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1.
Trauma Surg Acute Care Open ; 4(1): e000376, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31673635

RESUMO

This is a joint statement from the American College of Surgeons Committee on Trauma, the American College of Emergency Physicians, the National Association of Emergency Medical Services Physicians and the National Association of Emergency Medical Technicians regarding the clinical use of resuscitative endovascular balloon occlusion of the aorta (REBOA) in civilian trauma systems in the USA. This statement addresses the system of care needed to manage trauma patients requiring the use of REBOA, in light of the current evidence available in this patient population. This statement was developed by an expert panel following a comprehensive review of the literature with representation from all sponsoring organizations and the US Military. This is an update to the previous statement published in 2018. It has been formally endorsed by the four sponsoring organizations.

2.
J Comp Pathol ; 142 Suppl 1: S96-101, 2010 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-19962714

RESUMO

The persistence of protection induced by vaccines is a key aspect of the implementation of human vaccination policies, particularly for ageing populations. At the time of initial licensure, the duration of protection induced by a vaccine is generally only documented by longitudinal follow up of cohorts of subjects enrolled in the pre-licensure trials over a period of 1-5 years. The follow up of these cohorts provides two types of data: antibody kinetics (or another clinically relevant immunological parameter) over time and the disease incidence. Generally, the latter trials, if implemented during the pre-licensure period, are designed to follow-up cohorts in order to demonstrate vaccine efficacy above the minimal level required for the license. For vaccines already licensed, additional tools exist. The use of immunological surrogate markers of protection is a practical way to monitor the duration of protection. Measuring the persistence of circulating antibodies is widely used in human vaccines. For several vaccines, observed data have allowed the creation of mathematical models to predict the antibody persistence over periods of time longer than those effectively documented. Clinical trials assessing the capacity of the immune system to mount a quick anamnestic response upon re-stimulation a long time after initial priming (measurement of immune memory) is also a tool employed to document the duration of protection. The waning of protection can also be demonstrated by an increase of disease incidence in the subsequent 'time-to-last-vaccine administration' age segments. Seroprevalence studies in a given age group of people that were vaccinated under real-life conditions are another way to document the persistence of protection. Finally, case-control studies in outbreak situations or in situations of persisting endemicity can also be used to document the persistence of the vaccine efficacy. All of these tools are used in the development of new vaccines, and also during their use in the field, in order to develop the best (re)vaccination policies.


Assuntos
Memória Imunológica/imunologia , Vacinas/imunologia , Ensaios Clínicos como Assunto , Humanos , Fatores de Tempo , Vacinação
3.
J Comp Pathol ; 137 Suppl 1: S62-6, 2007 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-17560593

RESUMO

Vaccine interference may be intra- or inter-vaccine in nature. Intra-vaccine interference is determined by the nature and dose of the individual vaccine valences, the nature and quality of any additives and the pharmaceutical formulation of the product. Additionally, vaccinee factors including the presence of pre-existing immunity, the stage of immunological maturation, genetic and environmental background may also determine interference. The vaccine schedule and mode of delivery are further contributory factors. In practice, the phenomenon of vaccine interference argues that individual vaccines should not be combined or associated in the absence of specific data sheet recommendations to do so.


Assuntos
Interações Medicamentosas/imunologia , Vacinas/efeitos adversos , Pré-Escolar , Relação Dose-Resposta a Droga , Relação Dose-Resposta Imunológica , Sistemas de Liberação de Medicamentos , Humanos , Lactente , Recém-Nascido , Vacinas/administração & dosagem , Vacinas/imunologia
4.
J Comp Pathol ; 137 Suppl 1: S42-5, 2007 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-17555761

RESUMO

Infection by hepatitis A virus (HAV) is a significant cause of childhood disease but effective vaccines are available. Naturally acquired anti-HAV antibodies ensure transfer of protective immunity which persists for up to 6 months in the newborn. Such maternal anti-HAV antibodies are able to inhibit the antibody responses in infants vaccinated with inactivated hepatitis A vaccines, although no clinically significant consequences of this are observed. By increasing the number of doses, for example by using a three dose primary vaccination schedule, and by increasing the amount of vaccinal antigen, this interfering effect may be partially overcome.


Assuntos
Vacinas contra Hepatite A/administração & dosagem , Hepatite A/prevenção & controle , Imunidade Materno-Adquirida/imunologia , Recém-Nascido/imunologia , Anticorpos Antivirais/metabolismo , Formação de Anticorpos/imunologia , Formação de Anticorpos/fisiologia , Hepatite A/imunologia , Vacinas contra Hepatite A/imunologia , Vírus da Hepatite A/imunologia , Humanos , Esquemas de Imunização , Lactente , Vacinação/métodos
5.
J Hazard Mater ; 135(1-3): 311-8, 2006 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-16442223

RESUMO

In this study, the hydrometallurgical processing of electric arc furnace (EAF) steelmaking dust is investigated on a laboratory scale under normal temperature and pressure conditions. The behaviour of zinc and iron under the influence of sulphuric acid as the leaching agent is discussed. The dependence between the temperature and acid concentration is investigated. The main aim is the transfer of zinc into the solution while iron ought to remain as a solid residue. The hydrometallurgical recovery of zinc from EAF dust is feasible with relatively high recovery yield, while iron mostly remains in the solid phase. It results from the use of sulphuric acid in low concentration. This way, it is possible to set up the conditions for the EAF dust leaching, adjusting sulphuric acid concentration in order to achieve an optimum zinc yield to the solution without iron dissolution. However, the problem is that the chemical and mineralogical composition of each steelmaking dust is individual.


Assuntos
Carbono/química , Poeira , Eletricidade , Metalurgia/métodos , Aço/química , Concentração de Íons de Hidrogênio , Resíduos Industriais , Ferro/química , Tamanho da Partícula , Soluções , Ácidos Sulfônicos/química , Temperatura , Água/química , Difração de Raios X , Zinco/química
6.
Eur J Clin Microbiol Infect Dis ; 23(4): 300-9, 2004 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-15007703

RESUMO

Inactivated hepatitis A vaccines were developed in the 1980s and were introduced during the early 1990s. The Aventis Pasteur (AvP) inactivated hepatitis A virus antigen is used in several different vaccine formulations licensed for adults and children. Presented here are the immunogenicity results compiled from 37 clinical trials performed in 20 different countries between 1991 and 2001 in which these vaccines were administered to adults (16 years of age and over), children (aged 12 months-17 years), and infants (younger than 12 months). The accumulated clinical experience with these hepatitis A virus-containing vaccines demonstrates the excellent immunogenicity of this antigen in a wide range of situations. As with other licensed inactivated hepatitis A vaccines, immunological priming is achieved in virtually all vaccinees after a single-dose primary immunization, and it may be reinforced by a booster vaccination administered 6-36 months after the primary vaccination.


Assuntos
Anticorpos Anti-Hepatite A/imunologia , Vacinas contra Hepatite A/administração & dosagem , Hepatite A/imunologia , Hepatite A/prevenção & controle , Adolescente , Adulto , Criança , Pré-Escolar , Ensaios Clínicos como Assunto , Ensaio de Imunoadsorção Enzimática , Feminino , Anticorpos Anti-Hepatite A/análise , Humanos , Imunidade/fisiologia , Esquemas de Imunização , Lactente , Masculino , Estudos Multicêntricos como Assunto , Fatores de Risco , Sensibilidade e Especificidade , Vacinas de Produtos Inativados/administração & dosagem
7.
Infect Immun ; 69(8): 4759-66, 2001 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-11447148

RESUMO

Despite increasing knowledge on the biology of Helicobacter pylori, little is known about the expression pattern of its genome during infection. While mouse models of infection have been widely used for the screening of protective antigens, the reliability of the mouse model for gene expression analysis has not been assessed. In an attempt to address this question, we have developed a quantitative reverse transcriptase PCR (RT-PCR) that allowed the detection of minute amounts of mRNA within the gastric mucosa. The expression of four genes, 16S rRNA, ureA (encoding urease A subunit), katA (catalase), and alpA (an adhesin), was monitored during the course of a 6-month infection of mice and in biopsy samples from of 15 infected humans. We found that the selected genes were all expressed within both mouse and human infected mucosae. Moreover, the relative abundance of transcripts was the same (16S rRNA > ureA > katA > alpA), in the two models. Finally, results obtained with the mouse model suggest a negative effect of bacterial burden on the number of transcripts of each gene expressed per CFU (P < 0.05 for 16S rRNA, alpA, and katA). Overall, this study demonstrates that real-time RT-PCR is a powerful tool for the detection and quantification of H. pylori gene expression within the gastric mucosa and strongly indicates that mice experimentally infected with H. pylori provide a valuable model for the analysis of bacterial gene expression during infection.


Assuntos
Proteínas de Escherichia coli , Mucosa Gástrica/microbiologia , Expressão Gênica , Genes Bacterianos , Infecções por Helicobacter/microbiologia , Helicobacter pylori/genética , Animais , Proteínas de Bactérias/genética , Catalase/genética , Feminino , Mucosa Gástrica/patologia , Perfilação da Expressão Gênica , Infecções por Helicobacter/patologia , Humanos , Camundongos , RNA Ribossômico 16S , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Estômago/patologia , Fatores de Tempo , Fatores de Transcrição/genética , Transcrição Gênica
8.
Curr Med Res Opin ; 17(3): 197-209, 2001.
Artigo em Inglês | MEDLINE | ID: mdl-11900313

RESUMO

Immunogenicity data obtained after primary series immunisations against Haemophilus influenzae type b (Hib), using a vaccine prepared by conjugating the capsular polysaccharide of Hib to tetanus toxoid (ActHIB), were compiled from 146 study groups comprising 85 clinical trials or vaccination programs conducted between 1987 and 1999. ActHIB was administered as a monovalent lyophilised vaccine, injected either in association with another paediatric vaccine (at separate administration sites) or in combination (where the different vaccines are mixed together in the same syringe before injection). Review of these data reveals two trends. First, PRP-T vaccine, given either alone or in combination with DTwcP, resulted in a stronger anti-PRP serum antibody response than when PRP-T was combined with DTacP vaccine. Second, an accelerated (i.e. one-month interval) immunisation schedule tended to induce a poorer anti-PRP antibody response than did the more widely spaced, standard inoculation schedules. Although an in-depth analysis of these over 11000 study subjects on an individual basis with multivariate analysis or multifactorial statistical methods might eventually provide working hypotheses to fully understand these phenomenon, the various licensed, PRP-T-containing paediatric combination vaccines have proved to be clinically effective.


Assuntos
Vacinas Anti-Haemophilus/administração & dosagem , Esquemas de Imunização , Anticorpos Antibacterianos/sangue , Bordetella pertussis/imunologia , Ensaios Clínicos como Assunto , Toxoide Diftérico/administração & dosagem , Toxoide Diftérico/imunologia , Vacinas Anti-Haemophilus/imunologia , Haemophilus influenzae/imunologia , Humanos , Toxoide Tetânico/administração & dosagem , Toxoide Tetânico/imunologia , Vacinas Combinadas , Vacinas Conjugadas
9.
Pediatr Infect Dis J ; 19(8): 710-7, 2000 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-10959738

RESUMO

BACKGROUND: We compared the antibody response to Haemophilus influenzae type b capsular polysaccharide (PRP) after three doses of a diphtheria toxoid, tetanus toxoid and acellular pertussis vaccine (DTaP) combined with a PRP-tetanus conjugate (PRP-T) in infants randomized to receive oral polio vaccine (OPV) or inactivated polio vaccine (IPV). The polio vaccine was given separately at the same visit. METHODS: Three hundred fifty-six infants from pediatric practices in suburban Chicago and New Orleans were randomized into two groups. Group A received OPV at 2 and 4 months of age; Group B received IPV at 2 and 4 months of age. Both groups received DTaP/PRP-T at 2, 4 and 6 months of age and hepatitis B vaccine at 2 and 4 months of age. A serum sample was obtained before immunization (age 2 months) and 1 month after 3 doses of DTaP/PRP-T (age 7 months). Sera were assayed for antibody responses to all relevant vaccine antigens. RESULTS: No significant vaccine antigen interference was found when polio immunization was provided by IPV or OPV for anti-PRP, diphtheria, tetanus or pertussis antibodies. OPV recipients had a significantly higher mean antibody response to serotype 1 (P = 0.03) and 2 (P = 0.0001) poliovirus. CONCLUSION: Whether polio immunization was accomplished with IPV or OPV did not significantly influence the antibody responses in sera obtained at 7 months of age for anti-PRP, anti-diphtheria and anti-tetanus toxoid antibodies and antibodies to pertussis antigens, when DTaP/PRP-T was given in the primary series.


Assuntos
Anticorpos Antibacterianos/imunologia , Anticorpos Antivirais/imunologia , Vacinas contra Difteria, Tétano e Coqueluche Acelular/administração & dosagem , Vacinas Anti-Haemophilus/administração & dosagem , Imunidade/fisiologia , Vacina Antipólio de Vírus Inativado/administração & dosagem , Vacina Antipólio Oral/administração & dosagem , Anticorpos Antibacterianos/análise , Anticorpos Antivirais/análise , Difteria/imunologia , Difteria/prevenção & controle , Feminino , Seguimentos , Humanos , Esquemas de Imunização , Lactente , Injeções Intramusculares , Masculino , Poliomielite/imunologia , Poliomielite/prevenção & controle , Tétano/imunologia , Tétano/prevenção & controle , Vacinas Combinadas/administração & dosagem , Coqueluche/imunologia , Coqueluche/prevenção & controle
10.
Pediatr Infect Dis J ; 19(12): 1119-27, 2000 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-11144370

RESUMO

OBJECTIVE: The immunogenicity and safety of a new liquid hexavalent vaccine (diphtheria-tetanus-acellular pertussis-inactivated polio vaccine-hepatitis B-polyribosyl ribitol phosphate conjugated to tetanus protein; Hexavac; Aventis Pasteur MSD, Lyon, France) are compared with those of reference vaccines [diphtheria-tetanus-acellular pertussis-inactivated polio vaccine reconstituting lyophilized purified Haemophilus influenzae polysaccharide conjugated to tetanus protein vaccine (Pentavac; Aventis Pasteur MSD) and hepatitis B vaccine (H-B-Vax II; Aventis Pasteur MSD)] injected separately at the same visit in a prospective multicenter, comparative, open label trial. METHODS: Infants were randomized to receive Hexavac (n = 423) or Pentavac and H-B-Vax II (n = 425) as a primary immunization series at 2, 4 and 6 months of age. Seroprotection and seroconversion rates against all antigens at 1 month after the primary series were compared between the two vaccine groups with 95% confidence intervals (CI0.95) and were considered clinically equivalent (not inferior) when the upper limit of the 95% confidence interval on the difference (reference, hexavalent) was below predefined differences. RESULTS: Hexavac met and surpassed the pre-defined criteria for clinical equivalence to Pentavac and H-B-Vax II given concomitantly. It elicited similar seroprotection and seroconversion rates against all antigens. Seroprotection and seroconversion rates obtained 1 month after the third dose of Hexavac were >90% for all antigens. The postimmunization antibody geometric mean titers (GMT) for hepatitis B and purified Haemophilus influenzae polysaccharide were about 2-fold higher in infants who received the reference vaccines than in infants who had received Hexavac. GMTs for poliovirus antibodies tended to be enhanced in infants vaccinated with Hexavac. GMTs for all other antigens were very similar among both groups. Hexavac was generally well-tolerated. At least one local reaction was reported in 20.3% of Hexavac injections compared with 15.8% at the Pentavac injections site and 3.8% at the H-B-Vax II injections site. These reactions were generally mild and transient. At least one systemic adverse event was reported in 45.7% of Hexavac injections compared with 42.2% of Pentavac and H-B-Vax II injections (mild fever, irritability and drowsiness were most frequently reported). The frequency of adverse events was not significantly different between groups. No vaccine-related serious adverse event occurred during the study. CONCLUSION: This liquid hexavalent vaccine was generally well-tolerated and provided immune responses adequate to be protective against six infectious diseases with a single injection, given at 2, 4 and 6 months of age.


Assuntos
Anticorpos Antibacterianos/sangue , Anticorpos Antivirais/sangue , Vacinas Combinadas/efeitos adversos , Vacinas Combinadas/imunologia , Vacina contra Difteria, Tétano e Coqueluche , Vacinas contra Difteria, Tétano e Coqueluche Acelular/administração & dosagem , Vacinas contra Difteria, Tétano e Coqueluche Acelular/efeitos adversos , Vacinas contra Difteria, Tétano e Coqueluche Acelular/imunologia , Feminino , Vacinas Anti-Haemophilus/administração & dosagem , Vacinas Anti-Haemophilus/efeitos adversos , Vacinas Anti-Haemophilus/imunologia , Vacinas contra Hepatite B/administração & dosagem , Vacinas contra Hepatite B/efeitos adversos , Vacinas contra Hepatite B/imunologia , Humanos , Esquemas de Imunização , Lactente , Masculino , Vacina Antipólio de Vírus Inativado/administração & dosagem , Vacina Antipólio de Vírus Inativado/efeitos adversos , Vacina Antipólio de Vírus Inativado/imunologia , Estudos Prospectivos , Vacinas Combinadas/administração & dosagem
11.
J Med Virol ; 60(1): 1-7, 2000 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-10568755

RESUMO

Very few studies with inactivated hepatitis A vaccines were designed for long-term follow-up of antibody persistence. Based on the serological data from these vaccine trials, mathematical models were developed to predict the decrease of anti-hepatitis A virus (anti-HAV) antibodies after vaccination. This study was designed to compare Avaxim (0-6 months) to Havrix 720 (0-1-6 months). In this paper, both groups of vaccinees are described considering the age, gender, and weight of the subjects at enrollment. For mathematical modelling, two different approaches were used: one starting the calculations from the geometric mean titres (GMTs) at each point in time, the other basing the calculations on individual anti-HAV titres. Both vaccines are very immunogenic, although Avaxim shows a higher GMT at each point in time. When these data are used in mathematical models to predict the persistence of anti-HAV antibodies, both vaccines (Avaxim and Havrix 720) show similar long-term antibody kinetics. Antibody levels > or = 20 mIU/ml are estimated to last on average for at least 10 years after completion of the full vaccination course. Ten years after the full course, approximately 53% of subjects are estimated to have antibody levels > or = 20 mIU/ml. At 15 years, these levels will be maintained by about 34% of vaccinees. Avaxim and Havrix 720 show a similar long-term profile of persistence of anti-HAV. A mathematical model based on GMTs appeared to give equivalent results to a model based on individual serological data. The GMT method is easier to apply than the individual based method. However, the advantage of the latter method is the possibility of calculating confidence limits for the predicted values and making estimates of the percentage of subjects having a certain level of antibody titres at a certain time.


Assuntos
Vírus da Hepatite A Humana/imunologia , Anticorpos Anti-Hepatite/sangue , Vacinação , Vacinas contra Hepatite Viral/imunologia , Adolescente , Adulto , Feminino , Vacinas contra Hepatite A , Humanos , Esquemas de Imunização , Imunização Secundária , Masculino , Pessoa de Meia-Idade , Modelos Imunológicos , Fatores de Tempo , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/imunologia , Vacinas contra Hepatite Viral/administração & dosagem
12.
Vaccine ; 17(15-16): 1919-25, 1999 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-10217590

RESUMO

The safety and immunogenicity of a new formulation of the inactivated hepatitis A vaccine, Avaxim, was evaluated in 189 children, aged 18 months to 15 years in a monocentric, open trial. Two vaccinations were given six months apart. Enrollment was balanced within three age groups: 18 months to 3 years, 4-8 years and 9-15 years. Antibody titers were measured blindly by an independent laboratory using a modified radioimmunoassay. Two weeks after the first dose, seroconversion was achieved by 94.6, 94.3 and 96.4% of initially HAV-seronegative subjects (antibody titre <20 mIU/ml) in each age group (youngest to oldest, respectively), with corresponding geometric mean titre concentrations (GMC) of 72.2, 54.3 and 47.1 mIU/ml. Just before the booster dose, the seroconversion rate was 100% in all groups, and the corresponding GMC values were 163, 169 and 111 mIU/ml. All groups included, a 22.6-fold rise in GMC from prebooster levels was observed four weeks after the booster dose. An explanatory analysis suggested a tendency for higher antibody levels in younger children at all vaccination time points. Local reactions were noted in 18.2% of the vaccinees after the first dose and in 8.5% after the booster dose. The rates of systemic reactions were 23.8% after the first dose and 11.4% after the booster dose. Overall, this trial demonstrated the good safety and immunogenicity profile of this vaccine in children aged 18 months to 15 years of age.


Assuntos
Anticorpos Anti-Hepatite/sangue , Hepatovirus/imunologia , Vacinas contra Hepatite Viral/efeitos adversos , Vacinas contra Hepatite Viral/imunologia , Adolescente , Criança , Pré-Escolar , Feminino , Anticorpos Anti-Hepatite A , Vacinas contra Hepatite A , Humanos , Imunização Secundária , Lactente , Masculino , Radioimunoensaio , Método Simples-Cego , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia , Vacinas contra Hepatite Viral/administração & dosagem
13.
Sante ; 8(5): 361-8, 1998.
Artigo em Francês | MEDLINE | ID: mdl-9854014

RESUMO

An attenuated vaccine against hepatitis A was developed from the GBM strain of the virus, cultured on human diploid MRC5 cells. Each dose contained 160 antigen units, inactivated by formalin and adsorbed onto 0.3 mg aluminum hydroxide, in a volume of 0.5 ml. Intramuscular injection of the vaccine conferred immunity to hepatitis A, with antibody titers greater than those obtained by passive immunization with immunoglobulin. In clinical studies, immunocompromised subjects became immune shortly after the first injection and more than 90% were found to be protected after 14 days (titer above 20 mIU/ml by RIA). All subjects (100%) were protected one month after the first injection. Immunity persisted for at least six months and was strengthened by a booster injection. The antibody titers determined after the first booster injection were consistent with a projected period of protection of ten years. Adverse reactions were mild and occurred within the first few days after vaccination, with the patient usually recovering spontaneously. The most common reaction was mild local pain, usually associated with redness of the skin. A nodule was observed at the injection site in a small number of cases. Mild fever, asthenia, headache, myalgia/arthralgia and gastrointestinal tract disorders were also reported. Reactions were reported less frequently after the booster injection than after the initial dose. The vaccine was as well tolerated by patients seropositive for the hepatitis A virus as by seronegative subjects. Thus, this vaccine can be used for active immunization against hepatitis A in adults and adolescents. It can be administered as primary immunization and as a booster injection.


Assuntos
Vacinas contra Hepatite Viral/imunologia , Adolescente , Adulto , Anticorpos Antivirais/sangue , Ensaios Clínicos Fase I como Assunto , Hepatite A/imunologia , Vacinas contra Hepatite A , Humanos , Imunização Secundária , Seleção de Pacientes , Fatores de Tempo , Vacinas Atenuadas , Vacinas contra Hepatite Viral/administração & dosagem , Vacinas contra Hepatite Viral/efeitos adversos
14.
J Travel Med ; 5(4): 167-72, 1998 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-9876189

RESUMO

BACKGROUND: Inactivated hepatitis A vaccines are licensed with a vaccination schedule based on two injections of vaccine given at least 6 months apart. METHODS: Two vaccination schedules for the inactivated hepatitis A vaccine, AvaximTM (Pasteur Mérieux Connaught, Lyon, France), were compared in a monocentric, randomized, open trial. Two doses of the vaccine were given at intervals of either 6 months (0-6 month group) or 12 months (0-12 month group) to 96 adult volunteers. Anti-hepatitis A virus (HAV) antibody titers were determined in a blind fashion using the modified RIA (mRIA) HAVABtrade mark assay. After excluding subjects with positive preimmunization anti-HAV titers and those with protocol deviations, both groups were still comparable by sex ratio and mean age. RESULTS: Four weeks (28 6 4 days) after the first dose, the seroconversion (SC) rate of initially HAV-seronegative subjects (antibody titer < 20 mIU/mL) was 100% in the 0-6 month group and 96. 9% in the 0-12 month group, with corresponding geometric mean titer (GMT) values (95% CI) of 369 mIU/mL (274-497 mIU/mL) and 445 mIU/mL (292-679 mIU/mL), respectively. After 6 months, SC was obtained in all subjects, and the corresponding GMT values were 349 mIU/mL and 359 mIU/mL in the 0-6 month group and the 0-12 month group, respectively. Four weeks after the booster dose given at 6 months, a 14.5-fold rise in GMT was observed. In the 0-12 month group, anti-HAV GMT values decreased by only 20% from 6 months to 12 months with a pre-booster GMT value of 286 mIU/mL at the 12-month evaluation. Four weeks after the booster given at 12 months, a 22. 5-fold rise in GMT was observed. Statistical analysis showed that the two vaccination schedules were comparable in their ability to boost antibody titers. Unsolicited reactions to vaccination were not different to those reported during earlier trials. Less than 12% of the vaccinees reported reactions after the first dose (11/93), or after the booster dose (11/92). CONCLUSIONS: This trial demonstrated antibody persistence is excellent for at least 12 months after one dose of this vaccine, and that a booster may be given at any time between 6 and 12 months after primary immunization.


Assuntos
Hepatite A/imunologia , Hepatite A/prevenção & controle , Esquemas de Imunização , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/sangue , Vacinas contra Hepatite Viral/administração & dosagem , Vacinas contra Hepatite Viral/sangue , Adolescente , Adulto , Feminino , Vacinas contra Hepatite A , Humanos , Masculino , Pessoa de Meia-Idade , Valores de Referência
15.
Pediatr Infect Dis J ; 16(9): 863-70, 1997 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-9306481

RESUMO

OBJECTIVE: The safety and immunogenicity of a diphtheria-tetanus toxoid-acellular pertussis vaccine (DTaP; Trepedia)/Haemophilus influenzae b polysaccharide (PRP-T; ActHib) combined vaccine (TriHibir; Pasteur Mérieux Connaught) was compared with DTaP and PRP-T given at the same visit but at separate sites in a prospective multicenter, open label trial. METHODS: Infants were randomized to four groups (three consistency lots of DTaP/PRP-T vs. one of the consistency lots given as separate vaccines); injections were administered at 2, 4 and 6 months of age. Pre-Dose 1 and post-Dose 3 sera were assayed for antibody titers against all antigens. Reactions to the vaccinations were assessed by parent questionnaire for 30 days after each injection visit. RESULTS: Four hundred eighty-five infants were enrolled; 296 evaluable infants were included in the DTaP/PRP-T group compared with 70 infants in the DTaP and PRP-T vaccine group. Infants who received the combined vaccine had higher post-Dose 3 geometric mean antibody titers to diphtheria antitoxin (P < 0.01) and pertussis filamentous hemagglutinin (P < 0.05) and lower geometric mean antibody titers to tetanus antitoxin (P < 0.05) and Haemophilus influenzae b (Hib) polysaccharide (PRP) (P < 0.05). The geometric mean anti-PRP antibody titer in the DTaP/PRP-T group was 4.3 micrograms/ml compared with 7.0 micrograms/ml in the separate vaccine group (P < 0.05), and the percentage of infants with antibody titers > or = 0.15 and 1 microgram/ml were, respectively, 95 and 86%, whereas they were 100% for both titers in the separate vaccines group. DTaP/ PRP-T vaccine given concomitantly or 1 month apart from hepatitis B vaccine and oral poliomyelitis vaccine caused no significant differences in immunogenicity or safety. The safety assessments for the DTaP/PRP-T vaccine showed no consistent differences in systemic or local injection site reactions compared with DTaP and PRP-T administered separately. CONCLUSION: Although the antibody responses to tetanus and Hib polysaccharide in the evaluated DTaP/PRP-T combined vaccine were significantly lower than those seen after separate DTaP and PRP-T administration, the combined vaccine elicited an immune response against diphtheria, tetanus, pertussis and Haemophilus influenzae b likely to confer protection.


Assuntos
Antígenos de Bactérias/imunologia , Vacina contra Difteria, Tétano e Coqueluche/administração & dosagem , Vacinas Anti-Haemophilus/administração & dosagem , Toxoide Tetânico/administração & dosagem , Vacinas Combinadas/administração & dosagem , Vacinas Conjugadas/administração & dosagem , Análise de Variância , Antígenos de Bactérias/análise , Distribuição de Qui-Quadrado , Toxoide Diftérico/administração & dosagem , Toxoide Diftérico/imunologia , Vacina contra Difteria, Tétano e Coqueluche/imunologia , Interações Medicamentosas , Feminino , Seguimentos , Vacinas contra Hepatite B/farmacologia , Humanos , Esquemas de Imunização , Lactente , Masculino , Vacina Antipólio Oral/farmacologia , Estudos Prospectivos , Toxoide Tetânico/imunologia , Vacinas Combinadas/imunologia
16.
J Infect ; 35(1): 37-40, 1997 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-9279722

RESUMO

Sera from 30 subjects vaccinated with the Pasteur Merieux Serums & Vaccins (PM) inactivated hepatitis A vaccine, and from 30 subjects vaccinated with the Smithkline Beecham (SB) inactivated hepatitis A vaccine, were tested in two laboratories in order to provide comparative data on neutralizing activities of vaccine-induced antibodies. Sera were also evaluated by a modified radioimmunoassay (mRIA) and results were compared to neutralization assays results. Neutralizing antibody titres provided by the two laboratories correlated well (coefficient or correlation 0.42, P < 0.001). Neutralizing antibodies were detected after vaccination with both vaccines, and the kinetics of neutralizing antibody were the same with both vaccines. The titres gradually increased between the second week after the first dose and the post-booster dose (week 28). A strong booster effect of the booster vaccine dose on neutralizing titres was observed. Significantly higher neutralizing antibody titres with the PM vaccine were observed as early immune response on week 2 titres on both series of results. Vaccine-induced neutralizing antibody titres and vaccine-induced antibody mRIA titres correlated well (coefficient of correlation 0.82 and 0.72, respectively, P < 0.0001 in both cases). These results demonstrate early appearance of neutralizing antibody at high titre with the PM vaccine.


Assuntos
Anticorpos Antivirais/análise , Vírus da Hepatite A Humana/imunologia , Vacinas contra Hepatite Viral/administração & dosagem , Adolescente , Adulto , Feminino , Hepatite A/prevenção & controle , Vacinas contra Hepatite A , Humanos , Masculino , Testes de Neutralização , Radioimunoensaio , Vacinas de Produtos Inativados/administração & dosagem
18.
Vaccine ; 15(4): 449-58, 1997 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-9141217

RESUMO

A new needleless jet-injector, Mini-Imojet, was developed that administers liquid vaccines from a single-use, pre-filled cartridge named Imule, which avoids the risk of cross-contamination. We conducted clinical trials in several settings in France and West Africa to compare the immunogenicity and tolerance of five vaccines (influenza vaccine, Vi capsular polysaccharide typhoid vaccine, tetanus toxoid vaccine, diphtheria-tetanus-whole cell pertussis vaccine, and inactivated hepatitis A vaccine) administered with the Imule system vs standard syringe technique. In each vaccine study, all subjects of either group were tested for serum antibody titres to calculate the geometrical mean titres and seroconversion rates after complete vaccination. Immediate local-reactions were noted after each injection, and local and general reactions were evaluated during a predetermined period of follow-up. When delivered by the Imule technique, all the administered vaccines were of equivalent or superior immunogenicity, compared to the syringe technique. The tolerance to vaccines injected by the Imule system was acceptable in all studies. The most frequently observed reactions were mild (e.g. minor bleeding, superficial papules, erythema and induration) and could be considered to be inherent to the injection technique. The technical and safety advantages of the Mini-Imojet/Imule system, compared to sterilizable, standard disposable or autodestruct syringes and to classical multi-dose vial jet-injectors, reinforces the interest of this new injection technique for collective immunizations.


Assuntos
Injeções a Jato/instrumentação , Seringas , Vacinas/administração & dosagem , Vacinas/imunologia , Adolescente , Adulto , África , Toxoide Diftérico/administração & dosagem , Toxoide Diftérico/imunologia , Vacina contra Difteria, Tétano e Coqueluche/efeitos adversos , Feminino , França , Vacinas contra Hepatite A , Vírus da Hepatite A Humana/imunologia , Humanos , Lactente , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/imunologia , Injeções a Jato/métodos , Injeções a Jato/normas , Masculino , Pessoa de Meia-Idade , Vacina contra Coqueluche/administração & dosagem , Vacina contra Coqueluche/imunologia , Padrões de Referência , Seringas/normas , Toxoide Tetânico/administração & dosagem , Toxoide Tetânico/efeitos adversos , Toxoide Tetânico/imunologia , Vacinas Tíficas-Paratíficas/administração & dosagem , Vacinas Tíficas-Paratíficas/efeitos adversos , Vacinas Tíficas-Paratíficas/imunologia , Vacinas/efeitos adversos , Vacinas de Produtos Inativados/efeitos adversos , Vacinas contra Hepatite Viral/administração & dosagem , Vacinas contra Hepatite Viral/efeitos adversos , Vacinas contra Hepatite Viral/imunologia
20.
J Hepatol ; 26(1): 25-30, 1997 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-9148018

RESUMO

BACKGROUND/AIMS: The aim of this study was to compare the immunogenicity of Pasteur Mérieux (P.M. s.v.) inactivated hepatitis A vaccine when given alone with its immunogenicity when given in combination with immunoglobulin. METHODS: We enrolled 80 healthy volunteers who were seronegative for anti-HAV. Forty subjects (group A) were given two doses of vaccine at 0 and 6 months plus 4 ml of immunoglobulin given simultaneously with the first vaccine injection; and 40 subjects (group B) were given vaccine alone. The population characteristics (age, sex, height and weight) of the two groups were comparable. RESULTS: Anti-HAV antibody was detectable at week 1 in 100% of group A and in 5.7% of group B, and in 100% of both groups at 4 and 8 weeks. Seroconversion rates (> or = 20 mIU/ml) were 97.4% in group A and 100% in group B at week 24 and were 100% in both groups 4 weeks after a booster injection at 6 months. The antibody response level was lower after concomitant administration of vaccine with immunoglobulin. The antibody geometric mean titer was higher at week 1 in subjects who had been given vaccine and immunoglobulin, but nearly 50% lower at week 4 and thereafter, indicating inhibition of the vaccine-induced immune response by immunoglobulin. At week 28, i.e. 4 weeks after the booster injection, geometric mean titers had increased about 13-15 times in both groups, reaching highly protective antibody levels (3351 mIU/ml in group A and 5843 mIU/ml in group B). No serious adverse effects were observed during the follow-up. CONCLUSIONS: These data indicate that P.M. s.v. hepatitis A vaccine is highly immunogenic and safe, even when given simultaneously with immunoglobulin. Despite the interference of the immunoglobulin with the active immune response, individuals who were immunized passively plus actively also developed high titers of anti-HAV antibody. It is therefore reasonable to expect that this inhibition will not affect the overall protection conferred by the vaccine.


Assuntos
Vírus da Hepatite A Humana/imunologia , Imunização Passiva , Vacinas de Produtos Inativados/imunologia , Vacinas contra Hepatite Viral/imunologia , Adulto , Feminino , Seguimentos , Vacinas contra Hepatite A , Humanos , Esquemas de Imunização , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Vacinas de Produtos Inativados/efeitos adversos , Vacinas contra Hepatite Viral/efeitos adversos
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