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

COVID-19 Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04916886
• Other study ID #: JSVCT118
• Status: Completed
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2022
• Source: CanSino Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2021
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 59 Years

Eligibility

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.).

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml
Containing 0.5E10vp
• Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml
Containing 0.3E10vp

Locations

Country	Name	City	State
China	Funing Center for Disease Control and Prevention	Yancheng	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
CanSino Biologics Inc.	Jiangsu Province Centers for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

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