A multicenter, open, parallel-controlled, internally randomized clinical trial to evaluate the safety and immunogenicity of enhanced vaccination using recombinant novel coronavirus XBB.1.5 variant vaccine (adenovirus type 5 vector) in people over 18 years of age who have completed basic immunization with novel coronavirus vaccine

Study of safety and immunogenicity of recombinant novel coronavirus XBB.1.5 variant vaccine (adenovirus type 5 vector) in adults (=18 years old)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300075626

Enrollment

Unknown

Registered

2023-09-11

Start date

2023-09-11

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 infection

Interventions

Cohort 1:Recombinant Novel coronavirus XBB.1.5 Variant Vaccine (Adenovirus Type 5 vector)

Cohort 2 (Control group):Recombinant trivalent novel coronavirus (XBB+BA.5+Delta variant) trimer protein vaccine (Sf9 cells)

Cohort 2 (Test group):Recombinant Novel coronavirus XBB.1.5 Variant Vaccine (Adenovirus Type 5 vector)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Volunteers aged 18 and above at the time of screening; 2. Obtain the informed consent of the volunteer, and the volunteer/witness can sign the informed consent; 3. The volunteer is able and willing to comply with the requirements of the clinical trial protocol and can complete the 6-month study follow-up.

Exclusion criteria

Exclusion criteria: 1. People who are allergic to the ingredients of the investigational drug, or who have been allergic to the same type of vaccine before; Patients with a history of severe allergic reactions to vaccines (such as acute allergic reactions, angioneurotic edema, dyspnea, etc.) and a history of severe allergic reactions to vaccines, foods, drugs, such as urticaria, anaphylactic shock, skin eczema, allergic dyspnea, angioneurotic edema, etc., or asthma; 2. Vaccination-related adverse events that result in hospitalization or emergency treatment after previous vaccination; 3. Fever, armpit temperature > 37.0?; 4. For females, urine pregnancy test positive or breastfeeding volunteers; volunteers themselvies or their partners have pregnancy plans within 6 months; 5. Medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the experimental protocol or affect the volunteers' signing of informed consent.

Design outcomes

Primary

Measure	Time frame
Incidence of adverse reactions;	—

Secondary

Measure	Time frame
Incidence of adverse reactions;Incidence of adverse events;Geometric mean titer (GMT), geometric mean growth multiple (GMI) and positive conversion rate of neutralizing antibodies against XBB.1.5 variant true virus;Geometric mean titers, geometric mean growth multiples, and positive conversion rates of anti-XBB.1.5 and EG.5 variant pseudovirus neutralizing antibodies;positive rates and response levels of novel coronavirus specific IFN-?+ T cells ;Incidence of SAE and pregnancy;	—

Measure

Time frame

Incidence of adverse reactions;Incidence of adverse events;Geometric mean titer (GMT), geometric mean growth multiple (GMI) and positive conversion rate of neutralizing antibodies against XBB.1.5 variant true virus;Geometric mean titers, geometric mean growth multiples, and positive conversion rates of anti-XBB.1.5 and EG.5 variant pseudovirus neutralizing antibodies;positive rates and response levels of novel coronavirus specific IFN-?+ T cells ;Incidence of SAE and pregnancy;

—

Countries

China

Contacts

Public ContactFeng zhichun

Seventh Medical Center of PLA General Hospital

zhichunfeng81@163.com+86 157 1100 1207

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026