Immunogenicity and Safety Study of SARS-CoV-2 DNA Vaccine (ICCOV) (NCT05904054) | Clinical Trial Compass
CompletedPhase 2
Immunogenicity and Safety Study of SARS-CoV-2 DNA Vaccine (ICCOV)
Hong Kong31 participantsStarted 2023-06-15
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Able and willing to comply with all study requirements.
✓. 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.
✓. BMI in between 18.5 and 30.0 kg/m2 (including upper and lower limits).
✓. 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):
Exclusion criteria
✕. 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.
✕. 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.
✕. Agreement to avoid blood donation during the study.
✕. Laboratory confirmed SARS-CoV-2 infection, defined by RT-PCR test.
✕. Fever (oral temperature ≥ 37.5°C/axillary temperature ≥ 37.3°C) on the day of vaccination or within recent 72 hours.
✕. 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.
What they're measuring
1
Frequencies of cross-reactive receptor binding domain (RBD)-specific IFN-γ producing T cells at Day 14
Timeframe: Day 14
2
Frequencies of cross-reactive receptor binding domain (RBD)-specific IFN-γ producing T cells at Day 28
Timeframe: Day 28
3
Frequencies of cross-reactive receptor binding domain (RBD)-specific CD4+ T cells at Day 14
Timeframe: Day 14
4
Frequencies of cross-reactive receptor binding domain (RBD)-specific CD4+ T cells at Day 28
Timeframe: Day 28
5
Frequencies of cross-reactive receptor binding domain (RBD)-specific CD8+ T cells at Day 14
Timeframe: Day 14
6
Frequencies of cross-reactive receptor binding domain (RBD)-specific CD8+ T cells at Day 28
✕. Abnormal laboratory tests of clinical significance involving hematology, serum biochemistry, coagulation function, or urinalysis as determined by the investigator.
✕. 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).