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

NCT05886790 | Unknown

• 1 other identifier: AMMS85-2301
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; vaccine; immunization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• The incidence of adverse reactions

  within 30 mins post vaccination

• The incidence of adverse event

  within 28 days post vaccination

• 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

  on 0, 28 days post vaccination

• specific neutralizing antibody against XBB and BA.5 variant at 14 days, 3 and 6 months

  at 14 days, 3 and 6 months

Study Arms (3)

1. Ad5-NCO5T-IH

EXPERIMENTAL

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

2. mbO5

EXPERIMENTAL

Vaccinated using Bivalent COVID-19 mRNA Vaccine

Biological: Bivalent COVID-19 mRNA Vaccine

3. Ad5-nCoV-IH

OTHER

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

Biological: Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation

Interventions

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

Containing two adenovirus type 5-based vaccines delivering the spike proteins of SARS-CoV-2 wild type and Omicron BA.4/5 mutant, respectively

Also known as: Ad5-NCO5T-IH

1. Ad5-NCO5T-IH

Bivalent COVID-19 mRNA Vaccine BIOLOGICAL

Containing two mRNA-based vaccines delivering the spike proteins of SARS-CoV-2 Beta and Omicron BA.4/5 mutant, respectively

Also known as: mbO5

2. mbO5

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

Containing adenovirus type 5-based vaccine delivering the spike proteins of SARS-CoV-2 wild type

Also known as: Ad5-nCoV-IH

3. Ad5-nCoV-IH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhongnan Hospital: lead
• Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China: collaborator

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (1)

• Wu S, Huang J, Wang B, Li J, Wu J, Zhang Z, Luo L, Zhang J, Huo N, Long J, Huang H, Chen Z, Zhang M, Zhao Z, Dan J, Song X, Mao H, Huo S, Yan H, Zhang Y, Wang X, Hou L. Safety and Immunogenicity of aerosolized adenovirus-vectored COVID-19 vaccine and intramuscular mRNA vaccine bivalent boosters: a randomized open-label clinical trial. Nat Commun. 2025 Aug 7;16(1):7281. doi: 10.1038/s41467-025-62698-7.

  PMID: 40775215 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jianying Huang

CONTACT

02167811702; znyylcsy@126.com

Jianyuan Wu

CONTACT

02167812668

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 2, 2023
• Study Start: May 30, 2023
• Primary Completion: December 31, 2023
• Study Completion: May 29, 2024
• Last Updated: June 2, 2023

Record last verified: 2023-06

Locations

CN (1)