Report of the 4th meeting on the “Evaluation of pandemic influenza prototype vaccines in clinical trials.” World Health Organization, Geneva, Switzerland, 14–15 February 2008

University Paris-Diderot, Lyon, France.
Vaccine (Impact Factor: 3.62). 06/2008; 26(39):4975-7. DOI: 10.1016/j.vaccine.2008.04.050
Source: PubMed
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    ABSTRACT: The timely development of safe and effective vaccines is likely to be the single most important public-health tool for decreasing the morbidity, mortality and economic effects of the influenza pandemic. The objective of this article is to provide a detailed description of the chemistry and immunogenicity of one of the better studied inactivated whole-virion aluminum phosphate-adjuvanted vaccines, Fluval (Omninvest, Hungary), while we discuss safety data of all clinical trials published on H5N1 vaccines to date. Fluval was chosen for detailed discussion owing to its immunogenicity after only one dose, the fact that it was one of the very first H5N1 vaccines that demonstrated the potential for dose sparing and, unlike all mainstream oil-in-water adjuvanted reverse genetics-derived H5N1 vaccines, it is whole virion based.
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    ABSTRACT: Dose-sparing strategies and new production technologies will be necessary to produce adequate supplies of vaccines for pandemic influenza. One approach is to include adjuvant, which can reduce the amount of antigen required for immunization and stimulate cross-reactive responses to drifted variants of novel viruses. Dose-sparing studies of adjuvant, itself a finite resource, have not previously been reported for H5N1 vaccine development. A total of 753 healthy 18-40-year-old adults were randomized to one of 12 groups (N approximately 60/group) to receive two intramuscular doses, 21 days apart, of 3.75, 7.5 or 15 microg of cell culture grown influenza A/H5N1 hemagglutinin (A/Indonesia/5/2005 (H5N1)/PR-8-IBCDC-RG2), each dose level formulated with 0%, 25%, 50% or 100% of the MF59 dose contained in licensed influenza vaccine. 752 subjects actually received one dose, and 695 a second dose. Serum hemagglutination inhibition and neutralizing antibody levels, were determined before and 21 days after each dose. Safety and reactogenicity were assessed by self-completed diary cards. Nonadjuvanted H5N1 formulations were poorly immunogenic, but antibody responses were significantly enhanced by all doses of MF59 for each antigen level. The 3.75 microg H5N1 containing 50% MF59 satisfied the European criteria for pandemic vaccine licensure. All formulations were well tolerated, although MF59 dose-dependent increases in the frequency of injection site pain were observed. The frequencies of injection site and systemic reactions were lower after receipt of the second dose of vaccine. No vaccine-related SAE was reported. Dose-sparing of both antigen and adjuvant is possible without compromising immunogenicity, while improving reactogenicity and is a promising strategy that will expand the availability of vaccines for global control of pandemic influenza.
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    ABSTRACT: Recent years' enzootic spread of highly pathogenic H5N1 virus among poultry and the many lethal zoonoses in its wake has stimulated basic and applied pandemic vaccine research. The quest for an efficacious, affordable and timely accessible pandemic vaccine has been high on the agenda. When a variant H1N1 strain of swine origin emerged as a pandemic virus, it surprised many, as this subtype is well-known to man as a seasonal virus. This review will cover some difficult vaccine questions, such as the immunological challenges, the new production platforms, and the limited supply and global equity issues.
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