A Phase I/II Clinical Trial of Intradermal, Controllable Self-Replicating Ribonucleic Acid Vaccine EXG-5003 against SARS-CoV-2
Abstract
:1. Introduction
2. Materials and Methods
2.1. EXG-5003 Vaccine
2.2. Trial Design and Participants
2.3. Study Procedures
2.4. Humoral Immunity Assays: Anti-RBD Antibody
2.5. Humoral Immunity Assays: Cell-Free SARS-CoV-2 Neutralization Assay
2.6. Humoral Immunity Assays: SARS-CoV-2 Spike Pseudotyped Lentivirus Assay
2.7. Cellular Immunity: FluoroSpot Assay
2.8. Safety Assessment
2.9. Statistical Analysis
3. Results
3.1. Participants
3.2. Safety
3.3. Short-Term Humoral Immunity Elicited by EXG-5003
3.4. Short-Term Cellular Immunity Elicited by EXG-5003
3.5. Long-Term Humoral Immunity Elicited by EXG-5003 following Administration of Licensed Vaccines
3.6. Long-Term Cellular Immunity Elicited by EXG-5003 following Administration of Licensed Vaccines
4. Discussion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Cohort 1 | Cohort 1 | Cohort 2 | Cohort 2 | |
---|---|---|---|---|
EXG-5003 5 µg | Placebo | EXG-5003 25 µg | Placebo | |
(n = 16) | (n = 4) | (n = 16) | (n = 4) | |
Race | ||||
Asian | 16 (100%) | 4 (100%) | 16 (100%) | 4 (100%) |
Gender | ||||
Male | 10 (62.5%) | 3 (75%) | 7 (43.8%) | 4 (100%) |
Female | 6 (37.5%) | 1 (25%) | 9 (56.2%) | 0 (0%) |
Age (year) | ||||
Mean | 39.375 | 46.75 | 39.562 | 42.75 |
SD | 8.405 | 7.932 | 10.354 | 4.272 |
Median | 39.5 | 48.0 | 43.0 | 44.0 |
Min–Max | 22–53 | 36–55 | 22–55 | 37–46 |
Weight (kg) | ||||
Mean | 66.862 | 64.8 | 63.094 | 74.625 |
SD | 18.756 | 4.721 | 12.837 | 10.633 |
Median | 61.5 | 65.85 | 63.05 | 72.9 |
Min–Max | 46.9–107.8 | 58.2–69.3 | 47.5–84.7 | 65–87.7 |
Height (cm) | ||||
Mean | 169.200 | 169.375 | 164.162 | 169.175 |
SD | 8.791 | 6.874 | 8.804 | 5.142 |
Median | 170.550 | 172.55 | 164.550 | 170.35 |
Min–Max | 154.2–183.1 | 159.1–173.3 | 152–180 | 162–174 |
BMI (kg/m2) | ||||
Mean | 23.265 | 22.575 | 23.301 | 26.173 |
SD | 6.072 | 0.534 | 3.680 | 4.374 |
Median | 21.484 | 22.593 | 22.637 | 26.269 |
Min–Max | 17.849–39.789 | 22.039–23.075 | 16.553–29.938 | 22.13–30.026 |
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Koseki, T.; Teramachi, M.; Koga, M.; Ko, M.S.H.; Amano, T.; Yu, H.; Amano, M.; Leyder, E.; Badiola, M.; Ray, P.; et al. A Phase I/II Clinical Trial of Intradermal, Controllable Self-Replicating Ribonucleic Acid Vaccine EXG-5003 against SARS-CoV-2. Vaccines 2023, 11, 1767. https://doi.org/10.3390/vaccines11121767
Koseki T, Teramachi M, Koga M, Ko MSH, Amano T, Yu H, Amano M, Leyder E, Badiola M, Ray P, et al. A Phase I/II Clinical Trial of Intradermal, Controllable Self-Replicating Ribonucleic Acid Vaccine EXG-5003 against SARS-CoV-2. Vaccines. 2023; 11(12):1767. https://doi.org/10.3390/vaccines11121767
Chicago/Turabian StyleKoseki, Takenao, Mayumi Teramachi, Minako Koga, Minoru S. H. Ko, Tomokazu Amano, Hong Yu, Misa Amano, Erica Leyder, Maria Badiola, Priyanka Ray, and et al. 2023. "A Phase I/II Clinical Trial of Intradermal, Controllable Self-Replicating Ribonucleic Acid Vaccine EXG-5003 against SARS-CoV-2" Vaccines 11, no. 12: 1767. https://doi.org/10.3390/vaccines11121767