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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05169008
• Other study ID #: CS-CTP-AD5NCOV-PD?
• Status: Terminated
• Phase: Phase 3
• Start date: February 25, 2022
• Est. completion date: January 13, 2023

Study information

• Verified date: January 2022
• Source: CanSino Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: January 13, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular injection
• Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)
Nebulized inhalation through the mouth

Locations

Country	Name	City	State
Chile	Hospital Base de Osorno	Osorno	Los Lagos
Chile	Hospital Carlos van Buren	Valparaíso	Región De Valparaíso

Sponsors (2)

Lead Sponsor	Collaborator
CanSino Biologics Inc.	Beijing Institute of Biotechnology

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy of booster vaccination	The number of all COVID-19 cases after vaccination	Up to 12 months post IM or IH
Primary	Incidence of SAE	Evaluate the incidence of severe adverse events (SAE)	Day 0 to 12 months post IM or IH
Primary	Immunogenicity of S-RBD IgG antibody	GMC of S-RBD IgG antibody by Elisa post vaccination	28 days post IM or IH
Secondary	Incidence of Adverse Reactions (ARs)	Incidence of solicited adverse reactions (ARs)	Within 14 days post IM or IH
Secondary	The incidence of AR and AE	Incidence of AR and AE within 28 days	Within 28 days post IM or IH
Secondary	Immunogenicity of S-RBD IgG antibody	GMC of S-RBD IgG antibody post vaccination by ELISA	14 days post IM or IH
Secondary	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
Secondary	Immunogenicity of S-RBD IgG antibody	GMI of S-RBD IgG antibody post vaccination by ELISA	14 and 28 days post IM or IH
Secondary	Immunogenicity of S-RBD IgG antibody	GMT of pseudo-virus neutralizing antibody by ELISA	14 and 28 days post IM or IH
Secondary	Immunogenicity of S-RBD IgG antibody	GMI of pseudo-virus neutralizing antibody by ELISA	14 and 28 days post IM or IH
Secondary	Immunogenicity of S-RBD IgG antibody	Seroconversion rate of pseudo-virus neutralizing antibody by ELISA	14 and 28 days post IM or IH