Booster immunization with two different COVID-19 vaccines

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 study is testing two different COVID-19 booster vaccines to see which one helps people build a stronger immune response after they've already had a vaccine.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhongnan Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05886790 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the immunogenicity and safety of two bivalent COVID-19 vaccines, one based on adenovirus type 5 and the other on mRNA technology. It will recruit 450 participants aged 18 and older who have received a previous COVID-19 vaccine at least three months prior. Participants will receive one dose of either the inhaled adenovirus vector vaccine or the mRNA vaccine, with follow-up assessments conducted for six months post-vaccination. The study aims to compare the immune responses generated by these two different vaccine platforms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have received a prior COVID-19 vaccine at least three months before enrollment.

Not a fit: Patients with a history of severe allergies to vaccines or serious neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance booster vaccination strategies against COVID-19, potentially improving immunity and safety for patients.

How similar studies have performed: Other studies have shown promising results with different vaccine platforms, but this specific comparison of inhaled and mRNA vaccines is relatively novel.

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.

Where this trial is running

Wuhan, Hubei

• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Jianying Huang

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