Sequential Immunization With Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Health Adults Based on 3 Doses Inactivated COVID-19 Vaccine

NCT ID: NCT05373030

Last Updated: 2022-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-14
• Study Completion Date: 2023-06-30

Brief Summary

COVID-19 is a novel coronavirus infection caused by respiratory droplets and contact transmission. With the spread of the epidemic, it has become a serious threat to global public health. China has launched a full range of vaccination including the third dose of homologous and sequential booster immunization. To further improve COVID-19 vaccine immunization strategy, we start the clinic research about sequential Immunization With Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Health Adults Based on 3 Doses Inactivated COVID-19 Vaccine in Zhejiang province.

Conditions

Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine Using for Sequential Immunization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Recombinant adenovirus type-5-vectored COVID-19 vaccine

Group Type: EXPERIMENTAL

Recombinant adenovirus type-5-vectored COVID-19 vaccine

Intervention Type: BIOLOGICAL

One dose COVID-19 vaccine

Inactivated COVID-19 vaccine

Group Type: ACTIVE_COMPARATOR

Recombinant adenovirus type-5-vectored COVID-19 vaccine

Intervention Type: BIOLOGICAL

One dose COVID-19 vaccine

Interventions

Recombinant adenovirus type-5-vectored COVID-19 vaccine

One dose COVID-19 vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Volunteers aged 18 and above at the time of screening;

2. Obtain the informed consent of the volunteers and sign the informed consent;

3. Volunteers are able and willing to comply with the requirements of the clinical trial protocol and complete the 6-month study follow-up;

4. Have received 3 doses of Sinovac/Beijing Biological Novel Coronavirus inactivated vaccine with an interval of 6-9 months.

Exclusion Criteria

1. Patients with history or family history of convulsion, epilepsy, encephalopathy and mental illness;

2. Those who are allergic to any of the components of the study vaccine, have had a severe allergic reaction to the vaccine in the past, a history of allergy or asthma;

3. Serious adverse events related to vaccination occurred after previous vaccination; 4) Positive urine pregnancy test in women during lactation or childbearing age;

5) Acute febrile disease, infectious disease, SARS history; 6) Axillary body temperature > 37.0℃; 7) Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrolled medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured on site); 8) Patients with serious chronic diseases that are in the advanced stage and cannot be controlled smoothly, such as diabetes and thyroid diseases; 9) Congenital or acquired angioedema/neuroedema; 10) Urticaria 1 year before receiving the test vaccine; 11) No spleen or functional no spleen; 12) Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities; 13) History of novel coronavirus infection/illness; 14) Have traveled to medium or high risk areas or left the country in the past 21 days; have a history of novel Coronavirus 2019-epidemiological contact; 15) The researcher made a judgment based on various medical, psychological, social or other conditions that might be contrary to the test protocol or affect the subjects to sign informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhejiang Provincial Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xihu District Center for Disease Control and Prevention

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hangjie Zhang, phD

Role: CONTACT

hjzhang@cdc.zj.cn

+86-13634159682

Facility Contacts

Nani Xu, MsH

Role: primary

xunani2@163.com

References

Zhang H, Xu N, Xu Y, Qin P, Dai R, Xu B, Wang S, Ding L, Fu J, Zhang S, Hua Q, Liao Y, Yang J, Hu X, Jiang J, Lv H. Safety and immunogenicity of Ad5-nCoV immunization after three-dose priming with inactivated SARS-CoV-2 vaccine in Chinese adults. Nat Commun. 2023 Aug 8;14(1):4757. doi: 10.1038/s41467-023-40489-2.

Reference Type: DERIVED

PMID: 37553338 (View on PubMed)

Other Identifiers

CS-NCOVIM-ZJ001

Identifier Type: -

Identifier Source: org_study_id