Effectiveness of a Second COVID-19 Vaccine Booster in Chinese Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-18

Study Completion Date

2024-12-31

Brief Summary

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This is a multicenter, parallel groups, partially randomized, open-label, blank-controlled adaptive platform study to evaluate the effectiveness of a second COVID-19 vaccine booster in Chinese adults who are charactered as the majority of whom with hybrid immunity of COVID-19 vaccination and COVID-19 breakthrough infection. Individuals aged 18 years and over, include the elderly over 60 years old or those with underlying diseases (history of underlying medical conditions diagnosed by a clinician, including hypertension, diabetes, heart disease, etc). The eligible participants with an interval ≥ 4 months after previous SARS-CoV-2 infection (or had never been infected) and ≥ 6 months from the first COVID-19 vaccine booster will be recruited. Participants who are not willing to receive the second booster but are consent to participate the surveillance for COVID-19, will be included as a blank control. Informed consent will be acquired from eligible participants. Other participants who are willing to receive the second booster and participate the surveillance for COVID-19, will be randomly allocated in a ratio of 1: k (k is the number of vaccine types) to the different investigational vaccines, stratified according to age and history of COVID-19 infection. The symptomatic COVID-19 cases will be reported and documented in both the investigational and control groups. The occurrence of serious adverse events within 6 months after vaccination will be observed. Moreover, blood and nasal mucosa samples will be collected on the day 0 before and day 14, month 3 and 6 after the booster vaccination in a subgroup for humoral, cellular and mucosal immunogenicity analysis. Moreover, oral specimens will be collected once for all participants on the day of enrollment.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

Subjects are assigned to receive one dose of intramuscularly administered Ad5-nCoV vaccine as the second booster.

Group Type EXPERIMENTAL

Intramuscularly administered Ad5-nCoV vaccine

Intervention Type BIOLOGICAL

This vaccine is produced by CanSino Biologics Inc.

Group 2

Subjects are assigned to receive one dose of aerosolized Ad5-nCoV vaccine as the second booster.

Group Type EXPERIMENTAL

Aerosolized Ad5-nCoV

Intervention Type BIOLOGICAL

This vaccine is produced by CanSino Biologics Inc.

Group 3

Subjects are assigned to receive two doses of DelNS1-2019-nCoV-RBD-OPT1 vaccine as the second booster.

Group Type EXPERIMENTAL

DelNS1-2019-nCoV-RBD-OPT1

Intervention Type BIOLOGICAL

This vaccine is produced by Wantai Biopharmaceutical Company.

Group 4

Subjects are assigned to receive one dose of SYS6006 vaccine as the second booster.

Group Type EXPERIMENTAL

SYS6006

Intervention Type BIOLOGICAL

This vaccine is produced by CSPC Pharmaceutical Group Co., Ltd.

Group 5

Subjects are not assigned any vaccines served as a blank control.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intramuscularly administered Ad5-nCoV vaccine

This vaccine is produced by CanSino Biologics Inc.

Intervention Type BIOLOGICAL

Aerosolized Ad5-nCoV

This vaccine is produced by CanSino Biologics Inc.

Intervention Type BIOLOGICAL

DelNS1-2019-nCoV-RBD-OPT1

This vaccine is produced by Wantai Biopharmaceutical Company.

Intervention Type BIOLOGICAL

SYS6006

This vaccine is produced by CSPC Pharmaceutical Group Co., Ltd.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Adults aged 18 years and over, including the elderly over 60 years and those with underlying diseases.
2. Volunteers are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form.
3. ≥ 4 months from the last SARS-CoV-2 infection (or never been infected), and 6 months or more from the first booster immunization of the COVID-19 vaccine.

Exclusion Criteria

1. Volunteers have suspected symptoms of COVID-19 when enrolled, such as dry throat, sore throat, cough, etc.
2. The COVID-19 Antigen Quick Test Kit is positive when volunteers are enrolled.
3. Fever, temperature \> 37.0°C.
4. Have received a second COVID-19 vaccine booster immunization.
5. Have a history of serious adverse reactions related to the vaccine and/or have a history of severe allergic reactions to any component of the investigational vaccine (only applicable to the vaccine groups).
6. Pregnant or lactating women.
7. HIV infection, tuberculosis, low immunity caused by disease or long-term medication.
8. Acute disease or acute onset of chronic disease.
9. Epilepsy and other progressive neurological disorders.
10. Other situations that are not suitable for participating in this research, according to the judgment of the researcher.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes