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

February 7, 2023 updated by: CanSino Biologics Inc.

To Evaluate the Immunogenicity Bridging Between Different Manufacture Scales and Between Different Lots of Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) in Population 6-59 Years of Age.

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

2021

Phase

  • Not Applicable

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
      • Yancheng, Jiangsu, China
        • Funing Center for Disease 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

6 years to 59 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.).

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 50L Scale (Age 18-59)
Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp.
Containing 0.5E10vp
EXPERIMENTAL: 500L Scale (Age 18-59)
Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp.
Containing 0.5E10vp
EXPERIMENTAL: 800L Scale (Age 18-59)
Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp.
Containing 0.5E10vp
EXPERIMENTAL: 800L Scale Lot 1 (Age 13-17)
Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp.
Containing 0.3E10vp
EXPERIMENTAL: 800L Scale Lot 2 (Age 13-17)
Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp.
Containing 0.3E10vp
EXPERIMENTAL: 800L Scale Lot 3 (Age 13-17)
Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp.
Containing 0.3E10vp
EXPERIMENTAL: 800L Scale Lot 1 (Age 6-12)
Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp.
Containing 0.3E10vp
EXPERIMENTAL: 800L Scale Lot 2 (Age 6-12)
Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp.
Containing 0.3E10vp
EXPERIMENTAL: 800L Scale Lot 3 (Age 6-12)
Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp.
Containing 0.3E10vp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GMT of anti SARS-CoV-2 specific neutralizing antibody
Time Frame: 28 days after vaccination
GMT of anti SARS-CoV-2 specific neutralizing antibody in all groups (wild type variants test).
28 days after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Time Frame: 28 days after vaccination
Seroconversion rate of anti SARS-CoV-2 specific neutralizing antibody (wild type variants test).
28 days after vaccination
GMI of SARS-CoV-2 neutralizing antibody
Time Frame: 28 days after vaccination
GMI of anti SARS-CoV-2 specific neutralizing antibody (wild type variants test).
28 days after vaccination
GMT of SARS-CoV-2 S protein RBD antibody
Time Frame: 28 days after vaccination
GMT of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups
28 days after vaccination
Seroconversion rate of SARS-CoV-2 S protein RBD antibody
Time Frame: 28 days after vaccination
Seroconversion rate of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups.
28 days after vaccination
GMI of SARS-CoV-2 S protein RBD antibody
Time Frame: 28 days after vaccination
GMI of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups.
28 days after vaccination
GMT of Ad5 vector neutralizing antibody
Time Frame: 28 days after vaccination
GMT of anti Ad5 vector neutralizing antibody responses post vaccination in all groups
28 days after vaccination
GMI of Ad5 vector neutralizing antibody
Time Frame: 28 days after vaccination
GMI of Ad5 vector neutralizing antibody responses post vaccination in all groups
28 days after vaccination
Stratified analysis on Ad5 vector neutralizing antibody
Time Frame: 28 days after vaccination
Stratified analysis based on the GMT of Ad5 vector neutralizing antibody responses post vaccination.
28 days after vaccination
Incidence of Adverse Reactions/Events (AE/AR)
Time Frame: Within 30 minutes after vaccination
The occurance of Adverse Reactions/Events within 30 minutes post vaccination
Within 30 minutes after vaccination
Incidence of Adverse Reactions/Events (AE/AR)
Time Frame: Within 0-7 days after vaccination
The occurance of Adverse Reactions/Events (AE/AR) within 7 days post vaccination.
Within 0-7 days after vaccination
Incidence of Adverse Reactions/Events (AE/AR)
Time Frame: Within 0-28 days after vaccination
The occurance of Adverse Reactions/Events (AE/AR) within 28 days post vaccination.
Within 0-28 days after vaccination
Incidence of Serious Adverse Events (SAE)
Time Frame: Within 12 months after vaccination
Occurance of Serious Adverse Events (SAE) post vaccination.
Within 12 months after vaccination
Incidence of Adverse Events of Special Interest (AESI)
Time Frame: Within 12 months after vaccination
Occurance of Adverse Events of Special Interest (AESI) post vaccination.
Within 12 months after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this 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)

June 3, 2021

Primary Completion (ACTUAL)

July 31, 2022

Study Completion (ACTUAL)

July 31, 2022

Study Registration Dates

First Submitted

May 30, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (ACTUAL)

June 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

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.

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