Toksisitas Kandidat Vaksin Influenza (INF) pada Kelinci: Kajian terhadap Fungsi Hati

BTARI GAVRILLA L, Dr. Arief Nurrochmad, M.Si., M.Sc., Apt.; Dr. Ika Puspita Sari, M.Si., Apt.

2018 | Skripsi | S1 FARMASI

Influenza merupakan salah satu penyakit menular yang paling umum terjadi di dunia. Keadaan ini menyebabkan dampak buruk bagi masyarakat luas, namun dapat dicegah atau dikurangi tingkat keparahannya dengan vaksinasi. Virus influenza dapat mengalami mutasi sehingga vaksin perlu diperbaharui. Pembaharuan komposisi vaksin memerlukan uji preklinis. Uji toksisitas sebagai uji preklinis yang menjadi dasar untuk merencanakan protokol uji klinis pada manusia. Tujuan penelitian ini adalah untuk mengetahui efek toksik vaksin INF terhadap fungsi hati dengan parameter aktivitas SGOT dan SGPT serta kadar protein total dan albumin pada hewan uji kelinci galur New Zealand. Metode uji yang digunakan mengacu pada WHO TRS 927 Annex I mengenai WHO Guideline on Non-clinical Evaluation of Vaccine. Kandidat vaksin dipejankan ke hewan uji kelinci sebanyak tiga kali selama pengamatan 52 hari. Hewan uji dibagi menjadi dua kelompok besar, yaitu kelompok vaksin (A) dan PBS (B). Data yang diperoleh kemudian dianalisis secara statistik dengan Independent Sample T-Test dan Mann-Whitney Test. Hasil penelitian menunjukkan bahwa pemberian kandidat vaksin influenza sebanyak satu, dua, dan tiga kali tidak mempengaruhi kadar SGPT, SGOT, protein total, dan albumin secara signifikan. Pemberian kandidat vaksin influenza juga tidak memunculkan efek yang tertunda pada kadar SGPT, SGOT, protein total, dan albumin sehingga kandidat vaksin influenza tidak menyebabkan efek toksik pada fungsi hati kelinci galur New Zealand baik jantan maupun betina.

Influenza is one the most common contagious disease in the world. It causes adverse effects to the community, but can be prevented or reduced its severity by vaccination. Influenza viruses can mutate so that the vaccine needs to be updated. Renewal of vaccine composition requires preclinical testing. Toxicity study as preclinical trial is a basic study to design a clinical trial protocol in human. The method used in this study refers to WHO TRS 927 Annex I about WHO Guideline on Non-clinical Evaluation of Vaccine. The aim of this study was to discover the toxic effects of influenza vaccine on liver function with SGPT, SGOT, total protein and albumin as parameters. Animal that used in this research is New Zealand rabbit. Influenza vaccine was injected into the rabbit three times during 52 days observation. Rabbits were divided into two major groups, that are vaccine group and Phosphat Buffer Saline (PBS) control group. The data obtained were then analyzed statistically using Shapiro-Wilk normality test and homogenity test. Data analysis continued with Independent Sample T-Test and Mann-Whitney Test. The results showed that administration of INF vaccine did not significantly affect activity of SGPT, SGOT, total protein, and albumin. It also did not affect those parameters in their reversibility period. Therefore, the INF vaccine candidate does not cause toxic effects on liver organ of New Zealand white rabbits.

Kata Kunci : influenza, vaksin, WHO TRS 927 Annex I, SGPT, SGOT, kelinci