COVID-19Phase 1/2NCT04352608

Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)

A Phase 1/2 study testing Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule, Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule and Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule in people with COVID-19, run by Sinovac Research and Development Co., Ltd. at 1 site 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 to 59 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule, Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule and Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 744 participants
Where: 1 siteChina
Study dates: 16 Apr 2020to 24 Jul 2021
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 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults aged 18-59 years;
Proven legal identity;
Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ;

Who cannot join

Travel history / residence history of Wuhan city and surrounding areas, or other communities with case reports within 14 days;
History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
Self-reported history of SARS;
Self-reported history of new coronavirus infection;

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Positive in serum antibodies (IgG or IgM) screening of COVID-19;
Positive in nasopharyngeal swabs or anal swabs through RT-PCR;
Women who are breastfeeding, pregnant or planning to become pregnant during the study period;
BMI≥35 kg/m2;
History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
Autoimmune disease or immunodeficiency / immunosuppression;
Suffering from severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver and kidney diseases, malignant tumors, etc.;
Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months;
Abnormal laboratory test results in the physical examination such as clinically significant abnormal hematology and biochemistry beyond the reference value range (only applicable to Phase I clinical trials);
History of alcohol or drug abuse;
Receipt of blood products within in the past 3 months;
Receipt of other investigational drugs in the past 30 days;
Receipt of attenuated live vaccines in the past 14 days;
Receipt of inactivated or subunit vaccines in the past 7 days;
Attacks of acute diseases or chronic diseases in the past 7 days;
Axillary temperature >37.0°C;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu, 221200

Other trials in China

About this study

Official title: A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18~59 Years

This study is a randomized, double-blinded, and placebo controlled phase Ⅰ/Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults aged 18~59 Years.

Read the detailed description

This study is a randomized, double-blinded, single-center, placebo-controlled phase Ⅰ/Ⅱ clinical trial in adults aged 18~59 years. The purpose of this study is to evaluate the immunogenicity and safety of the experimental SARS-CoV-2 inactivated vaccine. The experimental vaccine and placebo were both manufactured by Sinovac Research \& Development Co., Ltd. A total of 744 subjects will be enrolled, with 144 at phase Ⅰ, and 600 at phase Ⅱ. All of participants in phase Ⅰ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28.300 participants in phase Ⅱ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28 and one dose of booster immunization will be given 6 months after primary immunization of day 0,14 or day 0,28.The other 300 participants in phase Ⅱ will be assigned to receive three doses of experimental vaccine or placebo on the schedule of day 0,14,42 or 0,28,56 .

Conditions: COVID-19
Being tested: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule, Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule, Two doses of placebo at the emergency vaccination schedule, Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule, Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Medical subject headings: COVID-19

What participants receive

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

Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination scheduleBiological
Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination scheduleBiological
Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
Two doses of placebo at the emergency vaccination scheduleBiological
Two doses of placebo at the schedule of day 0,14 and one dose of booster immunization with placebo 6 months after the schedule of day 0,14 in phaseⅡ.
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination scheduleBiological
Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ.
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination scheduleBiological
Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ
Two doses of placebo at the routine vaccination scheduleBiological
Two doses of placebo at the schedule of day 0,28 and one dose of booster immunization with placebo 6 months after the schedule of day 0,28 in phaseⅡ.
Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination scheduleBiological
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination scheduleBiological
Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
Three doses of placebo at the emergency vaccination scheduleBiological
Three doses of placebo at the schedule of day 0,14,42
Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination scheduleBiological
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination scheduleBiological
Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
Three doses of placebo at the routine vaccination scheduleBiological
Three doses of placebo at the schedule of day 0,28,56

Study groups in NCT04352608
Study group	Role	What they receive
Emergency schedule & Two doses of medium dosage vaccine	Experimental	24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the emergency schedule Receives: Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Emergency schedule & Two doses of high dosage vaccine	Experimental	24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the emergency schedule Receives: Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Emergency schedule &Two doses of placebo	Placebo comparator	24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the emergency vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the emergency schedule Receives: Biological: Two doses of placebo at the emergency vaccination schedule
Routine schedule & Two doses of medium dosage vaccine	Experimental	24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the routine schedule Receives: Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Routine schedule &Two doses of high dosage vaccine	Experimental	24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the routine schedule Receives: Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Routine schedule & Two doses of placebo	Placebo comparator	24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the routine vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the routine schedule Receives: Biological: Two doses of placebo at the routine vaccination schedule
Emergency schedule & Three doses of medium dosage vaccine	Experimental	60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Receives: Biological: Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Emergency schedule & Three doses of high dosage vaccine	Experimental	60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Receives: Biological: Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Emergency schedule &Three doses of placebo	Placebo comparator	30 participants in phase Ⅱ will receive three doses of placebo at the emergency vaccination schedule Receives: Biological: Three doses of placebo at the emergency vaccination schedule
Routine schedule & Three doses of medium dosage vaccine	Experimental	60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Receives: Biological: Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Routine schedule &Three doses of high dosage vaccine	Experimental	60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Receives: Biological: Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Routine schedule &Three doses of placebo	Placebo comparator	30 participants in phase Ⅱ will receive three doses of placebo at the routine vaccination schedule Receives: Biological: Three doses of placebo at the routine vaccination schedule

What is being measured

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

Safety indexes of adverse reactions
Incidence of adverse reactions occured from Day 0 to Day 28 after each dose
Measured: From Day 0 to Day 28 after each dose
Immunogenicity indexes of neutralizing-antibody seroconversion rates
The seroconversion rate of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after the two-dose vaccination.
Measured: The 14th day /the 28th day after two doses of vaccination

Secondary outcomes (11)

Safety indexes of adverse reactions
Incidence of adverse reactions 7 days after each dose of vaccination
Measured: 7 days after each dose of vaccination
Safety indexes of Incidence of abnormal laboratory index
Incidence of abnormal laboratory index (blood routine test, blood chemistry test,and urine routine test) on the 3th day after each dose of vaccination in phase Ⅰ
Measured: On the 3th day after each dose of vaccination in phase Ⅰ
Safety indexes of serious adverse events (SAEs）
Incidence of SAEs from the beginning of the vaccination to 6 months post the whole-schedule vaccination
Measured: From the beginning of the vaccination to 6 months post the whole-schedule vaccination
Immunogenicity indexes of the seropositive rate, GMT, and GMI of neutralizing antibodies
The seropositive rate, GMT, and GMI of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination
Measured: 14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies
The seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies 28 days after the two doses (emergency schedule)
Measured: 28 days after the two doses (emergency schedule)
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅱ
Phase Ⅱ:The seroconversion rate, seropositive rate, GMT, and GMI 28 days after the third dose（only for days 0,14,42 and days 0,28,56 schedule）
Measured: 28 days after the third dose （only for days 0,14,42 and days 0,28,56 schedule）
Immunogenicity indexes of the seropositivity rate, GMT, and GMI in Phase Ⅱ
Phase Ⅱ:The seropositivity rate, GMT, and GMI 14 day (emergency schedule)/28 days (routine schedule) after the booster dose （only for days 0,14 and days 0,28 schedule）
Measured: 14 day (emergency schedule)/28 days (routine schedule) after the booster dose （only for days 0,14 and days 0,28 schedule）
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ
Phase Ⅰ:The seroconversion rate, seropositive rate, GMT, and GMI 7/14/21 days after the first dose vaccination (emergency schedule)
Measured: 7/14/21 days after the first dose vaccination (emergency schedule)
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ
Phase Ⅰ:The seroconversion rate, seropositive rate, GMT, and GMI 28/35/42 days after the first dose vaccination (routine schedules)
Measured: 28/35/42 days after the first dose vaccination (routine schedules)
Immunogenicity indexes of the seropositive rate of IgG, IgM antibodies
Phase Ⅰ:The seropositive rate of IgG, IgM antibodies 7/14/21/28/42 days after the first dose vaccination (emergency schedule)
Measured: 7/14/21/28/42 days after the first dose vaccination (emergency schedule)
Immunogenicity indexes of the seropositive rate of IgG,IgM antibodies
Phase Ⅰ: The seropositive rate of IgG,IgM antibodies 28/35/42/56 days after the first dose vaccination (routine schedule)
Measured: 28/35/42/56 days after the first dose vaccination (routine schedule)

Timeline

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

16 Apr 202024 Jul 2021

First posted20 Apr 2020
Study start16 Apr 2020
Primary completion10 Jul 2020
Study completion24 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 744 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04352608
Sponsor's protocol ID: PRO-nCOV-1001
Status last verified: Jul 2021
First submitted: 14 Apr 2020
Last updated: 24 Feb 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Xin Q, Wu Q, Chen X, Han B, Chu K, Song Y, Jin H, Chen P, Lu W, Yang T, Li M, Zhao Y, Pan H, Yu H, Wang L. Six-month follow-up of a booster dose of CoronaVac in two single-centre phase 2 clinical trials. Nat Commun. 2022 Jun 3;13(1):3100. doi: 10.1038/s41467-022-30864-w.
PubMed 35660738
Zeng G, Wu Q, Pan H, Li M, Yang J, Wang L, Wu Z, Jiang D, Deng X, Chu K, Zheng W, Wang L, Lu W, Han B, Zhao Y, Zhu F, Yu H, Yin W. Immunogenicity and safety of a third dose of CoronaVac, and immune persistence of a two-dose schedule, in healthy adults: interim results from two single-centre, double-blind, randomised, placebo-controlled phase 2 clinical trials. Lancet Infect Dis. 2022 Apr;22(4):483-495. doi: 10.1016/S1473-3099(21)00681-2. Epub 2021 Dec 8.
PubMed 34890537
Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, Chen X, Hu Y, Liu X, Jiang C, Li J, Yang M, Song Y, Wang X, Gao Q, Zhu F. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Feb;21(2):181-192. doi: 10.1016/S1473-3099(20)30843-4. Epub 2020 Nov 17.
PubMed 33217362

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 24 Feb 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 and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18~59 Years
ClinicalTrials.gov ID: NCT04352608
Acronym / sponsor ID: PRO-nCOV-1001
Conditions: COVID-19
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 744 participants (actual)
Lead sponsor: Sinovac Research and Development Co., Ltd.Industry (pharma, biotech, devices)
Study start: 16 Apr 2020 (actual)
Primary completion: 10 Jul 2020 (actual)
Study completion: 24 Jul 2021 (actual)
First posted: 20 Apr 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 12

Arm	Type	Receives
Emergency schedule & Two doses of medium dosage vaccine	Experimental	Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the emergency schedule
Emergency schedule & Two doses of high dosage vaccine	Experimental	Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the emergency schedule
Emergency schedule &Two doses of placebo	Placebo comparator	Biological: Two doses of placebo at the emergency vaccination schedule24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the emergency vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the emergency schedule
Routine schedule & Two doses of medium dosage vaccine	Experimental	Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the routine schedule
Routine schedule &Two doses of high dosage vaccine	Experimental	Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the routine schedule
Routine schedule & Two doses of placebo	Placebo comparator	Biological: Two doses of placebo at the routine vaccination schedule24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the routine vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the routine schedule
Emergency schedule & Three doses of medium dosage vaccine	Experimental	Biological: Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Emergency schedule & Three doses of high dosage vaccine	Experimental	Biological: Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Emergency schedule &Three doses of placebo	Placebo comparator	Biological: Three doses of placebo at the emergency vaccination schedule30 participants in phase Ⅱ will receive three doses of placebo at the emergency vaccination schedule
Routine schedule & Three doses of medium dosage vaccine	Experimental	Biological: Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Routine schedule &Three doses of high dosage vaccine	Experimental	Biological: Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Routine schedule &Three doses of placebo	Placebo comparator	Biological: Three doses of placebo at the routine vaccination schedule30 participants in phase Ⅱ will receive three doses of placebo at the routine vaccination schedule

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy adults aged 18-59 years;
Proven legal identity;
Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ;

Key exclusion criteria (27 listed)

Travel history / residence history of Wuhan city and surrounding areas, or other communities with case reports within 14 days;
History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
Self-reported history of SARS;

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
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination scheduleTwo doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.	Biological	Emergency schedule & Two doses of medium dosage vaccine
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination scheduleTwo doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.	Biological	Emergency schedule & Two doses of high dosage vaccine
Two doses of placebo at the emergency vaccination scheduleTwo doses of placebo at the schedule of day 0,14 and one dose of booster immunization with placebo 6 months after the schedule of day 0,14 in phaseⅡ.	Biological	Emergency schedule &Two doses of placebo
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination scheduleTwo doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ.	Biological	Routine schedule & Two doses of medium dosage vaccine
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination scheduleTwo doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ	Biological	Routine schedule &Two doses of high dosage vaccine
Two doses of placebo at the routine vaccination scheduleTwo doses of placebo at the schedule of day 0,28 and one dose of booster immunization with placebo 6 months after the schedule of day 0,28 in phaseⅡ.	Biological	Routine schedule & Two doses of placebo
Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination scheduleThree doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,42	Biological	Emergency schedule & Three doses of medium dosage vaccine
Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination scheduleThree doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14,42	Biological	Emergency schedule & Three doses of high dosage vaccine
Three doses of placebo at the emergency vaccination scheduleThree doses of placebo at the schedule of day 0,14,42	Biological	Emergency schedule &Three doses of placebo
Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination scheduleThree doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,56	Biological	Routine schedule & Three doses of medium dosage vaccine
Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination scheduleThree doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28,56	Biological	Routine schedule &Three doses of high dosage vaccine
Three doses of placebo at the routine vaccination scheduleThree doses of placebo at the schedule of day 0,28,56	Biological	Routine schedule &Three doses of placebo

Primary outcome

Safety indexes of adverse reactions
Time frame: From Day 0 to Day 28 after each dose
Incidence of adverse reactions occured from Day 0 to Day 28 after each dose
Immunogenicity indexes of neutralizing-antibody seroconversion rates
Time frame: The 14th day /the 28th day after two doses of vaccination
The seroconversion rate of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after the two-dose vaccination.

11 secondary outcomes

Safety indexes of adverse reactions
Time frame: 7 days after each dose of vaccination
Safety indexes of Incidence of abnormal laboratory index
Time frame: On the 3th day after each dose of vaccination in phase Ⅰ
Safety indexes of serious adverse events (SAEs）
Time frame: From the beginning of the vaccination to 6 months post the whole-schedule vaccination
Immunogenicity indexes of the seropositive rate, GMT, and GMI of neutralizing antibodies
Time frame: 14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies
Time frame: 28 days after the two doses (emergency schedule)
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅱ
Time frame: 28 days after the third dose （only for days 0,14,42 and days 0,28,56 schedule）
Immunogenicity indexes of the seropositivity rate, GMT, and GMI in Phase Ⅱ
Time frame: 14 day (emergency schedule)/28 days (routine schedule) after the booster dose （only for days 0,14 and days 0,28 schedule）
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ
Time frame: 7/14/21 days after the first dose vaccination (emergency schedule)
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ
Time frame: 28/35/42 days after the first dose vaccination (routine schedules)
Immunogenicity indexes of the seropositive rate of IgG, IgM antibodies
Time frame: 7/14/21/28/42 days after the first dose vaccination (emergency schedule)
Immunogenicity indexes of the seropositive rate of IgG,IgM antibodies
Time frame: 28/35/42/56 days after the first dose vaccination (routine schedule)

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 24 Feb 2022.
Derived from this study: PubMed 35660738Xin Q, Wu Q, Chen X, Han B, Chu K, Song Y, Jin H, Chen P, Lu W, Yang T, Li M, Zhao Y, Pan H, Yu H, Wang L. Six-month follow-up of a booster dose of CoronaVac in two single-centre phase 2 clinical trials. Nat Commun. 2022 Jun 3;13(1):3100. doi: 10.1038/s41467-022-30864-w.
Derived from this study: PubMed 34890537Zeng G, Wu Q, Pan H, Li M, Yang J, Wang L, Wu Z, Jiang D, Deng X, Chu K, Zheng W, Wang L, Lu W, Han B, Zhao Y, Zhu F, Yu H, Yin W. Immunogenicity and safety of a third dose of CoronaVac, and immune persistence of a two-dose schedule, in healthy adults: interim results from two single-centre, double-blind, randomised, placebo-controlled phase 2 clinical trials. Lancet Infect Dis. 2022 Apr;22(4):483-495. doi: 10.1016/S1473-3099(21)00681-2. Epub 2021 Dec 8.
Derived from this study: PubMed 33217362Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, Chen X, Hu Y, Liu X, Jiang C, Li J, Yang M, Song Y, Wang X, Gao Q, Zhu F. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Feb;21(2):181-192. doi: 10.1016/S1473-3099(20)30843-4. Epub 2020 Nov 17.

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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.

Fengcai Zhu, Doctor principal investigator

Jiangsu Province Centers for Disease Control and Prevention

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

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 27 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 24 Feb 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 China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

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

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety indexes of adverse reactions (time frame: From Day 0 to Day 28 after each dose). 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?

On the ClinicalTrials.gov record for NCT04352608, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.