Gałaj Andrzej, Grześk Grzegorz, Borys Dorota, Durmowicz Anna, Grześk Elzbieta, Szadujkis-Szadurski Leszek
Zakładu Farmakologii i Terapii Akademii Medycznej w Bydgoszczy.
Wiad Lek. 2004;57(5-6):217-20.
The objective of the study was to compare the immunogenicity and the safety profile of Engerix B and Twinrix vaccines. 72 people were qualified for the vaccination, including 41 women (average age 41.2) and 31 men (average age 44.8). The subjects were divided into two groups: Group I--vaccinated with Engerix B (37 persons) and Group II--vaccinated with Twinrix (35 persons). The vaccines were prepared and administered according to the recommended vaccination scheme: 0-1-6 months. 30 days after the last vaccine dose, qualitative and quantitative tests were performed for antibodies anti-HBs (Group I and II) and anti-HAV (Group II). Also, the occurrence of local and general adverse events after vaccinations was observed--on the vaccination day and during 3 consecutive days. In Group I, presence of anti-HBs antibodies was observed in 35 persons, not observed in 2 persons, while in Group II, anti-HBs antibodies were found in 34 persons, while in 1 person no such antibodies were stated. Anti-HAV antibodies were observed in 33 persons from Group II. The anti-HBs antibodies titres did not show significant statistical differences in the groups studied, except for the range 500-1000 IU/l (3 persons in Group I, lack in Group II) and 1000-5000 IU/l (2 persons in Group I, lack in Group II). Local side effects (redness, pain at the injection site, swelling) and general adverse events (fatigue, headache, temperature > 37.5 degrees C) were rare and disappeared within the 4-day observation period. The results achieved are a good recommendation for the vaccines studied, suggesting that vaccination with them are a safe and efficient form of prophylaxis against viral hepatitis.
该研究的目的是比较安在时(Engerix B)疫苗和双福立适(Twinrix)疫苗的免疫原性和安全性。72人符合接种条件,其中包括41名女性(平均年龄41.2岁)和31名男性(平均年龄44.8岁)。受试者被分为两组:第一组——接种安在时疫苗(37人),第二组——接种双福立适疫苗(35人)。疫苗按照推荐的接种方案(0-1-6月)进行制备和接种。在最后一剂疫苗接种30天后,对两组的抗-HBs抗体以及第二组的抗-HAV抗体进行了定性和定量检测。此外,观察了接种疫苗后当天及连续3天内局部和全身不良反应的发生情况。在第一组中,35人检测到抗-HBs抗体,2人未检测到;在第二组中,34人检测到抗-HBs抗体,1人未检测到。第二组中有33人检测到抗-HAV抗体。除了500-1000 IU/l范围(第一组有3人,第二组没有)和1000-5000 IU/l范围(第一组有2人,第二组没有)外,所研究组之间抗-HBs抗体滴度没有显著统计学差异。局部副作用(注射部位发红、疼痛、肿胀)和全身不良反应(疲劳、头痛、体温>37.5摄氏度)很少见,且在4天观察期内消失。所取得的结果对所研究的疫苗是一个很好的推荐,表明接种这些疫苗是预防病毒性肝炎的一种安全有效的方式。