COVID-19 VaccinePhase 4NCT05012800
Safety and Immunogenicity of COVID-19 Vaccine Administered in Older Adults
A Phase 4 study testing COVID-19 Vaccine in people with COVID-19 Vaccine and Older Adults, run by Beijing 302 Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccine, Older Adults
- What is being tested?
- COVID-19 Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2021to 30 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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℃.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
302 Hospital
Beijing, 100039
Yun-Bo Xie, MD, 01066933331, 15110140963@163.com
Hong-Hong Liu, MD
About this study
Official title: 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.
Read the 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
- Being tested
- COVID-19 Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccineBiological
Coronavirus vaccine was inoculated on day 0 and day 21, respectively.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of coronavirus vaccine
Recorded the adverse effects after COVID-19 vaccination
Measured: 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
Measured: Within 2 months after the first dose of coronavirus vaccine
Secondary outcomes (2)
Safety of coronavirus vaccine
Recorded the adverse effects after COVID-19 vaccination
Measured: Through study completion, an average of 13 months
Immunogenicity
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
Measured: Through study completion, an average of 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start28 Jul 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012800
- Sponsor's protocol ID
- ky-2021-7-7-1
- Status last verified
- Jul 2021
- First submitted
- 12 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of COVID-19 Vaccine Administered in Older Adults: A Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT05012800
- Acronym / sponsor ID
- ky-2021-7-7-1
- Conditions
- COVID-19 Vaccine, Older Adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Collaborators
- Shanxi Provincial People's Hospital
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Vaccines in older adults | Experimental | Biological: COVID-19 VaccineHealthy people between the ages of 60 and 80 inoculated coronavirus vaccine on day 0 and day 21, respectively. |
| COVID-19 Vaccines in young adults | Experimental | Biological: COVID-19 VaccineHealthy people between the ages of 20 and 59 inoculated coronavirus vaccine on day 0 and day 21, respectively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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℃.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 VaccineCoronavirus vaccine was inoculated on day 0 and day 21, respectively. | Biological | COVID-19 Vaccines in older adults, COVID-19 Vaccines in young adults |
Primary outcome
Safety of coronavirus vaccine
Time frame: Within 2 months after the first dose of coronavirus vaccine
Recorded the adverse effects after COVID-19 vaccination
Immunogenicity of coronavirus vaccine
Time frame: Within 2 months after the first dose of coronavirus vaccine
Detected the dynamics and titers of anti-SARS-CoV-2 antibodies
2 secondary outcomes
Safety of coronavirus vaccine
Time frame: Through study completion, an average of 13 months
Immunogenicity
Time frame: Through study completion, an average of 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: Yes
Related trials for COVID-19 Vaccine
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
RecruitingPhase 4
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
SARS-CoV-2
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing COVID-19 Vaccine in people with COVID-19 Vaccine and Older Adults, run by Beijing 302 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of coronavirus vaccine (time frame: Within 2 months after the first dose of coronavirus vaccine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.