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"Smallpox."
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Fighting smallpox
The highly contagious disease smallpox was a frightening scourge throughout history. Up to 1959, 50 million people each year became infected with the disease. Not only did it leave terrible scars on those that were lucky enough to survive but it weakened the body and left the afflicted vulnerable to yet more deadly complications. Readers will learn about the biology of the smallpox virus, historical figures who contracted it, and the massive vaccination campaign that eradicated smallpox in just 10 years, giving us hope that a similar approach may help eliminate other fatal diseases.
Book
Phase 3 Efficacy Trial of Modified Vaccinia Ankara as a Vaccine against Smallpox
A candidate vaccine against smallpox, modified vaccinia Ankara, was studied in 440 participants. MVA elicited immune responses similar to those associated with the established vaccinia-based vaccine and attenuated vaccinia replication in a human challenge model.
Journal Article
Safety, Immunogenicity, and Surrogate Markers of Clinical Efficacy for Modified Vaccinia Ankara as a Smallpox Vaccine in HIV-Infected Subjects
Background. Human immunodeficiency virus (HIV)—infected persons are at higher risk for serious complications associated with traditional smallpox vaccines. Alternative smallpox vaccines with an improved safety profile would address this unmet medical need. Methods. The safety and immunogenicity of modified vaccinia Ankara (MVA) was assessed in 91 HIV-infected adult subjects (CD4 + T-cell counts, ≥350 cells/mm 3 ) and 60 uninfected volunteers. The primary objectives were to evaluate the safety of MVA and immunogenicity in HIV-infected and uninfected subjects. As a measure of the potential efficacy of MVA, the ability to boost the memory response in people previously vaccinated against smallpox was evaluated by the inclusion of vaccinia-experienced HIV-infected and HIV-uninfected subjects. Results. MVA was well tolerated and immunogenic in all subjects. Antibody responses were comparable between uninfected and HIV-infected populations, with only 1 significantly lower total antibody titer at 2 weeks after the second vaccination, while no significant differences were observed for neutralizing antibodies. MVA rapidly boosted the antibody responses in vaccinia-experienced subjects, supporting the efficacy of MVA against variola. Conclusions. MVA is a promising candidate as a safer smallpox vaccine, even for immunocompromised individuals, a group for whom current smallpox vaccines have an unacceptable safety profile. Clinical Trials Registration. NCT00189904.
Journal Article
House on fire : the fight to eradicate smallpox
\"A story of courage and risk-taking, House on Fire tells how smallpox, a disease that killed, blinded, and scarred millions over centuries of human history, was completely eradicated in a spectacular triumph of medicine and public health. Part autobiography, part mystery, the story is told by a man who was one of the architects of a radical vaccination scheme that became a key strategy in ending the horrible disease when it was finally contained in India. In House on Fire, William H. Foege describes his own experiences in public health and details the remarkable program that involved people from countries around the world in pursuit of a single objective: eliminating smallpox forever. Rich with the details of everyday life, as well as a few adventures, House on Fire gives an intimate sense of what it is like to work on the ground in some of the world's most impoverished countries -- and tells what it is like to contribute to programs that really do change the world\"--Dust jacket.
Book
Smallpox in the Post-Eradication Era
Widespread vaccination programmes led to the global eradication of smallpox, which was certified by the World Health Organisation (WHO), and, since 1978, there has been no case of smallpox anywhere in the world. However, the viable variola virus (VARV), the causative agent of smallpox, is still kept in two maximum security laboratories in Russia and the USA. Despite the eradication of the disease smallpox, clandestine stocks of VARV may exist. In a rapidly changing world, the impact of an intentional VARV release in the human population would nowadays result in a public health emergency of global concern: vaccination programmes were abolished, the percentage of immunosuppressed individuals in the human population is higher, and an increased intercontinental air travel allows for the rapid viral spread of diseases around the world. The WHO has authorised the temporary retention of VARV to enable essential research for public health benefit to take place. This work aims to develop diagnostic tests, antiviral drugs, and safer vaccines. Advances in synthetic biology have made it possible to produce infectious poxvirus particles from chemicals in vitro so that it is now possible to reconstruct VARV. The status of smallpox in the post-eradication era is reviewed.
Journal Article
A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE
IMVAMUNE
® is a Modified Vaccinia Ankara (MVA)-based virus that is being developed as a safer 3rd generation smallpox vaccine. In order to determine the optimal dose for further development, a double-blind, randomized Phase II trial was performed testing three different doses of IMVAMUNE
® in 164 healthy volunteers. All three IMVAMUNE
® doses displayed a favourable safety profile, with local reactions as the most frequent observation. The 1
×
10
8
TCID
50 IMVAMUNE
® dose induced a total antibody response in 94% of the subjects following the first vaccination and the highest peak seroconversion rates by ELISA (100%) and PRNT (71%). This IMVAMUNE
® dose was considered to be optimal for the further clinical development of this highly attenuated poxvirus as a safer smallpox vaccine.
Journal Article
Comparison of lyophilized versus liquid modified vaccinia Ankara (MVA) formulations and subcutaneous versus intradermal routes of administration in healthy vaccinia-naïve subjects
•Lyophilized MVA was more immunogenic than the current liquid formulation of MVA.•The lower ID dose of MVA was immunologically non-inferior to the standard SC dose.•The ID route resulted in more erythema and/or induration than the SC route.•The ID route may increase the number of available doses in an emergency situation.
Modified vaccinia Ankara (MVA) is being developed as a safer smallpox vaccine and is being placed in the US Strategic National Stockpile (SNS) as a liquid formulation for subcutaneous (SC) administration at a dose of 1×108 TCID50 in a volume of 0.5mL. This study compared the safety and immunogenicity of the standard formulation, dose and route with both a more stable, lyophilized formulation and with an antigen-sparing intradermal (ID) route of administration.
524 subjects were randomized to receive either a full dose of Lyophilized-SC, a full dose of Liquid-SC or 20% (2×107 TCID50 in 0.1mL) of a full dose Liquid-ID MVA on Days 0 and 28. Safety and immunogenicity were followed through 180 days post second vaccination.
Among the 3 groups, the proportion of subjects with moderate/severe functional local reactions was significantly different (P=0.0013) between the Lyophilized-SC group (30.3%), the Liquid-SC group (13.8%) and Liquid-ID group (22.0%) only after first vaccination; and for moderate/severe measured erythema and/or induration after any vaccination (P=0.0001) between the Lyophilized-SC group (58.2%), the Liquid-SC group (58.1%) and the Liquid-ID group (94.8%) and the reactions lasted longer in the Liquid-ID group. In the ID Group, 36.1% of subjects had mild injection site skin discoloration lasting ≥6 months.
After second vaccination Day (42–208), geometric mean of peak neutralization titers were 87.8, 49.5 and 59.5 for the Lyophilized-SC, Liquid-SC and Liquid-ID groups, respectively, and the maximum number of responders based on peak titer in each group was 142/145 (97.9%), 142/149 (95.3%) and 138/146 (94.5%), respectively. At 180 days after the second vaccination, geometric mean neutralization titers declined to 11.7, 10.2 and 10.4 with only 54.3%, 39.2% and 35.2% of subjects remaining seropositive for the Lyophilized-SC, Liquid-SC and Liquid-ID groups, respectively. Both the Lyophilized-SC and Liquid-ID groups were considered non-inferior (primary objective) to the Liquid-SC group.
Transitioning to a lyophilized formulation, which has a longer shelf life, will not negatively impact immunogenicity. In a situation where insufficient vaccine is available, ID vaccination could be used, increasing the number of available doses of vaccine in the SNS 5-fold (i.e., from 20 million to 100 million doses).
Journal Article