CoronavirusPhase 1NCT04550351
Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2 Phase I Clinical Trial (≥60 Years Old)
A Phase 1 study testing Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group and Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group in people with Coronavirus, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus
- What is being tested?
- Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group and Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2020to 31 Dec 2021
- Phase
- Phase 1
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- The results of physical examination and laboratory examination before screening are abnormal and clinically significant as judged by clinicians, or systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg before screening;
- A history of severe allergies to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction), dyspnea, blood vessels Neuroedema, etc.; or any previous history of serious side effects after the use of any vaccine or drug;
- People with a history of SARS and SARS-CoV-2 (meet any of the following: ①Have a history of SARS and SARS-CoV-2 infection or onset; ②During this SRAS-CoV-2 epidemic, there are patients who have been diagnosed with the new crown/ Suspected patient contact history);
- Have taken antipyretic or analgesic within 24 hours before the first dose of vaccination;
- Inoculate subunit vaccine and/or inactivated vaccine within 14 days before the first dose of vaccine, and inoculate live attenuated vaccine within 30 days;
- People suffering from the following diseases:
Show all 21Show fewer
- Acute (within 72 hours) feverish illness;
- Suffering from digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days;
- Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Congenital or acquired immunodeficiency or autoimmune disease history or receiving immunomodulator treatment within 6 months, such as hormones; or monoclonal antibodies; or thymosin; or interferon, etc.; but local medication (such as ointment, Eye drops, inhalation or nasal spray);
- Known to have been diagnosed with infectious diseases, such as: tuberculosis, viral hepatitis and/or human immunodeficiency virus HIV antibody positive or syphilis specific antibody positive;
- Neurological diseases or neurodevelopmental dysfunction (for example, migraine, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis; History of mental illness or family history;
- ⑦Functional asplenia, as well as any cause of aspleen or splenectomy;
- ⑧Severe chronic diseases or conditions that cannot be controlled smoothly in the advanced stage, such as diabetes and thyroid disease;
- ⑨Severe liver and kidney diseases; respiratory diseases that currently require daily drug treatment (for example, chronic obstructive pulmonary disease [COPD], asthma) or any treatment for exacerbation of respiratory diseases (for example, asthma exacerbation) in the last 5 years; suffering from severe History of cardiovascular disease (such as congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease) or myocarditis or pericarditis;
- ⑩Have thrombocytopenia, any coagulation dysfunction or receive anticoagulant treatment, etc.;
- ?Tumor patients;
- Have received blood or blood-related products, including immunoglobulin, within 3 months; or plan to use it during the research period;
- Those who are already pregnant (including a positive urine pregnancy test), or are breastfeeding;
- Any research or unregistered products (drugs, vaccines, biological products or devices) other than research products have been used within 3 months, or planned to be used during the research period;
- The investigator believes that any disease or condition in the subject may put the subject at an unacceptable risk; the subject cannot meet the requirements of the protocol; it interferes with the assessment of the vaccine response.
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center for Disease Control and Prevention
Xiangtan, Changsha, 411228
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of Recombinant New Coronavirus Vaccines (CHO Cells) in Healthy People Aged 60 Years and Above
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells).
Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted.
Read more
Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women.
Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.
Read the detailed description
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Product name: Recombinant new coronavirus vaccine (CHO cell),Each dose contains 25μg/0.5mL/bottle (low dose), 50μg/0.5mL/bottle (high dose) Indications: Prevention of respiratory diseases caused by new coronavirus infection Research population: healthy people ≥60 years old Research Unit: Hunan Provincial Center for Disease Control and Prevention Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells).
Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted.
Immunization program: 0, 1, and 2 months. Dose: Divided into low-dose group (25μg/0.5mL) and high-dose group (50μg/0.5mL).
Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women.
Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.
Research plan and implementation:Volunteers aged 60 and above signed the informed consent form and asked about medical history, residence history and other information and then performed relevant examinations, including height, weight, vital signs, physical examination, laboratory tests (blood routine, urine routine, blood biochemistry), urine Pregnancy (women of childbearing age). After the study number is assigned, the subjects will collect throat swabs for SARS-CoV-2 real-time fluorescent RT-PCR nucleic acid detection, and blood will be collected for SARS-CoV-2 IgM and IgG antibody detection. Subjects will be in accordance with 0, 1, and 2 months Vaccination procedures are carried out. According to the order of the dose from low to high, it is divided into two stages and inoculated sequentially. Among them, placebo/five people per dose group, test vaccine/20 people per dose group, and qualified subjects were randomly enrolled into the test vaccine group and the placebo control group. In the first phase, subjects in the low-dose group (20 cases) and the placebo group (5 cases) were randomly enrolled; the safety data of the first 7-day vaccination was evaluated by DSMB, and if the suspension/termination criteria were not met, the first In the second-phase study, subjects in the high-dose group (20 cases) and the placebo group (5 cases) were randomly enrolled. Follow-up to 30 days after each dose, if the suspension/termination criteria is reached, DSMB will decide whether to inoculate the follow-up doses; in other cases, the investigator will decide whether to inoculate the follow-up doses.
Safety endpoint:
- The incidence of all AEs within 1 month after the first dose to the full course of vaccination:
- Total AE incidence;
- The incidence of AEs related to research vaccines;
- The incidence of grade 3 and above AE;
- The incidence of grade 3 and above AEs related to research vaccines;
- The incidence of AEs leading to withdrawal;
- The incidence of AEs related to research vaccines leading to withdrawal; 2. The incidence of all serious adverse events (SAE) and the incidence of SAE related to the vaccine within 12 months after the first dose to the full course of vaccination; 3. Changes in the clinical significance of the laboratory test indicators after each dose of inoculation compared to before the first dose.
Immunogenicity endpoint:
Humoral immunity: before the first dose of vaccination, 1 month and 6 months after the full vaccination, neutralizing antibodies of novel coronavirus (SARS-CoV-2), S protein binding antibody (IgG), RBD protein binding antibody (IgG) ) Positive rate; The levels of neutralizing antibodies against SARS-CoV-2, S protein binding antibody (IgG) and RBD protein binding antibody (IgG) and their relative immunity 1 month and 6 months after the full vaccination of all subjects Increase the multiple before.
- Conditions
- Coronavirus
- Being tested
- Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group, Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group, Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group
- Keywords
- Recombinant Novel Coronavirus Vaccine
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose groupBiological
Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose groupBiological
Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo groupBiological
Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
| Study group | Role | What they receive |
|---|---|---|
| Population I | Experimental | Population I has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population I is intramuscular injection of deltoid muscle of upper arm with low dose of vaccine. Receives: Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group |
| Population II | Experimental | Population II has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population II is a high-dose vaccine intramuscular injection of deltoid muscle of the upper arm. Receives: Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group |
| Population Ⅲ | Placebo comparator | Population Ⅲ has 10 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅲ is a placebo intramuscular injection of deltoid muscle of the upper arm. Receives: Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of adverse events after intramuscular injection
The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site.
Measured: 12 months after full vaccination
Immunogenic end point
The positive rate of neutralizing antibody, S protein binding antibody (IgG), RBD protein binding antibody (IgG) of all subjects before the first dose, 1 month and 6 months after the full vaccination And titer levels and their fold increase before immunity.
Measured: Within 6 months after the last dose of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start19 Aug 2020
- Primary completion18 Dec 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550351
- Sponsor's protocol ID
- LKM-2020-NCV03
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2020
- Last updated
- 27 Jan 2021
- 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 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of Recombinant New Coronavirus Vaccines (CHO Cells) in Healthy People Aged 60 Years and Above
- ClinicalTrials.gov ID
- NCT04550351
- Acronym / sponsor ID
- LKM-2020-NCV03
- Conditions
- Coronavirus
- Keywords
- Recombinant Novel Coronavirus Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Sep 2020 (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.
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells).
Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted.
Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women.
Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.
Detailed description
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Product name: Recombinant new coronavirus vaccine (CHO cell),Each dose contains 25μg/0.5mL/bottle (low dose), 50μg/0.5mL/bottle (high dose) Indications: Prevention of respiratory diseases caused by new coronavirus infection Research population: healthy people ≥60 years old Research Unit: Hunan Provincial Center for Disease Control and Prevention Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells).
Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted.
Immunization program: 0, 1, and 2 months. Dose: Divided into low-dose group (25μg/0.5mL) and high-dose group (50μg/0.5mL).
Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women.
Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.
Research plan and implementation:Volunteers aged 60 and above signed the informed consent form and asked about medical history, residence history and other information and then performed relevant examinations, including height, weight, vital signs, physical examination, laboratory tests (blood routine, urine routine, blood biochemistry), urine Pregnancy (women of childbearing age). After the study number is assigned, the subjects will collect throat swabs for SARS-CoV-2 real-time fluorescent RT-PCR nucleic acid detection, and blood will be collected for SARS-CoV-2 IgM and IgG antibody detection. Subjects will be in accordance with 0, 1, and 2 months Vaccination procedures are carried out. According to the order of the dose from low to high, it is divided into two stages and inoculated sequentially. Among them, placebo/five people per dose group, test vaccine/20 people per dose group, and qualified subjects were randomly enrolled into the test vaccine group and the placebo control group. In the first phase, subjects in the low-dose group (20 cases) and the placebo group (5 cases) were randomly enrolled; the safety data of the first 7-day vaccination was evaluated by DSMB, and if the suspension/termination criteria were not met, the first In the second-phase study, subjects in the high-dose group (20 cases) and the placebo group (5 cases) were randomly enrolled. Follow-up to 30 days after each dose, if the suspension/termination criteria is reached, DSMB will decide whether to inoculate the follow-up doses; in other cases, the investigator will decide whether to inoculate the follow-up doses.
Safety endpoint:
- The incidence of all AEs within 1 month after the first dose to the full course of vaccination:
- Total AE incidence;
- The incidence of AEs related to research vaccines;
- The incidence of grade 3 and above AE;
- The incidence of grade 3 and above AEs related to research vaccines;
- The incidence of AEs leading to withdrawal;
- The incidence of AEs related to research vaccines leading to withdrawal; 2. The incidence of all serious adverse events (SAE) and the incidence of SAE related to the vaccine within 12 months after the first dose to the full course of vaccination; 3. Changes in the clinical significance of the laboratory test indicators after each dose of inoculation compared to before the first dose.
Immunogenicity endpoint:
Humoral immunity: before the first dose of vaccination, 1 month and 6 months after the full vaccination, neutralizing antibodies of novel coronavirus (SARS-CoV-2), S protein binding antibody (IgG), RBD protein binding antibody (IgG) ) Positive rate; The levels of neutralizing antibodies against SARS-CoV-2, S protein binding antibody (IgG) and RBD protein binding antibody (IgG) and their relative immunity 1 month and 6 months after the full vaccination of all subjects Increase the multiple before.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Population I | Experimental | Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose groupPopulation I has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population I is intramuscular injection of deltoid muscle of upper arm with low dose of vaccine. |
| Population II | Experimental | Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose groupPopulation II has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population II is a high-dose vaccine intramuscular injection of deltoid muscle of the upper arm. |
| Population Ⅲ | Placebo comparator | Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo groupPopulation Ⅲ has 10 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅲ is a placebo intramuscular injection of deltoid muscle of the upper arm. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- The results of physical examination and laboratory examination before screening are abnormal and clinically significant as judged by clinicians, or systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg before screening;
- A history of severe allergies to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction), dyspnea, blood vessels Neuroedema, etc.; or any previous history of serious side effects after the use of any vaccine or drug;
- People with a history of SARS and SARS-CoV-2 (meet any of the following: ①Have a history of SARS and SARS-CoV-2 infection or onset; ②During this SRAS-CoV-2 epidemic, there are patients who have been diagnosed with the new crown/ Suspected patient contact history);
- Have taken antipyretic or analgesic within 24 hours before the first dose of vaccination;
- Inoculate subunit vaccine and/or inactivated vaccine within 14 days before the first dose of vaccine, and inoculate live attenuated vaccine within 30 days;
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 |
|---|---|---|
| Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose groupIntramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). | Biological | Population I |
| Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose groupIntramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). | Biological | Population II |
| Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo groupIntramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). | Biological | Population Ⅲ |
Primary outcome
The number of adverse events after intramuscular injection
Time frame: 12 months after full vaccination
The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site.
Immunogenic end point
Time frame: Within 6 months after the last dose of vaccination
The positive rate of neutralizing antibody, S protein binding antibody (IgG), RBD protein binding antibody (IgG) of all subjects before the first dose, 1 month and 6 months after the full vaccination And titer levels and their fold increase before immunity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group and Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group in people with Coronavirus, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site 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 0 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 27 Jan 2021. 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 China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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.
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?
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?
The number of adverse events after intramuscular injection (time frame: 12 months after full vaccination). The study lists 2 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 27 Jan 2021.