Back to results

Clinical Evaluation for Batch Consistency of Ad5-nCoV in Chinese Healthy Adults

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

batch 1 of Ad5-nCoV

batch 2 of Ad5-nCoV

batch 3 of Ad5-nCoV

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring SARS-CoV-2 Vaccine, Batches consistency, Adenovirus type-5-vectored, Safety, Immunogenicity

Eligibility Criteria

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

Inclusion Criteria:

healthy participants aged 18 years and above who have not received COVID-19 vaccine.
The subjects can provide with informed consent and sign informed consent form (ICF).

4. The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the follow-up of the study.

5. Axillary temperature ≤ 37.0℃. 6. negative IgM and IgG against SARS-CoV-2 7. with BMI between18.5 to 30.0 8. No history of epidemiological contact with COVID-2019 9. have not been to medium or high risk areas in the past 21 days and have no history of departure.

10. be determined to be healthy by medical history, physical examination and clinical examination and meet the requirements for immunization of this product.

Exclusion criteria:

Medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
Allergic to any component of the research vaccines, or a history of hypersensitivity or serious reactions to vaccination.
Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan in this study.
Suffering from acute febrile disease, infectious disease, or SARS infection history
Serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension, which cannot be controlled by medication (systolic blood pressure ≥180mmHg, diastolic blood pressure ≥110mmHg)
Have severe chronic diseases or unstable condition ( Grade 3 or higher as defined in the guidelines for the classification of adverse events in clinical trials for prophylactic vaccines), Such as diabetes, thyroid disease and so on.
Congenital or acquired angioedema / neuroedema.
had urticaria one year before this vaccination.
Asplenia or functional asplenia.
Thrombocytopenia or other clotting disorder (this may contraindicate intramuscular injection).
Faintng during acupuncture treatment
Received immunosuppressant therapy, antiallergic therapy, cytotoxic therapy, high dose inhaled corticosteroid over the past 6 months (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid for acute non-complicated dermatitis, and corticosteroid with dose less than 20mg/ day)
Received blood products within 4 months before vaccination.
Received other investigational drugs within 1 month prior to receiving the investigational vaccines.
Received other live attenuated vaccines within 1 month prior to receiving the investigational vaccines.
Received subunit or inactivated vaccine within 14 days prior to receiving investigational vaccine.
Be receiving anti-tuberculosis treatment
Have the history of SARS-CoV-2 infection or COVID-19
Any medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the study protocol or affect the subjects' informed consent

Sites / Locations

Guanyun Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

batch 1 of Ad5-nCoV

batch 2 of Ad5-nCoV

batch 3 of Ad5-nCoV

Arm Description

Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202101001.

Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202101002.

Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202102003.

Outcomes

Primary Outcome Measures

GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.

Secondary Outcome Measures

GMFIs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.

Propotion of participants with at least four-fold increase of post-vaccination antibody level against SARS-CoV-2 RBD-specific binding IgG compared to that at baseline on day 28 after vaccination.

GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination stratified by neutralizing antibody levels against Ad5 at baseline.

GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination stratified by neutralizing antibody

Incidence of solicited adverse events within 7 days after vaccination.

Incidence of adverse reactions within 28 days after vaccination.

Incidence of unsolicited adverse events within 28 days after vaccination.

Incidence of serious adverse events (SAE) within the 6 months after vaccination.

Full Information

NCT ID

NCT05313646

First Posted

March 28, 2022

Last Updated

April 5, 2022

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT05313646

Brief Title

Clinical Evaluation for Batch Consistency of Ad5-nCoV in Chinese Healthy Adults

Official Title

Safety, Immunogenicity, and Batch Consistency of a Single Dose of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Chinese Healthy Adults Aged 18 Years and Above: a Randomized, Double-blind, Parallel-controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

March 8, 2021 (Actual)

Primary Completion Date

April 8, 2021 (Actual)

Study Completion Date

September 8, 2021 (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, double-blind, parallel-controlled, equivalence trial, for evaluation of safety and immunogenicity, and batch-to-batch consistency of a recombinant adenovirus type-5-vectored Covid-19 vaccine Convidecia in one shot schedule in Chinese healthy adults aged 18 years and above. In total 1050 healthy adults will be recruited in this study. Subjects in both cohort will be randomized stratified into two cohort by age(18~59 years and≥60 years) in a 1:1:1 ratio to receive one of three consecutive batches of Convidecia. The primary objective is to test the equivalence of the immune responses to three consecutive manufacturing lots of Convidecia in healthy adults. The secondary objectives were to evaluate the immunogenicity and safety of Convidecia for each lot and the pooled data of three lots)

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, Batches consistency, Adenovirus type-5-vectored, Safety, Immunogenicity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Subjects in adults cohort and elderly cohort will be randomized in a 1:1:1 ratio to receive one of three consecutive batches of Convidecia, respectively.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Participants and investigators will be kept blinded.

Allocation

Randomized

Enrollment

1050 (Actual)

8. Arms, Groups, and Interventions

Arm Title

batch 1 of Ad5-nCoV

Arm Type

Experimental

Arm Description

Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202101001.

Arm Title

batch 2 of Ad5-nCoV

Arm Type

Experimental

Arm Description

Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202101002.

Arm Title

batch 3 of Ad5-nCoV

Arm Type

Experimental

Arm Description

Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202102003.

Intervention Type

Biological

Intervention Name(s)

batch 1 of Ad5-nCoV

Other Intervention Name(s)

Convidecia

Intervention Description

The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202101001. It contains 5×10^10 viral particles per 0.5 mL in a vial.

Intervention Type

Biological

Intervention Name(s)

batch 2 of Ad5-nCoV

Other Intervention Name(s)

Convidecia

Intervention Description

The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202101002. It contains 5×10^10 viral particles per 0.5 mL in a vial.

Intervention Type

Biological

Intervention Name(s)

batch 3 of Ad5-nCoV

Other Intervention Name(s)

Convidecia

Intervention Description

The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202102003. It contains 5×10^10 viral particles per 0.5 mL in a vial.

Primary Outcome Measure Information:

Title

GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.

Description

GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.

Time Frame

On day 28 after vaccination

Secondary Outcome Measure Information:

Title

GMFIs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.

Description

GMFIs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.

Time Frame

On day 28 after vaccination

Title

Propotion of participants with at least four-fold increase of post-vaccination antibody level against SARS-CoV-2 RBD-specific binding IgG compared to that at baseline on day 28 after vaccination.

Description

Propotion of participants with at least four-fold increase of post-vaccination antibody level against SARS-CoV-2 RBD-specific binding IgG compared to that at baseline on day 28 after vaccination.

Time Frame

On day 28 after vaccination

Title

GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination stratified by neutralizing antibody levels against Ad5 at baseline.

Description

GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination stratified by neutralizing antibody

Time Frame

On day 28 after vaccination

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

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 unsolicited adverse events 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) within the 6 months after vaccination.

Description

Incidence of serious adverse events (SAE) within the 6 months after vaccination.

Time Frame

Within the 6 months after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: healthy participants aged 18 years and above who have not received COVID-19 vaccine. The subjects can provide with informed consent and sign informed consent form (ICF). 4. The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the follow-up of the study. 5. Axillary temperature ≤ 37.0℃. 6. negative IgM and IgG against SARS-CoV-2 7. with BMI between18.5 to 30.0 8. No history of epidemiological contact with COVID-2019 9. have not been to medium or high risk areas in the past 21 days and have no history of departure. 10. be determined to be healthy by medical history, physical examination and clinical examination and meet the requirements for immunization of this product. Exclusion criteria: Medical history or family history of convulsion, epilepsy, encephalopathy and psychosis. Allergic to any component of the research vaccines, or a history of hypersensitivity or serious reactions to vaccination. Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan in this study. Suffering from acute febrile disease, infectious disease, or SARS infection history Serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension, which cannot be controlled by medication (systolic blood pressure ≥180mmHg, diastolic blood pressure ≥110mmHg) Have severe chronic diseases or unstable condition ( Grade 3 or higher as defined in the guidelines for the classification of adverse events in clinical trials for prophylactic vaccines), Such as diabetes, thyroid disease and so on. Congenital or acquired angioedema / neuroedema. had urticaria one year before this vaccination. Asplenia or functional asplenia. Thrombocytopenia or other clotting disorder (this may contraindicate intramuscular injection). Faintng during acupuncture treatment Received immunosuppressant therapy, antiallergic therapy, cytotoxic therapy, high dose inhaled corticosteroid over the past 6 months (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid for acute non-complicated dermatitis, and corticosteroid with dose less than 20mg/ day) Received blood products within 4 months before vaccination. Received other investigational drugs within 1 month prior to receiving the investigational vaccines. Received other live attenuated vaccines within 1 month prior to receiving the investigational vaccines. Received subunit or inactivated vaccine within 14 days prior to receiving investigational vaccine. Be receiving anti-tuberculosis treatment Have the history of SARS-CoV-2 infection or COVID-19 Any medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the study protocol or affect the subjects' informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fengcai Zhu, MSc

Organizational Affiliation

Jiangsu Provincial Center for Diseases Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guanyun Center for Disease Control and Prevention

City

Lianyungang

State/Province

Jiangsu

ZIP/Postal Code

222000

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

36048417

Citation

Li ZP, Shi YF, Hou LH, Jin PF, Ma SH, Pan HX, Zhang JL, Shan YM, Huang HT, Wu SP, Du P, Wang X, Wang LL, Wang RJ, Wang Y, Wang XW, Zhu FC, Li JX. Batch-to-batch consistency trial of an adenovirus type-5 vector-based COVID-19 vaccine in adults aged 18 years and above. Expert Rev Vaccines. 2022 Dec;21(12):1843-1849. doi: 10.1080/14760584.2022.2119133. Epub 2022 Sep 1.

Results Reference

derived

Learn more about this trial

Clinical Evaluation for Batch Consistency of Ad5-nCoV in Chinese Healthy Adults

We'll reach out to this number within 24 hrs