COVID-19Phase 4NCT05095298
Reactogenicity and Immunogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines
A Phase 4 study testing Vaccine, COVID19 in people with COVID-19, run by Huashan Hospital at 2 sites in China.
Trial summary
It is a prospective open-labeled study, We intended to recruit the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before, and volunteered to receive the third dose of vaccine (inactivated vaccine, recombinant subunit protein vaccine or mRNA vaccine) into the experimental group, and the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Vaccine, COVID19
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2021to 1 Aug 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old,
- Through asking medical history and physical examination, the investigator judged that the health condition is good: the chronic disease is stable and there is no change within 3 months of medication;
- has been completed 2 doses of Covid-19 Inactivated vaccine 4-8 months ago;
- Female participants of childbearing age who were not breast-feeding or pregnant (negative blood pregnancy test), and had no family planning in the first 3 months after enrollment and took effective contraceptive measures. Take effective contraceptive measures within 2 weeks before inclusion;
- Volunteered to receive the third dose of vaccine.And during the entire follow-up research period, be able and willing to complete the entire prescribed research plan; Have the ability to self-understand research procedures, informed consent \& voluntarily sign informed consent, and be able to comply with the requirements of the plan
Who cannot join
- RT-qPCR detects active SARS-Cov-2 infection;
- a history of COVID-19, SARS, MERS infection (self-report, on-site inquiry);
- a high-risk factor for COVID-19 infection:
- a history of close contact with people infected with the new coronavirus, a history of living in high-risk areas, and a history of contact with patients with fever or respiratory symptoms in high-risk areas or abroad.
- Fever, dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, dyspnea, etc. 7 days before enrollment;
- receiving COVID-19 booster vaccination;
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- allergic to the active ingredients of the SARS-CoV-2 vaccine, any of the inactive ingredients, the substances used in the production process, or those who have had allergies during previous vaccination of similar vaccines;
- those who have had severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioedema, respiratory Difficulties, urticaria, angioedema or abdominal pain);
- body temperature >37.0℃ before vaccination;
- blood pregnancy test positive;
- with uncontrolled epilepsy and other serious neurological diseases (such as transmissive myelitis, Guillain-Barre syndrome) , Demyelinating diseases, etc.), or have a history or family history of encephalopathy or mental disease;
- severe liver and kidney disease, uncontrollable hypertension (systolic blood pressure ≥180 mmHg, diastolic blood pressure ≥100 mmHg), diabetic complications, Malignant tumors, various acute diseases or acute attacks of chronic diseases;
- diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- receiving anti-tuberculosis treatment;
- a history of coagulopathy ( Such as coagulation factor deficiency, coagulation disease) within 3 months of subjects receiving immunotherapy or inhibitor therapy (continuous oral or infusion for more than 14 days), or after 3 months of hormone therapy, the average daily dose is ≥20mg/day (Prednisone);
- Receiving live attenuated vaccine within 1 month before this vaccination, other vaccines within 14 days before this vaccination;
- Receiving other research drugs within 3 months before vaccination; participating in other research vaccines Or subjects in clinical trials of research drugs;
- other conditions that the investigator judges are not suitable for this clinical trial;
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Ditan Hospital Capital Medical University
Beijing
Huashan Hospital affiliated to Fudan University
Shanghai, Jingan, 200041
About this study
It is a prospective open-labeled study, We intended to recruit the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before, and volunteered to receive the third dose of vaccine (inactivated vaccine, recombinant subunit protein vaccine or mRNA vaccine) into the experimental group, and the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before without a third dose of vaccination plan into the control group. Participants in the experimental group received the third dose of SARS-CoV-2 vaccination at baseline, and participants in the control group received no intervention. Each subject will be followed up for one year after enrollment, and neutralizing antibodies and total antibodies will be tested at the specified time points, as well as the records of adverse events and adverse reactions.
- Conditions
- COVID-19
- Being tested
- Vaccine, COVID19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine, COVID19Drug
It is a prospective open-labeled study, We intended to recruit the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before, and volunteered to receive the third dose of vaccine (inactivated vaccine, recombinant subunit protein vaccine or mRNA vaccine) into the experimental group, and the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before without a third dose of vaccination plan into the control group. Participants in the experimental group received the third dose of SARS-CoV-2 vaccination at baseline, and participants in the control group received no intervention. Each subject will be followed up for one year after enrollment, and neutralizing antibodies and total antibodies will be tested at the specified time points, as well as the records of adverse events and adverse reactions.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants volunteered not to receive the third dose of vaccine, and agreed to be followed-up for 1 year |
| Inactivated Vaccine Group | Experimental | Participants volunteered to receive the third dose of inactivated vaccine Receives: Drug: Vaccine, COVID19 |
| Recombinant subunit protein vaccine | Experimental | Participants volunteered to receive the third dose of subunit protein vaccine Receives: Drug: Vaccine, COVID19 |
| mRNA vaccine Group | Experimental | Participants volunteered to receive the third dose of mRNA vaccine ( To be enrolled, the vaccine has not been approved in China) Receives: Drug: Vaccine, COVID19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines
Observe the 28th day of the subjects' pseudovirus neutralizing antibody geometric mean titers (GMTs) and mean geometric titers fold growth (GMFR) changes
Measured: Day 28
Reactogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines
All solicited and non-solicited adverse events within 28 days.
Measured: Day 28
Secondary outcomes (4)
The seropositive rate of neutralizing antibodies
The seropositive rate of neutralizing antibodies after third vaccination shots
Measured: 3 days/14 days/28days/45days/60 days/90 days/180 days/365 days
GMT of neutralizing antibodies
GMT of neutralizing antibodies after third vaccination shots
Measured: 3 days/14 days/28days/45days/60 days/90 days/180 days/365 days
GMFR of neutralizing antibodies
GMFR of neutralizing antibodies after third vaccination shots
Measured: 3 days/14 days/28days/45days/60 days/90 days/180 days/365 days
severe adverse events and adverse events of special interest
severe adverse events and adverse events of special interest
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Aug 2021
- Primary completion15 Mar 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095298
- Sponsor's protocol ID
- BOOST
- Status last verified
- Feb 2022
- First submitted
- 2 Oct 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactogenicity and Immunogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines
- ClinicalTrials.gov ID
- NCT05095298
- Acronym / sponsor ID
- BOOST
- Conditions
- COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 27 Oct 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.
It is a prospective open-labeled study, We intended to recruit the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before, and volunteered to receive the third dose of vaccine (inactivated vaccine, recombinant subunit protein vaccine or mRNA vaccine) into the experimental group, and the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before without a third dose of vaccination plan into the control group. Participants in the experimental group received the third dose of SARS-CoV-2 vaccination at baseline, and participants in the control group received no intervention. Each subject will be followed up for one year after enrollment, and neutralizing antibodies and total antibodies will be tested at the specified time points, as well as the records of adverse events and adverse reactions.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants volunteered not to receive the third dose of vaccine, and agreed to be followed-up for 1 year |
| Inactivated Vaccine Group | Experimental | Drug: Vaccine, COVID19Participants volunteered to receive the third dose of inactivated vaccine |
| Recombinant subunit protein vaccine | Experimental | Drug: Vaccine, COVID19Participants volunteered to receive the third dose of subunit protein vaccine |
| mRNA vaccine Group | Experimental | Drug: Vaccine, COVID19Participants volunteered to receive the third dose of mRNA vaccine ( To be enrolled, the vaccine has not been approved in China) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old,
- Through asking medical history and physical examination, the investigator judged that the health condition is good: the chronic disease is stable and there is no change within 3 months of medication;
- has been completed 2 doses of Covid-19 Inactivated vaccine 4-8 months ago;
- Female participants of childbearing age who were not breast-feeding or pregnant (negative blood pregnancy test), and had no family planning in the first 3 months after enrollment and took effective contraceptive measures. Take effective contraceptive measures within 2 weeks before inclusion;
- Volunteered to receive the third dose of vaccine.And during the entire follow-up research period, be able and willing to complete the entire prescribed research plan; Have the ability to self-understand research procedures, informed consent \& voluntarily sign informed consent, and be able to comply with the requirements of the plan
Key exclusion criteria (18 listed)
- RT-qPCR detects active SARS-Cov-2 infection;
- a history of COVID-19, SARS, MERS infection (self-report, on-site inquiry);
- a high-risk factor for COVID-19 infection:
- a history of close contact with people infected with the new coronavirus, a history of living in high-risk areas, and a history of contact with patients with fever or respiratory symptoms in high-risk areas or abroad.
- Fever, dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, dyspnea, etc. 7 days before enrollment;
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 |
|---|---|---|
| Vaccine, COVID19It is a prospective open-labeled study, We intended to recruit the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before, and volunteered to receive the third dose of vaccine (inactivated vaccine, recombinant subunit protein vaccine or mRNA vaccine) into the experimental group, and the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before without a third dose of vaccination plan into the control group. Participants in the experimental group received the third dose of SARS-CoV-2 vaccination at baseline, and participants in the control group received no intervention. Each subject will be followed up for one year after enrollment, and neutralizing antibodies and total antibodies will be tested at the specified time points, as well as the records of adverse events and adverse reactions. | Drug | Inactivated Vaccine Group, Recombinant subunit protein vaccine, mRNA vaccine Group |
Primary outcome
Immunogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines
Time frame: Day 28
Observe the 28th day of the subjects' pseudovirus neutralizing antibody geometric mean titers (GMTs) and mean geometric titers fold growth (GMFR) changes
Reactogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines
Time frame: Day 28
All solicited and non-solicited adverse events within 28 days.
4 secondary outcomes
The seropositive rate of neutralizing antibodies
Time frame: 3 days/14 days/28days/45days/60 days/90 days/180 days/365 days
GMT of neutralizing antibodies
Time frame: 3 days/14 days/28days/45days/60 days/90 days/180 days/365 days
GMFR of neutralizing antibodies
Time frame: 3 days/14 days/28days/45days/60 days/90 days/180 days/365 days
severe adverse events and adverse events of special interest
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaccine, COVID19 in people with COVID-19, run by Huashan Hospital at 2 sites 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 18 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines (time frame: Day 28). 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 2 Mar 2022.