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

NCT05855408 | Unknown Phase 4

• 1 other identifier: JSVCT178
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

SARS-CoV-2; effectiveness; hybrid immunity; booster immunization; adaptive platform trial

Outcome Measures

Primary Outcomes (1)

• The incidence of COVID-19 from 14 days to 6 months after the booster immunization.

  from 14 days to 6 months after the booster dose

Secondary Outcomes (18)

• The incidence of COVID-19 from 7 days to 6 months after the booster immunization.

  from 7 days to 6 months the booster dose

• The incidence of COVID-19 from 28 days to 6 months after the booster immunization.

  from 28 days to 6 months the booster dose

• The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 7 days to 6 months after the booster immunization.

  from 7 days to 6 months the booster dose

• The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 14 days to 6 months after the booster immunization.

  from 14 days to 6 months the booster dose

• The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 28 days to 6 months after the booster immunization.

  from 28 days to 6 months the booster dose

Other Outcomes (8)

• The effectiveness for preventing COVID-19 from 7 days after the booster dose will be analyzed stratified based on the S-RBD IgG antibody level at enrollment.

  on day 7 after the booster dose

• The effectiveness for preventing COVID-19 from 14 days after the booster dose will be analyzed stratified based on the S-RBD IgG antibody level at enrollment.

  on day 14 after the booster dose

• The effectiveness for preventing COVID-19 on day 28 after the booster dose will be analyzed stratified based on the S-RBD IgG antibody level at enrollment.

  on day 28 after the booster dose

Study Arms (5)

Group 1

EXPERIMENTAL

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

Biological: Intramuscularly administered Ad5-nCoV vaccine

Group 2

EXPERIMENTAL

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

Biological: Aerosolized Ad5-nCoV

Group 3

EXPERIMENTAL

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

Biological: DelNS1-2019-nCoV-RBD-OPT1

Group 4

EXPERIMENTAL

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

Biological: SYS6006

Group 5

NO INTERVENTION

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

Interventions

Intramuscularly administered Ad5-nCoV vaccine BIOLOGICAL

This vaccine is produced by CanSino Biologics Inc.

Group 1

Aerosolized Ad5-nCoV BIOLOGICAL

This vaccine is produced by CanSino Biologics Inc.

Group 2

DelNS1-2019-nCoV-RBD-OPT1 BIOLOGICAL

This vaccine is produced by Wantai Biopharmaceutical Company.

Group 3

SYS6006 BIOLOGICAL

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

Group 4

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 over, including the elderly over 60 years and those with underlying diseases.
• Volunteers are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form.
• ≥ 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.

You may not qualify if:

• Volunteers have suspected symptoms of COVID-19 when enrolled, such as dry throat, sore throat, cough, etc.
• The COVID-19 Antigen Quick Test Kit is positive when volunteers are enrolled.
• Fever, temperature \> 37.0°C.
• Have received a second COVID-19 vaccine booster immunization.
• 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).
• Pregnant or lactating women.
• HIV infection, tuberculosis, low immunity caused by disease or long-term medication.
• Acute disease or acute onset of chronic disease.
• Epilepsy and other progressive neurological disorders.
• Other situations that are not suitable for participating in this research, according to the judgment of the researcher.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

SYS6006 COVID-19 vaccine

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

Study Officials

• Jing-Xin Li, PhD

  Jiangsu Provincial Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing-Xin Li, PhD

CONTACT

86-25-83759913; jingxin42102209@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 11, 2023
• Study Start: May 18, 2023
• Primary Completion: May 18, 2024
• Study Completion: December 31, 2024
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

CN (1)