[Comparison of immunogenicity and safety of Engerix B and Twinrix vaccine].
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.
Gałaj
Andrzej
A
Zakładu Farmakologii i Terapii Akademii Medycznej w Bydgoszczy.
Grześk
Grzegorz
G
Borys
Dorota
D
Durmowicz
Anna
A
Grześk
Elzbieta
E
Szadujkis-Szadurski
Leszek
L
D000328:Adult; D005260:Female; D006506:Hepatitis A / Q000276:immunology / Q000517:prevention & control*; D035922:Hepatitis A Antibodies / Q000097:blood; D022362:Hepatitis A Vaccines / Q000009:adverse effects* / Q000276:immunology*; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome; D017778:Vaccines, Combined / Q000009:adverse effects / Q000276:immunology; D014614:Vaccines, Synthetic / Q000009:adverse effects* / Q000276:immunology*
C075654:Engerix-B; D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined; D014614:Vaccines, Synthetic; C433226:twinrix