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Study on Sequential Immunization of Inactivated COVID-19 Vaccine and Recombinant COVID-19 Vaccine (Ad5 Vector) in Elderly Adults

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Recombinant SARS-CoV-2 Ad5 vectored vaccine
Inactive SARS-CoV-2 vaccine (Vero cell)
Sponsored by
Jiangsu Province Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19 Vaccine, Sequential immunization, Heterologous prime-boost, Ad5 vectored vaccine

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Health subjects aged 60 and above, who have been completed two-dose regimen of inactive SARS-CoV-2 vaccine in the past 3-6 months, or received one dose of inactive SARS-CoV-2 vaccine in the past 1-3 months.
  • The subject can provide with informed consent and sign informed consent form (ICF).
  • The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study.
  • Axillary temperature ≤ 37.0#.
  • Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization

Exclusion Criteria:

  • have the medical history or family history of convulsion, epilepsy,encephalopathy and psychosis.
  • be allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination.
  • women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months.
  • have acute febrile diseases and infectious diseases.
  • have severe chronic diseases or condition in progress cannot be controlled.
  • congenital or acquired angioedema / neuroedema
  • have the history of urticaria 1 year before receiving the investigational vaccine.
  • have asplenia or functional asplenia.
  • have thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
  • have needle sickness.
  • have the history of immunosuppressive therapy, anti-allergy therapy,cytotoxic therapy or inhaled corticosteroids (excluding corticosteroidspray therapy for allergic rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months.
  • have received blood products within 4 months before injection of investigational vaccines.
  • under anti-tuberculosis treatment.
  • not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to variousmedical, psychological, social or other conditions.

Sites / Locations

  • Jiangsu Provincial Center for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

heterologous boost arm with Ad5 vectored vaccine

homogeneous boost arm with inactive vaccine

heterologous regimen with Ad5 vectored vaccine

homogeneous regimen arm with inactive vaccine

Arm Description

Subjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster of recombinant SARS-CoV-2 Ad5 vectored vaccine after 3~6 months.

Subjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster dose of inactive SARS-CoV-2 vaccine after 3~6 months.

Subjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of recombinant SARS-CoV-2 Ad5 vectored vaccine after 1~3 months

Subjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of inactive SARS-CoV-2 vaccine after 1~3 months.

Outcomes

Primary Outcome Measures

Incidence of adverse reactions within 28 days after the booster dose.
Incidence of adverse reactions within 28 days after vaccination.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the vaccination.

Secondary Outcome Measures

Incidence of solicited AE within 14 days after the booster dose
Incidence of solicited adverse events (AE) within 14 days after the booster vaccination.
Incidence of unsolicited AE within 28 days after the booster dose.
Incidence of unsolicited adverse events (AE) within 28 days after vaccination.
Incidence of serious adverse events (SAE) till the 6 months after the booster dose.
Incidence of serious adverse events (SAE) till the 6 months after booster vaccination.
GMT of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster dose.
GMT of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA on day 14, day 28 and month 6after the booster vaccination.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.
Fold increase of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.
Fold increase of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA, as compared to baseline, on day 14, day 28 and month 6 after the booster vaccination.
Fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 14, day 28 and month 6 after the booster vaccination.
Fold increase of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, on day 14, day 28 and month 6 after the booster vaccination.
Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.
Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.
Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2virus on day 14, day 28 and month 6 after the booster vaccination.
Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2virus, as compared to baseline, at Day 14, Day 28 and Month 6 after the booster vaccination.
Specific T cell responses on day 14 after the booster vaccination.
Specific T cell responses on day 14 after the booster vaccination detected by ELISPOT.

Full Information

First Posted
July 3, 2021
Last Updated
August 12, 2022
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
CanSino Biologics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04952727
Brief Title
Study on Sequential Immunization of Inactivated COVID-19 Vaccine and Recombinant COVID-19 Vaccine (Ad5 Vector) in Elderly Adults
Official Title
Safety and Immunogenicity of Sequential Immunization of Inactivated COVID-19 Vaccine and Recombinant COVID-19 Vaccine (Ad5 Vector) inChinese Healthy Adults Aged 60 and Above: a Randomized, Observer-blind,Parallel-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 26, 2021 (Actual)
Primary Completion Date
November 26, 2021 (Actual)
Study Completion Date
May 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
CanSino Biologics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, observer-blind, parallel-controlled study, for evaluation of safety and immunogenicity of sequential immunization of a recombinant COVID-19 vaccine (adenovirus type 5 vector) in Chinese healthy adults aged 60 and above after the priming vaccination of inactivated vaccine. 300 healthy subjects aged 60 and above will be recruited in this study. Of them, 200 subjects who have been vaccinated with two dose of inactive SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 3~6 months later. Other 100 subjects who have been vaccinated with one dose of inactivated SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 1~3 months later. The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed. In addition, blood samples will be collected on day 0 before the boosting with ad5 vectored vaccine and on day 14, 28 and month 6 after the boosting. Serum antibody levels, cellular immune responses and the subgroups or germlines of the specific B cells will be analyzed. Each subject will remain in this study for approximately 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19 Vaccine, Sequential immunization, Heterologous prime-boost, Ad5 vectored vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Subjects who have been primed with one dose or two doses of inactive SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive abooster dose of inactive SARS-CoV-2 vaccine or recombinant SARS-CoV-2Ad5 vectored vaccine
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
heterologous boost arm with Ad5 vectored vaccine
Arm Type
Experimental
Arm Description
Subjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster of recombinant SARS-CoV-2 Ad5 vectored vaccine after 3~6 months.
Arm Title
homogeneous boost arm with inactive vaccine
Arm Type
Active Comparator
Arm Description
Subjects who have been primed with two doses of inactive SARS-CoV-2 vaccine will receive a booster dose of inactive SARS-CoV-2 vaccine after 3~6 months.
Arm Title
heterologous regimen with Ad5 vectored vaccine
Arm Type
Experimental
Arm Description
Subjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of recombinant SARS-CoV-2 Ad5 vectored vaccine after 1~3 months
Arm Title
homogeneous regimen arm with inactive vaccine
Arm Type
Active Comparator
Arm Description
Subjects who have been primed with one dose of inactive SARS-CoV-2 vaccine will receive one dose of inactive SARS-CoV-2 vaccine after 1~3 months.
Intervention Type
Biological
Intervention Name(s)
Recombinant SARS-CoV-2 Ad5 vectored vaccine
Other Intervention Name(s)
Ad5-nCoV
Intervention Description
This vaccine contains 5×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle.
Intervention Type
Biological
Intervention Name(s)
Inactive SARS-CoV-2 vaccine (Vero cell)
Other Intervention Name(s)
CoronaVac
Intervention Description
This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle.
Primary Outcome Measure Information:
Title
Incidence of adverse reactions within 28 days after the booster dose.
Description
Incidence of adverse reactions within 28 days after vaccination.
Time Frame
Within 28 days after the booster dose
Title
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.
Description
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the vaccination.
Time Frame
On day 14 after the booster dose
Secondary Outcome Measure Information:
Title
Incidence of solicited AE within 14 days after the booster dose
Description
Incidence of solicited adverse events (AE) within 14 days after the booster vaccination.
Time Frame
within 14 days after the booster dose
Title
Incidence of unsolicited AE within 28 days after the booster dose.
Description
Incidence of unsolicited adverse events (AE) within 28 days after vaccination.
Time Frame
within 28 days after the booster dose
Title
Incidence of serious adverse events (SAE) till the 6 months after the booster dose.
Description
Incidence of serious adverse events (SAE) till the 6 months after booster vaccination.
Time Frame
within 6 months after the booster dose
Title
GMT of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster dose.
Description
GMT of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA on day 14, day 28 and month 6after the booster vaccination.
Time Frame
on day 14, day 28 and month 6 after the booster vaccination
Title
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.
Description
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.
Time Frame
on day 28 and month 6 after the last dose of vaccination
Title
Fold increase of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.
Description
Fold increase of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA, as compared to baseline, on day 14, day 28 and month 6 after the booster vaccination.
Time Frame
on day 14, day 28 and month 6 after the booster vaccination
Title
Fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 14, day 28 and month 6 after the booster vaccination.
Description
Fold increase of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, on day 14, day 28 and month 6 after the booster vaccination.
Time Frame
on day 14, day 28 and month 6 after the last dose of vaccination
Title
Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.
Description
Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.
Time Frame
on day 14, day 28 and month 6 after the booster vaccination
Title
Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2virus on day 14, day 28 and month 6 after the booster vaccination.
Description
Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2virus, as compared to baseline, at Day 14, Day 28 and Month 6 after the booster vaccination.
Time Frame
on day 14, day 28 and month 6 after the booster vaccination
Title
Specific T cell responses on day 14 after the booster vaccination.
Description
Specific T cell responses on day 14 after the booster vaccination detected by ELISPOT.
Time Frame
on day 14 after the booster vaccination
Other Pre-specified Outcome Measures:
Title
Types of IgG binding to SARS-CoV-2 S protein on day 14, day 28 and month 6 after the booster vaccination.
Description
Types of IgG binding to SARS-CoV-2 S protein on day 14, day 28 and month 6 after the booster vaccination.
Time Frame
on day 14, day 28 and month 6 after the booster vaccination
Title
GMT of neutralizing antibodies against P.1 variants on day 28 after the booster vaccination.
Description
GMT of neutralizing antibodies against P.1 variants on day 28 after the booster vaccination.
Time Frame
on day 28 after the booster vaccination
Title
GMT of neutralizing antibodies against 501Y.V2 variants on day 28 after the booster vaccination.
Description
GMT of neutralizing antibodies against 501Y.V2 variants on day 28 after the booster vaccination.
Time Frame
on day 28 after the booster vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Health subjects aged 60 and above, who have been completed two-dose regimen of inactive SARS-CoV-2 vaccine in the past 3-6 months, or received one dose of inactive SARS-CoV-2 vaccine in the past 1-3 months. The subject can provide with informed consent and sign informed consent form (ICF). The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study. Axillary temperature ≤ 37.0#. Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization Exclusion Criteria: have the medical history or family history of convulsion, epilepsy,encephalopathy and psychosis. be allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination. women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months. have acute febrile diseases and infectious diseases. have severe chronic diseases or condition in progress cannot be controlled. congenital or acquired angioedema / neuroedema have the history of urticaria 1 year before receiving the investigational vaccine. have asplenia or functional asplenia. have thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection). have needle sickness. have the history of immunosuppressive therapy, anti-allergy therapy,cytotoxic therapy or inhaled corticosteroids (excluding corticosteroidspray therapy for allergic rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months. have received blood products within 4 months before injection of investigational vaccines. under anti-tuberculosis treatment. not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to variousmedical, psychological, social or other conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-Xin Li, PhD
Organizational Affiliation
Jiangsu Provincial Center for Diseases Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Provincial Center for Diseases Control and Prevention
City
Nanjing
State/Province
Jiangsu
Country
China

12. IPD Sharing Statement

Learn more about this trial

Study on Sequential Immunization of Inactivated COVID-19 Vaccine and Recombinant COVID-19 Vaccine (Ad5 Vector) in Elderly Adults

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