Clinical trial NCT05886790: A Clinical Trial on Booster Immunization of Two COVID-19 Vaccines Constructed From Different Technical Routes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2
vaccine
immunization
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
Collaborators: name: Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
First posted: 2023-06-02
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Anti-XBB-specific neutralizing antibody
timeFrame: on day 28 post vaccination
measure: The incidence of adverse reactions
timeFrame: within 28 days post vaccination
Secondary outcomes:
measure: The incidence of adverse reactions
timeFrame: within 30 mins post vaccination
measure: The incidence of adverse event
timeFrame: within 28 days post vaccination
measure: The incidence of SAE and AESI
timeFrame: within 6 months post vaccination
measure: specific neutralizing antibody against XBB and BA.5 variant on 0 and 28 days
timeFrame: on 0, 28 days post vaccination
measure: specific neutralizing antibody against XBB and BA.5 variant at 14 days, 3 and 6 months
timeFrame: at 14 days, 3 and 6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References: