A Study to Evaluate the Safety and Immunogenicity of Ad5-nCoV and Ad5-nCoV-IH in CoronaVac Immunized Children and Adolescents

A Multicenter, Randomized, and Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of Intramuscular and Inhaled COVID-19 Vaccine in Children Aged 6-12 Years and Adolescents Aged 13-17 Years Who Have Been Immunized With Two Doses of CoronaVac

This is a multicenter, randomized, 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) or Ad5-nCoV-IH (nebulized inhalation) ≥ 90 days after receiving two doses of CoronaVac.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector); Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)

Detailed Description

A total of 1000 participants will be equally divided into the two study groups, children of 6-12 years and adolescents of 13-17 years. In each age group, they will have an equal chance to received either one dose of Ad5-nCoV (intramuscular injection) or Ad5-nCoV-IH (nebulized inhalation). The enrollment of the children group will start after the safety profiles in 7 days post-vaccination of the adolescent group have been deemed acceptable. Investigators should try to balance the age and sex of the participants during enrollment.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 3

Contacts and Locations

Study Locations

• Chile
  • Los Lagos
    • Osorno, Los Lagos, Chile
      • Hospital Base de Osorno
  • Región De Valparaíso
    • Valparaíso, Región De Valparaíso, Chile
      • Hospital Carlos Van Buren

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Children aged 6-12 years and adolescents aged 13-17 years at the time of randomization.
2. Have received a complete two dose schedule of CoronaVac for ≥ 90 days.
3. Obtain written informed assent from participants and consent from parents, guardians or legal representatives.
4. 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.
6. Have had asthma attacks within 2 years.
7. Have severe 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. Have 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. History of COVID-19 disease.
15. Have a positive result at the examination of rapid SARS-CoV-2 antibody assay (S-RBD IgG) before vaccination.
16. Have received COVID vaccines other than CoronaVac.
17. Received or plan to receive any non-COVID vaccines (licensed or investigational), within 14 days before and after study vaccination.
18. Current diagnosis of or treatment for cancer, e.g. leukemia.
19. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccine Group; 1000 participants，500 children aged 6-12 years and 500 adolescents aged 13-17 years, Ad5-nCoV or Ad5-nCoV-IH, ≥90 days after two doses of CoronaVac. Intramuscular injection or 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of SAE	Evaluate the incidence of severe adverse events (SAE)	Day 0 to 12 months post IM or IH
Immunogenicity of S-RBD IgG antibody	GMC of S-RBD IgG antibody by Elisa post vaccination	28 days post IM or IH

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Reactions (ARs)	Incidence of solicited adverse reactions (ARs)	Within 14 days post IM or IH
The incidence of AR and AE	Incidence of AR and AE within 28 days	Within 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody	GMC of S-RBD IgG antibody post vaccination by ELISA	14 days post IM or IH
Immunogenicity of S-RBD IgG antibody	Seroconversion rate of S-RBD IgG antibody post vaccination by ELISA	14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody	GMI of S-RBD IgG antibody post vaccination by ELISA	14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody	GMT of pseudo-virus neutralizing antibody by ELISA	14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody	GMI of pseudo-virus neutralizing antibody by ELISA	14 and 28 days post IM or IH
Immunogenicity of S-RBD IgG antibody	Seroconversion rate of pseudo-virus neutralizing antibody by ELISA	14 and 28 days post IM or IH

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of booster vaccination	The number of all COVID-19 cases after vaccination	Up to 12 months post IM or IH

Collaborators and Investigators

• Sponsor: CanSino Biologics Inc.
• Collaborators: Beijing Institute of Biotechnology
• Investigators: Principal Investigator: Stephania Passalacqua, Hospital Base de Osorno, Chile

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Adolescents; Safety; Children; Immunogenicity; Ad5; Inhalation; COVID-19 Vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CS-CTP-AD5NCOV-PDⅢ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No