COVID-19Phase 1NCT05373485

Phase I Clinical Trial of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older

A Phase 1 study testing COVID-19 mRNA vaccine in people with COVID-19, run by CanSino Biologics Inc. at 3 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?: COVID-19 mRNA vaccine
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: 3 sitesChina
Study dates: 17 May 2022to 8 Aug 2022
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adults aged 18 years and above with BMI of 18 to 30 (including boundary values);
Volunteers are able and willing to comply with the requirements of the clinical trial protocol, and volunteers or witnesses can sign informed consent forms;
Willing to discuss the medical history with the investigator or doctor and allow access to all medical records related to this trial;
Provide 48-hour PCR negative report;
Have not received any other COVID-19 vaccines.

Who cannot join

Criteria for exclusion of the first dose
Other medical or psychiatric conditions, including recent (within the past year) or current presence of suicidal ideation/behavior, or laboratory abnormalities that may increase the risk of participating in the study, or subjects who are not suitable to participate in the study according to the investigator's judgment;
Positive for human immunodeficiency virus (HIV);
History of infection or disease of Middle East Respiratory Syndrome (MERS), SARS or other coronaviruses or related immunizations;
History of serious adverse reactions associated with the vaccine and/or a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine under study;
Immunocompromised patients with known or suspected immunodeficiency identified by medical history and/or physical examination;

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Bleeding constitution or condition associated with prolonged bleeding which investigators believe that intramuscular injection is contraindicated;
Women who test positive for blood pregnancy or are breastfeeding, volunteers or their partners have a pregnancy plan within 12 months;
Severe hypertension and uncontrollable medication (on-site measurement: systolic blood pressure ≥ 160mmHg, diastolic blood pressure ≥ 100mmHg);
Have a serious chronic disease or the condition is in the progression period can not be smoothly controlled, such as diabetes, thyroid disease, etc.;
History of severe myocarditis, pericarditis and other heart diseases;
Abnormal laboratory tests during the screening window and judged by researchers to be of clinical significance;
Plans to receive other vaccines within 28 days before and after receiving the test vaccine;
Those receiving immunosuppressive therapy, including cytotoxic drugs or systemic corticosteroids, such as for cancer or autoimmune diseases, or who were scheduled to receive treatment throughout the study period. If systemic corticosteroids are used in a short period of time (< 14 days) for the treatment of acute illness, subjects should not enter this study until at least 28 days after corticosteroid therapy has been discontinued prior to study vaccination. Inhalation/spraying, intra-articular, intraskeletal, or topical (skin or eyes) use of corticosteroids is permitted;
Receiving blood/plasma products or immunoglobulins 60 days prior to study vaccination or plan to receive for the entire study duration;
Engage in other interventional studies within 28 days prior to entering the study and/or during the study's participation;
Participated in other interventional studies of lipid-containing nanoparticles;
Have symptoms of COVID-19 such as respiratory symptoms, fever, cough, shortness of breath, and dyspnea;
Fever, axillary temperature > 37.0 °C.
Second dose exclusion criteria:
Severe allergic reactions occur after the first vaccination;
Serious adverse reactions with causal relationship during the first vaccination;
Those who are newly discovered or newly occurring after the first vaccination do not meet the inclusion criteria of the first dose or meet the exclusion criteria of the first dose, and the investigator shall decide whether to continue to participate in the study;
Other reasons for exclusion that the investigators believe.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Beijing Friendship Hospital
Beijing, Beijing Municipality
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan
Hebei Petro China Center Hospital
Langfang, Hebei

Other trials in China

About this study

Official title: A Randomized, Double-blind, Dose-exploring, Placebo-controlled, Multi-center Phase I Clinical Trial Evaluating the Safety and Immunogenicity of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older

To evaluate the safety and immunogenicity of the COVID-19 mRNA vaccine in people aged 18 years and older, 80 participants will be enrolled and divided into two groups: low- and high-dose groups. Each dose group will be divided into 2 age groups (20 people each):18 to 59 years old and ≥ 60 years old. Subjects will be randomized into vaccine group or placebo group in a ratio of 3:1. Subjects will receive 2 doses of either vaccine or placebo on Day 0 and Day 21, in which the low-dose group will received 0.3 ml of the study vaccine or placebo, and the high dose group will receive 0.5 ml of the study vaccine or placebo.

Conditions: COVID-19
Being tested: COVID-19 mRNA vaccine, Placebo
Keywords: COVID, mRNA, Vaccine, Placebo, Safety, Immunogenicity
Medical subject headings: COVID-19

What participants receive

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

COVID-19 mRNA vaccineBiological
2 doses of vaccine on Day 0 and Day 21
PlaceboBiological
2 doses of placebo on Day 0 and Day 21

Study groups in NCT05373485
Study group	Role	What they receive
Vaccine Group, low dose, 18-59 year-old	Experimental	2 doses of COVID-19 mRNA vaccine (30µg, 0.3 ml) on Day 0 and Day 21 Receives: Biological: COVID-19 mRNA vaccine
Vaccine Group, low dose, 60 year-old and above	Experimental	2 doses of COVID-19 mRNA vaccine (30µg, 0.3 ml) on Day 0 and Day 21 Receives: Biological: COVID-19 mRNA vaccine
Vaccine Group, high dose, 18-59 year-old	Experimental	2 doses of COVID-19 mRNA vaccine (50µg, 0.5 ml) on Day 0 and Day 21 Receives: Biological: COVID-19 mRNA vaccine
Vaccine Group, high dose, 60 year-old and above	Experimental	2 doses of COVID-19 mRNA vaccine (50µg, 0.5 ml) on Day 0 and Day 21 Receives: Biological: COVID-19 mRNA vaccine
Placebo Group, low dose, 18-59 year-old	Placebo comparator	2 doses of placebo (0µg, 0.3 ml) on Day 0 and Day 21 Receives: Biological: Placebo
Placebo Group, low dose, 60 year-old and above	Placebo comparator	2 doses of placebo (0µg, 0.3 ml) on Day 0 and Day 21 Receives: Biological: Placebo
Placebo Group, high dose, 18-59 year-old	Placebo comparator	2 doses of placebo (0µg, 0.5 ml) on Day 0 and Day 21 Receives: Biological: Placebo
Placebo Group, high dose, 60 year-old and above	Placebo comparator	2 doses of placebo (0µg, 0.5 ml) on Day 0 and Day 21 Receives: Biological: Placebo

What is being measured

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

The incidence of adverse reactions (AR)
To evaluate the incidence of adverse reactions (AR) within 14 days of immunization in all subjects
Measured: within 14 days of immunization

Secondary outcomes (17)

The incidence of adverse reactions (AR)
To evaluate the incidence of adverse reactions (AR) within 28 days of immunization in all subjects
Measured: within 28 days of immunization
The incidence of SAE, MAE and AESI
To evaluation the incidence of SAE, MAE, and AESI within 12 months of full immunization in all subjects
Measured: From vaccination to post of 12 months vaccination
The incidence of adverse reactions (AR)
To evaluate the incidence of adverse reactions (AR) within 60 minutes of each vaccination in all subjects
Measured: Within 60 minutes of each vaccination
Changes in laboratory indicators
Changes in white blood cell count
Measured: Day 4 and Day 7 post each vaccination
Changes in laboratory indicators
Changes in neutrophils
Measured: Day 4 and Day 7 post each vaccination
Changes in laboratory indicators
Changes in lymphocyte count;
Measured: Day 4 and Day 7 post each vaccination
Changes in laboratory indicators
Changes in platelet count;
Measured: Day 4 and Day 7 post each vaccination
Immunogenicity of wild type neutralizing antibodies
Sero-conversation rate of anti-wild type neutralizing antibodies
Measured: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of wild type neutralizing antibodies
Geometric mean titer (GMT) of wild type neutralizing antibodies
Measured: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of wild type neutralizing antibodies
GMI of wild type neutralizing antibodies
Measured: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of anti-S-RBD Ig G antibodies
Sero-conversation rate of anti-S-RBD Ig G antibodies
Measured: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of anti-S-RBD Ig G antibodies
GMC of anti-S-RBD Ig G antibodies
Measured: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of anti-S-RBD Ig G antibodies
GMI of anti-S-RBD Ig G antibodies
Measured: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Changes in vital signs
The incidence of outliers detected on vital signs
Measured: Day 1 to 4 , Day 7 after the first dose, and the day of second dose, Day 4 after the second dose, and day 7 after the second dose
Immuno-persistency of wild type neutralizing antibodies
Sero-conversation rate of anti-wild type virus neutralizing antibodies
Measured: Month 3,6 and 12 post second vaccination
Immuno-persistency of wild type neutralizing antibodies
GMT of wild type neutralizing antibodies
Measured: Month 3,6 and 12 post second vaccination
Immuno-persistency of wild type neutralizing antibodies
GMI of wild type neutralizing antibodies
Measured: Month 3,6 and 12 post second vaccination

Timeline

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

17 May 20228 Aug 2022

First posted13 May 2022
Study start17 May 2022
Primary completion8 Aug 2022
Study completion8 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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 CanSino Biologics Inc.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
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05373485
Sponsor's protocol ID: CTP-NCVM-001
Status last verified: Dec 2024
First submitted: 12 May 2022
Last updated: 4 Dec 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Jin Z, Wu J, Wang Y, Huang T, Zhao K, Liu J, Wang H, Zhu T, Gou J, Huang H, Wu X, Yin H, Song J, Li R, Zhang J, Li L, Chen J, Li X, Zhang M, Li J, Hou M, Song Y, Wang B, Gao Q, Wu L, Kong Y, Dong R. Safety and immunogenicity of the COVID-19 mRNA vaccine CS-2034: A randomized, double-blind, dose-exploration, placebo-controlled multicenter Phase I clinical trial in healthy Chinese adults. J Infect. 2023 Dec;87(6):556-570. doi: 10.1016/j.jinf.2023.10.012. Epub 2023 Oct 28.
PubMed 37898410

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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Dose-exploring, Placebo-controlled, Multi-center Phase I Clinical Trial Evaluating the Safety and Immunogenicity of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older
ClinicalTrials.gov ID: NCT05373485
Acronym / sponsor ID: CTP-NCVM-001
Conditions: COVID-19
Keywords: COVID, mRNA, Vaccine, Placebo, Safety, Immunogenicity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: CanSino Biologics Inc.Industry (pharma, biotech, devices)
Study start: 17 May 2022 (actual)
Primary completion: 8 Aug 2022 (actual)
Study completion: 8 Aug 2022 (actual)
First posted: 13 May 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Vaccine Group, low dose, 18-59 year-old	Experimental	Biological: COVID-19 mRNA vaccine2 doses of COVID-19 mRNA vaccine (30µg, 0.3 ml) on Day 0 and Day 21
Vaccine Group, low dose, 60 year-old and above	Experimental	Biological: COVID-19 mRNA vaccine2 doses of COVID-19 mRNA vaccine (30µg, 0.3 ml) on Day 0 and Day 21
Vaccine Group, high dose, 18-59 year-old	Experimental	Biological: COVID-19 mRNA vaccine2 doses of COVID-19 mRNA vaccine (50µg, 0.5 ml) on Day 0 and Day 21
Vaccine Group, high dose, 60 year-old and above	Experimental	Biological: COVID-19 mRNA vaccine2 doses of COVID-19 mRNA vaccine (50µg, 0.5 ml) on Day 0 and Day 21
Placebo Group, low dose, 18-59 year-old	Placebo comparator	Biological: Placebo2 doses of placebo (0µg, 0.3 ml) on Day 0 and Day 21
Placebo Group, low dose, 60 year-old and above	Placebo comparator	Biological: Placebo2 doses of placebo (0µg, 0.3 ml) on Day 0 and Day 21
Placebo Group, high dose, 18-59 year-old	Placebo comparator	Biological: Placebo2 doses of placebo (0µg, 0.5 ml) on Day 0 and Day 21
Placebo Group, high dose, 60 year-old and above	Placebo comparator	Biological: Placebo2 doses of placebo (0µg, 0.5 ml) on Day 0 and Day 21

Who may qualify

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

Key inclusion criteria (5 listed)

Adults aged 18 years and above with BMI of 18 to 30 (including boundary values);
Volunteers are able and willing to comply with the requirements of the clinical trial protocol, and volunteers or witnesses can sign informed consent forms;
Willing to discuss the medical history with the investigator or doctor and allow access to all medical records related to this trial;
Provide 48-hour PCR negative report;
Have not received any other COVID-19 vaccines.

Key exclusion criteria (24 listed)

Criteria for exclusion of the first dose
Severe allergic reactions occur after the first vaccination;
Serious adverse reactions with causal relationship during the first vaccination;
Those who are newly discovered or newly occurring after the first vaccination do not meet the inclusion criteria of the first dose or meet the exclusion criteria of the first dose, and the investigator shall decide whether to continue to participate in the study;
Other reasons for exclusion that the investigators believe.

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
COVID-19 mRNA vaccine2 doses of vaccine on Day 0 and Day 21	Biological	Vaccine Group, high dose, 18-59 year-old, Vaccine Group, high dose, 60 year-old and above, Vaccine Group, low dose, 18-59 year-old, Vaccine Group, low dose, 60 year-old and above
Placebo2 doses of placebo on Day 0 and Day 21	Biological	Placebo Group, high dose, 18-59 year-old, Placebo Group, high dose, 60 year-old and above, Placebo Group, low dose, 18-59 year-old, Placebo Group, low dose, 60 year-old and above

Primary outcome

The incidence of adverse reactions (AR)
Time frame: within 14 days of immunization
To evaluate the incidence of adverse reactions (AR) within 14 days of immunization in all subjects

17 secondary outcomes

The incidence of adverse reactions (AR)
Time frame: within 28 days of immunization
The incidence of SAE, MAE and AESI
Time frame: From vaccination to post of 12 months vaccination
The incidence of adverse reactions (AR)
Time frame: Within 60 minutes of each vaccination
Changes in laboratory indicators
Time frame: Day 4 and Day 7 post each vaccination
Changes in laboratory indicators
Time frame: Day 4 and Day 7 post each vaccination
Changes in laboratory indicators
Time frame: Day 4 and Day 7 post each vaccination
Changes in laboratory indicators
Time frame: Day 4 and Day 7 post each vaccination
Immunogenicity of wild type neutralizing antibodies
Time frame: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of wild type neutralizing antibodies
Time frame: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of wild type neutralizing antibodies
Time frame: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of anti-S-RBD Ig G antibodies
Time frame: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of anti-S-RBD Ig G antibodies
Time frame: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Immunogenicity of anti-S-RBD Ig G antibodies
Time frame: Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose
Changes in vital signs
Time frame: Day 1 to 4 , Day 7 after the first dose, and the day of second dose, Day 4 after the second dose, and day 7 after the second dose
Immuno-persistency of wild type neutralizing antibodies
Time frame: Month 3,6 and 12 post second vaccination
Immuno-persistency of wild type neutralizing antibodies
Time frame: Month 3,6 and 12 post second vaccination
Immuno-persistency of wild type neutralizing antibodies
Time frame: Month 3,6 and 12 post 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 4 Dec 2024.
Derived from this study: PubMed 37898410Jin Z, Wu J, Wang Y, Huang T, Zhao K, Liu J, Wang H, Zhu T, Gou J, Huang H, Wu X, Yin H, Song J, Li R, Zhang J, Li L, Chen J, Li X, Zhang M, Li J, Hou M, Song Y, Wang B, Gao Q, Wu L, Kong Y, Dong R. Safety and immunogenicity of the COVID-19 mRNA vaccine CS-2034: A randomized, double-blind, dose-exploration, placebo-controlled multicenter Phase I clinical trial in healthy Chinese adults. J Infect. 2023 Dec;87(6):556-570. doi: 10.1016/j.jinf.2023.10.012. Epub 2023 Oct 28.

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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.

Ruihua Dong principal investigator

Beijing Friendship Hospital

Kexin Zhao principal investigator

Hebei Petro China Center Hospital

Tao Huang principal investigator

Hunan Provincial Center for Disease Control and Prevention

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing COVID-19 mRNA vaccine in people with COVID-19, run by CanSino Biologics Inc. at 3 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 5 inclusion and 24 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 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 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?

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?

The incidence of adverse reactions (AR) (time frame: within 14 days of immunization). 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 NCT05373485, which also lists 1 linked publication.

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 4 Dec 2024.