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: Influenza vaccines are potentially the most efficacious means of mitigating the impact of influenza pandemic and might contribute to the rapid containment of an emerging pandemic virus. On the 12-13 February 2009, the Initiative For Vaccine Research (IVR) of the World Health Organisation convened the 5th meeting on the 'Evaluation of pandemic influenza prototype vaccines in clinical trials' in Geneva. This was a follow-up meeting to the 4th meeting held on 14-15 February 2008 [Girard M, Palkonyay L, Kieny MP. Report of the 4th meeting on the evaluation of pandemic influenza prototype vaccines in clinical trials. Vaccine 2008;26:4975-7], and presentations were made by representatives from industry, academia, and governmental organisations. This year's meeting aimed to update the progress made during the past year on H5N1 and other prototype pandemic vaccines that have undergone clinical trials. A number of vaccine types were covered, including classical egg-derived inactivated vaccines, cell-derived inactivated vaccines, live-attenuated vaccines (LAIV) and vaccines developed using new technologies. The effects of different adjuvants and prime-boosting schedules were important topics, and further data were presented to show that children mount vigorous antibody responses to several H5N1 vaccines. Other subjects presented and discussed were standardisation, and regulatory issues concerning pandemic vaccines.
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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.
    Vaccine 10/2009; 28(3):840-8. DOI:10.1016/j.vaccine.2009.10.019 · 3.62 Impact Factor
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