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

Primary Purpose

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

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Recombinant adenovirus type-5-vectored COVID-19 vaccine
Sponsored by
Zhejiang Provincial Center for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine Using for Sequential Immunization

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Xihu District Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Recombinant adenovirus type-5-vectored COVID-19 vaccine

Inactivated COVID-19 vaccine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2022
Last Updated
May 12, 2022
Sponsor
Zhejiang Provincial Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05373030
Brief Title
Sequential Immunization With Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Health Adults Based on 3 Doses Inactivated COVID-19 Vaccine
Official Title
Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Healthy Adults (18-80 Years Old) Finished 3 Doses Inactivated COVID-19 Vaccine: a Randomised, Double-blind, Parallel Controlled, Clinic Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 14, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Provincial Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine Using for Sequential Immunization

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recombinant adenovirus type-5-vectored COVID-19 vaccine
Arm Type
Experimental
Arm Title
Inactivated COVID-19 vaccine
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Recombinant adenovirus type-5-vectored COVID-19 vaccine
Intervention Description
One dose COVID-19 vaccine
Primary Outcome Measure Information:
Title
Incidence of adverse reactions (AR) in 0-14 days after immunization
Description
Incidence of adverse reactions (AR)
Time Frame
14 days
Title
Geometric mean titer (GMT) of neutralizing antibody against SARS-COV-2 at 14 days after immunization
Description
Geometric mean titer (GMT) of neutralizing antibody against SARS-COV-2
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hangjie Zhang, phD
Phone
+86-13634159682
Email
hjzhang@cdc.zj.cn
Facility Information:
Facility Name
Xihu District Center for Disease Control and Prevention
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nani Xu, MsH
Email
xunani2@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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