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Not yet recruitingNCT05855408Updated May 22, 2023

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

A Phase 4 interventional study of Intramuscularly administered Ad5-nCoV vaccine and Aerosolized Ad5-nCoV in COVID-19, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-22.

Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
10,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • COVID-19

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Keywords

  • SARS-CoV-2
  • effectiveness
  • hybrid immunity
  • booster immunization
  • adaptive platform trial
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10,000 participants (estimated)

Study arms

  • Experimental
    Group 1

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

    Biological: Intramuscularly administered Ad5-nCoV vaccine

  • Experimental
    Group 2

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

    Biological: Aerosolized Ad5-nCoV

  • Experimental
    Group 3

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

    Biological: DelNS1-2019-nCoV-RBD-OPT1

  • Experimental
    Group 4

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

    Biological: SYS6006

  • No intervention
    Group 5

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

Interventions

  • BiologicalIntramuscularly administered Ad5-nCoV vaccine

    This vaccine is produced by CanSino Biologics Inc.

  • BiologicalAerosolized Ad5-nCoV

    This vaccine is produced by CanSino Biologics Inc.

  • BiologicalDelNS1-2019-nCoV-RBD-OPT1

    This vaccine is produced by Wantai Biopharmaceutical Company.

  • BiologicalSYS6006

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

05

What researchers measure

Primary outcomes

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

    Time frame: from 14 days to 6 months after the booster dose

Secondary outcomes

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

    Time frame: from 7 days to 6 months the booster dose

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

    Time frame: from 28 days to 6 months the booster dose

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

    Time frame: from 7 days to 6 months the booster dose

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

    Time frame: from 14 days to 6 months the booster dose

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

    Time frame: from 28 days to 6 months the booster dose

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

    Time frame: from 7 days to 6 months the booster dose

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

    Time frame: from 14 days to 6 months the booster dose

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

    Time frame: from 28 days to 6 months the booster dose

  9. Geometric mean titer (GMT), Geometric mean fold increase (GMFI) and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on day 14 after the booster vaccination in the immunogenic subgroup.

    Time frame: On day 14 after the booster vaccination

  10. GMT, GMFI and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on month 3 after the booster vaccination in the immunogenic subgroup.

    Time frame: On month 3 after the booster vaccination

  11. GMT, GMFI and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on month 6 after the booster vaccination in the immunogenic subgroup.

    Time frame: On month 6 after the booster vaccination

  12. GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on day 14 after the booster vaccination in the immunogenic subgroup.

    Time frame: On day 14 after the booster vaccination

  13. GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on month 3 after the booster vaccination in the immunogenic subgroup.

    Time frame: On month 3 after the booster vaccination

  14. GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on month 6 after the booster vaccination in the immunogenic subgroup.

    Time frame: On month 6 after the booster vaccination

  15. GMT, GMFI and seroconversion of nasal specific IgA antibodies on day 14 after the booster vaccination in the immunogenic subgroup.

    Time frame: On day 14 after the booster vaccination

  16. GMT, GMFI and seroconversion of nasal specific IgA antibodies on month 3 after the booster vaccination in the immunogenic subgroup.

    Time frame: On month 3 after the booster vaccination

  17. GMT, GMFI and seroconversion of nasal specific IgA antibodies on month 6 after the booster vaccination in the immunogenic subgroup.

    Time frame: On month 6 after the booster vaccination

  18. The incidence of serious adverse events within 6 months after the booster vaccination.

    Time frame: within 6 months after the booster dose

Other outcomes

  1. 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.

    Time frame: on day 7 after the booster dose

  2. 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.

    Time frame: on day 14 after the booster dose

  3. 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.

    Time frame: on day 28 after the booster dose

  4. Cross-neutralizing antibody levels against other variants on day 14 after the booster vaccination in the immunogenic subgroup.

    Time frame: On day 14 after the booster vaccination

  5. Cross-neutralizing antibody levels against other variants on month 3 after the booster vaccination in the immunogenic subgroup.

    Time frame: On month 3 after the booster vaccination

  6. Cross-neutralizing antibody levels against other variants on month 6 after the booster vaccination in the immunogenic subgroup.

    Time frame: On month 6 after the booster vaccination

  7. Effectiveness and immunogenicity after the second booster immunization will be subgroup analyzed in the elderly over 60 years old and those with underlying diseases.

    Time frame: from 14 days to 6 months after the booster dose

  8. The impact of the human genome on the effect of vaccination.

    Time frame: from 14 days to 6 months after the booster dose

06

Study locations

1 site
  • Jiangsu Provincial Center for Disease Control and Prevention
    Nanjing, Jiangsu 210009, China
07

Registry details

Key details

Study ID
NCT05855408
Lead sponsor
Jiangsu Province Centers for Disease Control and Prevention
Responsible party
Sponsor
First posted
May 11, 2023
Start date
May 18, 2023 (estimated)
Primary completion
May 18, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 22, 2023

Study contacts

Jing-Xin Li, PhD
Contact
jingxin42102209@126.com
86-25-83759913
Jing-Xin Li, PhD
principal investigator · Jiangsu Provincial Center for Diseases Control and Prevention

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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