A simplified 4-site economical intradermal post-exposure rabies vaccine regimen: a randomised controlled comparison with standard methods
| Autor: | Ly-Mee Yu, Andrew J. Pollard, Laurent Audry, Sharon M. Brookes, David A. Warrell, François-Xavier Meslin, Judith Phipps, Linda Diggle, Richard Moxon, Anthony R. Fooks, Hervé Bourhy, Jonathan J Deeks, Mary J. Warrell, Anna Riddell |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
medicine.medical_treatment 0302 clinical medicine Rabies vaccine 030212 general & internal medicine Virology/Vaccines Confusion Viral Vaccine lcsh:Public aspects of medicine Standard methods Middle Aged 3. Good health Vaccinology Infectious Diseases Female medicine.symptom medicine.drug Research Article Infectious Diseases/Tropical and Travel-Associated Diseases Adult medicine.medical_specialty Post exposure lcsh:Arctic medicine. Tropical medicine Adolescent Injections Intradermal lcsh:RC955-962 Rabies Immunology 030231 tropical medicine Public Health and Epidemiology/Immunization 03 medical and health sciences Young Adult Infectious Diseases/Viral Infections medicine Humans Post-exposure prophylaxis Intensive care medicine Neurological Disorders/Infectious Diseases of the Nervous System Infectious Diseases/Infectious Diseases of the Nervous System business.industry Public Health Environmental and Occupational Health lcsh:RA1-1270 medicine.disease Regimen Infectious Diseases/Neglected Tropical Diseases Rabies Vaccines Public Health and Epidemiology/Preventive Medicine business |
| Zdroj: | PLoS Neglected Tropical Diseases PLoS Neglected Tropical Diseases, Vol 2, Iss 4, p e224 (2008) |
| Popis: | Background The need for economical rabies post-exposure prophylaxis (PEP) is increasing in developing countries. Implementation of the two currently approved economical intradermal (ID) vaccine regimens is restricted due to confusion over different vaccines, regimens and dosages, lack of confidence in intradermal technique, and pharmaceutical regulations. We therefore compared a simplified 4-site economical PEP regimen with standard methods. Methods Two hundred and fifty-four volunteers were randomly allocated to a single blind controlled trial. Each received purified vero cell rabies vaccine by one of four PEP regimens: the currently accepted 2-site ID; the 8-site regimen using 0.05 ml per ID site; a new 4-site ID regimen (on day 0, approximately 0.1 ml at 4 ID sites, using the whole 0.5 ml ampoule of vaccine; on day 7, 0.1 ml ID at 2 sites and at one site on days 28 and 90); or the standard 5-dose intramuscular regimen. All ID regimens required the same total amount of vaccine, 60% less than the intramuscular method. Neutralising antibody responses were measured five times over a year in 229 people, for whom complete data were available. Findings All ID regimens showed similar immunogenicity. The intramuscular regimen gave the lowest geometric mean antibody titres. Using the rapid fluorescent focus inhibition test, some sera had unexpectedly high antibody levels that were not attributable to previous vaccination. The results were confirmed using the fluorescent antibody virus neutralisation method. Conclusions This 4-site PEP regimen proved as immunogenic as current regimens, and has the advantages of requiring fewer clinic visits, being more practicable, and having a wider margin of safety, especially in inexperienced hands, than the 2-site regimen. It is more convenient than the 8-site method, and can be used economically with vaccines formulated in 1.0 or 0.5 ml ampoules. The 4-site regimen now meets all requirements of immunogenicity for PEP and can be introduced without further studies. Trial Registration Controlled-Trials.com ISRCTN 30087513 Author Summary All human deaths from rabies result from failure to give adequate prophylaxis. After a rabid animal bite, immediate wound cleaning, rabies vaccine and immunoglobulin injections effectively prevent fatal infection. Immunoglobulin is very rarely available in developing countries, where prevention relies on efficacious vaccine. WHO approved vaccines are prohibitively expensive, but 2 economical regimens (injecting small amounts of vaccine intradermally, into the skin, at 2 or 8 sites on the first day of the course) have been used for many years in a few places. Practical or perceived difficulties have restricted widespread uptake of economical methods. These could largely be overcome by introducing a new, simpler regimen, involving 4 site injections on the first day. We vaccinated volunteers to compare the antibody levels induced by the 4-site intradermal regimen with those induced by the current 2-site and 8-site regimens and the “gold standard” intramuscular regimen favoured internationally. All the economical intradermal regimens were at least as immunogenic as the intramuscular method. The results provide sufficient evidence that the 4-site regimen meets the criteria necessary for its recommendation for use wherever the cost of vaccine is prohibitive and especially where 2 or more patients are treated on the same day. |
| Databáze: | OpenAIRE |
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