COVID-19Phase 1/2NCT04412538

Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19

A Phase 1/2 study testing Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule, Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule and Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule in people with COVID-19, run by Institute of Medical Biology, Chinese Academy of Medical Sciences 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

This study is a randomized, double-blinded, and placebo-controlled phase Ia/IIa clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged 18~59 Years. Read more about this study

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule, Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule and Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 942 participants
Where: 1 siteChina
Study dates: 15 May 2020to 31 Aug 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

Phase Ia:
Healthy adults aged 18 to 59 years (including boundary values), both men and women.
Proven legal identity.
Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
Axillary temperature ≤37.0 ℃.

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Phase IIa:
Healthy adults aged 18 to 59 years (including boundary values), both men and women.
Proven legal identity.
Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
Axillary temperature ≤37.0 ℃.

Who cannot join

Phase Ia:
Contraindications for vaccination.
History of allergy to vaccines or drugs.
Immunization with any vaccine within 1 month.
History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.

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Those who have a hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis or bleeding disorders.
Those who cannot tolerate venipuncture, or have a history of halo needles or halo blood.
Surgical removal of spleen or other important organs for any reason.
Those who have undergone surgery within 3 months before signing the informed consent, or those who plan to perform surgery during the trial or within 3 months after the end of the trial (including cosmetic surgery, dental and oral surgery).
Those who donated or lost blood (≥400 mL) in the past 3 months, who received blood transfusion or use of blood products, or who planned blood donation during the trial.
Receipt of other investigational or unregistered products (drugs, vaccines, biological product or devices) in the past 3 months, or plan to use other investigational or unregistered products during the study.
Receipt of immunosuppressive therapy within 6 months before signing the informed consent form, such as long-term systemic glucocorticoid therapy (with systemic glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone or similar drugs) ), but local administration (such as ointment, eye drops, inhalation, or nasal spray) is allowed. The local administration should not exceed the dosage recommended in the instructions or have any signs of systemic exposure.
Those who have took soft drugs (such as marijuana) within 3 months before signing the informed consent form or took hard drugs (such as: cocaine, phencyclidine, etc.) within 1 year before the trial.
Those who smoked more than 5 cigarettes per day within 3 months before signing the informed consent form.
The weekly drinking volume is greater than 14 units within 3 months before signing the informed consent form (1 unit alcohol approximately equal to 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine).
The comprehensive physical examination does not meet the health standards, mainly including: (1) Those with abnormal vital signs with clinical significance. (2) BMI<18 kg/m^2 or> 30 kg/m^2. (3) Abnormal laboratory examination with clinical significance. (4) Those who tested positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B e antigen, hepatitis C virus antibody, or Treponema pallidum antibody (tp-trust).
Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 12 months after the second vaccination.
Positive in drug abuse screening during the screening period (Morphine, Methamphetamine, Ketamine, MDMA and Tetrahydrocannabinolic acid).
Positive in alcohol breath test during the screening period.
Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM) screening.
History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) or other coronavirus infection (HCoV-229E, HCoV-OC43, HCoV-NL63, HCoV-HKU1).
History of contact with confirmed or suspected cases infected with SARS-CoV-2 within 1 month.
Any other situations judged by investigators as not suitable for participating in this study.
Phase IIa:
Contraindications for vaccination.
History of allergy to vaccines or drugs.
Immunization with any vaccine within 1 month.
History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
Those who have a hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis or bleeding disorders.
Surgical removal of spleen or other important organs for any reason.
Those who have undergone surgery within 3 months before signing the informed consent, or those who plan to perform surgery during the trial or within 3 months after the end of the trial (including cosmetic surgery, dental and oral surgery).
Those who donated or lost blood (≥400 mL) in the past 3 months, who received blood transfusion or use of blood products, or who planned blood donation during the trial.
Receipt of other investigational or unregistered products (drugs, vaccines, biological product or devices) in the past 3 months, or plan to use other investigational or unregistered products during the study.
Receipt of immunosuppressive therapy within 6 months before signing the informed consent form, such as long-term systemic glucocorticoid therapy (with systemic glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone or similar drugs) ), but local administration (such as ointment, eye drops, inhalation, or nasal spray) is allowed. The local administration should not exceed the dosage recommended in the instructions or have any signs of systemic exposure.
The comprehensive physical examination does not meet the health standards, mainly including: (1) Those with abnormal vital signs (Pulse <55 beats per minute or> 100 beats per minute at rest, Systolic blood pressure ≥140mmHg or Diastolic blood pressure ≥90mmHg, breathing> 20 beats per minute or <12 beats per minute). (2) Those who tested positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B e antigen, hepatitis C virus antibody, or Treponema pallidum antibody (tp-trust).
Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 12 months after the second vaccination.
Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM) screening.
History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) or other coronavirus infection (HCoV-229E, HCoV-OC43, HCoV-NL63, HCoV-HKU1).
History of contact with confirmed or suspected cases infected with SARS-CoV-2 within 1 month.
Any other situations judged by investigators as not suitable for participating in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

West China Second University Hospital, Sichuan University / West China women's and children's Hospital
Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase Ia/IIa Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged 18 to 59 Years

Read the detailed description

This phase Ia/IIa trial is designed to evaluate the safety and immunogenicity of different doses of the Inactivated SARS-CoV-2 Vaccine inoculated with different immunization schedules based upon the randomized, double-blind and placebo-controlled principle. A total of 942 subjects aged 18 to 59 years old will be enrolled in the study, of which 192 and 750 will be enrolled for phase Ia and phase Ⅱa,respectively.The enrolled subjects in phase Ia receive two doses of low-, medium-, or high-dose of experimental vaccines or placebo at an interval of 14 or 28 days, while the enrolled subjects in Phase Ⅱa receive two doses of medium, high-dose experimental vaccines or placebo at an interval of 14 or 28 days.

Conditions: COVID-19
Being tested: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule, Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule, Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule, Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule, High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day 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.

Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleBiological
Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day scheduleBiological
Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleBiological
Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day scheduleBiological
Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleBiological
Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day scheduleBiological
Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
Placebo on a 0- and 28-day scheduleBiological
Two doses of placebo at the vaccination schedule of day 0,28
Placebo on a 0- and 14-day scheduleBiological
Two doses of placebo at the vaccination schedule of day 0,14

Study groups in NCT04412538
Study group	Role	What they receive
Low dosage vaccine on a 0- and 28-day schedule	Experimental	Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28 Receives: Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
Low dosage vaccine on a 0- and 14-day schedule	Experimental	Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14 Receives: Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
Medium dosage vaccine on a 0- and 28-day schedule	Experimental	Two doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28 Receives: Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
Medium dosage vaccine on a 0- and 14-day schedule	Experimental	Two doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14 Receives: Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
High dosage vaccine on a 0- and 28-day schedule	Experimental	Two doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28 Receives: Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
High dosage vaccine on a 0- and 14-day schedule	Experimental	Two doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14 Receives: Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
Placebo on a 0- and 28-day schedule	Placebo comparator	Two doses of placebo at the vaccination schedule of day 0, 28 Receives: Biological: Placebo on a 0- and 28-day schedule
Placebo on a 0- and 14-day schedule	Placebo comparator	Two doses of placebo at the vaccination schedule of day 0, 14 Receives: Biological: Placebo on a 0- and 14-day schedule

What is being measured

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

Adverse reactions/events rate
Occurence of adverse reactions/events after vaccination
Measured: 7 days after vaccination
Adverse reactions/events rate
Occurence of adverse reactions/events after vaccination
Measured: 28 days after vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
Measured: 14 days after the second vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
Measured: 28 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
Measured: 14 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
Measured: 28 days after the second vaccination

Secondary outcomes (13)

Serious adverse events
Occurence of Serious adverse events after vaccination
Measured: 12 months after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14
Measured: 7, 14 and 28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
Measured: 14 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
Measured: 7, 14 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
Measured: 14 and 28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28
Measured: 7 and 28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
Measured: 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
Measured: 7 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
Measured: 28 days after the second vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14
Measured: 14 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
Measured: 14 days after the second vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28
Measured: 28 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
Measured: 28 days after the second vaccination

Timeline

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

15 May 202031 Aug 2021

First posted2 Jun 2020
Study start15 May 2020
Primary completion10 Aug 2020
Study completion31 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)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: 942 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04412538
Sponsor's protocol ID: 20200401
Status last verified: Oct 2023
First submitted: 21 May 2020
Last updated: 11 Oct 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Pu J, Yu Q, Yin Z, Zhang Y, Li X, Yin Q, Chen H, Long R, Zhao Z, Mou T, Zhao H, Feng S, Xie Z, Wang L, He Z, Liao Y, Fan S, Jiang R, Wang J, Zhang L, Li J, Zheng H, Cui P, Jiang G, Guo L, Xu M, Yang H, Lu S, Wang X, Gao Y, Xu X, Cai L, Zhou J, Yu L, Chen Z, Hong C, Du D, Zhao H, Li Y, Ma K, Ma Y, Liu D, Yao S, Li C, Che Y, Liu L, Li Q. The safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in Chinese adults aged 18-59 years: A phase I randomized, double-blinded, controlled trial. Vaccine. 2021 May 12;39(20):2746-2754. doi: 10.1016/j.vaccine.2021.04.006. Epub 2021 Apr 9.
PubMed 33875266
Che Y, Liu X, Pu Y, Zhou M, Zhao Z, Jiang R, Yin Z, Xu M, Yin Q, Wang J, Pu J, Zhao H, Zhang Y, Wang L, Jiang Y, Lei J, Zheng Y, Liao Y, Long R, Yu L, Cui P, Yang H, Zhang Y, Li J, Chen W, He Z, Ma K, Hong C, Li D, Jiang G, Liu D, Xu X, Fan S, Cheng C, Zhao H, Yang J, Li Y, Zou Y, Zhu Y, Zhou Y, Guo Y, Yang T, Chen H, Xie Z, Li C, Li Q. Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in Healthy Adults. Clin Infect Dis. 2021 Dec 6;73(11):e3949-e3955. doi: 10.1093/cid/ciaa1703.
PubMed 33165503

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 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Phase Ia/IIa Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged 18 to 59 Years
ClinicalTrials.gov ID: NCT04412538
Acronym / sponsor ID: 20200401
Conditions: COVID-19
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 942 participants (actual)
Lead sponsor: Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
Collaborators: West China Second University Hospital, Yunnan Center for Disease Control and Prevention
Study start: 15 May 2020 (actual)
Primary completion: 10 Aug 2020 (actual)
Study completion: 31 Aug 2021 (actual)
First posted: 2 Jun 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: 8

Arm	Type	Receives
Low dosage vaccine on a 0- and 28-day schedule	Experimental	Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleTwo doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
Low dosage vaccine on a 0- and 14-day schedule	Experimental	Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day scheduleTwo doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14
Medium dosage vaccine on a 0- and 28-day schedule	Experimental	Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleTwo doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
Medium dosage vaccine on a 0- and 14-day schedule	Experimental	Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day scheduleTwo doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14
High dosage vaccine on a 0- and 28-day schedule	Experimental	Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleTwo doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
High dosage vaccine on a 0- and 14-day schedule	Experimental	Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day scheduleTwo doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14
Placebo on a 0- and 28-day schedule	Placebo comparator	Biological: Placebo on a 0- and 28-day scheduleTwo doses of placebo at the vaccination schedule of day 0, 28
Placebo on a 0- and 14-day schedule	Placebo comparator	Biological: Placebo on a 0- and 14-day scheduleTwo doses of placebo at the vaccination schedule of day 0, 14

Who may qualify

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

Key inclusion criteria (12 listed)

Phase Ia:
Phase IIa:

Key exclusion criteria (42 listed)

Phase Ia:
Phase IIa:

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
Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleTwo doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28	Biological	Low dosage vaccine on a 0- and 28-day schedule
Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day scheduleTwo doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14	Biological	Low dosage vaccine on a 0- and 14-day schedule
Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleTwo doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28	Biological	Medium dosage vaccine on a 0- and 28-day schedule
Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day scheduleTwo doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14	Biological	Medium dosage vaccine on a 0- and 14-day schedule
High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleTwo doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28	Biological	High dosage vaccine on a 0- and 28-day schedule
High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day scheduleTwo doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14	Biological	High dosage vaccine on a 0- and 14-day schedule
Placebo on a 0- and 28-day scheduleTwo doses of placebo at the vaccination schedule of day 0,28	Biological	Placebo on a 0- and 28-day schedule
Placebo on a 0- and 14-day scheduleTwo doses of placebo at the vaccination schedule of day 0,14	Biological	Placebo on a 0- and 14-day schedule

Primary outcome

Adverse reactions/events rate
Time frame: 7 days after vaccination
Occurence of adverse reactions/events after vaccination
Adverse reactions/events rate
Time frame: 28 days after vaccination
Occurence of adverse reactions/events after vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Time frame: 14 days after the second vaccination
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Time frame: 28 days after the second vaccination
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Time frame: 14 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Time frame: 28 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28

13 secondary outcomes

Serious adverse events
Time frame: 12 months after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Time frame: 7, 14 and 28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Time frame: 14 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Time frame: 7, 14 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Time frame: 14 and 28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Time frame: 7 and 28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Time frame: 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Time frame: 7 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Time frame: 28 days after the second vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Time frame: 14 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Time frame: 14 days after the second vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Time frame: 28 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Time frame: 28 days after the 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 11 Oct 2023.
Derived from this study: PubMed 33875266Pu J, Yu Q, Yin Z, Zhang Y, Li X, Yin Q, Chen H, Long R, Zhao Z, Mou T, Zhao H, Feng S, Xie Z, Wang L, He Z, Liao Y, Fan S, Jiang R, Wang J, Zhang L, Li J, Zheng H, Cui P, Jiang G, Guo L, Xu M, Yang H, Lu S, Wang X, Gao Y, Xu X, Cai L, Zhou J, Yu L, Chen Z, Hong C, Du D, Zhao H, Li Y, Ma K, Ma Y, Liu D, Yao S, Li C, Che Y, Liu L, Li Q. The safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in Chinese adults aged 18-59 years: A phase I randomized, double-blinded, controlled trial. Vaccine. 2021 May 12;39(20):2746-2754. doi: 10.1016/j.vaccine.2021.04.006. Epub 2021 Apr 9.
Derived from this study: PubMed 33165503Che Y, Liu X, Pu Y, Zhou M, Zhao Z, Jiang R, Yin Z, Xu M, Yin Q, Wang J, Pu J, Zhao H, Zhang Y, Wang L, Jiang Y, Lei J, Zheng Y, Liao Y, Long R, Yu L, Cui P, Yang H, Zhang Y, Li J, Chen W, He Z, Ma K, Hong C, Li D, Jiang G, Liu D, Xu X, Fan S, Cheng C, Zhao H, Yang J, Li Y, Zou Y, Zhu Y, Zhou Y, Guo Y, Yang T, Chen H, Xie Z, Li C, Li Q. Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in Healthy Adults. Clin Infect Dis. 2021 Dec 6;73(11):e3949-e3955. doi: 10.1093/cid/ciaa1703.

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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.

Qin Yu principal investigator

West China Second University Hospital

Xiaoqiang Liu principal investigator

Yunnan Center 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 12 inclusion and 42 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 11 Oct 2023. 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?

Adverse reactions/events rate (time frame: 7 days after vaccination). The study lists 6 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 NCT04412538, which also lists 2 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 11 Oct 2023.