COVID-19 Clinical Trial
Official title:
An Open-label and Single-center Phase IIa Trial to Evaluate the Immunogenicity and Safety of SARS-CoV-2 DNA Vaccine (ICCOV) in Healthy Subjects Aged 18-75 Years
Verified date | February 2024 |
Source | Immuno Cure Holding (HK) Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-labeled, no placebo, Phase IIa clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of one booster vaccine dose of SARS-CoV-2 DNA Vaccine (ICCOV) in adults aged 18 to 75 years who have received two to four dosese of COVID-19 vaccine.
Status | Active, not recruiting |
Enrollment | 31 |
Est. completion date | May 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Able and willing to comply with all study requirements. 2. Give informed consent and sign informed consent form (ICF). For subjects who are unable to read or write, the consent must be witnessed by a literate third party not involved in the study. 3. BMI in between 18.5 and 30.0 kg/m2 (including upper and lower limits). 4. For each group, meet the following criteria regarding age, COVID-19 vaccination history (as confirmed by COVID-19 vaccination records), and SARS-CoV-2 infection history (as confirmed by the investigator according to WHO definitions, Appendix III): Group 1: Adult-CoronaVac® group - Aged 18-59 AND received 2 to 4 homologous doses of CoronaVac® at least 3 months prior to enrollment AND without SARS-CoV-2 infection history. Group 2: Adult-Comirnaty® group - Aged 18-59 AND received 2 to 4 heterologous doses of CoronaVac® and Comirnaty® at least 3 months prior to enrollment AND without SARS-CoV-2 infection history; OR Group 3: Adult-mixed group - Aged 18-59 AND received 2 to 4 heterologous doses of CoronaVac® and Comirnaty® at least 3 months prior to enrollment AND without SARS-CoV-2 infection history; OR - Aged 18-59 AND received 2 to 4 heterologous doses of CoronaVac® and Comirnaty® at least 3 months prior to enrollment AND recovered from SARS-CoV-2 infection at least 3 months prior to enrollment; OR - Aged 18-59 AND received 2 to 4 homologous doses of CoronaVac® or Comirnaty® at least 3 months prior to enrollment AND recovered from SARS-CoV-2 infection at least 3 months prior to enrollment. Group 4: Elderly-mixed group - Aged 60-75 AND received 2 to 4 heterologous doses of CoronaVac® and Comirnaty® at least 3 months prior to enrollment AND without SARS-CoV-2 infection history; OR - Aged 60-75 AND received 2 to 4 heterologous doses of CoronaVac® and Comirnaty® at least 3 months prior to enrollment AND recovered from SARS-CoV-2 infection at least 3 months prior to enrollment; OR - Aged 60-75 AND received 2 to 4 homologous doses of CoronaVac® or Comirnaty® at least 3 months prior to enrollment AND without SARS-CoV-2 infection history; OR - Aged 60-75 AND received 2 to 4 homologous doses of CoronaVac® or Comirnaty® at least 3 months prior to enrollment AND recovered from SARS-CoV-2 infection at least 3 months prior to enrollment. 5. Healthy subjects, or subjects with stable medical condition who have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrollment. 6. Female subjects of childbearing potential with have negative pregnancy test shall be willing to practice continuous effective contraception and not to breastfeed until 12 months after ICCOV administration. - Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal. A follicle-stimulating hormone (FSH) level and the amenorrhea duration (e.g., amenorrhea for = 12 consecutive months prior to screening without an alternative medical cause) may be measured at the discretion of the investigator to confirm postmenopausal status. - The effective contraceptive methods include sexual abstinence or adequate contraceptive measures such as intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, condoms (male), diaphragm, and cervical cap, etc. 7. Male subjects who are involved in heterosexual sexual activity must agree to practice adequate contraception (as described above) and refrain from donating sperm until 12 months after ICCOV administration. 8. Agreement to avoid blood donation during the study. Exclusion Criteria: 1. Laboratory confirmed SARS-CoV-2 infection, defined by RT-PCR test. 2. Fever (oral temperature = 37.5°C/axillary temperature = 37.3°C) on the day of vaccination or within recent 72 hours. 3. Medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) within 12 months, and COVID-19 within 3 months prior to enrollment. 4. Abnormal laboratory tests of clinical significance involving hematology, serum biochemistry, coagulation function, or urinalysis as determined by the investigator. 5. Females who are pregnant or breastfeeding or those who plan to give birth in coming 12 months (including in female subjects or the female partners of male subjects). 6. Participated in other clinical trials and received any other investigational products within 1 month (or 5 half-lives of the drug, whichever is longer) prior to enrollment or plan to receive any other investigational products during the study. 7. History of severe allergies to any vaccine or drug, such as urticaria, dyspnea, edema, abdominal pain and other symptoms after administration, especially hypersensitivity to the components of ICCOV. 8. Have malignant tumor (except for skin basal cell carcinoma or carcinoma uterine cervix in situ) and immune disease (e.g., human immunodeficiency virus [HIV] infection, systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy, severe combined immunodeficiency disorder [SCID], and other immune disease that may influence immune response at the investigator's discretion). 9. Have other severe and/or uncontrolled conditions, including but not limited to, acute infectious disease, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, hematology disease, endocrine disorder, psychiatric condition and neurological illness (e.g., Guillain-Barre Syndrome, uncontrolled epilepsy, etc.). Mild/moderate well-controlled comorbidities are allowed to participate as deemed appropriate by the investigator. 10. Received any investigational or licensed COVID-19 vaccine other than described in inclusion criteria, or any investigational or approved vaccine against a coronavirus (including but not limited to SARS-CoV-1 and MERS-CoV) at any time prior to enrollment. 11. Received any investigational or approved vaccines within 3 months prior to enrollment or plan to receive any other vaccines during the study. 12. Received any blood products or immunoglobulin products within 3 months prior to enrollment or plan to receive that during the study. 13. Received interferon, systemic corticosteroids, or other immunosuppressants/ immunomodulators (except for local application) for 14 or more consecutive days within 6 months prior to enrollment. 14. Medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study. 15. Needle phobia. 16. Have contraindications for intramuscular administration, such as confirmed thrombocytopenia, any coagulation dysfunction, or being receiving anticoagulation therapy. 17. Have contraindications for electroporation, such as implanted with pacemaker, implanted with Automatic Implantable Cardioverter Defibrillator (AICD), or abnormal electrocardiogram at screening as determined by the investigator. 18. Any other conditions considered by the investigator as not suitable to participate in this study. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Gleneagles Hospital Hong Kong | Wong Chuk Hang |
Lead Sponsor | Collaborator |
---|---|
Immuno Cure 3 Limited | The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Geometric mean titres (GMTs) of neutraliziing antibody against SARS-CoV-2 prototype and epidemic variants | GMTs of neutralizing antibody against SARS-CoV-2 prototype and epidemic variants at Day 14 after ICCOV administration, as measured by pseudovirus-based assay. | Day 14 | |
Other | Geometric mean titres (GMTs) of neutraliziing antibody against SARS-CoV-2 prototype and epidemic variants | GMTs of neutralizing antibody against SARS-CoV-2 prototype and epidemic variants at Day 28 after ICCOV administration, as measured by pseudovirus-based assay. | Day 28 | |
Other | Geometric mean titres (GMTs) of neutraliziing antibody against SARS-CoV-2 prototype and epidemic variants | GMTs of neutralizing antibody against SARS-CoV-2 prototype and epidemic variants at Day 60 after ICCOV administration, as measured by pseudovirus-based assay. | Day 60 | |
Other | Geometric mean increases (GMIs) of neutraliziing antibody against SARS-CoV-2 prototype and epidemic variants | GMIs of neutralizing antibody against SARS-CoV-2 prototype and epidemic variants at Day 14 after ICCOV administration, as measured by pseudovirus-based assay. | Day 14 | |
Other | Geometric mean increases (GMIs) of neutraliziing antibody against SARS-CoV-2 prototype and epidemic variants | GMIs of neutralizing antibody against SARS-CoV-2 prototype and epidemic variants at Day 28 after ICCOV administration, as measured by pseudovirus-based assay. | Day 28 | |
Other | Geometric mean increases (GMIs) of neutraliziing antibody against SARS-CoV-2 prototype and epidemic variants | GMIs of neutralizing antibody against SARS-CoV-2 prototype and epidemic variants at Day 60 after ICCOV administration, as measured by pseudovirus-based assay. | Day 60 | |
Other | Seroconversion rates (SCRs) of neutraliziing antibody against SARS-CoV-2 prototype and epidemic variants | SCRs of neutralizing antibody against SARS-CoV-2 prototype and epidemic variants at Day 14 after ICCOV administration, as measured by pseudovirus-based assay. | Day 14 | |
Other | Seroconversion rates (SCRs) of neutraliziing antibody against SARS-CoV-2 prototype and epidemic variants | SCRs of neutralizing antibody against SARS-CoV-2 prototype and epidemic variants at Day 28 after ICCOV administration, as measured by pseudovirus-based assay. | Day 28 | |
Other | Seroconversion rates (SCRs) of neutraliziing antibody against SARS-CoV-2 prototype and epidemic variants | SCRs of neutralizing antibody against SARS-CoV-2 prototype and epidemic variants at Day 60 after ICCOV administration, as measured by pseudovirus-based assay. | Day 60 | |
Other | Geometric mean titres (GMTs) of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants | GMTs of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants at Day 14 after ICCOV administration, as measured by ELISA. | Day 14 | |
Other | Geometric mean titres (GMTs) of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants | GMTs of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants at Day 28 after ICCOV administration, as measured by ELISA. | Day 28 | |
Other | Geometric mean titres (GMTs) of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants | GMTs of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants at Day 60 after ICCOV administration, as measured by ELISA. | Day 60 | |
Other | Geometric mean increases (GMIs) of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants | GMIs of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants at Day 14, 28, and 60 after ICCOV administration, as measured by ELISA. | Day 14, Day 28, and Day 60 | |
Other | Geometric mean increases (GMIs) of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants | GMIs of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants at Day 14, 28, and 60 after ICCOV administration, as measured by ELISA. | Day 28 | |
Other | Geometric mean increases (GMIs) of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants | GMIs of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants at Day 60 after ICCOV administration, as measured by ELISA. | Day 60 | |
Other | Seroconversion rates (SCRs) of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants | SCRs of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants at Day 14 after ICCOV administration, as measured by ELISA. | Day 14 | |
Other | Seroconversion rates (SCRs) of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants | SCRs of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants at Day 28 after ICCOV administration, as measured by ELISA. | Day 28 | |
Other | Seroconversion rates (SCRs) of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants | SCRs of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants at Day 60 after ICCOV administration, as measured by ELISA. | Day 60 | |
Primary | Frequencies of cross-reactive receptor binding domain (RBD)-specific IFN-? producing T cells at Day 14 | Frequencies of cross-reactive receptor binding domain (RBD)-specific RBD-specific IFN-? producing T cells at Day 14 after ICCOV administration compared to baseline (Day 0), as measured by numbers of IFN-?+ spot-forming unit /1 million PBMC by ELISpot assay. | Day 14 | |
Primary | Frequencies of cross-reactive receptor binding domain (RBD)-specific IFN-? producing T cells at Day 28 | Frequencies of cross-reactive receptor binding domain (RBD)-specific RBD-specific IFN-? producing T cells at Day 28 after ICCOV administration compared to baseline (Day 0), as measured by numbers of IFN-?+ spot-forming unit /1 million PBMC by ELISpot assay. | Day 28 | |
Primary | Frequencies of cross-reactive receptor binding domain (RBD)-specific CD4+ T cells at Day 14 | Frequencies of cross-reactive RBD-specific CD4+ T cell responses at Day 14 after ICCOV administration compared to baseline (Day 0), as analyzed by flow cytometry-based intracellular cytokine staining assays. | Day 14 | |
Primary | Frequencies of cross-reactive receptor binding domain (RBD)-specific CD4+ T cells at Day 28 | Frequencies of cross-reactive RBD-specific CD4+ T cell responses at Day 28 after ICCOV administration compared to baseline (Day 0), as analyzed by flow cytometry-based intracellular cytokine staining assays. | Day 28 | |
Primary | Frequencies of cross-reactive receptor binding domain (RBD)-specific CD8+ T cells at Day 14 | Frequencies of cross-reactive RBD-specific CD8+ T cell responses at Day 14 after ICCOV administration compared to baseline (Day 0), as analyzed by flow cytometry-based intracellular cytokine staining assays. | Day 14 | |
Primary | Frequencies of cross-reactive receptor binding domain (RBD)-specific CD8+ T cells at Day 28 | Frequencies of cross-reactive RBD-specific CD8+ T cell responses at Day 28 after ICCOV administration compared to baseline (Day 0), as analyzed by flow cytometry-based intracellular cytokine staining assays. | Day 28 | |
Secondary | Frequencies of cross-reactive receptor binding domain (RBD)-specific IFN-? producing T cells at Day 60 | Frequencies of cross-reactive receptor binding domain (RBD)-specific RBD-specific IFN-? producing T cells at Day 60 after ICCOV administration, as measured by numbers of IFN-?+ spot-forming unit /1 million PBMC by ELISpot assay. | Day 60 | |
Secondary | Frequencies of cross-reactive receptor binding domain (RBD)-specific CD8+ T cells at Day 60 | Frequencies of cross-reactive RBD-specific CD8+ T cell responses at Day 60 after ICCOV administration, as analyzed by flow cytometry-based intracellular cytokine staining assays. | Day 60 | |
Secondary | Frequencies of cross-reactive receptor binding domain (RBD)-specific CD4+ T cells at Day 60 | Frequencies of cross-reactive RBD-specific CD4+ T cell responses at Day 60 after ICCOV administration, as analyzed by flow cytometry-based intracellular cytokine staining assays. | Day 60 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|