Clinical trial NCT04916886: A Clinical Trial of Immunobridging and Lot-to-lot Consistency of COVID-19 Vaccine (Ad5-nCoV) in Different Age Groups.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
Vaccine
Ad5
Immunobridging
Lot-to-lot consistency
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Province Centers for Disease Control and Prevention
First posted: 2021-06-08
Enrollment: 2021
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.).

Primary outcomes:
measure: GMT of anti SARS-CoV-2 specific neutralizing antibody
timeFrame: 28 days after vaccination
Secondary outcomes:
measure: Seroconversion rate of SARS-CoV-2 neutralizing antibody
timeFrame: 28 days after vaccination
measure: GMI of SARS-CoV-2 neutralizing antibody
timeFrame: 28 days after vaccination
measure: GMT of SARS-CoV-2 S protein RBD antibody
timeFrame: 28 days after vaccination
measure: Seroconversion rate of SARS-CoV-2 S protein RBD antibody
timeFrame: 28 days after vaccination
measure: GMI of SARS-CoV-2 S protein RBD antibody
timeFrame: 28 days after vaccination
measure: GMT of Ad5 vector neutralizing antibody
timeFrame: 28 days after vaccination
measure: GMI of Ad5 vector neutralizing antibody
timeFrame: 28 days after vaccination
measure: Stratified analysis on Ad5 vector neutralizing antibody
timeFrame: 28 days after vaccination
measure: Incidence of Adverse Reactions/Events (AE/AR)
timeFrame: Within 30 minutes after vaccination
measure: Incidence of Adverse Reactions/Events (AE/AR)
timeFrame: Within 0-7 days after vaccination
measure: Incidence of Adverse Reactions/Events (AE/AR)
timeFrame: Within 0-28 days after vaccination
measure: Incidence of Serious Adverse Events (SAE)
timeFrame: Within 12 months after vaccination
measure: Incidence of Adverse Events of Special Interest (AESI)
timeFrame: Within 12 months after vaccination
Other outcomes:
Locations:
city: Yancheng
country: China
facility: Funing Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincal Center for Disease Control and Prevention
name: Fengcai Zhu, MSD
role: PRINCIPAL_INVESTIGATOR
References: