A Study to Evaluate the Safety and Immunogenicity of Ad5-vector Based Vaccine Against Coronavirus Variants in Adults (≥18 Years) Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine

NCT ID: NCT05442684

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2023-06-30

Brief Summary

Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1.

Detailed Description

This is a multicenter, randomized, observer-blind, and parallel-controlled clinical study to evaluate the immune responses and safety profiles in adults (≥ 18 years) receiving investigational products (intramuscular injection or nebulized inhalation) ≥ 180 days after the immunization of 2 doses of BNT162b2 vaccines plus one dose of booster AZD1222 vaccine. This study will enroll about 30% participants aged 60 years and above.

Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Ad5-nCoV/O group

Group Type: EXPERIMENTAL

Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector)

Intervention Type: BIOLOGICAL

Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O

Ad5-nCoV/O-IH group

Group Type: EXPERIMENTAL

Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation

Intervention Type: BIOLOGICAL

Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O-IH

mRNA-based COVID-19 vaccine group

Group Type: ACTIVE_COMPARATOR

mRNA-based COVID-19 vaccine

Intervention Type: BIOLOGICAL

Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of mRNA-based COVID-19 vaccine

Interventions

Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector)

Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O

Intervention Type: BIOLOGICAL

Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation

Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O-IH

Intervention Type: BIOLOGICAL

mRNA-based COVID-19 vaccine

Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of mRNA-based COVID-19 vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Participants aged 18 years and above at the time of screening.

2. Received the 1st booster vaccination at least 180 days earlier.

3. Agree to attend all visits and sign the written informed consent form.

Exclusion Criteria

1. Have a history of seizures, epilepsy, encephalopathy, psychosis.

2. History of severe anaphylaxis or allergy to any vaccine component.

3. Positive urine pregnancy test result, pregnant, lactating women.

4. Medical history of Guillain-Barré syndrome.

5. Have had asthma attacks within 2 years.

6. Have severe nasal or oral diseases, such as rhinitis (sinusitis), allergic rhinitis, oral ulcer, throat swelling, etc.

7. Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder).

8. Have chronic systematic infection or chronic obstructive pulmonary disease (COPD), etc.

9. Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.

10. Current diagnosis or receiving treatment for tuberculosis or cancer.

11. History of SARS-CoV-2 infection for less than 3 months.

12. Received or plan to receive any vaccines (licensed or investigational), within 14 days before and after study vaccination.

13. Have an axillary temperature of > 37.0℃.

14. Any other significant diseases, disorders or findings 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CanSino Biologics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CTP-AD5NCOV/O-001

Identifier Type: -

Identifier Source: org_study_id