SARS-CoV-2 InfectionPhase 1/2NCT05490108
Evaluation of Safety and Immunogenicity of the Recombinant ZR202-CoV and ZR202a-CoV Vaccines in Adults.
A Phase 1/2 study testing ZR202-CoV, ZR202a-CoV and Comirnaty® in people with SARS-CoV-2 Infection and COVID-19, run by Shanghai Zerun Biotechnology Co.,Ltd at 1 site in Mali.
Trial summary
For Phase 1 only. Additional information will be provided when Phase 2 is implemented. This is a two-part phase I/II, single-center, observer-blind, randomized, controlled vaccine trial to evaluate the safety, reactogenicity, and immunogenicity of the recombinant ZR202-CoV and ZR202a-CoV vaccines administered at 0 and… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection, COVID-19
- What is being tested?
- ZR202-CoV, ZR202a-CoV and Comirnaty®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMali
- Study dates
- 2 Jun 2022to Aug 2023
- Phase
- Phase 1/2
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults of both genders, 18 years of age and older, not older than 55 years of age in Part 1.
- The subject has a BMI (Body Mass Index) ≤30 kg/m2, inclusive, at Screening.
- Having understood the contents of the ICF and patient information sheet, and having signed the ICF.
- Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator.
- Clinical laboratory test results within normal reference range, or results with acceptable deviations that are judged to be NCS (Not Clinically Significant) by the investigator. (Part 1 only)
- Willing to come to study site and/or to receive home visits for the entire study period.
- Residence in the study area.
- Female subjects of childbearing potential have used available contraceptive methods during their sexual life within 14 days before enrollment, have no pregnancy plan and will take effective contraceptive measures from enrollment to 1 month after the 2nd vaccination.
Who cannot join
- Medical history of COVID-19 or previous vaccination with SARS-CoV-2 vaccine.
- Fever (body temperature ≥37.5℃/axillary temperature ≥37.3℃) on the day of vaccination or in the 72 hours prior to vaccination.
- Suffering from any acute clinically significant diseases or being in the acute exacerbation of chronic disease or body temperature ≥37.5℃ (this does not include minor illness such as diarrhea or mild respiratory tract infection) in the 72 hours prior to vaccination.
- Prior history of allergic reaction or anaphylaxis to any vaccine or drug, e.g., hypersensitivity, urticaria, serious eczema, dyspnea, laryngeal edema, and angioedema etc.
- Having received or planning to receive any vaccine other than the vaccines used in this clinical study from 28 days prior to the first vaccination to study end (except "vaccines for emergency" such as tetanus vaccine or rabies vaccine).
- Having participated in or planned to participate in clinical studies of other drugs from 28 days prior to the 1st vaccination to study end (6 months after the 2nd vaccination in Part 1).
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- Presence of uncontrolled chronic pulmonary, cardiovascular, renal, hepatic, neurologic, hematologic, or metabolic (including diabetes mellitus) disorders, which would include the potential subject in a high-risk category for SARS-CoV-2 infection and/or its complications as judged by the investigator.
- Having hereditary hemorrhagic tendency or coagulation dysfunction (e.g., cytokine defects, coagulation disorders or platelet disorders), or history of significant bleeding, or history of intramuscular injection or venipuncture injury.
- Known medical history or a previous diagnosis of thrombosis including thrombocytopenia.
- Known medical history or diagnosis confirming that subjects have diseases affecting immune system function, including cancer (except skin basal cell carcinoma), congenital or acquired immunodeficiency (e.g., infection with HIV [Human Immunodeficiency Virus]), uncontrolled autoimmune disease.
- Asplenia or functional asplenia.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within 90 days prior to the administration of study vaccines (including systemic corticosteroids, this means prednisone, or equivalent, ≥0.5 mg/kg/day; topical steroids including inhaled steroids are allowed).
- Having received immunoglobulins and/or blood products within 3 months prior to the 1st vaccination in this study.
- Planning to permanently move from the local area before study completion or leave the local area for a long time during the period of study visits.
- Positive for the pregnancy test (a pregnancy test will be required before each vaccination for all women of childbearing potential) or lactation.
- Previous inclusion of 5 family members in the study (i.e., subjects belonging to the same family - biological father, mother, child, and brothers and sisters may be included up to a maximum of 5 members from the same family).
- Any chronic disease, condition, or criteria that in the opinion of the investigator might compromise the wellbeing of the subject or the compliance with study procedures or interfere with the outcome of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-part, Phase I/II, Randomized, Observer-blinded, Controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Recombinant ZR202-CoV and ZR202a-CoV Vaccines Administered at 0 and 28 Days as Compared to Comirnaty ®, and of a Booster Dose of ZR202a-CoV Vaccine in Healthy Adults.
For Phase 1 only. Additional information will be provided when Phase 2 is implemented.
This is a two-part phase I/II, single-center, observer-blind, randomized, controlled vaccine trial to evaluate the safety, reactogenicity, and immunogenicity of the recombinant ZR202-CoV and ZR202a-CoV vaccines administered at 0 and 28 days as compared to Comirnaty®, and of a booster dose of ZR202a-CoV vaccine in healthy adults.
Read more
Part 1:
A total of 60 eligible subjects will be randomized in a 1:1:1 ratio into one of the three vaccine groups (ZR202-CoV, ZR202a-CoV, or Comirnaty®), receiving 2 doses vaccination at 28 days interval. To assess safety and preliminary immunogenicity profile after primary series vaccination at pre-defined time points during the study.
The DSMB will review the safety data and provide a recommendation to the Sponsor on whether the safety profile is acceptable for advancing to Part 2.
- Conditions
- SARS-CoV-2 Infection, COVID-19
- Being tested
- ZR202-CoV, ZR202a-CoV, Comirnaty®
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZR202-CoVBiological
SARS-CoV-2 adjuvanted recombinant protein vaccine (prototype)
ZR202a-CoVBiological
SARS-CoV-2 adjuvanted recombinant protein vaccine (variant)
Comirnaty®Biological
Comirnaty® (Pfizer-BioNTech)
| Study group | Role | What they receive |
|---|---|---|
| ZR202-CoV - Phase 1 | Experimental | Two doses of SARS-CoV-2 adjuvanted recombinant protein vaccine (prototype), 1 dose each on Day 0 and 28. Receives: Biological: ZR202-CoV |
| ZR202a-COV - Phase 1 | Experimental | Two doses of SARS-CoV-2 adjuvanted recombinant protein vaccine (variant), 1 dose each on Day 0 and 28. Receives: Biological: ZR202a-CoV |
| Comirnaty® - Phase 1 | Active comparator | Two doses of Comirnaty® (Pfizer-BioNTech), 1 dose each on Day 0 and 28. Receives: Biological: Comirnaty® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects reporting solicited AEs within 7 days after each vaccination (Part 1)
Measured: 7 days after the first or second vaccination
Percentage of subjects reporting unsolicited AEs within 28 days after each vaccination (Part 1)
Measured: 28 days after the first or second vaccination
Occurrence of out-of-normal range clinical laboratory test results (including change from baseline values) 14 days post vaccination - (Part 1)
Measured: Screening Visit, 14 days after the 1st and 2nd vaccinations at Day 14 and Day 42, and 28 days after both vaccinations at Day 28 and Day 56
Secondary outcomes (3)
Immunogenicity as assess for SARS-CoV-2 specific neutralizing antibodies titers 28 days after each vaccination as measured by neutralization assay
Measured: Day 28 and Day 56
Percentages of subjects reporting SAEs, AESIs (including COVID-19), MAAEs
Measured: From 1st vaccination until 6 months after the 2nd vaccination (Part 1)
Immunogenicity as assess for SARS-CoV-2-specific anti-S protein IgG binding antibodies 28 days after each vaccination as measured by ELISA.
Measured: Day 28 and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start2 Jun 2022
- Primary completion26 Sep 2022
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samba Sow, Principal investigator, Center for Vaccine Development - Mali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490108
- Sponsor's protocol ID
- 202a-COV-2001
- Status last verified
- Apr 2023
- First submitted
- 3 Aug 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Phase I/II, Randomized, Observer-blinded, Controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Recombinant ZR202-CoV and ZR202a-CoV Vaccines Administered at 0 and 28 Days as Compared to Comirnaty ®, and of a Booster Dose of ZR202a-CoV Vaccine in Healthy Adults.
- ClinicalTrials.gov ID
- NCT05490108
- Acronym / sponsor ID
- 202a-COV-2001
- Conditions
- SARS-CoV-2 Infection, COVID-19
- Keywords
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- Aug 2023 (estimated)
- First posted
- 5 Aug 2022 (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.
For Phase 1 only. Additional information will be provided when Phase 2 is implemented.
This is a two-part phase I/II, single-center, observer-blind, randomized, controlled vaccine trial to evaluate the safety, reactogenicity, and immunogenicity of the recombinant ZR202-CoV and ZR202a-CoV vaccines administered at 0 and 28 days as compared to Comirnaty®, and of a booster dose of ZR202a-CoV vaccine in healthy adults.
Part 1:
A total of 60 eligible subjects will be randomized in a 1:1:1 ratio into one of the three vaccine groups (ZR202-CoV, ZR202a-CoV, or Comirnaty®), receiving 2 doses vaccination at 28 days interval. To assess safety and preliminary immunogenicity profile after primary series vaccination at pre-defined time points during the study.
The DSMB will review the safety data and provide a recommendation to the Sponsor on whether the safety profile is acceptable for advancing to Part 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZR202-CoV - Phase 1 | Experimental | Biological: ZR202-CoVTwo doses of SARS-CoV-2 adjuvanted recombinant protein vaccine (prototype), 1 dose each on Day 0 and 28. |
| ZR202a-COV - Phase 1 | Experimental | Biological: ZR202a-CoVTwo doses of SARS-CoV-2 adjuvanted recombinant protein vaccine (variant), 1 dose each on Day 0 and 28. |
| Comirnaty® - Phase 1 | Active comparator | Biological: Comirnaty®Two doses of Comirnaty® (Pfizer-BioNTech), 1 dose each on Day 0 and 28. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults of both genders, 18 years of age and older, not older than 55 years of age in Part 1.
- The subject has a BMI (Body Mass Index) ≤30 kg/m2, inclusive, at Screening.
- Having understood the contents of the ICF and patient information sheet, and having signed the ICF.
- Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator.
- Clinical laboratory test results within normal reference range, or results with acceptable deviations that are judged to be NCS (Not Clinically Significant) by the investigator. (Part 1 only)
Key exclusion criteria (17 listed)
- Medical history of COVID-19 or previous vaccination with SARS-CoV-2 vaccine.
- Fever (body temperature ≥37.5℃/axillary temperature ≥37.3℃) on the day of vaccination or in the 72 hours prior to vaccination.
- Suffering from any acute clinically significant diseases or being in the acute exacerbation of chronic disease or body temperature ≥37.5℃ (this does not include minor illness such as diarrhea or mild respiratory tract infection) in the 72 hours prior to vaccination.
- Prior history of allergic reaction or anaphylaxis to any vaccine or drug, e.g., hypersensitivity, urticaria, serious eczema, dyspnea, laryngeal edema, and angioedema etc.
- Having received or planning to receive any vaccine other than the vaccines used in this clinical study from 28 days prior to the first vaccination to study end (except "vaccines for emergency" such as tetanus vaccine or rabies vaccine).
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 |
|---|---|---|
| ZR202-CoVSARS-CoV-2 adjuvanted recombinant protein vaccine (prototype) | Biological | ZR202-CoV - Phase 1 |
| ZR202a-CoVSARS-CoV-2 adjuvanted recombinant protein vaccine (variant) | Biological | ZR202a-COV - Phase 1 |
| Comirnaty®Comirnaty® (Pfizer-BioNTech) | Biological | Comirnaty® - Phase 1 |
Primary outcome
Percentage of subjects reporting solicited AEs within 7 days after each vaccination (Part 1)
Time frame: 7 days after the first or second vaccination
Percentage of subjects reporting unsolicited AEs within 28 days after each vaccination (Part 1)
Time frame: 28 days after the first or second vaccination
Occurrence of out-of-normal range clinical laboratory test results (including change from baseline values) 14 days post vaccination - (Part 1)
Time frame: Screening Visit, 14 days after the 1st and 2nd vaccinations at Day 14 and Day 42, and 28 days after both vaccinations at Day 28 and Day 56
3 secondary outcomes
Immunogenicity as assess for SARS-CoV-2 specific neutralizing antibodies titers 28 days after each vaccination as measured by neutralization assay
Time frame: Day 28 and Day 56
Percentages of subjects reporting SAEs, AESIs (including COVID-19), MAAEs
Time frame: From 1st vaccination until 6 months after the 2nd vaccination (Part 1)
Immunogenicity as assess for SARS-CoV-2-specific anti-S protein IgG binding antibodies 28 days after each vaccination as measured by ELISA.
Time frame: Day 28 and Day 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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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.
Samba Sow principal investigator
Center for Vaccine Development - Mali
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ZR202-CoV, ZR202a-CoV and Comirnaty® in people with SARS-CoV-2 Infection and COVID-19, run by Shanghai Zerun Biotechnology Co.,Ltd at 1 site in Mali.
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 17 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 20 Apr 2023. 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 Mali. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of subjects reporting solicited AEs within 7 days after each vaccination (Part 1) (time frame: 7 days after the first or second vaccination). The study lists 3 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 20 Apr 2023.