COVID-19
Conditions
Keywords
ICCOV, COVID-19, DNA Vaccine
Brief summary
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.
Detailed description
This is an open-labeled, no placebo, Phase IIa clinical trial 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. The primary purpose of this study is to evaluate cross-reactive T cell responses against SARS-CoV-2 prototype and epidemic variants induced by one booster dose of ICCOV. The secondary purposes are 1) to evaluate other variables of cross-reactive T cell responses against SARS-CoV-2 prototype and epidemic variants induced by one booster dose of ICCOV; 2) to evaluate humoral immunity responses against SARS-CoV-2 prototype and epidemic variants induced by one boosterdose of ICCOV; and 3) to evaluate the safety and reactogenicity of ICCOV.
Interventions
BIOLOGICALSARS-CoV-2 DNA Vaccine (ICCOV)
The SARS-CoV-2 DNA Vaccine (ICCOV) was developed by Immuno Cure Holding (HK) Limited.The product is a pre-filled syringe or a vial with an extractable volume of 0.5 mL. The unit dose strength is 1 mg/0.5 mL and the dose volume is 1.0 mL/dose.
Sponsors
The University of Hong Kong
Immuno Cure 3 Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequencies of cross-reactive receptor binding domain (RBD)-specific CD8+ T cells at Day 28 | 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. |
| Frequencies of cross-reactive receptor binding domain (RBD)-specific IFN-γ producing T cells at Day 14 | Day 14 | Frequencies of cross-reactive receptor binding domain (RBD)-specific RBD-specific IFN-γ producing T cells at Day 14 after ICCOV administration compared to baseline (Day 0), as measured by numbers of IFN-γ+ spot-forming unit /1 million PBMC by ELISpot assay. |
| Frequencies of cross-reactive receptor binding domain (RBD)-specific CD8+ T cells at Day 14 | 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. |
| Frequencies of cross-reactive receptor binding domain (RBD)-specific CD4+ T cells at Day 28 | 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. |
| Frequencies of cross-reactive receptor binding domain (RBD)-specific CD4+ T cells at Day 14 | 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. |
| Frequencies of cross-reactive receptor binding domain (RBD)-specific IFN-γ producing T cells at Day 28 | Day 28 | Frequencies of cross-reactive receptor binding domain (RBD)-specific RBD-specific IFN-γ producing T cells at Day 28 after ICCOV administration compared to baseline (Day 0), as measured by numbers of IFN-γ+ spot-forming unit /1 million PBMC by ELISpot assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequencies of cross-reactive receptor binding domain (RBD)-specific CD8+ T cells at Day 60 | 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. |
| Frequencies of cross-reactive receptor binding domain (RBD)-specific IFN-γ producing T cells at Day 60 | Day 60 | Frequencies of cross-reactive receptor binding domain (RBD)-specific RBD-specific IFN-γ producing T cells at Day 60 after ICCOV administration, as measured by numbers of IFN-γ+ spot-forming unit /1 million PBMC by ELISpot assay. |
| Frequencies of cross-reactive receptor binding domain (RBD)-specific CD4+ T cells at Day 60 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean titres (GMTs) of neutraliziing antibody against SARS-CoV-2 prototype and epidemic variants | Day 14 | GMTs of neutralizing antibody against SARS-CoV-2 prototype and epidemic variants at Day 14 after ICCOV administration, as measured by pseudovirus-based assay. |
| Seroconversion rates (SCRs) of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants | Day 14 | SCRs of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants at Day 14 after ICCOV administration, as measured by ELISA. |
| Geometric mean increases (GMIs) of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants | Day 14, Day 28, and Day 60 | 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. |
| Geometric mean titres (GMTs) of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants | Day 14 | GMTs of anti-RBD binding antibody against SARS-CoV-2 prototype and epidemic variants at Day 14 after ICCOV administration, as measured by ELISA. |
| Seroconversion rates (SCRs) of neutraliziing antibody against SARS-CoV-2 prototype and epidemic variants | Day 14 | SCRs of neutralizing antibody against SARS-CoV-2 prototype and epidemic variants at Day 14 after ICCOV administration, as measured by pseudovirus-based assay. |
| Geometric mean increases (GMIs) of neutraliziing antibody against SARS-CoV-2 prototype and epidemic variants | Day 14 | GMIs of neutralizing antibody against SARS-CoV-2 prototype and epidemic variants at Day 14 after ICCOV administration, as measured by pseudovirus-based assay. |
Countries
Hong Kong
Outcome results
None listed