COVID-19NCT05886790
A Clinical Trial on Booster Immunization of Two COVID-19 Vaccines Constructed From Different Technical Routes
A study testing Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation, Bivalent COVID-19 mRNA Vaccine and Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation in people with COVID-19, run by Zhongnan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation, Bivalent COVID-19 mRNA Vaccine and Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2023to 29 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers aged 18 and above at the time of screening;
- Volunteers can provide with informed consent and sign informed consent form (ICF);
- Have received COVID-19 vaccine, and the interval between the last vaccination ≥ 3 months.
Who cannot join
- Those with convulsions, epilepsy, encephalopathy and serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.) in the past five years;
- Those who are allergic to the active ingredient, any inactive ingredient, or substances used in the production process of the research vaccine, or those who are allergic to the similar vaccines previously; Those who have had severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioedema, dyspnea, etc.), and have any previous history of severe allergies to vaccines, foods, drugs, such as: urticaria, anaphylactic shock, skin eczema, allergic dyspnea, angioedema, etc. or a history of asthma;
- Those who have previously suffered from severe heart diseases such as myocarditis and pericarditis;
- Those who have experienced vaccination-related hospitalization or emergency care after previous vaccination;
- Female urine pregnancy test positive or lactating volunteers, volunteers or their partners have not taken effective contraception 2 weeks before screening or have a pregnancy plan within 6 months;
- Fever, axillary body temperature≥ 37.3°C;
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- Those with suspected symptoms of COVID-19 in the past 3 months (fever, cough, muscle pain, loss of smell or taste, etc.);
- Investigators judge that they have known or suspected concomitant serious diseases with unstable drug control, including: respiratory diseases, tuberculosis, acute infection or active chronic disease, liver and kidney disease, cardiovascular disease (cardiopulmonary failure), hypertension (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥100 mmHg), malignant tumors, infectious or allergic skin diseases;
- No spleen or functional spleen;
- Thrombocytopenia, bleeding disorders, or other coagulation disorders (which may cause contraindications to intramuscular injection);
- Immunosuppressant therapy, anti-allergic therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, superficial corticosteroid therapy for acute non-complicated dermatitis) in the past 6 months;
- Suffering from nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, mouth ulcers, throat redness and swelling, etc.;
- Have received blood products within 3 months prior to receiving the test vaccine;
- Have received other vaccines or investigational drugs within 1 month prior to receiving the test vaccine;
- Are receiving anti-tuberculosis treatment;
- Those with a history of COVID-19 infection in the past 3 months;
- Those who have a positive test result of the novel coronavirus antigen at the time of screening;
- Those with positive HIV infection results at screening;
- Participated in other interventional studies of lipid-containing nanoparticles;
- According to the judgment of the investigator, due to various medical, psychological, social or other conditions, it is contrary to the trial protocol, or affects the volunteers' signing of informed consent.
Trial locations and contacts
1 site in 1 country.
Jianyuan Wu contact
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000
Jianying Huang
Jianyuan Wu, 67812668
About this study
Official title: A Randomized, Open-Label, Parallel-controlled Clinical Study on Booster Immunization of Two COVID-19 Vaccines Constructed From Different Technical Routes Among People Aged 18 Years and Older
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.
Read the detailed description
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.
- Conditions
- COVID-19
- Being tested
- Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation, Bivalent COVID-19 mRNA Vaccine, Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation
- Keywords
- COVID-19, SARS-CoV-2, vaccine, immunization
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For InhalationBiological
Also called Ad5-NCO5T-IH
Containing two adenovirus type 5-based vaccines delivering the spike proteins of SARS-CoV-2 wild type and Omicron BA.4/5 mutant, respectively
Bivalent COVID-19 mRNA VaccineBiological
Also called mbO5
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 InhalationBiological
Also called Ad5-nCoV-IH
Containing adenovirus type 5-based vaccine delivering the spike proteins of SARS-CoV-2 wild type
| Study group | Role | What they receive |
|---|---|---|
| 1. Ad5-NCO5T-IH | Experimental | Vaccinated using Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation Receives: Biological: 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 Receives: Biological: Bivalent COVID-19 mRNA Vaccine |
| 3. Ad5-nCoV-IH | Other | Vaccinated using Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation Receives: Biological: Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-XBB-specific neutralizing antibody
GMT of anti-XBB-specific neutralizing antibody on day 28 post vaccination
Measured: on day 28 post vaccination
The incidence of adverse reactions
The incidence of adverse reactions within 28 days post vaccination
Measured: within 28 days post vaccination
Secondary outcomes (5)
The incidence of adverse reactions
The incidence of adverse reactions within 30 mins post vaccination
Measured: within 30 mins post vaccination
The incidence of adverse event
The incidence of adverse event within 28 days post vaccination
Measured: within 28 days post vaccination
The incidence of SAE and AESI
The incidence of SAE and AESI within 6 months post vaccination
Measured: 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
Measured: 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
Measured: at 14 days, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start30 May 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion29 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In people aged 18 years and older, people were divided into in three groups and vaccinated using three kinds of vaccines: 1. Test vaccine 1: Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation 2. Test vaccine 2: Bivalent COVID-19 mRNA Vaccine 3. Control vaccine: Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
- Responsible party
- Principal investigator, Jianying Huang, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886790
- Sponsor's protocol ID
- AMMS85-2301
- Status last verified
- Jun 2023
- First submitted
- 29 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40775215
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-controlled Clinical Study on Booster Immunization of Two COVID-19 Vaccines Constructed From Different Technical Routes Among People Aged 18 Years and Older
- ClinicalTrials.gov ID
- NCT05886790
- Acronym / sponsor ID
- AMMS85-2301
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, vaccine, immunization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Collaborators
- Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
- Study start
- 30 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 29 May 2024 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In people aged 18 years and older, people were divided into in three groups and vaccinated using three kinds of vaccines: 1. Test vaccine 1: Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation 2. Test vaccine 2: Bivalent COVID-19 mRNA Vaccine 3. Control vaccine: Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation
| Arm | Type | Receives |
|---|---|---|
| 1. Ad5-NCO5T-IH | Experimental | Biological: Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For InhalationVaccinated using Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation |
| 2. mbO5 | Experimental | Biological: Bivalent COVID-19 mRNA VaccineVaccinated using Bivalent COVID-19 mRNA Vaccine |
| 3. Ad5-nCoV-IH | Other | Biological: Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For InhalationVaccinated using Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteers aged 18 and above at the time of screening;
- Volunteers can provide with informed consent and sign informed consent form (ICF);
- Have received COVID-19 vaccine, and the interval between the last vaccination ≥ 3 months.
Key exclusion criteria (20 listed)
- Those with convulsions, epilepsy, encephalopathy and serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.) in the past five years;
- Those who are allergic to the active ingredient, any inactive ingredient, or substances used in the production process of the research vaccine, or those who are allergic to the similar vaccines previously; Those who have had severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioedema, dyspnea, etc.), and have any previous history of severe allergies to vaccines, foods, drugs, such as: urticaria, anaphylactic shock, skin eczema, allergic dyspnea, angioedema, etc. or a history of asthma;
- Those who have previously suffered from severe heart diseases such as myocarditis and pericarditis;
- Those who have experienced vaccination-related hospitalization or emergency care after previous vaccination;
- Female urine pregnancy test positive or lactating volunteers, volunteers or their partners have not taken effective contraception 2 weeks before screening or have a pregnancy plan within 6 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For InhalationAlso: Ad5-NCO5T-IHContaining two adenovirus type 5-based vaccines delivering the spike proteins of SARS-CoV-2 wild type and Omicron BA.4/5 mutant, respectively | Biological | 1. Ad5-NCO5T-IH |
| Bivalent COVID-19 mRNA VaccineAlso: mbO5Containing two mRNA-based vaccines delivering the spike proteins of SARS-CoV-2 Beta and Omicron BA.4/5 mutant, respectively | Biological | 2. mbO5 |
| Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For InhalationAlso: Ad5-nCoV-IHContaining adenovirus type 5-based vaccine delivering the spike proteins of SARS-CoV-2 wild type | Biological | 3. Ad5-nCoV-IH |
Primary outcome
Anti-XBB-specific neutralizing antibody
Time frame: on day 28 post vaccination
GMT of anti-XBB-specific neutralizing antibody on day 28 post vaccination
The incidence of adverse reactions
Time frame: within 28 days post vaccination
The incidence of adverse reactions within 28 days post vaccination
5 secondary outcomes
The incidence of adverse reactions
Time frame: within 30 mins post vaccination
The incidence of adverse event
Time frame: within 28 days post vaccination
The incidence of SAE and AESI
Time frame: within 6 months post vaccination
specific neutralizing antibody against XBB and BA.5 variant on 0 and 28 days
Time frame: on 0, 28 days post vaccination
specific neutralizing antibody against XBB and BA.5 variant at 14 days, 3 and 6 months
Time frame: at 14 days, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Derived from this study: PubMed 40775215Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianyuan Wu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation, Bivalent COVID-19 mRNA Vaccine and Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation in people with COVID-19, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianying Huang (02167811702, znyylcsy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-XBB-specific neutralizing antibody (time frame: on day 28 post vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05886790, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.