Clinical trial NCT05442684: 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
Official title: A Multicenter, Randomized, and Observer-blind Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-based COVID-19 Vaccine Against Coronavirus Variants in Adults (≥ 18 Years) Who Have Been Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Immunogenicity of Ad5-nCoV/O or Ad5-nCoV/O-IH versus BNT162b2 as the 2nd booster dose.
timeFrame: Day 28 post vaccination
Secondary outcomes:
measure: Incidence of Adverse Reactions (ARs)
timeFrame: within 30 min post vaccination
measure: Incidence of Adverse Reactions (ARs)
timeFrame: within 14 days post vaccination
measure: The incidence of AR and AE
timeFrame: within 28 days post vaccination
measure: Incidence of SAE
timeFrame: within 12 months post vaccination
measure: Immunogenicity of pseudovirus neutralizing antibody
timeFrame: on Day 14 and Day 28 post-vaccination
measure: Immunogenicity of S-RBD IgG antibody
timeFrame: on Day 14 and Day 28 post-vaccination
measure: Immunogenicity of S-RBD serum IgA antibody
timeFrame: on Day 14 and Day 28 post-vaccination
measure: Immunogenicity of pseudovirus neutralizing antibody
timeFrame: on Month 3, Month 6, and Month 12 post-vaccination
measure: Immunogenicity of S-RBD IgG antibody
timeFrame: on Month 3, Month 6, and Month 12 post-vaccination
measure: Immunogenicity of S-RBD serum IgA antibody
timeFrame: on Month 3, Month 6, and Month 12 post-vaccination
measure: Virological confirmed COVID-19 cases
timeFrame: from Day 14 post-vaccination
measure: Virological confirmed severe COVID-19 cases.
timeFrame: from Day 14 post-vaccination
measure: Virological confirmed asymptomatic COVID-19 cases
timeFrame: from Day 14 post-vaccination
measure: Immunogenicity of anti-Nucleocapsid antibody
timeFrame: before vaccination
measure: Immunogenicity of saliva secretory IgA (SIgA)
timeFrame: on Day 14 and Day 28 post-vaccination
measure: The level and positive rate of interferon γ (IFN-γ)
timeFrame: on Day 14 and Day 28 after the 2nd booster dose
measure: The neutralizing antibody against other VOCs or emerging variant(s).
timeFrame: on Day 28
Other outcomes:
Locations:
Study officials:
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