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

NCT05169008 | Terminated Phase 3 DMC

• 1 other identifier: CS-CTP-AD5NCOV-PDⅢ
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

COVID-19

Keywords

COVID-19 Vaccine; Inhalation; Ad5; Safety; Immunogenicity; Children; Adolescents

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Incidence of Adverse Reactions (ARs)

  Within 14 days post IM or IH

• The incidence of AR and AE

  Within 28 days post IM or IH

• Immunogenicity of S-RBD IgG antibody

  14 days post IM or IH

• Immunogenicity of S-RBD IgG antibody

  14 and 28 days post IM or IH

• Immunogenicity of S-RBD IgG antibody

  14 and 28 days post IM or IH

Other Outcomes (1)

• Efficacy of booster vaccination

  Up to 12 months post IM or IH

Study Arms (1)

Vaccine Group

EXPERIMENTAL

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); Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)

Interventions

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) BIOLOGICAL

Intramuscular injection

Vaccine Group

Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) BIOLOGICAL

Nebulized inhalation through the mouth

Vaccine Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-12 years and adolescents aged 13-17 years at the time of randomization.
• Have received a complete two dose schedule of CoronaVac for ≥ 90 days.
• 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.

You may not qualify if:

• 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.
• Have had asthma attacks within 2 years.
• Have severe 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.
• Have 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.
• History of COVID-19 disease.
• Have a positive result at the examination of rapid SARS-CoV-2 antibody assay (S-RBD IgG) before vaccination.

Sponsors & Collaborators

• CanSino Biologics Inc.: lead
• Beijing Institute of Biotechnology: collaborator

Study Sites (2)

Hospital Base de Osorno

Osorno, Los Lagos Region, Chile

Location

Hospital Carlos van Buren

Valparaíso, Región de Valparaíso, Chile

Location

MeSH Terms

Conditions

COVID-19; Respiratory Aspiration; Alzheimer Disease 5

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephania Passalacqua

  Hospital Base de Osorno, Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 23, 2021
• Study Start: February 25, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: June 15, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)