the risk of participating in the trial, and other interventions that are available if they do not participate in the trial;
- The participant can read, understand, and fill in record cards by himself/herself or with help;
- Fertile men and women of childbearing potential voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the last dose of study vaccination.
Who cannot join
- Presence of fever (oral temperature ≥37.5℃) within 3 days before the 1st study vaccination;
- For Cohort 2 only: Known history of COVID-19 or asymptomatic SRAS-CoV-2 infection;
- A history of allergic reactions to any vaccines or drugs, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
- Immunocompromised patients suffering from immunodeficiency diseases, significant diseases, or 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 six months prior to enrollment. Whereas short-term (≤14 days) use of oral, inhaled and topical steroids are allowed;
- Those who have a history of HIV or tested positive for HIV;
Show all 21Show fewer
- For Cohort 1, participants received any drugs or vaccines used to prevent COVID-19; for Cohort 2, participants received other drugs or vaccines used to prevent COVID-19 besides inactivated COVID-19 vaccines;
- A history of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or related vaccination;
- A medical or family history of seizure, epilepsy, encephalopathy and psychosis;
- 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;
- Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders;
- Patients on antituberculosis therapy;
- Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study;
- Participants who received other investigational drugs within 1 month before the study vaccination;
- Participants who have acute illness, such as acute onset of chronic heart failure, acute sore throat, hypertensive encephalopathy, acute pneumonia, acute renal insufficiency, acute cholecystitis;
- 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 or plan to be pregnant during the study period;
- 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 or confound the study results, or non-conformance with the maximal benefits of the participants.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E-1 (Alpha/Beta/Delta/Omicron (BA.1/BA.4/BA.5) Variants S-Trimer COVID-19 Vaccine) in Population Aged 18 Years and Older
The study is a randomized, double-blind Phase II study. It will evaluate the immunogenicity and safety of SCTV01E-1. Approximately 400 participants aged 18 years and older will be enrolled in this study. 160 participants who have not been vaccinated with any COVID-19 vaccine will be enrolled in Cohort 1 and randomly assigned to receive SCTV01E-1 or SCTV01E in a ratio of 1:1. 240 participants who were fully vaccinated with 2 or 3 doses of inactivated COVID-19 vaccines at least three months ago will be enrolled in Cohort 2 and randomly assigned to receive SCTV01E-1 or SCTV01E in a ratio of 1:1.
Read the detailed description
The study is a randomized, double-blind Phase II study. It will evaluate the immunogenicity and safety of SCTV01E-1. Approximately 400 participants aged 18 years and older will be enrolled in this study.
160 participants who have not been vaccinated with any COVID-19 vaccine will be enrolled in Cohort 1 and randomly assigned to the Group SCTV01E-1 and Group SCTV01E in a ratio of 1:1. All participants will receive 3 doses of vaccinations: Vaccination 1 on D0, Vaccination 2 on D28 and Vaccination 3 on D150. Participants in Group SCTV01E-1 will receive 3 doses of SCTV01E-1, and participants in Group SCTV01E will receive 3 doses of SCTV01E.
240 participants who were fully vaccinated with 2 or 3 doses of inactivated COVID-19 vaccines at least three months ago will be enrolled in Cohort 2 and randomly assigned to Group SCTV01E-1 and Group SCTV01E in a ratio of 1:1. All participants will receive 2 doses of vaccinations: Vaccination 1 on D0 and Vaccination 2 on D120. Participants in Group SCTV01E-1 will receive 2 doses of SCTV01E-1, and participants in Group SCTV01E will receive 2 doses of SCTV01E.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- SCTV01E-1 on D0, SCTV01E-1 on D28, SCTV01E-1 on D150, SCTV01E on D0, SCTV01E on D28
- Keywords
- SARS-CoV-2, COVID-19, 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.
SCTV01E-1 on D0Biological
Day 0; intramuscular injection
SCTV01E-1 on D28Biological
Day 28; intramuscular injection
SCTV01E-1 on D150Biological
Day 150; intramuscular injection
SCTV01E on D0Biological
Day 0; intramuscular injection
SCTV01E on D28Biological
Day 28; intramuscular injection
SCTV01E on D150Biological
Day 150; intramuscular injection
SCTV01E-1 on D120Biological
Day 120; intramuscular injection
SCTV01E on D120Biological
Day 120; intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Group SCTV01E-1 | Experimental | 3 doses of SCTV01E-1 Receives: Biological: SCTV01E-1 on D0; Biological: SCTV01E-1 on D28; Biological: SCTV01E-1 on D150 |
| Cohort 1: Group SCTV01E | Active comparator | 3 doses of SCTV01E Receives: Biological: SCTV01E on D0; Biological: SCTV01E on D28; Biological: SCTV01E on D150 |
| Cohort 2: Group SCTV01E-1 | Experimental | 2 doses of SCTV01E-1 Receives: Biological: SCTV01E-1 on D0; Biological: SCTV01E-1 on D120 |
| Cohort 2: Group SCTV01E | Active comparator | 2 doses of SCTV01E Receives: Biological: SCTV01E on D0; Biological: SCTV01E on D120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Geometric mean titers (GMT) of neutralizing antibodies (nAb) against Omicron subvariant (BA.5) on Day 42.
Measured: Day 42 after the study vaccination
Cohort 1: Geometric mean titers (GMT) of neutralizing antibodies (nAb) against Omicron subvariant (BA.5) on Day 178.
Measured: Day 178 after the study vaccination
Cohort 2: Geometric mean titers (GMT) of neutralizing antibodies (nAb) against Omicron subvariant (BA.5) on Day 28.
Measured: Day 28 after the study vaccination
Cohort 2: Geometric mean titers (GMT) of neutralizing antibodies (nAb) against Omicron subvariant (BA.5) on Day 148.
Measured: Day 148 after the study vaccination
Secondary outcomes (10)
Cohort 1: Seroresponse rates of nAb against Omicron subvariant (BA.5) on Day 42.
Measured: Day 42 after the study vaccination
Cohort 1: Seroresponse rates of nAb against Omicron subvariant (BA.5) on Day 178.
Measured: Day 178 after the study vaccination
Cohort 1: Incidence and severity of solicited AEs within 7 days after each of the study vaccination.
Measured: Day 0 to Day 7 after each of the study vaccination
Cohort 1: Incidence and severity of unsolicited AEs within 28 days after each of the study vaccination.
Measured: Day 0 to Day 28 after each of the study vaccination
Cohort 1: Incidence and severity of SAEs and AESIs within 180 days after each of the study vaccination.
Measured: During the whole study
Cohort 2: Seroresponse rates of nAb against Omicron subvariant (BA.5) on Day 28.
Measured: Day 28 after the study vaccination
Cohort 2: Seroresponse rates of nAb against Omicron subvariant (BA.5) on Day 148.
Measured: Day 148 after the study vaccination
Cohort 2: Incidence and severity of solicited AEs within 7 days after each of the study vaccination.
Measured: Day 0 to Day 7 after each of the study vaccination
Cohort 2: Incidence and severity of unsolicited AEs within 28 days after each of the study vaccination.
Measured: Day 0 to Day 28 after each of the study vaccination
Cohort 2: Incidence and severity of SAEs and AESIs within 180 days after each of the study vaccination.
Measured: During the whole study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start15 Oct 2022 (estimated)
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Dec 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522829
- Sponsor's protocol ID
- SCTV01E-1-UAE-1
- Status last verified
- Aug 2022
- First submitted
- 30 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E-1 (Alpha/Beta/Delta/Omicron (BA.1/BA.4/BA.5) Variants S-Trimer COVID-19 Vaccine) in Population Aged 18 Years and Older
- ClinicalTrials.gov ID
- NCT05522829
- Acronym / sponsor ID
- SCTV01E-1-UAE-1
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Keywords
- SARS-CoV-2, COVID-19, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2022 (estimated)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 31 Aug 2022 (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 study is a randomized, double-blind Phase II study. It will evaluate the immunogenicity and safety of SCTV01E-1. Approximately 400 participants aged 18 years and older will be enrolled in this study. 160 participants who have not been vaccinated with any COVID-19 vaccine will be enrolled in Cohort 1 and randomly assigned to receive SCTV01E-1 or SCTV01E in a ratio of 1:1. 240 participants who were fully vaccinated with 2 or 3 doses of inactivated COVID-19 vaccines at least three months ago will be enrolled in Cohort 2 and randomly assigned to receive SCTV01E-1 or SCTV01E in a ratio of 1:1.
Detailed description
The study is a randomized, double-blind Phase II study. It will evaluate the immunogenicity and safety of SCTV01E-1. Approximately 400 participants aged 18 years and older will be enrolled in this study.
160 participants who have not been vaccinated with any COVID-19 vaccine will be enrolled in Cohort 1 and randomly assigned to the Group SCTV01E-1 and Group SCTV01E in a ratio of 1:1. All participants will receive 3 doses of vaccinations: Vaccination 1 on D0, Vaccination 2 on D28 and Vaccination 3 on D150. Participants in Group SCTV01E-1 will receive 3 doses of SCTV01E-1, and participants in Group SCTV01E will receive 3 doses of SCTV01E.
240 participants who were fully vaccinated with 2 or 3 doses of inactivated COVID-19 vaccines at least three months ago will be enrolled in Cohort 2 and randomly assigned to Group SCTV01E-1 and Group SCTV01E in a ratio of 1:1. All participants will receive 2 doses of vaccinations: Vaccination 1 on D0 and Vaccination 2 on D120. Participants in Group SCTV01E-1 will receive 2 doses of SCTV01E-1, and participants in Group SCTV01E will receive 2 doses of SCTV01E.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Group SCTV01E-1 | Experimental | Biological: SCTV01E-1 on D0, Biological: SCTV01E-1 on D28, Biological: SCTV01E-1 on D1503 doses of SCTV01E-1 |
| Cohort 1: Group SCTV01E | Active comparator | Biological: SCTV01E on D0, Biological: SCTV01E on D28, Biological: SCTV01E on D1503 doses of SCTV01E |
| Cohort 2: Group SCTV01E-1 | Experimental | Biological: SCTV01E-1 on D0, Biological: SCTV01E-1 on D1202 doses of SCTV01E-1 |
| Cohort 2: Group SCTV01E | Active comparator | Biological: SCTV01E on D0, Biological: SCTV01E on D1202 doses of SCTV01E |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged ≥18 years when signing ICF;
- For Cohort 1: Participants who have not been vaccinated with any COVID-19 vaccine; For Cohort 2: Participants who were fully vaccinated with 2 or 3 doses of inactivated COVID-19 vaccine and the interval between the last dose of previously vaccination and the 1st study vaccination is 3 to 24 months;
- Healthy participants or participants with pre-existing medical conditions that are in stable condition. The "pre-existing medical conditions" include but not limited to hypertension, diabetes, chronic cholecystitis and cholelithiasis, chronic gastritis, etc. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization as a consequence of worsening disease state for at least 3 months prior to study participation;
- The participant or his/her legal representative can sign written ICF, and can fully understand the trial procedure, the risk of participating in the trial, and other interventions that are available if they do not participate in the trial;
- The participant can read, understand, and fill in record cards by himself/herself or with help;
Key exclusion criteria (21 listed)
- Presence of fever (oral temperature ≥37.5℃) within 3 days before the 1st study vaccination;
- For Cohort 2 only: Known history of COVID-19 or asymptomatic SRAS-CoV-2 infection;
- A history of allergic reactions to any vaccines or drugs, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
- Immunocompromised patients suffering from immunodeficiency diseases, significant diseases, or 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 six months prior to enrollment. Whereas short-term (≤14 days) use of oral, inhaled and topical steroids are allowed;
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 |
|---|---|---|
| SCTV01E-1 on D0Day 0; intramuscular injection | Biological | Cohort 1: Group SCTV01E-1, Cohort 2: Group SCTV01E-1 |
| SCTV01E-1 on D28Day 28; intramuscular injection | Biological | Cohort 1: Group SCTV01E-1 |
| SCTV01E-1 on D150Day 150; intramuscular injection | Biological | Cohort 1: Group SCTV01E-1 |
| SCTV01E on D0Day 0; intramuscular injection | Biological | Cohort 1: Group SCTV01E, Cohort 2: Group SCTV01E |
| SCTV01E on D28Day 28; intramuscular injection | Biological | Cohort 1: Group SCTV01E |
| SCTV01E on D150Day 150; intramuscular injection | Biological | Cohort 1: Group SCTV01E |
| SCTV01E-1 on D120Day 120; intramuscular injection | Biological | Cohort 2: Group SCTV01E-1 |
| SCTV01E on D120Day 120; intramuscular injection | Biological | Cohort 2: Group SCTV01E |
Primary outcome
Cohort 1: Geometric mean titers (GMT) of neutralizing antibodies (nAb) against Omicron subvariant (BA.5) on Day 42.
Time frame: Day 42 after the study vaccination
Cohort 1: Geometric mean titers (GMT) of neutralizing antibodies (nAb) against Omicron subvariant (BA.5) on Day 178.
Time frame: Day 178 after the study vaccination
Cohort 2: Geometric mean titers (GMT) of neutralizing antibodies (nAb) against Omicron subvariant (BA.5) on Day 28.
Time frame: Day 28 after the study vaccination
Cohort 2: Geometric mean titers (GMT) of neutralizing antibodies (nAb) against Omicron subvariant (BA.5) on Day 148.
Time frame: Day 148 after the study vaccination
10 secondary outcomes
Cohort 1: Seroresponse rates of nAb against Omicron subvariant (BA.5) on Day 42.
Time frame: Day 42 after the study vaccination
Cohort 1: Seroresponse rates of nAb against Omicron subvariant (BA.5) on Day 178.
Time frame: Day 178 after the study vaccination
Cohort 1: Incidence and severity of solicited AEs within 7 days after each of the study vaccination.
Time frame: Day 0 to Day 7 after each of the study vaccination
Cohort 1: Incidence and severity of unsolicited AEs within 28 days after each of the study vaccination.
Time frame: Day 0 to Day 28 after each of the study vaccination
Cohort 1: Incidence and severity of SAEs and AESIs within 180 days after each of the study vaccination.
Time frame: During the whole study
Cohort 2: Seroresponse rates of nAb against Omicron subvariant (BA.5) on Day 28.
Time frame: Day 28 after the study vaccination
Cohort 2: Seroresponse rates of nAb against Omicron subvariant (BA.5) on Day 148.
Time frame: Day 148 after the study vaccination
Cohort 2: Incidence and severity of solicited AEs within 7 days after each of the study vaccination.
Time frame: Day 0 to Day 7 after each of the study vaccination
Cohort 2: Incidence and severity of unsolicited AEs within 28 days after each of the study vaccination.
Time frame: Day 0 to Day 28 after each of the study vaccination
Cohort 2: Incidence and severity of SAEs and AESIs within 180 days after each of the study vaccination.
Time frame: During the whole study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCTV01E-1 on D0, SCTV01E-1 on D28 and SCTV01E-1 on D150 in people with COVID-19 and SARS-CoV-2 Infection, run by Sinocelltech Ltd..
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 21 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 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilihumare ·Niyazi (+86 10 58628288-9014, dilihumare_niyazi@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Geometric mean titers (GMT) of neutralizing antibodies (nAb) against Omicron subvariant (BA.5) on Day 42. (time frame: Day 42 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 31 Aug 2022.