Protektivitas, Reaksi Lokal dan Sistemik setelah Imunisasi dengan Vaksin Td pada Anak Sekolah Dasar di Indonesia

Abstract

penelitian ini adalah untuk mengetahui reaksi dan respon imun setelah memperoleh 1 dosis vaksin Td. Penelitian ini merupakan Post Marketing Surveillance, dengan desain kohort pada anak sekolah dasar di Jawa Timur. Reaksi lokal dan sistemik dicatat pada kartu harian hingga 28 hari setelah imunisasi. Darah diambil sebelum dan 28 hari setelah imunisasi. Pengukuran antibodi menggunakan metode uji double antigen ELISA, dengan batas proteksi 0,01 IU/mL baik untuk anti-tetanus maupun anti-difteria. Pengamatan yang berlangsung dari Oktober 2010 hingga April 2011 ini melibatkan sebanyak 2978 anak sekolah dasar, termasuk 159 anak untuk kelompok respon imun. Sebanyak 1,18%-2,45% anak mengalami demam dengan instensitas mayoritas ringan. Reaksi lokal terbanyak adalah nyeri pada 30 menit setelah imunisasi 62,49% naik menjadi 83,38% pada hari ke-1, dan menurun pada hari berikutnya dengan intensitas mayoritas adalah ringan. Tidak ditemukan kejadian pasca imunisasi serius. Sebanyak 98,11% dan 99,37% anak terlindungi terhadap difteria dan tetanus dengan Geometric Mean Titer 1,2280 IU/mL (p=0,000) untuk anti-difteria dan 10,6068 IU/mL (p=0,009) untuk anti-tetanus. Simpulan, dari hasil pengamatan menunjukkan bahwa vaksin ini bersifat imunogenik dan aman setelah pemberian 1 (satu) dosis pada anak sekolah dasar.

Kata kunci: Post Marketing Surveillance (PMS), reaksi lokal, reaksi sistemik, vaksin Td


Protectivity, Local and Systemic Reactions Following Td Vaccination among Elementary School Students in Indonesia


Td vaccine is given to provide protection to tetanus and diphtheria in children 7 years of age or above. The objectives of this study are to evaluate the reactions and immune response after 1 dose of Td vaccine. This study is a post marketing surveillance with a cohort design among elementary school students in East Java. Systemic and local reactions were recorded in diary cards untill 28 days after immunization. Blood was collected before and 28 days after immunization. Antibody titers were measured using double antigen ELISA with cut off protection rate >0,01 IU/ml. Observation were done between October 2010 to April 2011 which involved 2978 included 159 subjects for immune response group. In this study, fever was occured in 1,18%-2,45% subjects at the first three days with mild in intensity and resolved immediately without any medication. The most often local reaction was pain in 62,49% subjects at 30 minutes after injection, and increased to 83,38% at day 1 after immunization, and decreased the day after, with the intensity mostly were mild. No serious adverse reactions was found. 98,11% and 99,37% subjects were protected to diphtheria and tetanus, with the Geometric Mean Titer 1,2280 IU/mL (p=0,000) for anti-diphtheria and 10,6068 IU/mL (p=0.009) for anti-tetanus. In conclusion, Td vaccine is safe and immunogenic after 1 (one) dose in school age children, and there were no serious adverse event.

Keywords: local reactions, post marketing surveillance (PMS), systemic reactions, Td vaccine

DOI: 10.15395/mkb.v46n3.315