Efficacy and Safety of Hepatitis B Virus Vaccine(HBV) in Treatment of Cutaneous Warts

Cutaneous Warts Clinical Trial

Official title:

Efficacy and Safety of Hepatitis B Virus Vaccine(HBV) in Treatment of Cutaneous Warts

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05902624
• Other study ID #: cutaneous warts treatment
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 10, 2023
• Est. completion date: August 20, 2024

Study information

• Verified date: June 2023
• Source: Assiut University
• Contact: Maria Awny, Master
• Phone: 01274724482
• Email: maria.awny11[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of the work: 1. Evaluate efficacy and safety of Intralesional HBV vaccine injection as a treatment of plane and genital warts. 2. Evaluate efficacy and safety of Intramuscular HBV vaccine injection as a treatment of plane and genital warts. 3. Compare the efficacy of different doses(0.3ml vs 0.5ml )of intralesional HBV vaccine injection for treatment of plane and genital warts. 4. Compare the efficacy of intralesional HBV vaccine injection vs Intramuscular HBV vaccine injection in treatment of plane and genital warts.

Description:

INTRODUCTION: Warts are common, benign and epithelial proliferations and growths affecting the skin and/or the mucosa caused by human papilloma virus (HPV) which is a double stranded DNA virus with a worldwide distribution. There are approximately 218 types of HPV identified as causing infections in humans . Infection occurs predominantly via direct contact, although skin lesions can be transmitted indirectly, via contaminated surfaces, Abrations and microtraumas expose the basal layer keratinocytes and facilitate contagion . The clinical manifestations of HPV-related diseases vary depending upon the HPV type and the site of inoculation .Extragenital cutaneous warts can present as common warts, plane warts, plantar warts .HPV infection is one of the most common sexually transmitted infections with the most common manifestation of HPV in the genital area is anogenital warts or condylomata acuminate . Infections due to these viruses may result in a wide spectrum of clinical manifestations in the skin and mucosa. Although cutaneous warts are mostly benign with spontaneous resolution after months or years in healthy patients. Nonetheless, they can grow, cause discomfort or embarrassment to patients, or persist for months or years, increasing viral transmission between individuals. Also, anogenital warts caused by high risk strains possess an oncogenic potential . Several therapeutic modalities have been used to treat HPV infections. The choice of treatment should take into account factors such as age, location, number and size of the lesions, clinical subtype and the patient's immunological status. Available treatment modalities include physical destruction (e.g., cryotherapy, electrosurgery, ablative laser, or surgical removal), chemical destruction (e.g., salicylic acid or trichloroacetic acid), and anti-proliferative agents (e.g., podophyllin, 5-fluorouracil or bleomycin). Unfortunately, no treatment has yet shown 100% effectiveness as a cure. Furthermore these modalities have side-effects (e.g. pain, erythema, burning sensation and scarring) .Classical treatment lines are associated with high recurrence rates as they are limited to local application and do not act systemically .So, there is a need for therapies with a greater efficacy and minimal side-effects . Immunotherapeutic agents act by enhancing the host cell-mediated immunity that helps to eliminate the virus rather than simply destroying visible skin lesions and have recently received increasing attention for the treatment of warts because of their non-destructive action, high safety profiles, promising results, and low recurrence rates. Contact immunotherapy using contact sensitizers (diphenylcyclopropenone or dinitrochlorobenzene), topical imiquimod, oral cimetidine or intralesional immunotherapy has been attempted as viable immunotherapeutic options for treatment of warts. Intralesional immunotherapy has been assessed as an alternative therapeutic approach, particularly for cases of recalcitrant or multiple warts, since it may facilitate the clearance of not only the injected wart but also surrounding non-injected warts. Various immunotherapeutic agents including skin test antigens (mumps, Candida, and Trichophyton); the combined measles, mumps, and rubella vaccine(MMR); the tuberculin purified protein derivative(PPD); Mycobacterium w vaccine; and bacillus Calmette-Guérin(BCG) vaccine have been assessed. Hepatitis B virus (HBV) vaccine is a highly safe and effective DNA vaccine against HBV infection that is recommended for all infants at birth and for children. It is also recommended for adults at high risk for infection because of their jobs, lifestyle, or living situations. It is relatively cheap, easy to produce, and extremely stable. Besides, HBV vaccination is associated with the stimulation, not only of humoral immunity that induces antibody production against Hepatitis B surface antigen (HBsAg), but also of cell-mediated immunity, particularly T helper1 Th1 cytokines such as interferon γ( IFN-γ )and interleukin2(IL-2). Furthermore, HBV vaccine has the advantage of being a non-live vaccine that can be used safely in immunocompromised patients in contrast to the live vaccines such as measles, mumps, and rubella (MMR), Bacillus Calmette-Guerin (BCG) that may pose high risks to the immunocompromised patients . Only two researches studied the efficacy of intralesional HBV vaccine injection in treatment of multiple common warts. Both studies revealed low success rate (20.7% and 23.3% respectively) of intralesional HBV vaccine at a dose of 0.2ml injected into the largest wart in biweekly sessions for a maximum of 5 sessions. It Worth mentioning that one the two studies also examined the efficacy of intramuscular injection of HBV vaccine at higher doses (0.5 ml and 1 ml/ injection) for 3 injections and reported a complete clearance of common warts in 50% of the patients, which was statistically significant higher than percentage of those patients who achieved complete clearance after treatment with intralesional injection of HBV vaccine using 0.2 ml/session for five sessions. Whether this significant difference is related to the different treatment dosage or to the different administration routes is still to be unraveled by further studies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: August 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Any patients with multiple genital or plane warts of any site.
• Patients age above 10 years old
• No concurrent systemic or topical treatment of warts

Exclusion Criteria:

• Pregnancy and lactation.
• History of any bleeding, clotting disorder or using anticoagulants
• Chronic systemic diseases such as chronic renal failure, hepatic insufficiency, and cardiovascular disorders.
• Concurrent use of systemic or topical treatments of warts.
• Patients with history of neuropathy or peripheral ischemia.
• Patients with signs of inflammation or infection.
• Patients with history of a serious systemic or anaphylactic reaction or allergy to a prior dose of HBV vaccine or to any of its components.

Related Conditions & MeSH terms

• Cutaneous Warts
• Hepatitis B
• Warts

Intervention

Drug:
• Hepatitis B Virus Vaccine(HBV)
Hepatitis B Virus Vaccine(HBV)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (13)

Abou-Taleb DAE, Abou-Taleb HA, El-Badawy O, Ahmed AO, Thabiet Hassan AE, Awad SM. Intralesional vitamin D3 versus intralesional purified protein derivative in treatment of multiple warts: A comparative clinical and immunological study. Dermatol Ther. 2019 Sep;32(5):e13034. doi: 10.1111/dth.13034. Epub 2019 Aug 7. — View Citation

Araujo MG, Magalhaes GM, Garcia LC, Vieira EC, Carvalho-Leite MLR, Guedes ACM. Update on human papillomavirus - Part II: complementary diagnosis, treatment and prophylaxis. An Bras Dermatol. 2021 Mar-Apr;96(2):125-138. doi: 10.1016/j.abd.2020.11.005. Epub 2021 Feb 16. — View Citation

Burlamaqui JC, Cassanti AC, Borim GB, Damrose E, Villa LL, Silva L. Human Papillomavirus and students in Brazil: an assessment of knowledge of a common infection - preliminary report. Braz J Otorhinolaryngol. 2017 Mar-Apr;83(2):120-125. doi: 10.1016/j.bjorl.2016.02.006. Epub 2016 Apr 22. — View Citation

Colpani V, Soares Falcetta F, Bacelo Bidinotto A, Kops NL, Falavigna M, Serpa Hammes L, Schwartz Benzaken A, Kalume Maranhao AG, Domingues CMAS, Wendland EM. Prevalence of human papillomavirus (HPV) in Brazil: A systematic review and meta-analysis. PLoS One. 2020 Feb 21;15(2):e0229154. doi: 10.1371/journal.pone.0229154. eCollection 2020. — View Citation

Cubie HA. Diseases associated with human papillomavirus infection. Virology. 2013 Oct;445(1-2):21-34. doi: 10.1016/j.virol.2013.06.007. Epub 2013 Aug 9. — View Citation

Ju HJ, Park HR, Kim JY, Kim GM, Bae JM, Lee JH. Intralesional immunotherapy for non-genital warts: A systematic review and meta-analysis. Indian J Dermatol Venereol Leprol. 2022 Nov-Dec;88(6):724-737. doi: 10.25259/IJDVL_1369_20. — View Citation

Magalhaes GM, Vieira EC, Garcia LC, De Carvalho-Leite MLR, Guedes ACM, Araujo MG. Update on human papilloma virus - part I: epidemiology, pathogenesis, and clinical spectrum. An Bras Dermatol. 2021 Jan-Feb;96(1):1-16. doi: 10.1016/j.abd.2020.11.003. Epub 2020 Dec 10. — View Citation

Mohammed GF, Al-Dhubaibi MS, Bahaj SS, Elneam AIA. Systemic immunotherapy for the treatment of warts: A literature review. J Cosmet Dermatol. 2022 Nov;21(11):5532-5536. doi: 10.1111/jocd.15330. Epub 2022 Aug 31. — View Citation

Nofal A, Elaraby A, Elkholy BM. Intralesional Versus Intramuscular Hepatitis B Virus Vaccine in the Treatment of Multiple Common Warts. Dermatol Surg. 2022 Nov 1;48(11):1178-1184. doi: 10.1097/DSS.0000000000003595. Epub 2022 Sep 23. — View Citation

Nofal A, Elsayed E, Abdelshafy AS. Hepatitis B virus vaccine: A potential therapeutic alternative for the treatment of warts. J Am Acad Dermatol. 2021 Jan;84(1):212-213. doi: 10.1016/j.jaad.2020.04.128. Epub 2020 Apr 29. No abstract available. — View Citation

Nofal A, Salah E, Nofal E, Yosef A. Intralesional antigen immunotherapy for the treatment of warts: current concepts and future prospects. Am J Clin Dermatol. 2013 Aug;14(4):253-60. doi: 10.1007/s40257-013-0018-8. — View Citation

Perez-Gonzalez A, Cachay E, Ocampo A, Poveda E. Update on the Epidemiological Features and Clinical Implications of Human Papillomavirus Infection (HPV) and Human Immunodeficiency Virus (HIV) Coinfection. Microorganisms. 2022 May 18;10(5):1047. doi: 10.3390/microorganisms10051047. — View Citation

Thappa DM, Chiramel MJ. Evolving role of immunotherapy in the treatment of refractory warts. Indian Dermatol Online J. 2016 Sep-Oct;7(5):364-370. doi: 10.4103/2229-5178.190487. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Hepatitis B virus vaccine(HBV) in treatment of cutaneous warts .	size of cutaneous warts in millimeters will be measured every visit	10 weeks
Primary	Effectiveness of Hepatitis B virus vaccine(HBV) in treatment of cutaneous warts .	number of cutaneous warts will be measured every visit	10 weeks