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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation; Biological: Bivalent COVID-19 mRNA Vaccine; Biological: Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation

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 Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianying Huang; Phone Number: 02167811702; Email: znyylcsy@126.com
• Study Contact Backup: Name: Jianyuan Wu; Phone Number: 02167812668

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: JianYing Huang
      • Contact: Jianyuan Wu; Phone Number: 67812668

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1. Ad5-NCO5T-IH; Vaccinated using Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation	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 Names: Ad5-NCO5T-IH
Experimental: 2. mbO5; Vaccinated using Bivalent COVID-19 mRNA Vaccine	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 Names: mbO5
Other: 3. Ad5-nCoV-IH; Vaccinated using Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation	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 Names: Ad5-nCoV-IH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-XBB-specific neutralizing antibody	GMT of anti-XBB-specific neutralizing antibody on day 28 post vaccination	on day 28 post vaccination
The incidence of adverse reactions	The incidence of adverse reactions within 28 days post vaccination	within 28 days post vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of adverse reactions	The incidence of adverse reactions within 30 mins post vaccination	within 30 mins post vaccination
The incidence of adverse event	The incidence of adverse event within 28 days post vaccination	within 28 days post vaccination
The incidence of SAE and AESI	The incidence of SAE and AESI within 6 months post vaccination	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	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	at 14 days, 3 and 6 months

Collaborators and Investigators

• Sponsor: Zhongnan Hospital
• Collaborators: Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): May 29, 2024

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Estimated): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; vaccine; COVID-19; immunization
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: AMMS85-2301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No