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

NCT05373030 | Unknown Phase 4

• 1 other identifier: CS-NCOVIM-ZJ001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse reactions (AR) in 0-14 days after immunization

  Incidence of adverse reactions (AR)

  14 days

• Geometric mean titer (GMT) of neutralizing antibody against SARS-COV-2 at 14 days after immunization

  Geometric mean titer (GMT) of neutralizing antibody against SARS-COV-2

  14 days

Study Arms (2)

Recombinant adenovirus type-5-vectored COVID-19 vaccine

EXPERIMENTAL

Biological: Recombinant adenovirus type-5-vectored COVID-19 vaccine

Inactivated COVID-19 vaccine

ACTIVE COMPARATOR

Biological: Recombinant adenovirus type-5-vectored COVID-19 vaccine

Interventions

Recombinant adenovirus type-5-vectored COVID-19 vaccine BIOLOGICAL

One dose COVID-19 vaccine

Inactivated COVID-19 vaccine; Recombinant adenovirus type-5-vectored COVID-19 vaccine

Eligibility Criteria

• Age: 18 Years - 80 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;
• Obtain the informed consent of the volunteers and sign the informed consent;
• Volunteers are able and willing to comply with the requirements of the clinical trial protocol and complete the 6-month study follow-up;
• Have received 3 doses of Sinovac/Beijing Biological Novel Coronavirus inactivated vaccine with an interval of 6-9 months.

You may not qualify if:

• Patients with history or family history of convulsion, epilepsy, encephalopathy and mental illness;
• 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;
• Serious adverse events related to vaccination occurred after previous vaccination; 4) Positive urine pregnancy test in women during lactation or childbearing age;
• \) 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.

Sponsors & Collaborators

• Zhejiang Provincial Center for Disease Control and Prevention: lead

Study Sites (1)

Xihu District Center for Disease Control and Prevention

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37553338 DERIVED

Central Study Contacts

Hangjie Zhang, phD

CONTACT

+86-13634159682; hjzhang@cdc.zj.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 13, 2022
• Study Start: May 14, 2022
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)