Study of Ameliorating Effect of COVID-19 mRNA Vaccine in Individuals Immunized With Inactivated Vaccine

NCT04944381 | Unknown

• 1 other identifier: 20210624
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

this is a voluntary, investigator-initiated, inactivated COVID-19 vaccine controlled clinical trial to evaluate the immunogenicity and safety of COVID-19 mRNA vaccine in adults aged 18 years and above which have immunized with two dose of inactivated COVID-19 vaccine at least 6 months ago.

Conditions

SARS-CoV-2 Acute Respiratory Disease

Outcome Measures

Primary Outcomes (2)

• the geometric mean titer (GMT) of neutralizing antibody

  the geometric mean titer (GMT) of neutralizing antibody against SARS-Cov-2 14 days and 28 days after vaccine inoculation

  14 days and 28 days

• the incident of solicited adverse events(AEs)

  the incident of solicited AEs at the inoculation (local) and solicited AEs at the non-inoculation (systemic) within 7 days after immunization.

  7 days

Secondary Outcomes (4)

• The Geometric Mean Titer (GMT) of IgG antibody

  14 days and 28 days

• Specific T cells with ELISPOT assay

  28 days

• The incidence of AEs

  28 days

• The incidence of SAEs

  1 year

Study Arms (2)

SARS-Cov-2 mRNA vaccine immunization group

EXPERIMENTAL

The 98 participants will be inoculated with one dose SARS-Cov-2 mRNA vaccine from Stemirna Therapeutics Co., Ltd.

Biological: SARS-Cov-2 mRNA vaccine immunization

Inactivated SARS-Cov-2 vaccine immunization group

EXPERIMENTAL

The 14 participants will be inoculated with one dose inactivated SARS-Cov-2 vaccine from institute of medical biology, Chinese academy of medical sciences(IMBCAMS).

Biological: Inactivated SARS-Cov-2 vaccine immunization

Interventions

SARS-Cov-2 mRNA vaccine immunization BIOLOGICAL

The 98 participants will be inoculated with one dose SARS-Cov-2 mRNA vaccine from Stemirna Therapeutics Co., Ltd and .

SARS-Cov-2 mRNA vaccine immunization group

Inactivated SARS-Cov-2 vaccine immunization BIOLOGICAL

The 14 participants will be inoculated with one dose inactivated SARS-Cov-2 vaccine from institute of medical biology, Chinese academy of medical sciences(IMBCAMS).

Inactivated SARS-Cov-2 vaccine immunization group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and above (including boundary values), both female and male.
• Legal identification of the participants shall be provided.
• the participants have inoculation two doses of inactivated SARS-CoV-2 vaccine (vero cell) was manufactured by IMBCAMS at least 6 months ago.
• Participants shall understand the content in the Informed Consent Form (ICF) and the vaccine for administration, sign the ICF voluntarily and are capable of using thermometers and rulers, and filling in diary cards and contact cards as per the requirements.
• Subject shall be able to communicate well with investigators, understand and comply with the requirements of this study.
• Participants with oral temperature ≤ 37.9 ℃.
• Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile \[i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months\]) must agree to be heterosexually inactive OR consistently use any of the following methods of contraception: a) Condoms (male or female) b) Diaphragm with spermicide c) Cervical cap with spermicide d) Intrauterine device e) Oral or patch contraceptives f) Any country regulatory-approved contraceptive method that is designed to protect against pregnancy g) Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle (other approaches to abstinence are not acceptable).

You may not qualify if:

• Contraindications to commonly used vaccines;
• History of allergy to any vaccines or drug;
• Received any vaccine within 1 month before the vaccination；
• Serious diseases required to be excluded, including but not limited to history of diseases in nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other systems, and a history of malignant tumors;
• Before immunizing the investigational vaccine, 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 blood coagulation dysfunction, or a history of thrombosis or hemorrhagic disease；
• Surgical removal of whole or part of spleen for any reason；
• Those who have undergone surgery within 3 months before signing the ICF or those who plan to undergo surgery during or within 3 months after completion of the trial (including plastic 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 plan blood donation during the trial;
• Those who received other investigational or unregistered products (drugs, vaccines, biological product or devices) in the past 3 months before signing the ICF, or plan to use them during the study.
• Those who received immunosuppressant therapy within 6 months before signing the ICF, such as long-term systemic glucocorticoid treatment (with systemic glucocorticoid therapy for more than 2 consecutive weeks within 6 months, such as prednisone or similar drugs), but local administration is permitted (such as ointment, eye drops, inhalants, or nasal spray). The local administration should not exceed the recommended dose in the package insert or have any signs of systemic exposure;
• Participants cannot meet the criteria through the comprehensive physical examination, mainly including: - Abnormal vital signs with clinical significance (awakening heart rate \<55 beats/min or \>100 beats/min, systolic blood pressure ≥140 millimetre of mercury (mmHg) or diastolic blood pressure ≥90mmHg); - Those who tested positive for type 1 or type 2 human immunodeficiency virus (HIV-1/2) antibody, or SARS-CoV-2 nucleic acid;
• History of COVID-19;
• Participants who have a positive pregnancy test, or are breastfeeding, or planning pregnancy, or plan to donate sperm or eggs within 12 months from the screening period to the whole-course immunization;
• Participants who are considered as inappropriate for the trial by investigators.

Sponsors & Collaborators

• Qihan Li: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: June 29, 2021
• Study Start: July 2, 2021
• Primary Completion: August 2, 2021
• Study Completion: August 2, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share