Pustaka Ilmiah Universitas Padjadjaran

Abstrak

Manfaat Imunisasi Ulang Tetanus Difteria (Td) Pada Remaja Sebagai Salah Satu Upaya Mencegah Reemerging Disease Di Indonesia Ditinjau Dari Aspek Imunogenisitas Dan Keamanannya Berdasarkan Pengurangan Dosis Vaksin Difteria The Benefits Of Booster Tetanus Diphtheria (Td) Immunization On Adolescent To Prevent Reemerging Disease In Indonesia A Review Of Immune Response And Safety Perspective Based On Reduced Dose Diphtheria Vaccine

Hasil telaahan pada era tahun 1990-an di negara Sovyet terdapat kejadian luar biasa (KLB) difteria sebagai tanda terjadinya reemerging diseases di negara industri dengan kematian yang tinggi pada remaja dan dewasa. KLB difteria di kabupaten Cianjur berpotensi terjadi reemerging disease akibat belum adanya program imunisasi ulang yang berkesinambungan pada remaja. Penelitian ini bertujuan untuk menilai imunogenisitas dan keamanan vaksin tetanus, difteria (Td) yang diberikan sebagai imunisasi ulang pada remaja. Uji klinis prospective, randomized double-blind controlled dilakukan terhadap pelajar remaja sehat di kota Bandung, usia 10–18 tahun. Sebanyak 296 remaja sebagi subjek penelitian, dibagi 2 kelompok secara acak sederhana. Kelompok I mendapat dosis suntikan 0,5 mL yang diberikan intramuskular. Kelompok II mendapat vaksin TT sebagai kontrol. Pemeriksaan darah dilakukan sebelum dan 1 bulan setelah imunisasi menggunakan teknik enzyme-linked immunosorbent assays (ELISAs) untuk menilai konsentrasi antibodi difteria dan tetanus. Data tentang keamanan dikumpulkan sampai 1 bulan sejak imunisasi menggunakan buku harian. Perbedaan antara proporsi ditentukan dengan uji Chi-square atau eksak Fisher. Konsentrasi antibodi seroproteksi ( 0,1 IU/mL) terhadap difteria dan tetanus mencapai 93,2% and 100,0%. The geometric mean titer (GMT) terhadap difteria meningkat bermakna dari 0,0618 IU/mL ke 0,7583 IU/mL (p<0,001), dan terhadap tetanus meningkat bermakna dari 0,4413 IU/mL ke 14,4054 IU/mL (p37,5°C sedikit terjadi pada kedua kelompok (Rentang Td: 0,7-4,7%; Rentang TT: 3,4–6,7%). Tidak terdapat reaksi serius dan semua penerima vaksin dapat menerimanya dengan baik. Simpulan: Imunisasi ulang Td meningkatkan kadar immunoglobulin spesifik protektif terhadap difteria dan tetanus, serta aman diberikan pada remaja.

In the 1990s, a massive epidemic throughout the Newly Independent States of the former Soviet Union marked the reemergence of epidemic diphtheria in industrialized countries. In Indonesia, the same thing could potentially happen in the absence of continuous booster immunization program in adolescent. The aim of this study was to evaluate the immunogenicity and safety of a vaccine formulated with tetanus toxoid, diphtheria toxoid antigens (Td) compared with tetanus toxoid vaccine (TT) for booster immunization in adolescents. This prospective, randomized double-blind controlled clinical trial study on healthy adolescent aged 10 to 18 years. Two hundred and ninety six healthy adolescents were randomly divided into two groups by simple randomized sampling. Group I received a single 0.5 mL dose of Td vaccine, administered by intramuscular injection in the deltoid muscle. Group II received TT vaccine as a control. The safety data was collected up to one month after injection by diary card to record the appearance, the duration and the intensity of any local reaction and any systemic event. Blood samples were obtained before and 1 month after vaccination. Standardized enzyme-linked immunosorbent assays (ELISAs) were used to assess antibody concentrations to diphtheria and tetanus toxoids. Differences between proportions were determined by the Chi-square or Fisher’s exact test. Seroprotective antibody concentrations ( 0.1 IU/mL) against diphtheria and tetanus were achieved by 93.2% and 100.0%. The geometric mean titer (GMT) was significanly increased from 0.0618 IU/mL to 0.7583 IU/mL (p<0.001); while against tetanus the GMT was significanly increased from 0.4413 IU/mL to 14.4054 IU/mL (p37.5°C occurred infrequently in both Td and TT recipients (Td range: 0.7-4.7%; TT range: 3.4-6.7%). No serious adverse events occurred and all vaccinations were well tolerated. In conclusion: booster Td vaccine is highly immunogenic and safe in adolescent.

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