A Clinical Trial of Immunobridging and Lot-to-lot Consistency of COVID-19 Vaccine (Ad5-nCoV) in Different Age Groups.
- Conditions
- COVID-19
- Interventions
- Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3mlBiological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml
- Registration Number
- NCT04916886
- Lead Sponsor
- CanSino Biologics Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2021
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 800L Scale Lot 2 (Age 6-12) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. 500L Scale (Age 18-59) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp. 800L Scale Lot 2 (Age 13-17) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. 800L Scale (Age 18-59) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp. 800L Scale Lot 3 (Age 6-12) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. 50L Scale (Age 18-59) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp. 800L Scale Lot 1 (Age 6-12) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. 800L Scale Lot 3 (Age 13-17) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. 800L Scale Lot 1 (Age 13-17) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp.
- Primary Outcome Measures
Name Time Method GMT of anti SARS-CoV-2 specific neutralizing antibody 28 days after vaccination GMT of anti SARS-CoV-2 specific neutralizing antibody in all groups (wild type variants test).
- Secondary Outcome Measures
Name Time Method Stratified analysis on Ad5 vector neutralizing antibody 28 days after vaccination Stratified analysis based on the GMT of Ad5 vector neutralizing antibody responses post vaccination.
Incidence of Adverse Reactions/Events (AE/AR) Within 0-28 days after vaccination The occurance of Adverse Reactions/Events (AE/AR) within 28 days post vaccination.
Incidence of Serious Adverse Events (SAE) Within 12 months after vaccination Occurance of Serious Adverse Events (SAE) post vaccination.
GMI of SARS-CoV-2 neutralizing antibody 28 days after vaccination GMI of anti SARS-CoV-2 specific neutralizing antibody (wild type variants test).
GMT of Ad5 vector neutralizing antibody 28 days after vaccination GMT of anti Ad5 vector neutralizing antibody responses post vaccination in all groups
GMT of SARS-CoV-2 S protein RBD antibody 28 days after vaccination GMT of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups
Seroconversion rate of SARS-CoV-2 S protein RBD antibody 28 days after vaccination Seroconversion rate of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups.
Seroconversion rate of SARS-CoV-2 neutralizing antibody 28 days after vaccination Seroconversion rate of anti SARS-CoV-2 specific neutralizing antibody (wild type variants test).
GMI of Ad5 vector neutralizing antibody 28 days after vaccination GMI of Ad5 vector neutralizing antibody responses post vaccination in all groups
GMI of SARS-CoV-2 S protein RBD antibody 28 days after vaccination GMI of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups.
Incidence of Adverse Events of Special Interest (AESI) Within 12 months after vaccination Occurance of Adverse Events of Special Interest (AESI) post vaccination.
Trial Locations
- Locations (1)
Funing Center for Disease Control and Prevention
🇨🇳Yancheng, Jiangsu, China