Protektivitas, Reaksi Lokal dan Sistemik Pascaimunisasi dengan Vaksin Campak (Bio Farma) dari Bets Vaksin yang Berbeda pada Anak Sekolah Dasar di Sumatera Barat

Abstract

Post Marketing Surveillance perlu dilakukan secara berkala untuk memastikan produk yang telah dipasarkan tetap dalam kualitas yang baik. Tujuan penelitian ini adalah mengetahui protektivitas, serta reaksi sistemik dan lokal setelah memperoleh dosis boster vaksin campak dari bets vaksin yang berbeda yang diproduksi pada fasilitas yang berbeda. Penelitian ini menggunakan desain kohort pada anak sekolah dasar di Sumatera Barat. Subjek di Kabupaten Agam  mendapatkan vaksin dengan nomor bets 250210, sedangkan subjek di Kabupaten Limapuluh Kota  vaksin campak bets 253080. Darah diambil sebelum dan 28 hari setelah imunisasi. Pengukuran antibodi menggunakan metode uji netralisasi dengan batas proteksi > 200 mIU/mL. Reaksi lokal dan sistemik dicatat pada kartu harian hingga 28 hari setelah imunisasi. Pengamatan berlangsung dari November 2010 hingga Maret 2011 melibatkan 170 anak di Kabupaten Agam dan 166 anak di Kabupaten Limapuluh Kota. Sebanyak 1,18–1.2% anak mengalami demam pada 3 hari pertama setelah imunisasi dan 1 (0,6%) timbul  pada 14 hari setelah imunisasi dengan instensitas  ringan. Reaksi lokal terbanyak adalah kemerahan pada tempat suntikan (14,46%). Tidak ditemukan kejadian pascaimunisasi serius. Sejumlah 96,99% dan 96,77% anak mempunyai antibodi campak protektif 28 hari pascaimunisasi imunisasi di Kabupaten Agam dan Limapuluh Kota dengan kenaikan GMT dari 329,66 IU/mL menjadi 983,43 IU/mL dan dari 198,00 menjadi 535,10 IU/mL (p=0,000) di Kabupaten Agam dan Limapuluh Kota. Simpulannya adalah kedua bets vaksin campak menunjukkan keamanan dan respons imun yang baik. [MKB. 2015;47(3):144–51]

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

Protectiveness, Local Reaction, and Systemic Reaction after Measles Immunization using Different Batches of Bio Farma Vaccine in Elementary School Students in West Sumatra

Abstract

Post Marketing Surveillance should be conducted periodically to monitor whether the quality of marketed products is still favorable. The objectives of this study were to evaluate the protectiveness, local reaction, and systemic reaction after receiving booster dose of measles vaccine from different batch numbers. This study was a cohort study on elementary students in West Sumatra. Subjects from Agam District received measles vaccine with  a batch number of 250210 while subjects from Limapuluh Kota District received measles vaccine with a batch number of 253080. Blood samples were collected before and 28 days after immunization. Antibody titers were measured using neutralization assay with a protective level of >200 mIU/mL. Local and systemic reactions were recorded within 28 days after immunization. The observation was held from November 2010 to March 2011 and involved 336 students: 170 students from Agam District and 166 students from Limapuluh Kota District. There were 1.2% students who experienced fever in the first three days after immunization, and 1(0.6%) student experienced mild fever 14 days after immunization. The most common local reaction was redness in the injection site, contributing approximately 14.48%. There were no serious adverse events after immunization. About 96.99% and 96.77% students were protected against measles 28 days after immunization in Agam and Limapuluh Kota Districts with an increase in GMT from 329.66 IU/mL to 983.43 IU/mL and from 198.00 IU/mL to 535.10 IU/mL (p=0.000). In conclusion, both measles vaccine batches show good safety and immune response. [MKB. 2015;47(3):144–51]

Key words: Local reaction, measles, Post Marketing Surveillance (PMS), systemic reaction, vaccine

DOI: 10.15395/mkb.v47n3.595