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

NCT ID: NCT05012800

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2022-09-30

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.

Conditions

COVID-19 Vaccine; Older Adults

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

COVID-19 Vaccines in older adults

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

Group Type: EXPERIMENTAL

COVID-19 Vaccine

Intervention Type: BIOLOGICAL

Coronavirus vaccine was inoculated on day 0 and day 21, respectively.

COVID-19 Vaccines in young adults

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

Group Type: EXPERIMENTAL

COVID-19 Vaccine

Intervention Type: BIOLOGICAL

Coronavirus vaccine was inoculated on day 0 and day 21, respectively.

Interventions

COVID-19 Vaccine

Coronavirus vaccine was inoculated on day 0 and day 21, respectively.

Intervention Type: BIOLOGICAL

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.

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

Sponsors

People's Hospital of Hunyuan County, Shanxi Province

UNKNOWN

Sponsor Role: collaborator

Beijing 302 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

302 Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yun-Bo Xie, MD

Role: primary

15110140963@163.com

01066933331

Other Identifiers

ky-2021-7-7-1

Identifier Type: -

Identifier Source: org_study_id