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Study on Heterologous Prime-boost of Recombinant COVID-19 Vaccine (Ad5 Vector) and RBD-based Protein Subunit Vaccine

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

recombinant Ad5 vectored COVID-19 vaccine

RBD-based protein subunit vaccine (ZF2001) against COVID-19

trivalent split influenza vaccine

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring SARS-CoV-2 Vaccine, Recombinant Ad5 Vector, Subunit Vaccine, Safety, Immunogenicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

"0-28 days" vaccine group

"0-28 days" placebo group

"0-56 days" vaccine group

"0-56 days" placebo group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Incidence of solicited adverse events within 7 days after vaccination.

GMT of neutralizing antibodies against live SARS-CoV-2 virus at Day 14 after the booster vaccination.

Secondary Outcome Measures

Incidence of adverse reactions within 28 days after vaccination.

Incidence of adverse events within 28 days after vaccination.

Incidence of unsolicited AE within 28 days after vaccination.

Incidence of unsolicited adverse events 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.

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.

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.

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.

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.

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

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.

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.

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.

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.

Full Information

NCT ID

NCT04833101

First Posted

April 3, 2021

Last Updated

March 28, 2022

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT04833101

Brief Title

Study on Heterologous Prime-boost of Recombinant COVID-19 Vaccine (Ad5 Vector) and RBD-based Protein Subunit Vaccine

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

April 7, 2021 (Actual)

Primary Completion Date

September 18, 2021 (Actual)

Study Completion Date

March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Province Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

SARS-CoV-2 Vaccine, Recombinant Ad5 Vector, Subunit Vaccine, Safety, Immunogenicity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

"0-28 days" vaccine group

Arm Type

Experimental

Arm Description

Arm Title

"0-28 days" placebo group

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

"0-56 days" vaccine group

Arm Type

Experimental

Arm Description

Arm Title

"0-56 days" placebo group

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

recombinant Ad5 vectored COVID-19 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)

RBD-based protein subunit vaccine (ZF2001) against COVID-19

Other Intervention Name(s)

ZF2001 vaccine

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

trivalent split influenza vaccine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of solicited adverse events within 7 days after vaccination.

Description

Incidence of solicited adverse events within 7 days after vaccination.

Time Frame

Within 7 days after vaccination

Title

GMT of neutralizing antibodies against live SARS-CoV-2 virus at Day 14 after the booster vaccination.

Description

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

Secondary Outcome Measure Information:

Title

Incidence of adverse reactions within 28 days after vaccination.

Description

Incidence of adverse reactions within 28 days after vaccination.

Time Frame

Within 28 days after vaccination

Title

Incidence of adverse events within 28 days after vaccination.

Description

Incidence of adverse events within 28 days after vaccination.

Time Frame

Within 28 days after vaccination.

Title

Incidence of unsolicited AE within 28 days after vaccination.

Description

Incidence of unsolicited adverse events within 28 days after vaccination.

Time Frame

Within 28 days after vaccination.

Title

Incidence of serious adverse events(SAE) from the first dose to the 6 months after completing the last dose of vaccination.

Description

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.

Title

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.

Description

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.

Title

Description

Time Frame

at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.

Title

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.

Description

Time Frame

at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.

Title

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

Description

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

Title

Description

Time Frame

at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.

Title

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.

Description

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.

Time Frame

at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination.

Other Pre-specified Outcome Measures:

Title

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.

Description

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.

Title

Cross neutralizing of the antibodies to variants of SARS-CoV-2 measured by pseudovirus neutralization test at Day 28 after the booster vaccination.

Description

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.

Title

The immune cells' subgroups and germlines at Day 28 after vaccination.

Description

The immune cells', such as B cells and T cells, subgroups and germlines at Day 28 after vaccination.

Time Frame

At Day 28 after vaccination.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

35617368

Citation

Jin P, Guo X, Chen W, Ma S, Pan H, Dai L, Du P, Wang L, Jin L, Chen Y, Shi F, Liu J, Xu X, Zhang Y, Gao GF, Chen C, Feng J, Li J, Zhu F. Safety and immunogenicity of heterologous boost immunization with an adenovirus type-5-vectored and protein-subunit-based COVID-19 vaccine (Convidecia/ZF2001): A randomized, observer-blinded, placebo-controlled trial. PLoS Med. 2022 May 26;19(5):e1003953. doi: 10.1371/journal.pmed.1003953. eCollection 2022 May.

Results Reference

derived

Learn more about this trial

Study on Heterologous Prime-boost of Recombinant COVID-19 Vaccine (Ad5 Vector) and RBD-based Protein Subunit Vaccine

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