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BACKGROUND In 1997, pathogenic avian influenza A/Hong Kong/97 (H5N1) viruses emerged as a pandemic threat to human beings. A non-pathogenic variant, influenza A/Duck/Singapore/97 (H5N3), was identified as a leading vaccine candidate. We did an observer-blind, phase I, randomised trial in healthy volunteers to assess safety, tolerability, and antigenicity of(More)
Elderly people and subjects with underlying chronic diseases are at increased risk for influenza and related complications. Conventional influenza vaccines provide only limited protection in the elderly population. In order to enhance the immune response to influenza vaccines, several adjuvants have been evaluated. Among these, an oil in water adjuvant(More)
BACKGROUND Children have high morbidity and hospitalization rates from seasonal influenza. Meta-analyses suggest that conventional inactivated influenza vaccines are of low efficacy in young children, making vaccines that induce greater and broader immune protection in this vulnerable population a medical priority. Adjuvanted influenza vaccines may offer a(More)
The need to enhance the immunogenicity of purified subunit antigens has prompted the development of several new adjuvants. However, many of these new molecules have demonstrated a reactogenicity profile that is not suitable for their inclusion in vaccines for human use. In this context, the adjuvant emulsion MF59 has been developed, tested in combination(More)
Antigenically well-matched vaccines against highly pathogenic avian influenza H5N1 viruses are urgently required. Human serum samples after immunization with MF59 or nonadjuvanted A/duck/Singapore/97 (H5N3) vaccine were tested for antibody to 1997-2004 human H5N1 viruses. Antibody responses to 3 doses of nonadjuvanted vaccine were poor and were higher after(More)
To test whether inactivated influenza vaccines distributed during the 2003-2004 influenza season in the northern hemisphere were able to confer protection against the mismatched variant A/Fujian/411/2002 virus strain, we measured haemagglutination inhibiting (HI) antibodies in elderly subjects vaccinated with three inactivated vaccines against the(More)
The MF59 adjuvant has been included in a licensed influenza vaccine for a decade. Hence, we have a significant amount of clinical data to establish its potency and safety. We can now reassess our early preclinical studies and determine whether or not they were useful to predict human responses. The main lesson learned is that mouse models can be valuable,(More)
BACKGROUND Pathogenic avian influenza virus (H5N1) has the potential to cause a major global pandemic in humans. Safe and effective vaccines that induce immunologic memory and broad heterotypic response are needed. METHODS AND FINDINGS Healthy adults aged 18-60 and > 60 years (n = 313 and n = 173, respectively) were randomized (1:1) to receive two primary(More)
BACKGROUND The elderly are at a higher risk of morbidity and mortality associated with influenza infection than younger adults, but get less protection from conventional vaccination. OBJECTIVE We conducted a meta-analysis of all available data from clinical trials in the elderly on a recently introduced MF59-adjuvanted influenza vaccine to determine its(More)
In 1997, influenza A/Hong Kong/97 (H5N1) emerged as a potential human threat. In 1999, a randomised study comparing two doses of MF59-adjuvanted and non-adjuvanted influenza A/Duck/Singapore/97 (H5N3) surface-antigen vaccine found non-adjuvanted vaccine was poorly immunogenic. Addition of MF59 significantly boosted antibody to H5N1 to levels associated with(More)