- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04833101
Study on Heterologous Prime-boost of Recombinant COVID-19 Vaccine (Ad5 Vector) and RBD-based Protein Subunit Vaccine
March 28, 2022 updated by: Jiangsu Province Centers for Disease Control and Prevention
Safety and Immunogenicity of a Heterologous Immunization of Recombinant COVID-19 Vaccine (Ad5 Vector) and RBD-based Protein Subunit Vaccine Against COVID-19 in Chinese Healthy Population
This is a randomized, observer-blind, placebo-controlled study, for evaluation of safety and immunogenicity of heterologous prime-boost immunization of recombinant COVID-19 vaccine (adenovirus type-5 vector) and RBD-based protein subunit vaccine (ZF2001) against COVID-19 in Chinese healthy population.
120 healthy subjects aged over 18 years of age who have been vaccinated with recombinant adenovirus type-5 vectored vaccine will be recruited in this study.
Of them, 60 subjects will be enrolled in the "0-28 days" regimen and other 60 will be enrolled in "0-56 days" regimen.
Subjects, 30 of them are 18-59 years old and 30 are 60 years old and above in each regimen will be randomly vaccinated with the second dose of subunit vaccine(ZF2001) against COVID-19 or a commercial influenza vaccine in a ratio of 2:1.
They will then be vaccinated with the third dose of ZF2001 on month 4 after the second dose.
The occurrence of adverse events within 28 days and serious adverse events within 6 months after the last vaccination will be observed.
In addition, blood samples will be collected on day 0 before the second vaccination, day 14, 28 after the second vaccination and day 14, month 6 after third vaccination to test serum antibody levels and to profile the immune cells' subgroups and germlines.
Each subject will remain in this study for approximately 12 months.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China
- Jiangsu Provincial Center for Diseases Control and Prevention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subjects ≥ 18 years old who has completed one dose of recombinant Ad5 vectored COVID-19 vaccine.
- The subjects 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 can 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 these products immunization.
Exclusion Criteria:
- have a 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 smoothly controlled, such as asthma, diabetes, thyroid disease
- Congenital or acquired angioedema / neuroedema.
- have the history of urticaria 1 year before receiving the trial vaccine.
- have asplenia or functional asplenia.
- have thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
- 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 trial vaccines.
- have received another investigational product within one month before injection of trial vaccine.
- have received attenuated vaccine within 1 month before injection of trial vaccine except the recombinant Ad5 vectored COVID-19 vaccine.
- have received subunit or inactivated vaccine within 14 days before the vaccination with trial vaccine.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: "0-28 days" vaccine group
One dose of recombinant Ad5 vectored COVID-19 vaccine on day 0, the second dose of subunit vaccine (ZF2001) against COVID-19 on day 28, and a third of subunit vaccine (ZF2001) against COVID-19 on month 4.
|
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 Names:
This is a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19, made by using CHO cell, 25μg/dose, produced by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.
Other Names:
|
Placebo Comparator: "0-28 days" placebo group
One dose of recombinant Ad5 vectored COVID-19 vaccine on day 0, the second dose of a commercial influenza vaccine on day 28, a third of subunit vaccine (ZF2001) against COVID-19 on month 4.
|
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 Names:
This is a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19, made by using CHO cell, 25μg/dose, produced by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.
Other Names:
This vaccine contains 15 μ g H1NI, 15 μ g H3N2 and 15 μ g B-series hemagglutinin, produced by Dalian Aleph Biomedical Co., Ltd.It is a liquid dosage form, 0.5 ml / bottle.
|
Experimental: "0-56 days" vaccine group
One dose of recombinant Ad5 vectored COVID-19 vaccine on day 0, the second dose of subunit vaccine (ZF2001) against COVID-19 on day 56, a third of subunit vaccine (ZF2001) against COVID-19 on month 4.
|
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 Names:
This is a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19, made by using CHO cell, 25μg/dose, produced by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.
Other Names:
|
Placebo Comparator: "0-56 days" placebo group
One dose of recombinant Ad5 vectored COVID-19 vaccine on day 0, the second dose of a commercial influenza vaccine on day 56, a third of subunit vaccine (ZF2001) against COVID-19 on month 4.
|
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 Names:
This is a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19, made by using CHO cell, 25μg/dose, produced by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.
Other Names:
This vaccine contains 15 μ g H1NI, 15 μ g H3N2 and 15 μ g B-series hemagglutinin, produced by Dalian Aleph Biomedical Co., Ltd.It is a liquid dosage form, 0.5 ml / bottle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of solicited adverse events within 7 days after vaccination.
Time Frame: Within 7 days after vaccination
|
Incidence of solicited adverse events within 7 days after vaccination.
|
Within 7 days after vaccination
|
GMT of neutralizing antibodies against live SARS-CoV-2 virus at Day 14 after the booster vaccination.
Time Frame: At Day 14 after the booster vaccination
|
GMT of neutralizing antibodies against live SARS-CoV-2 virus at Day 14 after the booster vaccination.
|
At Day 14 after the booster vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse reactions within 28 days after vaccination.
Time Frame: Within 28 days after vaccination
|
Incidence of adverse reactions within 28 days after vaccination.
|
Within 28 days after vaccination
|
Incidence of adverse events within 28 days after vaccination.
Time Frame: Within 28 days after vaccination.
|
Incidence of adverse events within 28 days after vaccination.
|
Within 28 days after vaccination.
|
Incidence of unsolicited AE within 28 days after vaccination.
Time Frame: Within 28 days after vaccination.
|
Incidence of unsolicited adverse events within 28 days after vaccination.
|
Within 28 days after vaccination.
|
Incidence of serious adverse events(SAE) from the first dose to the 6 months after completing the last dose of vaccination.
Time Frame: From the first dose to the 6 months after completing the last dose of vaccination.
|
Incidence of serious adverse events(SAE) from the first dose to the 6 months after completing the last dose of vaccination.
|
From the first dose to the 6 months after completing the last dose of vaccination.
|
GMT of binding antibodies against SARS-CoV-2 S and RBD protein measured by ELISA at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
Time Frame: at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
|
GMT of binding antibodies against SARS-CoV-2 S and RBD protein measured by ELISA at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
|
at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
|
Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and RBD protein at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
Time Frame: at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
|
Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and RBD protein at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
|
at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
|
Fold increase of binding antibodies against SARS-CoV-2 S and RBD protein at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
Time Frame: at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
|
Fold increase of binding antibodies against SARS-CoV-2 S and RBD protein measured by ELISA, as compared to baseline, at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
|
at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
|
GMT of neutralizing antibodies against live SARS-CoV-2 virus at day 28 after the second vaccination, and day 14, month 6 after the third vaccination
Time Frame: at day 28 after the second vaccination, and day 14, month 6 after the third vaccination
|
GMT of neutralizing antibodies against live SARS-CoV-2 virus at day 28 after the second vaccination, and day 14, month 6 after the third vaccination
|
at day 28 after the second vaccination, and day 14, month 6 after the third vaccination
|
Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2 virus at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
Time Frame: at day 14, day 28 after the second vaccination, and day 14, month 6 after the third 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 28 after the second vaccination, and day 14, month 6 after the third vaccination.
|
at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.
|
Fold increase of neutralizing antibodies against live SARS-CoV-2 virus at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination.
Time Frame: at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination.
|
Fold increase of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination.
|
at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Types of binding antibodies IgG against SARS-CoV-2 S protein at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination.
Time Frame: at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination.
|
Types of binding antibodies IgG against SARS-CoV-2 S protein at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination.
|
at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination.
|
Cross neutralizing of the antibodies to variants of SARS-CoV-2 measured by pseudovirus neutralization test at Day 28 after the booster vaccination.
Time Frame: At Day 28 after the booster vaccination.
|
Cross neutralizing of the antibodies to variants of SARS-CoV-2 measured by pseudovirus neutralization test at Day 28 after the booster vaccination.
|
At Day 28 after the booster vaccination.
|
The immune cells' subgroups and germlines at Day 28 after vaccination.
Time Frame: At Day 28 after vaccination.
|
The immune cells', such as B cells and T cells, subgroups and germlines at Day 28 after vaccination.
|
At Day 28 after vaccination.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 7, 2021
Primary Completion (Actual)
September 18, 2021
Study Completion (Actual)
March 4, 2022
Study Registration Dates
First Submitted
April 3, 2021
First Submitted That Met QC Criteria
April 3, 2021
First Posted (Actual)
April 6, 2021
Study Record Updates
Last Update Posted (Actual)
April 6, 2022
Last Update Submitted That Met QC Criteria
March 28, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JSVCT115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Deidentified individual participant data will be available for request 1 month after the completion of the study
IPD Sharing Time Frame
1 month to 1 year after the completion of the study
IPD Sharing Access Criteria
Researchers who provide a scientifically sound proposal will be allowed access to the individual participant data.These proposals will be reviewed and approved by the sponsor, investigator, and collaborators on the basis of scientific merit.
To gain access, data requesters will need to sign a data access agreement.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
Clinical Trials on recombinant Ad5 vectored COVID-19 vaccine
-
Zhejiang Provincial Center for Disease Control...RecruitingImmunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine Using for Sequential ImmunizationChina
-
Zhongnan HospitalInstitute of Biotechnology, Academy of Military Medical Sciences, PLA of...Recruiting
-
Jiangsu Province Centers for Disease Control and...CompletedAdenovirus Type-5 Vectored COVID-19 VaccineChina
-
CanSino Biologics Inc.Beijing Institute of BiotechnologyWithdrawn
-
WestVac Biopharma Co., Ltd.Active, not recruiting
-
Jiangsu Province Centers for Disease Control and...CanSino Biologics Inc.Completed
-
Jiangsu Province Centers for Disease Control and...CanSino Biologics Inc.Completed
-
WestVac Biopharma Co., Ltd.Not yet recruitingCOVID-19 | SARS-CoV-2 InfectionMexico
-
Laboratorio Avi-Mex, S.A. de C.V.National Council of Science and Technology, Mexico; Instituto Nacional de Enfermedades...CompletedSARS-CoV-2 InfectionMexico
-
CanSino Biologics Inc.Beijing Institute of BiotechnologyTerminated