COVID-19Phase 4NCT05105295
Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With HIV Infected
A Phase 4 study testing Inactivated COVID-19 vaccine in people with COVID-19 and HIV Infections, run by China National Biotec Group Company Limited at 1 site in China.
Trial summary
Evaluation of immunogenicity, safety and persistence of the subjects with HIV infected received the third dose of inactivated COVID-19 vaccine . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, HIV Infections
- What is being tested?
- Inactivated COVID-19 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Dec 2021to 30 Jun 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged ≥18.
- Body temperature < 37.3 ° C confirmed by clinical examination before enrollment .
- Subjects who meet the diagnostic criteria for HIV infection and AIDS.
- CD4+ count is less than 500/ul and more than 50/ul .
- Female subjects of reproductive age declare that they are not pregnant, have no birth plan in the first 3 months after enrollment, and have taken effective contraceptive measures in the first 2 weeks before enrollment.
- Able and willing to complete the entire study plan during the study follow-up period.
- Have the ability to understand the study procedures, voluntarily sign informed consent, and comply with the requirements of the clinical study protocol.
- Subjects participating in the past clinical trial have completed two doses of COVID-19 vaccine and blood collection before and after immunization;
Who cannot join
- Subjects were previously confirmed cases of COVID-19 or asymptomatic infected persons.
- Being allergic to any component of vaccines (including excipients) .
- Subjects who have experienced severe allergic reactions to vaccines (e.g. acute anaphylaxis, urticaria, angoneeurotic edema, dyspnea, etc.).
- Having uncontrolled epilepsy and other progressive neurological disorders and a history of Guillain-Barre syndrome.
- Injection of non-specific immunoglobulin within 1 month before enrollment.
- Pregnant and lactating women.
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- The subjects are suffering from an acute illness; Or thrombocytopenia patients with platelet count < 20×10^9/L within three days before inoculation, that is, patients at high risk of spontaneous bleeding.
- Acute HIV infection and opportunistic infection.
- Subjects with co-opportunistic infections who did not receive antiviral therapy.
- Subjects with CD4+ count less than 50/ul who have not received antiviral therapy.
- HIV-infected subjects undergoing treatment with severe drug interactions and overlapping toxicity (kidney damage, liver damage, hematological problems, etc.).
- Patients with malignant tumors are undergoing chemotherapy and radiotherapy before and after surgery.
- Subjects who had vaccine-related adverse reactions after the second dose.
- Having high fever (axillary temperature ≥39.0℃) for three days after the second dose of inoculation, or severe allergic reaction.
- Having any adverse nervous system reaction after the second dose.
- Other subjects whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhejiang provincial center for disease control and prevention
Hangzhou, Zhejiang, 310051
About this study
Official title: Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With Human Immunodeficiency Virus Infected
Evaluation of immunogenicity, safety and persistence of the subjects with HIV infected received the third dose of inactivated COVID-19 vaccine .
Read the detailed description
The subjects aged ≥18 years with HIV infected who have completed the schedule of two doses for 3 months recruited to receive a third dose of inactivated COVID-19 vaccine.
Blood samples will be collected 3 times: before the third dose of vaccinatioin，28 days and 6 months after the third dose of vaccination.
Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.
- Conditions
- COVID-19, HIV Infections
- Being tested
- Inactivated COVID-19 vaccine
- Medical subject headings
- COVID-19, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated COVID-19 vaccineBiological
receive a third dose of inactivated COVID-19 vaccine
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Subjects receive a third dose of inactivated COVID-19 vaccine Receives: Biological: Inactivated COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate
The rate of seroconversion against coronavirus
Measured: 28 days after the 3th dose (Day 28)
Neutralizing antibody level
Neutralizing antibody GMT against coronavirus before the 3th dose
Measured: Before the 3th dose (Day 0)
Neutralizing antibody level
Neutralizing antibody GMT against coronavirus after the 3th dose
Measured: 28 days after the 3th dose (Day 28)
Neutralizing antibody level
Neutralizing antibody GMT against coronavirus after the 3th dose
Measured: 6 months after the 3th dose
Secondary outcomes (6)
Adverse events rate
Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
Measured: 0-21days following vaccinations
Serious adverse event rate
Report and analyse serious adverse events
Measured: 0-6 months
T cell count
T cell count （CD4+T，CD8+T，etc.）
Measured: before the 3th dose (Day 0)
T cell count
T cell count （CD4+T，CD8+T，etc.）
Measured: 28 days after the 3th dose (Day 28)
HIV viral load
HIV viral load
Measured: before the 3th dose (Day 0)
HIV viral load
HIV viral load
Measured: 28 days after the 3th dose (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study startDec 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects aged ≥18 with infected with HIV who have completed the schedule of two doses for 3 months receive a third dose of inactivated COVID-19 vaccine.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang Provincial Center for Disease Control and Prevention, Beijing Institute of Biological Products Co Ltd.
- Responsible party
- Sponsor
- Investigators
- Hanqing He, Principal investigator, Zhejiang Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105295
- Sponsor's protocol ID
- BIBP2021HIV-third dose
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With Human Immunodeficiency Virus Infected
- ClinicalTrials.gov ID
- NCT05105295
- Acronym / sponsor ID
- BIBP2021HIV-third dose
- Conditions
- COVID-19, HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Zhejiang Provincial Center for Disease Control and Prevention, Beijing Institute of Biological Products Co Ltd.
- Study start
- Dec 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 3 Nov 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.
Evaluation of immunogenicity, safety and persistence of the subjects with HIV infected received the third dose of inactivated COVID-19 vaccine .
Detailed description
The subjects aged ≥18 years with HIV infected who have completed the schedule of two doses for 3 months recruited to receive a third dose of inactivated COVID-19 vaccine.
Blood samples will be collected 3 times: before the third dose of vaccinatioin，28 days and 6 months after the third dose of vaccination.
Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects aged ≥18 with infected with HIV who have completed the schedule of two doses for 3 months receive a third dose of inactivated COVID-19 vaccine.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: Inactivated COVID-19 vaccineSubjects receive a third dose of inactivated COVID-19 vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects aged ≥18.
- Body temperature < 37.3 ° C confirmed by clinical examination before enrollment .
- Subjects who meet the diagnostic criteria for HIV infection and AIDS.
- CD4+ count is less than 500/ul and more than 50/ul .
- Female subjects of reproductive age declare that they are not pregnant, have no birth plan in the first 3 months after enrollment, and have taken effective contraceptive measures in the first 2 weeks before enrollment.
Key exclusion criteria (16 listed)
- Subjects were previously confirmed cases of COVID-19 or asymptomatic infected persons.
- Being allergic to any component of vaccines (including excipients) .
- Subjects who have experienced severe allergic reactions to vaccines (e.g. acute anaphylaxis, urticaria, angoneeurotic edema, dyspnea, etc.).
- Having uncontrolled epilepsy and other progressive neurological disorders and a history of Guillain-Barre syndrome.
- Injection of non-specific immunoglobulin within 1 month 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 |
|---|---|---|
| Inactivated COVID-19 vaccinereceive a third dose of inactivated COVID-19 vaccine | Biological | Experimental Group |
Primary outcome
Seroconversion rate
Time frame: 28 days after the 3th dose (Day 28)
The rate of seroconversion against coronavirus
Neutralizing antibody level
Time frame: Before the 3th dose (Day 0)
Neutralizing antibody GMT against coronavirus before the 3th dose
Neutralizing antibody level
Time frame: 28 days after the 3th dose (Day 28)
Neutralizing antibody GMT against coronavirus after the 3th dose
Neutralizing antibody level
Time frame: 6 months after the 3th dose
Neutralizing antibody GMT against coronavirus after the 3th dose
6 secondary outcomes
Adverse events rate
Time frame: 0-21days following vaccinations
Serious adverse event rate
Time frame: 0-6 months
T cell count
Time frame: before the 3th dose (Day 0)
T cell count
Time frame: 28 days after the 3th dose (Day 28)
HIV viral load
Time frame: before the 3th dose (Day 0)
HIV viral load
Time frame: 28 days after the 3th dose (Day 28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
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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.
Hanqing He principal investigator
Zhejiang Provincial Center for Disease Control and Prevention
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 Inactivated COVID-19 vaccine in people with COVID-19 and HIV Infections, run by China National Biotec Group Company Limited 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 8 inclusion and 16 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 3 Nov 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?
Contact Hanqing He (（0571）87115111, hanqinghe@cdc.zj.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate (time frame: 28 days after the 3th dose (Day 28)). The study lists 4 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 3 Nov 2021.