Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, randomized, parallel-controlled clinical trial conducted in people aged 18 years and older to evaluate the immunogenicity and safety of two SARS-CoV-2 bivalent vaccines constructed by adenovirus type 5-based or mRNA-based technics.
The clinical trial plans to recruit 450 subjects aged 18 years and above with an interval of ≥ 3 months between the previous dose of SARS-CoV-2 vaccine immunization and receive one dose of inhaled prototype strain and omicron BA.4/5 bivalent recombinant SARS-CoV-2 vaccine (adenovirus vector type 5) (Ad5-NCO5T-IH), beta strain and omicron BA.4/5 bivalent SARS-CoV-2 mRNA vaccine (mbO5) or inhaled prototype recombinant SARS-CoV-2 vaccine (adenovirus vector type 5) (Ad5-nCoV-IH) for follow-up until 6 months after vaccination.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Ad5-NCO5T-IH | Experimental | Vaccinated using Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation |
|
| 2. mbO5 | Experimental | Vaccinated using Bivalent COVID-19 mRNA Vaccine |
|
| 3. Ad5-nCoV-IH | Other | Vaccinated using Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation | Biological | Containing two adenovirus type 5-based vaccines delivering the spike proteins of SARS-CoV-2 wild type and Omicron BA.4/5 mutant, respectively |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-XBB-specific neutralizing antibody | GMT of anti-XBB-specific neutralizing antibody on day 28 post vaccination | on day 28 post vaccination |
| The incidence of adverse reactions | The incidence of adverse reactions within 28 days post vaccination | within 28 days post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse reactions | The incidence of adverse reactions within 30 mins post vaccination | within 30 mins post vaccination |
| The incidence of adverse event | The incidence of adverse event within 28 days post vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianying Huang | Contact | 02167811702 | znyylcsy@126.com | |
| Jianyuan Wu | Contact | 02167812668 |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40775215 | Derived | Wu S, Huang J, Wang B, Li J, Wu J, Zhang Z, Luo L, Zhang J, Huo N, Long J, Huang H, Chen Z, Zhang M, Zhao Z, Dan J, Song X, Mao H, Huo S, Yan H, Zhang Y, Wang X, Hou L. Safety and Immunogenicity of aerosolized adenovirus-vectored COVID-19 vaccine and intramuscular mRNA vaccine bivalent boosters: a randomized open-label clinical trial. Nat Commun. 2025 Aug 7;16(1):7281. doi: 10.1038/s41467-025-62698-7. |
Not provided
Not provided
Not provided
In people aged 18 years and older, people were divided into in three groups and vaccinated using three kinds of vaccines:
Not provided
Not provided
Not provided
Not provided
|
| Bivalent COVID-19 mRNA Vaccine | Biological | Containing two mRNA-based vaccines delivering the spike proteins of SARS-CoV-2 Beta and Omicron BA.4/5 mutant, respectively |
|
|
| Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation | Biological | Containing adenovirus type 5-based vaccine delivering the spike proteins of SARS-CoV-2 wild type |
|
|
| within 28 days post vaccination |
| The incidence of SAE and AESI | The incidence of SAE and AESI within 6 months post vaccination | within 6 months post vaccination |
| specific neutralizing antibody against XBB and BA.5 variant on 0 and 28 days | The positive conversion rate, GMT and GMI of specific neutralizing antibody against XBB and BA.5 variant on 0 and 28 days | on 0, 28 days post vaccination |
| specific neutralizing antibody against XBB and BA.5 variant at 14 days, 3 and 6 months | The positive conversion rate, GMT and GMI of specific neutralizing antibody against XBB and BA.5 variant from first 90 subjects at 14 days, 3 and 6 months | at 14 days, 3 and 6 months |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided