A Clinical Trial on Booster Immunization of Two COVID-19 Vaccines Constructed From Different Technical Routes

NCT ID: NCT05886790

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-30
• Study Completion Date: 2024-05-29

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1. Ad5-NCO5T-IH

Vaccinated using Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation

Group Type: EXPERIMENTAL

Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation

Intervention Type: 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

2. mbO5

Vaccinated using Bivalent COVID-19 mRNA Vaccine

Group Type: EXPERIMENTAL

Bivalent COVID-19 mRNA Vaccine

Intervention Type: BIOLOGICAL

Containing two mRNA-based vaccines delivering the spike proteins of SARS-CoV-2 Beta and Omicron BA.4/5 mutant, respectively

3. Ad5-nCoV-IH

Vaccinated using Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation

Group Type: OTHER

Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation

Intervention Type: BIOLOGICAL

Containing adenovirus type 5-based vaccine delivering the spike proteins of SARS-CoV-2 wild type

Interventions

Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation

Containing two adenovirus type 5-based vaccines delivering the spike proteins of SARS-CoV-2 wild type and Omicron BA.4/5 mutant, respectively

Intervention Type: BIOLOGICAL

Bivalent COVID-19 mRNA Vaccine

Containing two mRNA-based vaccines delivering the spike proteins of SARS-CoV-2 Beta and Omicron BA.4/5 mutant, respectively

Intervention Type: BIOLOGICAL

Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation

Containing adenovirus type 5-based vaccine delivering the spike proteins of SARS-CoV-2 wild type

Intervention Type: BIOLOGICAL

Other Intervention Names

Ad5-NCO5T-IH; mbO5; Ad5-nCoV-IH

Eligibility Criteria

Inclusion Criteria

1. Volunteers aged 18 and above at the time of screening;

2. Volunteers can provide with informed consent and sign informed consent form (ICF);

3. Have received COVID-19 vaccine, and the interval between the last vaccination ≥ 3 months.

Exclusion Criteria

1. Those with convulsions, epilepsy, encephalopathy and serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.) in the past five years;

2. 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;

3. Those who have previously suffered from severe heart diseases such as myocarditis and pericarditis;

4. Those who have experienced vaccination-related hospitalization or emergency care after previous vaccination;

5. 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;

6. Fever, axillary body temperature≥ 37.3°C;

7. Those with suspected symptoms of COVID-19 in the past 3 months (fever, cough, muscle pain, loss of smell or taste, etc.);

8. 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;

9. No spleen or functional spleen;

10. Thrombocytopenia, bleeding disorders, or other coagulation disorders (which may cause contraindications to intramuscular injection);

11. 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;

12. Suffering from nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, mouth ulcers, throat redness and swelling, etc.;

13. Have received blood products within 3 months prior to receiving the test vaccine;

14. Have received other vaccines or investigational drugs within 1 month prior to receiving the test vaccine;

15. Are receiving anti-tuberculosis treatment;

16. Those with a history of COVID-19 infection in the past 3 months;

17. Those who have a positive test result of the novel coronavirus antigen at the time of screening;

18. Those with positive HIV infection results at screening;

19. Participated in other interventional studies of lipid-containing nanoparticles;

20. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

OTHER

Sponsor Role: collaborator

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jianying Huang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianying Huang

Role: CONTACT

znyylcsy@126.com

02167811702

Jianyuan Wu

Role: CONTACT

02167812668

Facility Contacts

Jianying Huang

Role: primary

Jianyuan Wu

Role: backup

67812668

References

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.

Reference Type: DERIVED

PMID: 40775215 (View on PubMed)

Other Identifiers

AMMS85-2301

Identifier Type: -

Identifier Source: org_study_id