Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial
Abstract
:1. Introduction
2. Results
2.1. Parameters of Safety
2.2. Follow Up of Patients with CHB for 2 Years after EOT
2.3. Sustained Control of HBV DNA by NASVAC in CHB Patients 2 Years after EOT
2.4. Kinetics of ALT in Patients Receiving NASVAC
2.5. Role of NASVAC in HBeAg Positivity
2.6. Anti-Fibrotic Effects of NASVAC
3. Discussion
4. Materials and Methods
4.1. Therapeutic Vaccine: NASVAC
4.2. Phase III Clinical Trial with NASVAC in CHB Patients
4.3. Design of Long-Term Follow-Up of NASVAC-Recipient CHB Patients
4.4. Assessment of HBV DNA, ALT, and Hepatitis B e Antigen (HBeAg) and Abdominal Ultrasonography
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variables | Basal Level | EOT | 2-Year after EOT |
---|---|---|---|
White Blood (Counts/mm3) | 9.0 (5.3–10) | 9.0 (5.4–11) | 9.0 (5.8–10.0) |
Bilirubin (mg/dL) | 0.63 (0.2–1.26) | 0.7 (0.4–1.16) | 0.79 (0.56–0.97) |
Albumin (gm/dL) | 3.7 (3.4–4.2) | 4.1 (3.6–4.6) | 3.6 (3.2–4.1) |
Creatinine (mg/dL) | 0.99 (0.46–1.8) | 1.0 (0.62–1.42) | 0.89 (0.54–1.27) |
Hemoglobulin (gm/dL) | 13.2 (12.6–14.2) | 12.4 (11.3–15.2) | 12.5 (10.6–13.2) |
Platelets count | 230,000 (190,000–270,000) | 210,000 (195,000–245,000) | 205,000 (195,000–320,000) |
(A) Kinetics of HBV DNA | |||
Number of Patients | HBV DNA-Negative (<250 copies/mL) | HBV DNA Reduced from Basal Levels | HBV DNA Increased from Basal Levels |
66 | 33 | 30 | 3 |
(B) Kinetics of ALT | |||
Number of Patients | Alanine Aminotransferase (ALT) below upper Level of Normal (ULN) (0–42 IU/L) | Alanine Aminotransferase (ALT) above ULN and2×ULN(43–84 IU/L) | Alanine Aminotransferase (ALT) above 86 IU/L |
66 | 37 | 29 | 0 |
(C) HBeAg Negativity | |||
Number of Patients | HBeAg-Negative | HBeAg-Positive | |
12 | 8 | 4 |
Variables | Values | |
---|---|---|
Total | 66 | |
Male: Female | 59:7 | |
Age (Years) | 20 (18–50) | |
HBV DNA (copies/mL) | 4.33 × 103 (range: 1.5 × 103–1.0 × 1013) | |
ALT (IU/L) * | 30 (10–262) * | |
HBeAg-positive | 12 |
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Akbar, S.M.F.; Al Mahtab, M.; Aguilar, J.C.; Yoshida, O.; Penton, E.; Gerardo, G.N.; Hiasa, Y. Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial. Pathogens 2021, 10, 1440. https://doi.org/10.3390/pathogens10111440
Akbar SMF, Al Mahtab M, Aguilar JC, Yoshida O, Penton E, Gerardo GN, Hiasa Y. Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial. Pathogens. 2021; 10(11):1440. https://doi.org/10.3390/pathogens10111440
Chicago/Turabian StyleAkbar, Sheikh Mohammad Fazle, Mamun Al Mahtab, Julio Cesar Aguilar, Osamu Yoshida, Eduardo Penton, Guillen Nieto Gerardo, and Yoichi Hiasa. 2021. "Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial" Pathogens 10, no. 11: 1440. https://doi.org/10.3390/pathogens10111440
APA StyleAkbar, S. M. F., Al Mahtab, M., Aguilar, J. C., Yoshida, O., Penton, E., Gerardo, G. N., & Hiasa, Y. (2021). Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial. Pathogens, 10(11), 1440. https://doi.org/10.3390/pathogens10111440