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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
31
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.
Gleneagles Hospital Hong Kong
Wong Chuk Hang, Hong Kong
Frequencies of cross-reactive receptor binding domain (RBD)-specific IFN-γ producing T cells at 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.
Time frame: Day 14
Frequencies of cross-reactive receptor binding domain (RBD)-specific IFN-γ producing T cells at 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.
Time frame: Day 28
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.
Time frame: Day 14
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.
Time frame: Day 28
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.
Time frame: Day 14
Frequencies of cross-reactive receptor binding domain (RBD)-specific CD8+ T cells at Day 28
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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.
Time frame: Day 28
Frequencies of cross-reactive receptor binding domain (RBD)-specific IFN-γ producing T cells at 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.
Time frame: Day 60
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.
Time frame: Day 60
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.
Time frame: Day 60