Preformulasi dan Uji Aktivitas Vaksin Oral Human Papillomavirus (HPV) dalam Formula Nanopartikel dengan Aluminum Hidroksida-Kitosan sebagai Adjuvant

Sekar Ayu Kusumawardani, Dr. apt. Adhyatmika, M.Biotech.; Dr. apt. Soni Siswanto, M. Biomed.

2026 | Skripsi | FARMASI

Infeksi Human Papillomavirus (HPV) merupakan salah satu infeksi menular seksual yang paling umum dan berperan dalam perkembangan berbagai kanker, terutama kanker serviks yang didominasi oleh HPV tipe 16 dan 18. Meskipun vaksinasi HPV efektif menurunkan prevalensi infeksi HPV risiko tinggi, penggunaan vaksin berbasis injeksi masih memiliki keterbatasan dalam distribusi dan administrasi. Oleh karena itu, pengembangan vaksin oral menjadi pendekatan yang potensial karena bersifat non-invasif dan lebih praktis. Namun, vaksin oral menghadapi tantangan berupa degradasi antigen akibat pH lambung dan enzim pencernaan sehingga diperlukan sistem penghantaran yang mampu melindungi antigen dan meningkatkan respons imun.

Penelitian ini bertujuan melakukan preformulasi vaksin oral HPV berbasis Virus-Like Particles (VLP) tipe 16/18 menggunakan sistem nanopartikel dengan kombinasi adjuvant aluminum hidroksida dan kitosan. Karakterisasi preformulasi meliputi ukuran partikel, polydispersity index (PDI), potensial zeta, dan efisiensi penjerapan antigen (entrapment efficiency, EE%). Aktivitas imunogenik dievaluasi secara in vivo melalui pengukuran kadar antibodi IgG pada mencit jantan galur Balb/c menggunakan metode ELISA. Data penelitian disajikan dalam bentuk grafik dan tabel untuk menggambarkan karakteristik fisikokimia dan aktivitas imunogenik preformulasi vaksin oral HPV berbasis VLP. Berdasarkan uji karakterisasi didapatkan nilai ukuran partikel, distribusi ukuran partikel, dan potensial zeta yang sesuai dalam membentuk sistem nanopartikel yang stabil, serta mendapatkan nilai EE% yang optimal sebesar sebesar 91,803±0,823%. Uji in vivo membuktikan bahwa vaksin oral VLP HPV 16/18 dapat meningkatkan aktivitas imunomodulator melalui produksi antibodi IgG (p-value ? 0,05).

Human Papillomavirus (HPV) infection is one of the most common sexually transmitted infections and plays a significant role in the development of various cancers, particularly cervical cancer, which is predominantly associated with HPV types 16 and 18. Although HPV vaccination has been proven effective in reducing the prevalence of high-risk HPV infections, injectable vaccines still face limitations in terms of distribution and administration. Therefore, the development of oral vaccines has emerged as a promising alternative due to their non-invasive nature and ease of administration. However, oral vaccines encounter challenges related to antigen degradation caused by gastric acidity and digestive enzymes, necessitating the use of a delivery system capable of protecting the antigen and enhancing the immune response.

This study aimed to conduct a preformulation of an oral HPV vaccine based on HPV 16/18 Virus-Like Particles (VLP) using a nanoparticle delivery system combining aluminum hydroxide and chitosan as adjuvants. Preformulation characterization included particle size, polydispersity index (PDI), zeta potential, and antigen entrapment efficiency (EE%). Immunogenic activity was evaluated in vivo by measuring IgG antibody levels in male Balb/c mice using the enzyme-linked immunosorbent assay (ELISA) method. The data were presented in the form of graphs and tables to describe the physicochemical characteristics and immunogenic activity of the oral HPV vaccine preformulation. The characterization results demonstrated particle size, particle size distribution, and zeta potential values that were suitable for the formation of a stable nanoparticle system, with an optimal entrapment efficiency of 91.803 ± 0.823%. Furthermore, the in vivo study showed that the oral HPV 16/18 VLP vaccine was capable of enhancing immunomodulatory activity through increased IgG antibody production (p ? 0.05).

Kata Kunci : HPV, vaksin, adjuvant, kitosan, aluminum hidroksida