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

Safety and Immunogenicity of COVID-19 Vaccine Administered in Older Adults: A Multicenter Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: Older Adults; COVID-19 Vaccine
• Intervention / Treatment: Biological: COVID-19 Vaccine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100039
    • Recruiting
    • 302 Hospital
    • Contact: Yun-Bo Xie, MD; Phone Number: 01066933331; Email: 15110140963@163.com
    • Principal Investigator: Hong-Hong Liu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: COVID-19 Vaccine; Coronavirus vaccine was inoculated on day 0 and day 21, respectively.
Experimental: 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.	Biological: COVID-19 Vaccine; Coronavirus vaccine was inoculated on day 0 and day 21, respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of coronavirus vaccine	Recorded the adverse effects after COVID-19 vaccination	Through study completion, an average of 13 months
Immunogenicity	Detected the dynamics and titers of anti-SARS-CoV-2 antibodies	Through study completion, an average of 13 months

Collaborators and Investigators

• Sponsor: Beijing 302 Hospital
• Collaborators: People's Hospital of Hunyuan County, Shanxi Province

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ky-2021-7-7-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No