This is an open-label, randomized, parallel-controlled clinical trial conducted in peopleaged 18 years and older to evaluate the immunogenicity and safety of two SARS-CoV-2bivalent 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.
Biological: 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
Other Name: Ad5-NCO5T-IH
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
Other Name: mbO5
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
Other Name: Ad5-nCoV-IH
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.
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Investigator: Jianying Huang
Jianying Huang
02167811702
znyylcsy@126.com
Jianyuan Wu
02167812668
Not Provided