A Clinical Trial of Immunobridging and Lot-to-lot Consistency of COVID-19 Vaccine (Ad5-nCoV) in Different Age Groups.

NCT ID: NCT04916886

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2021 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2022-07-31

Brief Summary

The study is a single-center, randomized and double-blinded trial to evaluate the immunobridging between different manufacture scales, lot-to-lot consistency of the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)(Ad5-nCOV) in population 6-59 years of age. The immunobridging between different manufacture scales will be evaluated first, the immunobridging between different age groups will be evaluated second, the lot-to-lot consistency will be evaluated at last.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

50L Scale (Age 18-59)

Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp.

Group Type: EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml

Intervention Type: BIOLOGICAL

Containing 0.5E10vp

500L Scale (Age 18-59)

Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp.

Group Type: EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml

Intervention Type: BIOLOGICAL

Containing 0.5E10vp

800L Scale (Age 18-59)

Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp.

Group Type: EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml

Intervention Type: BIOLOGICAL

Containing 0.5E10vp

800L Scale Lot 1 (Age 13-17)

Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp.

Group Type: EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml

Intervention Type: BIOLOGICAL

Containing 0.3E10vp

800L Scale Lot 2 (Age 13-17)

Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp.

Group Type: EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml

Intervention Type: BIOLOGICAL

Containing 0.3E10vp

800L Scale Lot 3 (Age 13-17)

Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp.

Group Type: EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml

Intervention Type: BIOLOGICAL

Containing 0.3E10vp

800L Scale Lot 1 (Age 6-12)

Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp.

Group Type: EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml

Intervention Type: BIOLOGICAL

Containing 0.3E10vp

800L Scale Lot 2 (Age 6-12)

Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp.

Group Type: EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml

Intervention Type: BIOLOGICAL

Containing 0.3E10vp

800L Scale Lot 3 (Age 6-12)

Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp.

Group Type: EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml

Intervention Type: BIOLOGICAL

Containing 0.3E10vp

Interventions

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml

Containing 0.5E10vp

Intervention Type: BIOLOGICAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml

Containing 0.3E10vp

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 6-59 years of age at the time of enrollment;
• Able to provide consent or obtain consent from guardian to participate in the trial and sign an Informed Consent Form (ICF);
• Able and willing to complete all the scheduled study procedures during the whole study follow-up period;
• Axillary temperature ≤37.0℃;
• IgG ang IgM negative for Covid-19;
• Have not received any type of Covid-19 vaccines;
• No contact history of Covid-19; no travel history to medium and high risk regions and abroad in the past 21 days;
• Participants who are clinically determined to be healthy after checking medical history and physical examination are eligible to receive the product.

Exclusion Criteria

• Medical or family history of convulsions, epilepsy, encephalopathy, and psychosis disorders;
• History of allergies to any ingredient of Ad5-nCoV, history of serious allergic reactions to any vaccine, history of allergies and immune diseases;
• Women who are pregnant or lactating, positive urine pregnancy test or plan to become pregnant during the 12 months study period;
• Acute febrile diseases and infectious diseases, medical history of SARS (SARS-CoV-1);
• Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrollable medications (on-site measurement for 18-59 years of age: systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg), etc;
• Severe chronic diseases or with advanced stage conditions which cannot be controlled smoothly, such as diabetes, thyroid disease, etc;
• Congenital or acquired angioedema/neurological edema;
• Urticaria history within 1 year before receiving the study vaccine;
• Asplenia or functional aspleenia;
• Thrombocytopenia or other coagulation disorders (may cause contraindications for intramuscular injection);
• Trypanophobia；
• History of receiving immunosuppressant therapy, anti-allergic therapy, cytotoxic therapy, nebulized corticosteroid therapy in the past 6 months (not including corticosteroid spray treatment for allergic rhinitis, and surface corticosteroid treatment for acute non-complicated dermatitis);
• Prior administration of blood products in last 4 months;
• Received other investigational drugs within 1 month before the study;
• Prior administration of live attenuated vaccines within 1 month before the study;
• Prior administration of subunit or inactivated vaccines within 14 days before the study;
• Current anti-tuberculosis therapy;
• Medical history of Covid-19 disease/infection;
• Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives or informed consent (i.e. medical, psychological, social or other conditions, etc.).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: collaborator

CanSino Biologics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fengcai Zhu, MSD

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincal Center for Disease Control and Prevention

Locations

Funing Center for Disease Control and Prevention

Yancheng, Jiangsu, China

Countries

China

References

Wu YF, Wei MW, Wang RJ, Guo XL, Pan HX, Gao YC, Li XL, Wang X, Ma XM, Wan P, Zhou L, Zhu YW, Li JX, Zhu FC. Immunogenicity consistency and safety with different production scales of recombinant adenovirus type-5 vectored COVID-19 vaccine in healthy adults: a randomized, double-blinded, immunobridging trial. Expert Rev Vaccines. 2023 Jan-Dec;22(1):662-670. doi: 10.1080/14760584.2023.2234997.

Reference Type: DERIVED

PMID: 37432025 (View on PubMed)

Other Identifiers

JSVCT118

Identifier Type: -

Identifier Source: org_study_id