Skip to main content
OpenTrials
Completed

NCT Number: NCT04916886

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Funing Center for Disease Control and Prevention

Yancheng, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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

Biological

Containing 0.5E10vp

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

Biological

Containing 0.3E10vp

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. GMI of Ad5 vector neutralizing antibody

    Time frame: 28 days after vaccination

    GMI of Ad5 vector neutralizing antibody responses post vaccination in all groups

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. Incidence of Serious Adverse Events (SAE)

    Time frame: Within 12 months after vaccination

    Occurance of Serious Adverse Events (SAE) post vaccination.

  13. 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.

Sponsors and collaborators

Lead sponsor

CanSino Biologics Inc.

Industry

Collaborators

  • Jiangsu Province Centers for Disease Control and Prevention

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 8, 2021
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.