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

CanSino Biologics Inc.

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

COVID-19

Interventions

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

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

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 vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Immunogenicity of Ad5-nCoV/O or Ad5-nCoV/O-IH versus BNT162b2 as the 2nd booster dose.

The geometric mean titers (GMT) of anti-Omicron pseudovirus neutralizing antibody on Day 28 post vaccination in all participants

Time frame: Day 28 post vaccination

Secondary Outcomes

Incidence of Adverse Reactions (ARs)

The incidence of adverse reactions (ARs) within 30 min post vaccination.

Time frame: within 30 min post vaccination

Incidence of Adverse Reactions (ARs)

The incidence of adverse reactions (ARs) within 14 days post vaccination

Time frame: within 14 days post vaccination

The incidence of AR and AE

The incidence of ARs/adverse events (AEs) within 28 days post vaccination.

Time frame: within 28 days post vaccination

Incidence of SAE

The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months post vaccination.

Time frame: within 12 months post vaccination

Immunogenicity of pseudovirus neutralizing antibody

The GMT, geometric mean increase fold (GMI) and sero-conversion rate (SCR) of anti-Omicron pseudovirus neutralizing antibody on Day 14 and Day 28 post-vaccination in all participants.

Time frame: on Day 14 and Day 28 post-vaccination

Immunogenicity of S-RBD IgG antibody

The geometric mean concentration (GMC), GMI and SCR of anti-Omicron S-RBD IgG antibody on Day 14 and Day 28 post-vaccination in all participants.

Data from ClinicalTrials.gov

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