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, controlledvaccine trial to evaluate the safety, reactogenicity, and immunogenicity of therecombinant ZR202-CoV and ZR202a-CoV vaccines administered at 0 and 28 days as comparedto 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 threevaccine groups (ZR202-CoV, ZR202a-CoV, or Comirnaty®), receiving 2 doses vaccination at28 days interval. To assess safety and preliminary immunogenicity profile after primaryseries vaccination at pre-defined time points during the study.The DSMB will review the safety data and provide a recommendation to the Sponsor onwhether the safety profile is acceptable for advancing to Part 2.
Not Provided
Biological: ZR202-CoV
SARS-CoV-2 adjuvanted recombinant protein vaccine (prototype)
Biological: ZR202a-CoV
SARS-CoV-2 adjuvanted recombinant protein vaccine (variant)
Biological: Comirnaty®
Comirnaty® (Pfizer-BioNTech)
Inclusion Criteria:
1. Adults of both genders, 18 years of age and older, not older than 55 years of age in
Part 1.
2. The subject has a BMI (Body Mass Index) ≤30 kg/m2, inclusive, at Screening.
3. Having understood the contents of the ICF and patient information sheet, and having
signed the ICF.
4. Free of obvious health problems as established by medical history including physical
examination and clinical judgment of the investigator.
5. 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)
6. Willing to come to study site and/or to receive home visits for the entire study
period.
7. Residence in the study area.
8. 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.
Exclusion Criteria:
1. Medical history of COVID-19 or previous vaccination with SARS-CoV-2 vaccine.
2. Fever (body temperature ≥37.5℃/axillary temperature ≥37.3℃) on the day of
vaccination or in the 72 hours prior to vaccination.
3. 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.
4. Prior history of allergic reaction or anaphylaxis to any vaccine or drug, e.g.,
hypersensitivity, urticaria, serious eczema, dyspnea, laryngeal edema, and
angioedema etc.
5. 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).
6. 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).
7. 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.
8. 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.
9. Known medical history or a previous diagnosis of thrombosis including
thrombocytopenia.
10. 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.
11. Asplenia or functional asplenia.
12. 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).
13. Having received immunoglobulins and/or blood products within 3 months prior to the
1st vaccination in this study.
14. 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.
15. Positive for the pregnancy test (a pregnancy test will be required before each
vaccination for all women of childbearing potential) or lactation.
16. 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).
17. 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.
Center for Vaccine Development-Mali
Bamako, Mali
Samba Sow, Principal Investigator
Center for Vaccine Development - Mali