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A Study to Evaluate the Safety and Immunogenicity of a 2-dose Regimen COVID-19 Vaccine in Children and Adolescents Aged 6-17 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05169008
Recruitment Status : Not yet recruiting
First Posted : December 23, 2021
Last Update Posted : January 14, 2022
Sponsor:
Collaborator:
Beijing Institute of Biotechnology
Information provided by (Responsible Party):
CanSino Biologics Inc.

Brief Summary:
This is an international multicenter, single-arm, and open-label study to evaluate the immune responses and safety profiles of children aged 6-12 years and adolescents aged 13-17 years receiving Ad5-nCoV (intramuscular injection) and Ad5-nCoV-IH (nebulized inhalation) with 56 days interval.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) Phase 3

Detailed Description:
A total of 2000 participants will be equally divided into the two study countries, Mexico and Chile. All participants will receive a 1st dose of intramuscular Ad5-nCoV and a 2nd dose of inhaled Ad5-nCoV-IH with 56 days interval. The immunogenicity of S-RBD IgG antibody will be measured in the Extended-immunogenicity subgroup. Within the Extended-immunogenicity subgroup, 200 participants will be evaluated for immuno-persistency. All participants will be monitored for safety.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An International Multicenter, Single-arm, and Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of a 2-dose Regimen COVID-19 Vaccine in Children Aged 6-12 Years and Adolescents Aged 13-17 Years
Estimated Study Start Date : February 20, 2022
Estimated Primary Completion Date : April 20, 2023
Estimated Study Completion Date : August 20, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaccine Group
2000 participants,1000 children aged 6-12 years and 1000 adolescents aged 13-17 years, Ad5-nCoV + Ad5-nCoV-IH, 56 days interval. Intramuscular injection and nebulized inhalation.
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular injection

Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)
Nebulized inhalation through the mouth




Primary Outcome Measures :
  1. Incidence of SAE [ Time Frame: From first dose of intramuscular injection to 12 months post second dose of inhalation ]
    Evaluate the incidence of severe adverse events (SAE)

  2. Immunogenicity of S-RBD IgG antibody [ Time Frame: 28 days post second dose of inhalation ]
    GMTs of S-RBD IgG antibody by Elisa post vaccination


Secondary Outcome Measures :
  1. Incidence of Adverse Reactions (ARs) [ Time Frame: Within 14 days post each vaccination ]
    Incidence of solicited adverse reactions (ARs) within 14 days post each vaccination

  2. The incidence of AR and AE [ Time Frame: Within 28 days post each vaccination ]
    Incidence of AR and AE within 28 days post each vaccination

  3. Immunogenicity of S-RBD IgG antibody [ Time Frame: 28 days post second dose of inhalation ]
    GMI of S-RBD IgG antibody post vaccination in the extended immunogenicity subgroup

  4. Immunogenicity of S-RBD IgG antibody [ Time Frame: 28 days post second dose of inhalation ]
    Seroconversion rate of S-RBD IgG antibody post vaccination in the extended immunogenicity subgroup

  5. Immunogenicity of S-RBD IgG antibody [ Time Frame: 28 days post first dose of intramuscular injection ]
    GMT of S-RBD IgG antibody by Elisa post vaccination in the extended-immunogenicity subgroup

  6. Immunogenicity of S-RBD IgG antibody [ Time Frame: 28 days post first dose of intramuscular injection ]
    GMI of S-RBD IgG antibody post vaccination in the extended-immunogenicity subgroup

  7. Immunogenicity of neutralizing antibodies [ Time Frame: 28 days post first dose of intramuscular injection ]
    Seroconversion rate of S-RBD IgG antibody post vaccination in the extended-immunogenicity subgroup

  8. Baseline level of pre-existing anti Ad5 antibody [ Time Frame: Day 0 before first dose of intramuscular injection ]
    Baseline level of pre-existing anti Ad5 antibody before first dose of intramuscular injection



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Children aged 6-12 years and adolescents aged 13-17 years at the time of randomization.
  2. Obtain written informed assent from participants and consent from parents, guardians or legal representatives.
  3. Subjects are eligible for immunization of this product as evaluated by investigators after medical history examination, physical examination and clinical judgment of health.

Exclusion Criteria:

  1. Have a history of seizures, epilepsy, encephalopathy, psychosis.
  2. History of anaphylaxis to any vaccine component.
  3. Positive urine pregnancy test result, pregnant, lactation women. Female had menarche must conduct the urine pregnancy test.
  4. Congenital or acquired angioedema/neuroedema .
  5. Medical history of Guillain-Barré syndrome, or have had asthma attacks within 2 years.
  6. Received or plan to receive other COVID-19 vaccines (licensed or investigational).
  7. Have nasal or oral diseases, such as rhinitis (sinusitis), allergic rhinitis, oral ulcer, throat swelling, etc.
  8. Asplenia or functional absence of spleen.
  9. Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder).
  10. Any confirmed or suspected immunosuppressive or immunodeficient state; received immunosuppressive therapy, cytotoxic therapy, or chronic corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis) within the past 6 months.
  11. Has chronic systematic infection or chronic pulmonary disease
  12. Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
  13. Receiving anti-tuberculosis or cancer treatment.
  14. Has a positive result at the examination of rapid SARS-CoV-2 antibody assay (IgG and IgM) before vaccination.
  15. Received or plan to receive any non-COVID vaccines (licensed or investigational), within 14 days before and after study vaccination.
  16. Current diagnosis of or treatment for cancer, e.g. leukemia.
  17. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05169008


Contacts
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Contact: Meixu Yan +86-022-58213600 Ext. 6051 meixu.yan@cansinotech.com
Contact: Miguel Ángel Rodríguez Weber

Sponsors and Collaborators
CanSino Biologics Inc.
Beijing Institute of Biotechnology
Investigators
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Principal Investigator: Miguel Ángel Rodríguez Weber National Pediatric Institute, Mexico
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Responsible Party: CanSino Biologics Inc.
ClinicalTrials.gov Identifier: NCT05169008    
Other Study ID Numbers: CS-CTP-AD5NCOV-PDⅢ
First Posted: December 23, 2021    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CanSino Biologics Inc.:
COVID-19 Vaccine
Inhalation
Ad5
Safety
Immunogenicity
Children
Adolescents
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs