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The Cochrane Database of Systematic... Apr 2009Anthrax is a bacterial zoonosis that occasionally causes human disease and is potentially fatal. Anthrax vaccines include a live-attenuated vaccine, an alum-precipitated... (Review)
Review
BACKGROUND
Anthrax is a bacterial zoonosis that occasionally causes human disease and is potentially fatal. Anthrax vaccines include a live-attenuated vaccine, an alum-precipitated cell-free filtrate vaccine, and a recombinant protein vaccine.
OBJECTIVES
To evaluate the effectiveness, immunogenicity, and safety of vaccines for preventing anthrax.
SEARCH STRATEGY
We searched the following databases (November 2008): Cochrane Infectious Diseases Group Specialized Register; CENTRAL (The Cochrane Library 2008, Issue 4); MEDLINE; EMBASE; LILACS; and mRCT. We also searched reference lists.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) of individuals and cluster-RCTs comparing anthrax vaccine with placebo, other (non-anthrax) vaccines, or no intervention; or comparing administration routes or treatment regimens of anthrax vaccine.
DATA COLLECTION AND ANALYSIS
Two authors independently considered trial eligibility, assessed risk of bias, and extracted data. We presented cases of anthrax and seroconversion rates using risk ratios (RR) and 95% confidence intervals (CI). We summarized immunoglobulin G (IgG) concentrations using geometric means. We carried out a sensitivity analysis to investigate the effect of clustering on the results from one cluster-RCT. No meta-analysis was undertaken.
MAIN RESULTS
One cluster-RCT (with 157,259 participants) and four RCTs of individuals (1917 participants) met the inclusion criteria. The cluster-RCT from the former USSR showed that, compared with no vaccine, a live-attenuated vaccine (called STI) protected against clinical anthrax whether given by a needleless device (RR 0.16; 102,737 participants, 154 clusters) or the scarification method (RR 0.25; 104,496 participants, 151 clusters). Confidence intervals were statistically significant in unadjusted calculations, but when a small amount of association within clusters was assumed, the differences were not statistically significant. The four RCTs (of individuals) of inactivated vaccines (anthrax vaccine absorbed and recombinant protective antigen) showed a dose response relationship for the anti-protective antigen IgG antibody titre. Intramuscular administration was associated with fewer injection site reactions than subcutaneous injection, and injection site reaction rates were lower when the dosage interval was longer.
AUTHORS' CONCLUSIONS
One cluster-RCT provides limited evidence that a live-attenuated vaccine is effective in preventing cutaneous anthrax. Vaccines based on anthrax antigens are immunogenic in most vaccinees with few adverse events or reactions. Ongoing randomized controlled trials are investigating the immunogenicity and safety of anthrax vaccines.
Topics: Anthrax; Anthrax Vaccines; Humans; Randomized Controlled Trials as Topic; Vaccines, Attenuated
PubMed: 19370633
DOI: 10.1002/14651858.CD006403.pub2 -
The Cochrane Database of Systematic... Jul 2007Anthrax is a potentially fatal bacterial disease with cutaneous, inhalation, and gastrointestinal forms. Three anthrax vaccines are commercially available, but their... (Review)
Review
BACKGROUND
Anthrax is a potentially fatal bacterial disease with cutaneous, inhalation, and gastrointestinal forms. Three anthrax vaccines are commercially available, but their comparative effectiveness and safety is not clear.
OBJECTIVES
To assess the effectiveness and safety of vaccines against human anthrax in relation to adverse effects and disease incidence.
SEARCH STRATEGY
We searched the Cochrane Infectious Diseases Group Specialized Register (March 2004), CENTRAL (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to September 2005), EMBASE (1988 to September 2005), Science Citation Index (1981 to September 2005), the U.S. National Institutes of Health (NIH; September 2005), and the reference lists of articles. We contacted the UK Ministry of Defence, US Department of Defense, and individual researchers in the field.
SELECTION CRITERIA
Prospective randomized, quasi-randomized, and cluster randomized controlled trials comparing anthrax vaccines with placebo, other (non-anthrax) vaccines, or no intervention.
DATA COLLECTION AND ANALYSIS
Six reviewers independently assessed trial methodological quality and extracted data. Adverse effects data was collected from the trials.
MAIN RESULTS
Two trials involving 16,052 people met the inclusion criteria. Both trials had methodological limitations. Compared to placebo, vaccination was associated with a reduced risk of contracting anthrax (Relative Risk 0.16; 95% confidence interval 0.07 to 0.35). In the one trial reporting adverse effects, the killed vaccine was associated with a higher incidence of adverse effects compared to the placebo (Peto odds ratio 5.15; 95% confidence interval 2.28 to 11.61). Just over 5% of participants in the vaccine group reported adverse effects. The effectiveness of the vaccine does not appear to be influenced by the route of inoculation (scarifaction compared to needless injection - odds ratio 1.61; 95% confidence interval 0.39 to 6.75).
AUTHORS' CONCLUSIONS
Killed anthrax vaccines appear to be effective in reducing the risk of contracting anthrax with low rate of adverse effects. Further research should be carried out on the short and long term safety effects of available vaccines and if possible their effectiveness.
Topics: Adult; Anthrax; Humans; Vaccines
PubMed: 17636647
DOI: 10.1002/14651858.CD000975.pub2 -
Annali Di Igiene : Medicina Preventiva... 2020It is essential to make sure that vaccines are safe, effective, and of good quality. In the past years, there have been some reports of adverse effects regarding...
AIMS AND BACKGROUND
It is essential to make sure that vaccines are safe, effective, and of good quality. In the past years, there have been some reports of adverse effects regarding vaccination. One of these adverse effects is the development of Stevens-Johnson syndrome. Stevens-Johnson syndrome is a rare, severe, skin disorder, that usually occurs after medication. In Europe, its estimated incidence is of 2-3 cases/million population/year. Therefore, the aim of this study was to investigate, through a systematic review, the association between vaccination and the development of Stevens-Johnson syndrome.
MATERIALS AND METHODS
We performed a systematic review using PubMed, Scopus and Web of Science databases. We included studies dated between January 2000 and February 2018. The main selection criterion was the reporting of the disease, following vaccination.
RESULTS
Ten studies were selected, from a total of 391 studies. Of these, 5 were case reports, 3 were cohort studies and 2 were case-control. All the studies were regarding cases of Stevens-Johnson syndrome after vaccination. The selected studies reported cases following vaccines such as influenza vaccine, smallpox, anthrax and tetanus vaccine, MMR vaccine, varicella vaccine, DTaP-IPV vaccine or rabies vaccine. None of the cohort studies reported statistically significant associations between vaccination and the syndrome. In the case-control studies, it was not observed significant increased risk for the Stevens-Johnson syndrome following the administration of vaccines. Regarding the case reports, there was not sufficient evidence to form a positive association between these two factors, and more studies are needed.
CONCLUSIONS
In this review it was not possible to establish a positive relation between vaccination and the development of Stevens-Johnson syndrome.
Topics: Anthrax Vaccines; Case-Control Studies; Cohort Studies; Humans; Stevens-Johnson Syndrome; Vaccination; Viral Vaccines
PubMed: 31713580
DOI: 10.7416/ai.2020.2333