A clinical, epidemiological and laboratory study on avoiding the risk of transmitting viral hepatitis during vaccinations with the Dermojet protected by an anticontaminant disposable device.
Jet injectors may transmit blood-borne infections, such as hepatitis B virus (HBV) and human immunodeficiency virus (HIV). To evaluate the safety of an anticontaminant disposable device which protects the jet injector apparatus, 22,714 healthy subjects were intradermally inoculated (38,162 inoculations) with a variety of vaccines. All the subjects were systematically followed-up clinically and epidemiologically for 6-18 months after inoculation; blood samples from 1619 subjects, before and 60-75 days after inoculation, were examined by enzyme-linked immunosorbent assay (ELISA) for HBV, hepatitis C virus (HCV) and HIV. Before vaccination 212 (13.09%) subjects were positive: 204 positive for HBV markers and eight for the HCV marker. None of the subjects were positive for the anti-HIV marker. During the clinico-epidemiological surveillance and the laboratory investigations mentioned above no clinical viral hepatitis B or C case and no seroconversion to positivity for HBV or HCV markers among the susceptible persons in the group were reported. Considering that in similar situations there is a theoretical risk of transmission as high as 1 per 388 to 1 per 3367 injections and that in our case 38,162 inoculations were performed in 22,714 subjects with the same Dermojet protected by the same type of anticontaminant disposable device, no contamination risk being reported, the conclusion can be reached that jet injectors can be safely used in the medical practice if they are protected by the sterile anticontaminant disposable device.
Dimache
G
G
Bacterial Vaccines Laboratory, Cantacuzino Institute, Bucharest, Romania.
Croitoru
M
M
Balteanu
M
M
Butur
D
D
Negut
A
A
Dimache
A
A
Paul
F
F
Barbu
A
A
Velea
L
L
Alexandrescu
V
V
Isacu
F
F
D000293:Adolescent; D000328:Adult; D004797:Enzyme-Linked Immunosorbent Assay; D004866:Equipment Contamination / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control / Q000635:transmission; D006509:Hepatitis B / Q000453:epidemiology* / Q000517:prevention & control / Q000635:transmission*; D006510:Hepatitis B Antibodies / Q000096:biosynthesis / Q000276:immunology; D006512:Hepatitis B Core Antigens / Q000097:blood / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000097:blood / Q000276:immunology; D006526:Hepatitis C / Q000453:epidemiology* / Q000517:prevention & control / Q000635:transmission*; D018937:Hepatitis C Antibodies / Q000097:blood / Q000276:immunology; D018936:Hepatitis C Antigens / Q000097:blood / Q000276:immunology; D006801:Humans; D007271:Injections, Intradermal; D007277:Injections, Jet / Q000009:adverse effects / Q000295:instrumentation; D008297:Male; D012307:Risk Factors; D012383:Romania; D014611:Vaccination / Q000009:adverse effects* / Q000191:economics; D014612:Vaccines / Q000008:administration & dosage
D006510:Hepatitis B Antibodies; D006512:Hepatitis B Core Antigens; D006514:Hepatitis B Surface Antigens; D018937:Hepatitis C Antibodies; D018936:Hepatitis C Antigens; D014612:Vaccines