| Title: |
A phase II, randomised clinical trial to demonstrate the non-inferiority of low-dose MF59®-adjuvanted pre-pandemic A/H5N1 influenza vaccine in adult and elderly subjects |
| Authors: |
Czajka, H; Unal, S; Ulusoy, S; Usluer, G; Strus, A; Sennaroglu, E; Guzik, J; Topeli Iskit, A; Dargiewicz, A; Musial, D; Caylan, R; Dziduch, J; Eskioglu, E; Hasiec, B; Cwinarowiczliwa, E; Belli, R; Abdel-Messih, IA; Beygo, J; Fragapane, E |
| Source: |
Journal of Preventive Medicine and Hygiene; Vol. 53 No. 3 (2012) ; 2421-4248 ; 1121-2233 ; 10.15167/2421-4248/jpmh2012.53.3 |
| Publisher Information: |
Department of Health Science - University of Genoa |
| Publication Year: |
2012 |
| Collection: |
Journal of Preventive Medicine and Hygiene (JPMH) |
| Description: |
ackground. Effective planning and preparedness against a possi- ble future A/H5N1 influenza pandemic is a major global challenge. Because dose sparing strategies are required to meet the global demand for vaccine, efforts have focused on the development of adju- vanted vaccine formulations of relatively lower antigen content. Aim. This study aimed to demonstrate the non-inferiority of a low-antigen-dose (3.75 mg) A/H5N1 pre-pandemic vaccine com- pared with a licensed, higher-dose (7.5 mg) formulation in adult and elderly subjects. Immunogenicity was assessed according to European and U.S. licensure criteria. Methods. A total of 722 subjects were randomized in equal num- bers to receive either the licensed or low-dose formulation. All subjects received two vaccine doses administered three weeks apart. Immunogenicity was assessed three weeks after the admin- istration of each vaccine dose by hemagglutination inhibition HI), single radial haemolysis (SRH) and microneutralization assays (MN). Local and systemic reactions were assessed over a seven day period post-vaccination. Adverse events were recorded throughout. Results. The low-dose vaccine was demonstrated to be non-infe- rior to the licensed formulation in terms of antibody titres against the vaccine strain. All three European licensure criteria were met by adult subjects in response to the low-dose vaccine; two crite- ria were met by the elderly age group. Cross-reactive antibodies were detected against the heterologous A/H5N1 antigen strains A/Indonesia/05/05 and A/turkeyTurkey/01/05. Both vaccines were generally well tolerated by both age groups. Conclusion. These data demonstrate that a low antigen dose in combination with MF59® adjuvant is adequate for the routine pre-pandemic immunization of adult and elderly subjects. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
https://www.jpmh.org/index.php/jpmh/article/view/334/312; https://www.jpmh.org/index.php/jpmh/article/view/334 |
| Availability: |
https://www.jpmh.org/index.php/jpmh/article/view/334 |
| Rights: |
Copyright (c) 2015 Journal of Preventive Medicine and Hygiene |
| Accession Number: |
edsbas.79EC8991 |
| Database: |
BASE |