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
- Conditions
- COVID-19
- Interventions
- Biological: mRNA-based COVID-19 vaccineBiological: Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector)Biological: Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation
- Registration Number
- NCT05442684
- Lead Sponsor
- CanSino Biologics Inc.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mRNA-based COVID-19 vaccine group mRNA-based COVID-19 vaccine - Ad5-nCoV/O group Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) - Ad5-nCoV/O-IH group Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation -
- Primary Outcome Measures
Name Time Method Immunogenicity of Ad5-nCoV/O or Ad5-nCoV/O-IH versus BNT162b2 as the 2nd booster dose. Day 28 post vaccination The geometric mean titers (GMT) of anti-Omicron pseudovirus neutralizing antibody on Day 28 post vaccination in all participants
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Reactions (ARs) within 14 days post vaccination The incidence of adverse reactions (ARs) within 14 days post vaccination
Virological confirmed severe COVID-19 cases. from Day 14 post-vaccination The number of virological confirmed severe COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
Immunogenicity of anti-Nucleocapsid antibody before vaccination The GMT of anti-Nucleocapsid antibody before vaccination
Immunogenicity of S-RBD IgG antibody on Month 3, Month 6, and Month 12 post-vaccination 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.
Incidence of SAE within 12 months post vaccination The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months post vaccination.
Immunogenicity of S-RBD serum IgA antibody on Month 3, Month 6, and Month 12 post-vaccination 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 from Day 14 post-vaccination The number of virological confirmed COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
Immunogenicity of saliva secretory IgA (SIgA) on Day 14 and Day 28 post-vaccination 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) on Day 14 and Day 28 after the 2nd booster dose The level and positive rate of interferon γ (IFN-γ) on Day 14 and Day 28 after the 2nd booster dose.
The incidence of AR and AE within 28 days post vaccination The incidence of ARs/adverse events (AEs) within 28 days post vaccination.
Immunogenicity of pseudovirus neutralizing antibody on Month 3, Month 6, and Month 12 post-vaccination 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.
Virological confirmed asymptomatic COVID-19 cases from Day 14 post-vaccination The number of virological confirmed asymptomatic COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
The neutralizing antibody against other VOCs or emerging variant(s). on Day 28 The neutralizing antibody on Day 28 against VOCs or other emerging variants.