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Safety and Immunogenicity of COVID-19 Vaccine Administered in Older Adults

Primary Purpose

COVID-19 Vaccine, Older Adults

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
COVID-19 Vaccine
Sponsored by
Beijing 302 Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 Vaccine

Eligibility Criteria

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

Inclusion Criteria:

  • A COVID-19 vaccine is planned.
  • Older adults subjects aged 60-80 years or young adults subjects aged 18-59 years.
  • Able and willing to follow the requirements of the clinical trial protocol and complete the study follow-up for 12 months.
  • HBsAg, anti-HCV, HIV and TPHA were negative.
  • Body temperature ≤37.0℃.

Exclusion Criteria:

  • People who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
  • Women who is pregnant, breastfeeding, or planning to be pregnant within 6 months.
  • Sufferring serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
  • Patients with severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc.
  • Patients with congenital or acquired angioedema / neuroedema.
  • Patients with lymphoma, leukemia and other systemic malignancies.
  • Patients with convulsions, epilepsy, encephalopathy, psychiatric disorders and other progressive neurological disorders, or a family history of them.
  • Patients with acute attack of chronic diseases.
  • During vaccination, immunomodulators, systemic cytotoxic drugs, immune checkpoint inhibitors (PD-1 / PDL-1 / CTLA-4, etc.) and cell therapy, including NK cells, cytokine induced killer cells, Dendritic cells, CTL and Stem cells infusion are required.
  • Other conditions determined by the researcher.

Sites / Locations

  • 302 HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

COVID-19 Vaccines in older adults

COVID-19 Vaccines in young adults

Arm Description

Healthy people between the ages of 60 and 80 inoculated coronavirus vaccine on day 0 and day 21, respectively.

Healthy people between the ages of 20 and 59 inoculated coronavirus vaccine on day 0 and day 21, respectively.

Outcomes

Primary Outcome Measures

Safety of coronavirus vaccine
Recorded the adverse effects after COVID-19 vaccination
Immunogenicity of coronavirus vaccine
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies

Secondary Outcome Measures

Safety of coronavirus vaccine
Recorded the adverse effects after COVID-19 vaccination
Immunogenicity
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies

Full Information

First Posted
August 12, 2021
Last Updated
August 18, 2021
Sponsor
Beijing 302 Hospital
Collaborators
People's Hospital of Hunyuan County, Shanxi Province
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1. Study Identification

Unique Protocol Identification Number
NCT05012800
Brief Title
Safety and Immunogenicity of COVID-19 Vaccine Administered in Older Adults
Official Title
Safety and Immunogenicity of COVID-19 Vaccine Administered in Older Adults: A Multicenter Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing 302 Hospital
Collaborators
People's Hospital of Hunyuan County, Shanxi Province

4. Oversight

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

5. Study Description

Brief Summary
The COVID-19 pandemic is causing unprecedented morbidity and mortality.The safe and effective Novel coronavirus vaccine is an effective means to block the transmission of the virus by building up the immune barrier of the population.Clinical studies have shown that elderly people are at high risk of severe COVID-19 infection and have poor clinical prognosis.Considering the current situation of aging population in China, the elderly people should be given priority to vaccinate to obtain protection and reduce the risk of novel coronavirus infection.However, the current data on vaccines are mostly from young and middle-aged healthy people, while there is little research data on COVID-19 vaccination in the elderly.This study mainly studied the safety and effectiveness of COVID-19 vaccine in the elderly population and explored its potential immune mechanism.
Detailed Description
This study is a prospective, multicenter, controlled , open-label and phase I clinical trial. Older adults in the study included healthy people between the ages of 60 and 80 group. Those who is in line with the inclusion criteria and who is not in conformity with the exclusion criteria received two doses of COVID-19 vaccine at 0 days (baseline) and 21 days, respectively, and were followed up at 1, 3, 6, 9 and 12 months after completion of vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Vaccine, Older Adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 Vaccines in older adults
Arm Type
Experimental
Arm Description
Healthy people between the ages of 60 and 80 inoculated coronavirus vaccine on day 0 and day 21, respectively.
Arm Title
COVID-19 Vaccines in young adults
Arm Type
Experimental
Arm Description
Healthy people between the ages of 20 and 59 inoculated coronavirus vaccine on day 0 and day 21, respectively.
Intervention Type
Biological
Intervention Name(s)
COVID-19 Vaccine
Intervention Description
Coronavirus vaccine was inoculated on day 0 and day 21, respectively.
Primary Outcome Measure Information:
Title
Safety of coronavirus vaccine
Description
Recorded the adverse effects after COVID-19 vaccination
Time Frame
Within 2 months after the first dose of coronavirus vaccine
Title
Immunogenicity of coronavirus vaccine
Description
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
Time Frame
Within 2 months after the first dose of coronavirus vaccine
Secondary Outcome Measure Information:
Title
Safety of coronavirus vaccine
Description
Recorded the adverse effects after COVID-19 vaccination
Time Frame
Through study completion, an average of 13 months
Title
Immunogenicity
Description
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
Time Frame
Through study completion, an average of 13 months

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: A COVID-19 vaccine is planned. Older adults subjects aged 60-80 years or young adults subjects aged 18-59 years. Able and willing to follow the requirements of the clinical trial protocol and complete the study follow-up for 12 months. HBsAg, anti-HCV, HIV and TPHA were negative. Body temperature ≤37.0℃. Exclusion Criteria: People who are allergic to any component of the vaccine, or have a serious history of vaccine allergy. Women who is pregnant, breastfeeding, or planning to be pregnant within 6 months. Sufferring serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs. Patients with severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Patients with congenital or acquired angioedema / neuroedema. Patients with lymphoma, leukemia and other systemic malignancies. Patients with convulsions, epilepsy, encephalopathy, psychiatric disorders and other progressive neurological disorders, or a family history of them. Patients with acute attack of chronic diseases. During vaccination, immunomodulators, systemic cytotoxic drugs, immune checkpoint inhibitors (PD-1 / PDL-1 / CTLA-4, etc.) and cell therapy, including NK cells, cytokine induced killer cells, Dendritic cells, CTL and Stem cells infusion are required. Other conditions determined by the researcher.
Facility Information:
Facility Name
302 Hospital
City
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun-Bo Xie, MD
Phone
01066933331
Email
15110140963@163.com
First Name & Middle Initial & Last Name & Degree
Hong-Hong Liu, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Safety and Immunogenicity of COVID-19 Vaccine Administered in Older Adults

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