Official Title
Effectiveness of a Second COVID-19 Vaccine Booster in Chinese Adults Aged 18 Years or Above: a Multicenter, Parallel Groups, Partially Randomized, Open-label, Blank-controlled Adaptive Platform Trial
Brief Summary

This is a multicenter, parallel groups, partially randomized, open-label,blank-controlled adaptive platform study to evaluate the effectiveness of a secondCOVID-19 vaccine booster in Chinese adults who are charactered as the majority of whomwith 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 withunderlying diseases (history of underlying medical conditions diagnosed by a clinician,including hypertension, diabetes, heart disease, etc). The eligible participants with aninterval ≥ 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 whoare not willing to receive the second booster but are consent to participate thesurveillance for COVID-19, will be included as a blank control. Informed consent will beacquired from eligible participants. Other participants who are willing to receive thesecond booster and participate the surveillance for COVID-19, will be randomly allocatedin a ratio of 1: k (k is the number of vaccine types) to the different investigationalvaccines, stratified according to age and history of COVID-19 infection. The symptomaticCOVID-19 cases will be reported and documented in both the investigational and controlgroups. The occurrence of serious adverse events within 6 months after vaccination willbe observed. Moreover, blood and nasal mucosa samples will be collected on the day 0before 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 collectedonce for all participants on the day of enrollment.

Detailed Description

Not Provided

Not yet recruiting
COVID-19

Biological: Intramuscularly administered Ad5-nCoV vaccine

This vaccine is produced by CanSino Biologics Inc.

Biological: Aerosolized Ad5-nCoV

This vaccine is produced by CanSino Biologics Inc.

Biological: DelNS1-2019-nCoV-RBD-OPT1

This vaccine is produced by Wantai Biopharmaceutical Company.

Biological: SYS6006

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

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China

Investigator: Jing-Xin Li, PhD
Contact: 86-25-83759913
jingxin42102209@126.com

Contacts

Jing-Xin Li, PhD
86-25-83759913
jingxin42102209@126.com

Jing-Xin Li, PhD, Principal Investigator
Jiangsu Provincial Center for Diseases Control and Prevention

Jiangsu Province Centers for Disease Control and Prevention
NCT Number
Keywords
SARS-CoV-2
Effectiveness
hybrid immunity
booster immunization
adaptive platform trial
MeSH Terms
COVID-19