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
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector)
Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation
mRNA-based COVID-19 vaccine
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Participants aged 18 years and above at the time of screening.
- Received the 1st booster vaccination at least 180 days earlier.
- Agree to attend all visits and sign the written informed consent form.
Exclusion Criteria:
- Have a history of seizures, epilepsy, encephalopathy, psychosis.
- History of severe anaphylaxis or allergy to any vaccine component.
- Positive urine pregnancy test result, pregnant, lactating women.
- 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.
- Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder).
- Have chronic systematic infection or chronic obstructive pulmonary disease (COPD), etc.
- Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
- Current diagnosis or receiving treatment for tuberculosis or cancer.
- History of SARS-CoV-2 infection for less than 3 months.
- Received or plan to receive any vaccines (licensed or investigational), within 14 days before and after study vaccination.
- Have an axillary temperature of > 37.0℃.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Ad5-nCoV/O group
Ad5-nCoV/O-IH group
mRNA-based COVID-19 vaccine group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Incidence of Adverse Reactions (ARs)
The incidence of adverse reactions (ARs) within 30 min post vaccination.
Incidence of Adverse Reactions (ARs)
The incidence of adverse reactions (ARs) within 14 days post vaccination
The incidence of AR and AE
The incidence of ARs/adverse events (AEs) 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.
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.
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.
Immunogenicity of S-RBD serum IgA antibody
The GMT, GMI, and SCR of anti-Omicron S-RBD serum IgA antibody on Day 14 and Day 28 post-vaccination in all participants.
Immunogenicity of pseudovirus neutralizing antibody
The GMT, GMI and SCR of anti-Omicron pseudovirus neutralizing antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup.
Immunogenicity of S-RBD IgG antibody
The GMC, GMI and SCR of anti-Omicron S-RBD IgG antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup.
Immunogenicity of S-RBD serum IgA antibody
The GMC, GMI and SCR of anti-Omicron S-RBD serum IgA antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup
Virological confirmed COVID-19 cases
The number of virological confirmed COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
Virological confirmed severe COVID-19 cases.
The number of virological confirmed severe COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
Virological confirmed asymptomatic COVID-19 cases
The number of virological confirmed asymptomatic COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
Immunogenicity of anti-Nucleocapsid antibody
The GMT of anti-Nucleocapsid antibody before vaccination
Immunogenicity of saliva secretory IgA (SIgA)
The GMC, GMI, and SCR of saliva secretory IgA (SIgA) on Day 14 and Day 28 post-vaccination in participants of the immunogenicity subgroup.
The level and positive rate of interferon γ (IFN-γ)
The level and positive rate of interferon γ (IFN-γ) on Day 14 and Day 28 after the 2nd booster dose.
The neutralizing antibody against other VOCs or emerging variant(s).
The neutralizing antibody on Day 28 against VOCs or other emerging variants.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05442684
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The trial protocol was not approved by the regulatory authorities.
Study Start Date
November 30, 2022 (Anticipated)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CanSino Biologics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Masking Description
observer-blind clinical trial
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ad5-nCoV/O group
Arm Type
Experimental
Arm Title
Ad5-nCoV/O-IH group
Arm Type
Experimental
Arm Title
mRNA-based COVID-19 vaccine group
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector)
Intervention 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
Intervention Type
Biological
Intervention Name(s)
Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation
Intervention 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-IH
Intervention Type
Biological
Intervention Name(s)
mRNA-based COVID-19 vaccine
Intervention 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 mRNA-based COVID-19 vaccine
Primary Outcome Measure Information:
Title
Immunogenicity of Ad5-nCoV/O or Ad5-nCoV/O-IH versus BNT162b2 as the 2nd booster dose.
Description
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 Outcome Measure Information:
Title
Incidence of Adverse Reactions (ARs)
Description
The incidence of adverse reactions (ARs) within 30 min post vaccination.
Time Frame
within 30 min post vaccination
Title
Incidence of Adverse Reactions (ARs)
Description
The incidence of adverse reactions (ARs) within 14 days post vaccination
Time Frame
within 14 days post vaccination
Title
The incidence of AR and AE
Description
The incidence of ARs/adverse events (AEs) within 28 days post vaccination.
Time Frame
within 28 days post vaccination
Title
Incidence of SAE
Description
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
Title
Immunogenicity of pseudovirus neutralizing antibody
Description
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
Title
Immunogenicity of S-RBD IgG antibody
Description
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.
Time Frame
on Day 14 and Day 28 post-vaccination
Title
Immunogenicity of S-RBD serum IgA antibody
Description
The GMT, GMI, and SCR of anti-Omicron S-RBD serum IgA antibody on Day 14 and Day 28 post-vaccination in all participants.
Time Frame
on Day 14 and Day 28 post-vaccination
Title
Immunogenicity of pseudovirus neutralizing antibody
Description
The GMT, GMI and SCR of anti-Omicron pseudovirus neutralizing antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup.
Time Frame
on Month 3, Month 6, and Month 12 post-vaccination
Title
Immunogenicity of S-RBD IgG antibody
Description
The GMC, GMI and SCR of anti-Omicron S-RBD IgG antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup.
Time Frame
on Month 3, Month 6, and Month 12 post-vaccination
Title
Immunogenicity of S-RBD serum IgA antibody
Description
The GMC, GMI and SCR of anti-Omicron S-RBD serum IgA antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup
Time Frame
on Month 3, Month 6, and Month 12 post-vaccination
Title
Virological confirmed COVID-19 cases
Description
The number of virological confirmed COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
Time Frame
from Day 14 post-vaccination
Title
Virological confirmed severe COVID-19 cases.
Description
The number of virological confirmed severe COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
Time Frame
from Day 14 post-vaccination
Title
Virological confirmed asymptomatic COVID-19 cases
Description
The number of virological confirmed asymptomatic COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
Time Frame
from Day 14 post-vaccination
Title
Immunogenicity of anti-Nucleocapsid antibody
Description
The GMT of anti-Nucleocapsid antibody before vaccination
Time Frame
before vaccination
Title
Immunogenicity of saliva secretory IgA (SIgA)
Description
The GMC, GMI, and SCR of saliva secretory IgA (SIgA) on Day 14 and Day 28 post-vaccination in participants of the immunogenicity subgroup.
Time Frame
on Day 14 and Day 28 post-vaccination
Title
The level and positive rate of interferon γ (IFN-γ)
Description
The level and positive rate of interferon γ (IFN-γ) on Day 14 and Day 28 after the 2nd booster dose.
Time Frame
on Day 14 and Day 28 after the 2nd booster dose
Title
The neutralizing antibody against other VOCs or emerging variant(s).
Description
The neutralizing antibody on Day 28 against VOCs or other emerging variants.
Time Frame
on Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants aged 18 years and above at the time of screening.
Received the 1st booster vaccination at least 180 days earlier.
Agree to attend all visits and sign the written informed consent form.
Exclusion Criteria:
Have a history of seizures, epilepsy, encephalopathy, psychosis.
History of severe anaphylaxis or allergy to any vaccine component.
Positive urine pregnancy test result, pregnant, lactating women.
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.
Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder).
Have chronic systematic infection or chronic obstructive pulmonary disease (COPD), etc.
Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
Current diagnosis or receiving treatment for tuberculosis or cancer.
History of SARS-CoV-2 infection for less than 3 months.
Received or plan to receive any vaccines (licensed or investigational), within 14 days before and after study vaccination.
Have an axillary temperature of > 37.0℃.
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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