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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05886790
• Other study ID #: AMMS85-2301
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: May 29, 2024

Study information

• Verified date: June 2023
• Source: Zhongnan Hospital
• Contact: Jianying Huang
• Phone: 02167811702
• Email: znyylcsy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: May 29, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Zhongnan Hospital	Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-XBB-specific neutralizing antibody	GMT of anti-XBB-specific neutralizing antibody on day 28 post vaccination	on day 28 post vaccination
Primary	The incidence of adverse reactions	The incidence of adverse reactions within 28 days post vaccination	within 28 days post vaccination
Secondary	The incidence of adverse reactions	The incidence of adverse reactions within 30 mins post vaccination	within 30 mins post vaccination
Secondary	The incidence of adverse event	The incidence of adverse event within 28 days post vaccination	within 28 days post vaccination
Secondary	The incidence of SAE and AESI	The incidence of SAE and AESI within 6 months post vaccination	within 6 months post vaccination
Secondary	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
Secondary	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