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

NCT05012800 | Unknown Phase 4

• 1 other identifier: ky-2021-7-7-1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Vaccine; Older Adults

Outcome Measures

Primary Outcomes (2)

• Safety of coronavirus vaccine

  Recorded the adverse effects after COVID-19 vaccination

  Within 2 months after the first dose of coronavirus vaccine

• Immunogenicity of coronavirus vaccine

  Detected the dynamics and titers of anti-SARS-CoV-2 antibodies

  Within 2 months after the first dose of coronavirus vaccine

Secondary Outcomes (2)

• Safety of coronavirus vaccine

  Through study completion, an average of 13 months

• Immunogenicity

  Through study completion, an average of 13 months

Study Arms (2)

COVID-19 Vaccines in older adults

EXPERIMENTAL

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

Biological: COVID-19 Vaccine

COVID-19 Vaccines in young adults

EXPERIMENTAL

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

Biological: COVID-19 Vaccine

Interventions

COVID-19 Vaccine BIOLOGICAL

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

COVID-19 Vaccines in older adults; COVID-19 Vaccines in young adults

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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℃.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing 302 Hospital: lead
• People's Hospital of Hunyuan County, Shanxi Province: collaborator

Study Sites (1)

302 Hospital

Beijing, 100039, China

RECRUITING

MeSH Terms

Interventions

COVID-19 Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 19, 2021
• Study Start: July 28, 2021
• Primary Completion: August 31, 2022
• Study Completion: September 30, 2022
• Last Updated: August 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)