Clinical trial NCT05993325: Immunogenicity and Safety of AdCLD-CoV19-1 OMI As a Booster: a COVID-19 Preventive Vaccine in Healthy Volunteers
Official title: A Phase III Multinational, Multicenter, Observer-Blinded, Randomized, Active-Controlled Trial to Evaluate the Immunogenicity and Safety of the Preventive COVID-19 Vaccine AdCLD-CoV19-1 OMI Administered As a Booster to Adults Aged 19 Years Old and Above
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: COVID-19
Vaccines
Keywords: COVID-19
SARS-CoV-2
Omicron
B.1.1.529
Lead sponsor: Cellid Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-15
Enrollment: 4000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The immunogenicity and safety of AdCLD-CoV19-1 OMI (5.0x10\^10 VP (0.5 mL)/dose/Vial) administered as a booster in healthy adults aged 19 years old and above will be evaluated. Outcome assessment will be performed in comparison with Comirnaty Bivalent.


Eligibility criteria: Inclusion Criteria:

1. Individual aged 19 and above and willing to provide written informed consent to participate study voluntarily.
2. Individual fall under one or more of the following at the date of IP administration

   * At least past 16 weeks (112 days) without additional COVID-19 vaccination since the last COVID-19 vaccination.
   * At least past 16 weeks (112 days) since the release of quarantine due to COVID-19 confirmation.
3. Individual who agrees to use medically acceptable contraceptive methods† for at least 4 weeks prior to screening and 12 weeks post IP administration.
4. Individual who agrees not to donate or transfuse blood (including whole blood, plasma components, platelet components, platelet plasma components) throughout the study participation.

Exclusion Criteria:

1. Individual fall under one or more of the following at the date of IP administration

   * History of COVID-19 within 16 weeks (-111\~0 days) or considered to be infected prior to IP administration.
   * History of receiving COVID-19 vaccine within 16 weeks (-111\~0 days) prior to IP administration.
2. Clinically significant abnormalities on clinical laboratory tests, electrocardiograms, and chest X-rays performed during screening visit.
3. Positive HIV test result on the screening test.
4. Acute febrile illness with (≥38°C), or any suspected infectious diseases, or COVID-19-like symptoms (cough, shortness of breath, chills, myalgia, headache, sore throat, loss of taste/smell, etc.) within 3 days prior to administration of IP.
5. Any serious medical or psychiatric disease which in opinion of investigator judges unable to participate.

   * Respiratory diseases: Asthma, Chronic Obstructive Pulmonary Disease (COPD), active or latent tuberculosis which require medication, or individual who has received treatment due to worsening of the listed respiratory disease within 5 years prior to administration of IP.
   * Serious cardiovascular diseases: Congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension, thrombocytopenia or venous thrombosis, capillary leakage syndrome, myocarditis, pericarditis, etc.
   * Neurologic diseases: Epilepsy, seizure within past 3 years, migraine, stroke, encephalopathy, Guillain-Barre Syndrome, encephalomyelitis, transverse myelitis, etc.
   * Malignant cancer diagnosed within past 5 years (skin basal cell and squamous cell carcinoma are excluded).
   * Immune function disorders including autoimmune hypothyroidism, psoriasis.
   * Immunodeficiency diseases.
   * History of dependently administering psychotropic drugs or narcotic analgesics within 24 weeks prior to administration of IP, or psychiatric disease or behavioral impairment that, in the opinion of the investigator, could interfere with the participant's ability to participate in the study.
   * Other hepatobiliary, renal, endocrine, urinary tract, muscular skeletal diseases which the investigator considers clinically significant.
6. History of splenectomy.
7. Known history of allergic or hypersensitivity to the components of IP.
8. Known history of serious adverse reaction, allergies or hypersensitivity related to vaccination.
9. Individual with history of bleeding diathesis or thrombocytopenia, or history of severe bleeding or bruising after intramuscular injection or venipuncture or is receiving an anticoagulant (Individual receiving low dose aspirin (less than 100mg/day) can be enrolled in judgement of investigator).
10. History of hereditary or idiopathic angioneurotic edema.
11. History of systemic urticaria within 5 years prior to administration of IP.
12. Individual with history of solid organ or bone marrow transplantation.
13. Individual who is suspected or with history of drug or alcohol abuse within 24 weeks prior to administration of IP.
14. History of licensed drug for COVID-19 prevention aside from COVID-19 vaccine within 52 weeks prior to administration of IP.
15. Use of immunosuppressive or chronic use of systemic steroids within 6 weeks prior to administration of IP (Topical steroids, nasal spray and inhalers are allowed).

    * Immunosuppressive: Azathioprine, Cyclosporine, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, Cyclophosphamide, 6-Mercaptopurine, Methotrexate, Rapamycin, Leflunomide, etc.
    * Chronic steroid: \>10 mg/day prednisone equivalent for periods exceeding 14 days.
16. Individual who has administered other investigational product or device within 24 weeks prior to screening visit.
17. Individual who has received or planned to receive any other vaccines within 28 days prior and after the administration of IP (Flu vaccines can be administered up to 14 days prior to the date of IP administration).
18. Receipt of immunoglobulin or blood-derived products within 12 weeks prior to administration of IP.
19. Individual with scheduled surgery throughout the study period.
20. Pregnant or lactating women.
21. Individual directly related to the investigator and meets the following:

    * Personnel relationship or subordinate-superior relationship (employees of the investigator's department, staffs of this trial).
    * Students or researchers in the immediate department of the school to which the investigator belongs (e.g., medical university).
22. Individual who is unfit for this study for any other reason in judgement of investigator.

Primary outcomes:
measure: Ratio of GMT of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration
timeFrame: At 28 days post IP administration
measure: Difference in seroresponse rate (SRR) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration
timeFrame: At 28 days post IP administration
Secondary outcomes:
measure: SRR (proportion of subject who achieved seroresponse), GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.
timeFrame: At 26, 52 weeks post IP administration
measure: Differences in SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by serostatus of SARS-CoV-2 N protein antibody.
timeFrame: At 28 days post IP administration
measure: Differences in SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by country.
timeFrame: At 28 days post IP administration
measure: Proportion of immediate adverse events (AE)
timeFrame: Within 30 minutes post IP administraiton
measure: Proportion of solicited local and systemic AE
timeFrame: Within 7 days (Days 0 - 6) post IP administration
measure: Proportion of unsolicited AE
timeFrame: Within 28 days (Days 0 - 27) post IP administration
measure: Proportion of SAE
timeFrame: Throughout the study duration, 12 months post IP administration
measure: Proportion of Adverse Event Of Special Interest (AESI)
timeFrame: Throughout the study duration, 12 months post IP administration
measure: Proportion of Medically-Attended Adverse Events (MAAE)
timeFrame: Throughout the study duration, 12 months post IP administration
measure: Proportion of clinically significant changes in clinical laboratory tests
timeFrame: At 28 days post IP administration
measure: Proportion of clinically significant changes in vital signs
timeFrame: At 28 days post IP administration
measure: Proportion of clinically significant changes in physical examination
timeFrame: At 28 days post IP administration
Other outcomes:
measure: SRR, GMT, GMFR of SARS-CoV-2 Wuhan strain and Variants of concern (VOC) neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.
timeFrame: At 28 days post IP administration
measure: SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 S protein-specific antibody measured by ELISA at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.
timeFrame: At 28 days post IP administration
measure: Cellular immune response (CMI) measured by ELISpot at 28 days, 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.
timeFrame: At 28 days, 26, 52 weeks post IP administration.
measure: Differences of SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by previous COVID-19 vaccination series.
timeFrame: At 28 days post IP administration
measure: Differences of SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by age.
timeFrame: At 28 days post IP administration
measure: Proportion of COVID-19 cases confirmed by antigen test from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study.
timeFrame: Throughout the study duration, 12 months post IP administration
measure: Proportion of severe COVID-19 cases from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study.
timeFrame: Throughout the study duration, 12 months post IP administration
measure: Proportion of hospitalization due to COVID-19 cases from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study.
timeFrame: Throughout the study duration, 12 months post IP administration
measure: Proportion of mortality due to COVID-19 cases from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study.
timeFrame: Throughout the study duration, 12 months post IP administration
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-a University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea, ST. Vincent's Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Veterans Health Service Medical Center
city: Iloilo City
country: Philippines
facility: The Medical City-Iloilo
city: Iloilo City
country: Philippines
facility: West Visayas State University Medical Center
city: Makati
country: Philippines
facility: Tropical Disease Foundation, Inc.
city: Quezon City
country: Philippines
facility: Far Eastern University - Nicanor Reyes Medical Foundation
Study officials:
References: