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

Sponsor

CanSino Biologics Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05169008

Collaborator

Beijing Institute of Biotechnology (Other)

2,000

Enrollment

Arm

17.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Feb 20, 2022

Anticipated Primary Completion Date :

Apr 20, 2023

Anticipated Study Completion Date :

Aug 20, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of SAE [From first dose of intramuscular injection to 12 months post second dose of inhalation]
Evaluate the incidence of severe adverse events (SAE)
Immunogenicity of S-RBD IgG antibody [28 days post second dose of inhalation]
GMTs of S-RBD IgG antibody by Elisa post vaccination

Secondary Outcome Measures

Incidence of Adverse Reactions (ARs) [Within 14 days post each vaccination]
Incidence of solicited adverse reactions (ARs) within 14 days post each vaccination
The incidence of AR and AE [Within 28 days post each vaccination]
Incidence of AR and AE within 28 days post each vaccination
Immunogenicity of S-RBD IgG antibody [28 days post second dose of inhalation]
GMI of S-RBD IgG antibody post vaccination in the extended immunogenicity subgroup
Immunogenicity of S-RBD IgG antibody [28 days post second dose of inhalation]
Seroconversion rate of S-RBD IgG antibody post vaccination in the extended immunogenicity subgroup
Immunogenicity of S-RBD IgG antibody [28 days post first dose of intramuscular injection]
GMT of S-RBD IgG antibody by Elisa post vaccination in the extended-immunogenicity subgroup
Immunogenicity of S-RBD IgG antibody [28 days post first dose of intramuscular injection]
GMI of S-RBD IgG antibody post vaccination in the extended-immunogenicity subgroup
Immunogenicity of neutralizing antibodies [28 days post first dose of intramuscular injection]
Seroconversion rate of S-RBD IgG antibody post vaccination in the extended-immunogenicity subgroup
Baseline level of pre-existing anti Ad5 antibody [Day 0 before first dose of intramuscular injection]
Baseline level of pre-existing anti Ad5 antibody before first dose of intramuscular injection

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Children aged 6-12 years and adolescents aged 13-17 years at the time of randomization.
Obtain written informed assent from participants and consent from parents, guardians or legal representatives.
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:

Have a history of seizures, epilepsy, encephalopathy, psychosis.
History of anaphylaxis to any vaccine component.
Positive urine pregnancy test result, pregnant, lactation women. Female had menarche must conduct the urine pregnancy test.
Congenital or acquired angioedema/neuroedema .
Medical history of Guillain-Barré syndrome, or have had asthma attacks within 2 years.
Received or plan to receive other COVID-19 vaccines (licensed or investigational).
Have nasal or oral diseases, such as rhinitis (sinusitis), allergic rhinitis, oral ulcer, throat swelling, etc.
Asplenia or functional absence of spleen.
Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder).
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.
Has chronic systematic infection or chronic pulmonary disease
Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
Receiving anti-tuberculosis or cancer treatment.
Has a positive result at the examination of rapid SARS-CoV-2 antibody assay (IgG and IgM) before vaccination.
Received or plan to receive any non-COVID vaccines (licensed or investigational), within 14 days before and after study vaccination.
Current diagnosis of or treatment for cancer, e.g. leukemia.
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.