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

NCT04916886 | Completed DMC

• 1 other identifier: JSVCT118
• Study Type: interventional
• Target: 2,021
• Locations: 1 country
• Sites: 1

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

Keywords

COVID-19; Vaccine; Ad5; Immunobridging; Lot-to-lot consistency

Outcome Measures

Primary Outcomes (1)

• GMT of anti SARS-CoV-2 specific neutralizing antibody

  GMT of anti SARS-CoV-2 specific neutralizing antibody in all groups (wild type variants test).

  28 days after vaccination

Secondary Outcomes (13)

• Seroconversion rate of SARS-CoV-2 neutralizing antibody

  28 days after vaccination

• GMI of SARS-CoV-2 neutralizing antibody

  28 days after vaccination

• GMT of SARS-CoV-2 S protein RBD antibody

  28 days after vaccination

• Seroconversion rate of SARS-CoV-2 S protein RBD antibody

  28 days after vaccination

• GMI of SARS-CoV-2 S protein RBD antibody

  28 days after vaccination

Study Arms (9)

50L Scale (Age 18-59)

EXPERIMENTAL

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

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

500L Scale (Age 18-59)

EXPERIMENTAL

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

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

800L Scale (Age 18-59)

EXPERIMENTAL

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

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

800L Scale Lot 1 (Age 13-17)

EXPERIMENTAL

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

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

800L Scale Lot 2 (Age 13-17)

EXPERIMENTAL

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

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

800L Scale Lot 3 (Age 13-17)

EXPERIMENTAL

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

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

800L Scale Lot 1 (Age 6-12)

EXPERIMENTAL

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

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

800L Scale Lot 2 (Age 6-12)

EXPERIMENTAL

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

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

800L Scale Lot 3 (Age 6-12)

EXPERIMENTAL

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

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

Interventions

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

Containing 0.5E10vp

500L Scale (Age 18-59); 50L Scale (Age 18-59); 800L Scale (Age 18-59)

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

Containing 0.3E10vp

800L Scale Lot 1 (Age 13-17); 800L Scale Lot 1 (Age 6-12); 800L Scale Lot 2 (Age 13-17); 800L Scale Lot 2 (Age 6-12); 800L Scale Lot 3 (Age 13-17); 800L Scale Lot 3 (Age 6-12)

Eligibility Criteria

• Age: 6 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CanSino Biologics Inc.: lead
• Jiangsu Province Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Funing Center for Disease Control and Prevention

Yancheng, Jiangsu, China

Location

Related Publications (1)

• 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.

  PMID: 37432025 DERIVED

MeSH Terms

Conditions

COVID-19; Alzheimer Disease 5

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fengcai Zhu, MSD

  Jiangsu Provincal Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 8, 2021
• Study Start: June 3, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2022-10

Locations

CN (1)