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Study on Sequential Immunization of Inactivated SARS-CoV-2 Vaccine and Recombinant SARS-CoV-2 Vaccine (Ad5 Vector)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04892459
Recruitment Status : Completed
First Posted : May 19, 2021
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
CanSino Biologics Inc.
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

Study Description
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Brief Summary:
This is a randomized, observer-blind, parallel-controlled study, for evaluation of safety and immunogenicity of sequential immunization of a recombinant SARS-CoV-2 vaccine (adenovirus type 5 vector) in Chinese healthy adults aged 18-59 years after the priming vaccination of inactivated vaccine. 300 healthy subjects aged 18-59 years 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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Recombinant SARS-CoV-2 Ad5 vectored vaccine Biological: Inactive SARS-CoV-2 vaccine (Vero cell) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 a booster dose of inactive SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Unblinded staff will responsible for the vaccine administration and management, and other investigators will be kept blinded.
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Sequential Immunization of Inactivated SARS-CoV-2 Vaccine and Recombinant SARS-CoV-2 Vaccine (Ad5 Vector) in Chinese Healthy Adults Aged 18-59 Years: a Randomized, Observer-blind, Parallel-controlled Clinical Trial
Actual Study Start Date : May 25, 2021
Actual Primary Completion Date : July 25, 2021
Actual Study Completion Date : December 25, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: heterologous boost arm with Ad5 vectored vaccine
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.
 Biological: Recombinant SARS-CoV-2 Ad5 vectored vaccine
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.
Other Name: Ad5-nCoV
Active Comparator: homogeneous boost arm with inactive vaccine
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.
 Biological: Inactive SARS-CoV-2 vaccine (Vero cell)
This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle.
Other Name: CoronaVac
Experimental: heterologous regimen with Ad5 vectored vaccine
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.
 Biological: Recombinant SARS-CoV-2 Ad5 vectored vaccine
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.
Other Name: Ad5-nCoV
Active Comparator: homogeneous regimen arm with inactive vaccine
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.
 Biological: Inactive SARS-CoV-2 vaccine (Vero cell)
This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle.
Other Name: CoronaVac


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse reactions within 28 days after the booster dose. [ Time Frame: Within 28 days after the booster dose ]
    Incidence of adverse reactions within 28 days after vaccination.

  2. GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose. [ Time Frame: 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 :
  1. Incidence of solicited AE within 14 days after the booster dose [ Time Frame: within 14 days after the booster dose ]
    Incidence of solicited adverse events (AE) within 14 days after the booster vaccination.

  2. Incidence of unsolicited AE within 28 days after the booster dose. [ Time Frame: within 28 days after the booster dose ]
    Incidence of unsolicited adverse events (AE) within 28 days after vaccination.

  3. Incidence of serious adverse events (SAE) till the 6 months after the booster dose. [ Time Frame: within 6 months after the booster dose ]
    Incidence of serious adverse events (SAE) till the 6 months after booster vaccination.

  4. GMT of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster dose. [ Time Frame: on day 14, day 28 and month 6 after the booster vaccination ]
    GMT of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA on day 14, day 28 and month 6 after the booster vaccination.

  5. 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 ]
    GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.

  6. 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. [ Time Frame: 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.

  7. Fold increase of neutralizing antibodies against live SARS-CoV-2 virus 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 ]
    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.

  8. 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 ]
    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.

  9. Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2 virus 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 ]
    Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, at Day 14, Day 28 and Month 6 after the booster vaccination.

  10. Specific T cell responses on day 14 after the booster vaccination. [ Time Frame: on day 14 after the booster vaccination ]
    Specific T cell responses on day 14 after the booster vaccination detected by ELISPOT.


Other Outcome Measures:
  1. 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 ]
    Types of IgG binding to SARS-CoV-2 S protein on day 14, day 28 and month 6 after the booster vaccination.

  2. GMT of neutralizing antibodies against P.1 virants on day 28 after the booster vaccination. [ Time Frame: on day 28 after the booster vaccination ]
    GMT of neutralizing antibodies against P.1 virants on day 28 after the booster vaccination.

  3. GMT of neutralizing antibodies against 501Y.V2 virants on day 28 after the booster vaccination. [ Time Frame: on day 28 after the booster vaccination ]
    GMT of neutralizing antibodies against 501Y.V2 virants on day 28 after the booster vaccination.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Health subjects aged 18-59 years, 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 corticosteroid spray 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 various medical, psychological, social or other conditions.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04892459


Locations
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China, Jiangsu
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
CanSino Biologics Inc.
Investigators
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Principal Investigator: Jing-Xin Li, PhD Jiangsu Provincial Center for Diseases Control and Prevention
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT04892459    
Other Study ID Numbers: JSVCT116
First Posted: May 19, 2021    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
SARS-CoV-2 Vaccine
Sequential immunization
Heterologous prime-boost
Ad5 vectored vaccine
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs