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

NCT04412538 | Completed Phase 1 DMC

• 1 other identifier: 20200401
• Study Type: interventional
• Target: 942
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (6)

• Adverse reactions/events rate

  Occurence of adverse reactions/events after vaccination

  7 days after vaccination

• Adverse reactions/events rate

  Occurence of adverse reactions/events after vaccination

  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

  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

  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

  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

  28 days after the second vaccination

Secondary Outcomes (13)

• Serious adverse events

  12 months after the second vaccination

• Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)

  7, 14 and 28 days after the second vaccination

• Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)

  14 and 28 days after the second vaccination

• Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)

  7, 14 and 28 days after the second vaccination

• Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)

  14 and 28 days after the second vaccination

Other Outcomes (16)

• Level of IgM antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)

  7, 14 and 28 days after the second vaccination

• Level of IgM antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)

  14 and 28 days after the second vaccination

• Level of anti-N protein antibodies Phase Ia (Day 0, 14 schedule)

  7, 14 and 28 days after the second vaccination

Study Arms (8)

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

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

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

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

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

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

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

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

Biological: Placebo on a 0- and 14-day schedule

Interventions

Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule BIOLOGICAL

Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28

Low dosage vaccine on a 0- and 28-day schedule

Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule BIOLOGICAL

Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14

Low dosage vaccine on a 0- and 14-day schedule

Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule BIOLOGICAL

Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28

Medium dosage vaccine on a 0- and 28-day schedule

Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule BIOLOGICAL

Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14

Medium dosage vaccine on a 0- and 14-day schedule

High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule BIOLOGICAL

Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28

High dosage vaccine on a 0- and 28-day schedule

High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule BIOLOGICAL

Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14

High dosage vaccine on a 0- and 14-day schedule

Placebo on a 0- and 28-day schedule BIOLOGICAL

Two doses of placebo at the vaccination schedule of day 0,28

Placebo on a 0- and 28-day schedule

Placebo on a 0- and 14-day schedule BIOLOGICAL

Two doses of placebo at the vaccination schedule of day 0,14

Placebo on a 0- and 14-day schedule

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 ℃.
• 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 ℃.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Institute of Medical Biology, Chinese Academy of Medical Sciences: lead
• West China Second University Hospital: collaborator
• Yunnan Center for Disease Control and Prevention: collaborator

Study Sites (1)

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

Chengdu, Sichuan, 610041, China

Location

Related Publications (2)

• 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.

  PMID: 33875266 DERIVED

• 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.

  PMID: 33165503 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Appointments and Schedules

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration

Study Officials

• Qin Yu

  West China Second University Hospital

  PRINCIPAL INVESTIGATOR

• Xiaoqiang Liu

  Yunnan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 2, 2020
• Study Start: May 15, 2020
• Primary Completion: August 10, 2020
• Study Completion: August 31, 2021
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

CN (1)