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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation
Bivalent COVID-19 mRNA Vaccine
Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation
Sponsored by
Zhongnan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2, vaccine, immunization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Volunteers aged 18 and above at the time of screening; Volunteers can provide with informed consent and sign informed consent form (ICF); Have received COVID-19 vaccine, and the interval between the last vaccination ≥ 3 months. Exclusion Criteria: Those with convulsions, epilepsy, encephalopathy and serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.) in the past five years; 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; Those who have previously suffered from severe heart diseases such as myocarditis and pericarditis; Those who have experienced vaccination-related hospitalization or emergency care after previous vaccination; 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; Fever, axillary body temperature≥ 37.3°C; Those with suspected symptoms of COVID-19 in the past 3 months (fever, cough, muscle pain, loss of smell or taste, etc.); 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; No spleen or functional spleen; Thrombocytopenia, bleeding disorders, or other coagulation disorders (which may cause contraindications to intramuscular injection); 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; Suffering from nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, mouth ulcers, throat redness and swelling, etc.; Have received blood products within 3 months prior to receiving the test vaccine; Have received other vaccines or investigational drugs within 1 month prior to receiving the test vaccine; Are receiving anti-tuberculosis treatment; Those with a history of COVID-19 infection in the past 3 months; Those who have a positive test result of the novel coronavirus antigen at the time of screening; Those with positive HIV infection results at screening; Participated in other interventional studies of lipid-containing nanoparticles; 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.

Sites / Locations

  • Zhongnan Hospital of Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

1. Ad5-NCO5T-IH

2. mbO5

3. Ad5-nCoV-IH

Arm Description

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

Vaccinated using Bivalent COVID-19 mRNA Vaccine

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The incidence of adverse reactions
The incidence of adverse reactions within 30 mins post vaccination
The incidence of adverse event
The incidence of adverse event within 28 days post vaccination
The incidence of SAE and AESI
The incidence of SAE and AESI 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
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

Full Information

First Posted
May 29, 2023
Last Updated
June 1, 2023
Sponsor
Zhongnan Hospital
Collaborators
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
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1. Study Identification

Unique Protocol Identification Number
NCT05886790
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongnan Hospital
Collaborators
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, SARS-CoV-2, vaccine, immunization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In people aged 18 years and older, people were divided into in three groups and vaccinated using three kinds of vaccines: Test vaccine 1: Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation Test vaccine 2: Bivalent COVID-19 mRNA Vaccine Control vaccine: Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. Ad5-NCO5T-IH
Arm Type
Experimental
Arm Description
Vaccinated using Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation
Arm Title
2. mbO5
Arm Type
Experimental
Arm Description
Vaccinated using Bivalent COVID-19 mRNA Vaccine
Arm Title
3. Ad5-nCoV-IH
Arm Type
Other
Arm Description
Vaccinated using Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation
Intervention Type
Biological
Intervention Name(s)
Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation
Other Intervention Name(s)
Ad5-NCO5T-IH
Intervention Description
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
Intervention Name(s)
Bivalent COVID-19 mRNA Vaccine
Other Intervention Name(s)
mbO5
Intervention Description
Containing two mRNA-based vaccines delivering the spike proteins of SARS-CoV-2 Beta and Omicron BA.4/5 mutant, respectively
Intervention Type
Biological
Intervention Name(s)
Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation
Other Intervention Name(s)
Ad5-nCoV-IH
Intervention Description
Containing adenovirus type 5-based vaccine delivering the spike proteins of SARS-CoV-2 wild type
Primary Outcome Measure Information:
Title
Anti-XBB-specific neutralizing antibody
Description
GMT of anti-XBB-specific neutralizing antibody on day 28 post vaccination
Time Frame
on day 28 post vaccination
Title
The incidence of adverse reactions
Description
The incidence of adverse reactions within 28 days post vaccination
Time Frame
within 28 days post vaccination
Secondary Outcome Measure Information:
Title
The incidence of adverse reactions
Description
The incidence of adverse reactions within 30 mins post vaccination
Time Frame
within 30 mins post vaccination
Title
The incidence of adverse event
Description
The incidence of adverse event within 28 days post vaccination
Time Frame
within 28 days post vaccination
Title
The incidence of SAE and AESI
Description
The incidence of SAE and AESI within 6 months post vaccination
Time Frame
within 6 months post vaccination
Title
specific neutralizing antibody against XBB and BA.5 variant on 0 and 28 days
Description
The positive conversion rate, GMT and GMI of specific neutralizing antibody against XBB and BA.5 variant on 0 and 28 days
Time Frame
on 0, 28 days post vaccination
Title
specific neutralizing antibody against XBB and BA.5 variant at 14 days, 3 and 6 months
Description
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
Time Frame
at 14 days, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Volunteers aged 18 and above at the time of screening; Volunteers can provide with informed consent and sign informed consent form (ICF); Have received COVID-19 vaccine, and the interval between the last vaccination ≥ 3 months. Exclusion Criteria: Those with convulsions, epilepsy, encephalopathy and serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.) in the past five years; 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; Those who have previously suffered from severe heart diseases such as myocarditis and pericarditis; Those who have experienced vaccination-related hospitalization or emergency care after previous vaccination; 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; Fever, axillary body temperature≥ 37.3°C; Those with suspected symptoms of COVID-19 in the past 3 months (fever, cough, muscle pain, loss of smell or taste, etc.); 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; No spleen or functional spleen; Thrombocytopenia, bleeding disorders, or other coagulation disorders (which may cause contraindications to intramuscular injection); 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; Suffering from nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, mouth ulcers, throat redness and swelling, etc.; Have received blood products within 3 months prior to receiving the test vaccine; Have received other vaccines or investigational drugs within 1 month prior to receiving the test vaccine; Are receiving anti-tuberculosis treatment; Those with a history of COVID-19 infection in the past 3 months; Those who have a positive test result of the novel coronavirus antigen at the time of screening; Those with positive HIV infection results at screening; Participated in other interventional studies of lipid-containing nanoparticles; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianying Huang
Phone
02167811702
Email
znyylcsy@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianyuan Wu
Phone
02167812668
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianying Huang
First Name & Middle Initial & Last Name & Degree
Jianyuan Wu
Phone
67812668

12. IPD Sharing Statement

Learn more about this trial

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

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