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1.
Vaccine ; 33(31): 3766-72, 2015 Jul 17.
Artigo em Inglês | MEDLINE | ID: mdl-26065919

RESUMO

BACKGROUND: The P2-VP8 subunit vaccine for the prevention of rotavirus gastroenteritis is comprised of a truncated VP8 subunit protein from the rotavirus Wa strain (G1[P8]) fused to the tetanus toxin P2 epitope, and adsorbed on aluminum hydroxide for intramuscular administration. METHODS: Three groups of 16 adults were randomized to receive three injections of P2-VP8 (12) or placebo (4) at doses of 10, 30 or 60 µg of vaccine. IgG and IgA antibodies to P2-VP8 were assessed by ELISA in serum and lymphocyte supernatant (ALS). Serum samples were tested for neutralizing antibodies to homologous and heterologous strains of rotavirus. RESULTS: The vaccine was well-tolerated. All vaccine recipients demonstrated significant IgA responses and all but one demonstrated IgG responses; in the 60 µg cohort, geometric mean titers (GMTs) rose 70- and 80-fold for IgA and IgG, respectively. Homologous neutralizing antibody responses were observed in about half of participants in all three dose cohorts; in the 60 µg cohort, GMTs against Wa rose from 128 to 992. Neutralizing antibody responses were robust to P[8] strains, moderate to P[4] strains and negligible to P[6] strains. ALS IgA responses were dose dependent. CONCLUSIONS: The P2-VP8 subunit vaccine was well tolerated and evoked promising immune responses. CLINICAL TRIALS REGISTRATION: NCT01764256.


Assuntos
Gastroenterite/prevenção & controle , Proteínas de Ligação a RNA/imunologia , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus/efeitos adversos , Vacinas contra Rotavirus/imunologia , Proteínas não Estruturais Virais/imunologia , Adjuvantes Imunológicos/administração & dosagem , Adolescente , Adulto , Hidróxido de Alumínio/administração & dosagem , Anticorpos Neutralizantes/sangue , Método Duplo-Cego , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Ensaio de Imunoadsorção Enzimática , Feminino , Voluntários Saudáveis , Humanos , Imunoglobulina A/análise , Imunoglobulina A/sangue , Imunoglobulina G/análise , Imunoglobulina G/sangue , Injeções Intramusculares , Linfócitos/imunologia , Masculino , Pessoa de Meia-Idade , Testes de Neutralização , Placebos/administração & dosagem , Vacinas contra Rotavirus/administração & dosagem , Resultado do Tratamento , Vacinas de Subunidades Antigênicas/administração & dosagem , Vacinas de Subunidades Antigênicas/efeitos adversos , Vacinas de Subunidades Antigênicas/imunologia , Adulto Jovem
2.
Expert Rev Vaccines ; 11(8): 939-47, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-23002975

RESUMO

The 2009 influenza A/H1N1 pandemic demonstrated that a pandemic influenza virus has the potential to spread more rapidly in today's highly interconnected world than in the past. While pandemic morbidity and mortality are likely to be greatest in low-resource countries, manufacturing capacity and access to influenza vaccines predominantly exist in countries with greater resources and infrastructure. Even with recently expanded manufacturing capacity, the number of doses available within a 6-month timeframe would be inadequate to fully immunize the global population if the decision to implement a global vaccination program were made today. Improved, affordable vaccines are needed to limit the consequences of a global influenza outbreak and protect low-resource populations. PATH's Influenza Vaccine Project is supporting a range of activities in collaboration with private- and public-sector partners to advance the development of promising influenza vaccines that can be accessible and affordable for people in low-resource countries.


Assuntos
Transmissão de Doença Infecciosa/prevenção & controle , Vacinas contra Influenza/provisão & distribuição , Influenza Humana/prevenção & controle , Pobreza , Adjuvantes Imunológicos/química , Saúde Global , Humanos , Programas de Imunização/organização & administração , Vírus da Influenza A/patogenicidade , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/química , Cooperação Internacional , Pandemias/prevenção & controle , Estações do Ano , Vacinação/métodos , Vacinas Atenuadas/administração & dosagem , Vacinas Atenuadas/química , Vacinas Atenuadas/provisão & distribuição
4.
Vaccine ; 29(6): 1324-31, 2011 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-21134456

RESUMO

The current recommended infant vaccination schedules require many injections at multiple sites, which increase stress for infants and parents and may create challenges to vaccination compliance. Therefore, combination vaccines, which reduce the number of injections at each medical visit, can be an essential method to improve compliance. The objective of this study was to assess the safety and immunogenicity of an investigational, liquid, hexavalent, pediatric vaccine at 2, 4, 6, and 12-14 months of age. In this multicenter, open-label controlled study, 756 infants were randomized in approximately equal numbers to receive 0.5mL intramuscular dose of diptheria-tetanus-pertussis-polio-Haemophilus influenzae type b+hepatitis B vaccine, or 1 of 3 double-blind investigational formulations. All formulations included a hepatitis B surface antigen (HBsAg) concentration of 10µg/0.5mL. The three hexavalent vaccine formulations used in this study contained either Hib polyribosylribitol phosphate (PRP) conjugate component (tetanus toxoid [PRP-T, 12µg] or Neisseria meningitidis outer membrane protein complex [PRP-OPMC, 3µg or 6µg]): a minimum acceptable postdose 3 antibody response rate for each antigen was defined by the lower limit of a 95% confidence interval exceeding a prespecified target. Rates of adverse events (AEs) were similar among groups, with a trend for increased solicited vaccine-related injection-site reactions (pain, erythema, swelling) with increasing PRP-OMPC dose. No serious vaccine-related AEs were reported in the investigational groups. Both PRP-OMPC formulations met prespecified acceptability criteria for all antigens: PRP, HBsAg, pertussis, diphtheria, tetanus and poliovirus. The PRP-T formulation met the acceptability criterion for antibody responses to all antigens other than PRP at postdose 3. Postdose 4 responses were adequate for all antigens in all formulations. All vaccine formulations were well-tolerated. Both PRP-OMPC formulations met prespecified immunogenicity criteria of PRP-OMPC evaluation.


Assuntos
Vacina contra Difteria, Tétano e Coqueluche/efeitos adversos , Vacina contra Difteria, Tétano e Coqueluche/imunologia , Vacinas Anti-Haemophilus/efeitos adversos , Vacinas Anti-Haemophilus/imunologia , Vacinas contra Hepatite B/efeitos adversos , Vacinas contra Hepatite B/imunologia , Vacina Antipólio de Vírus Inativado/efeitos adversos , Vacina Antipólio de Vírus Inativado/imunologia , Anticorpos Antibacterianos/sangue , Anticorpos Antivirais/sangue , Vacina contra Difteria, Tétano e Coqueluche/administração & dosagem , Método Duplo-Cego , Feminino , Vacinas Anti-Haemophilus/administração & dosagem , Vacinas contra Hepatite B/administração & dosagem , Humanos , Lactente , Injeções Intramusculares , Masculino , Vacina Antipólio de Vírus Inativado/administração & dosagem , Dermatopatias/induzido quimicamente , Dermatopatias/epidemiologia , Vacinas Combinadas , Vacinas Conjugadas/administração & dosagem , Vacinas Conjugadas/efeitos adversos , Vacinas Conjugadas/imunologia
5.
Curr Top Microbiol Immunol ; 333: 471-93, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19768420

RESUMO

The global need for a pandemic influenza vaccine is large. High-income countries have stated their intent to provide universal access for pandemic influenza vaccine to their populations. Assuming that a two-dose schedule would be needed, providing universal coverage globally would represent approximately 6.5 billion two-dose courses or 13 billion doses. In the best case scenario, should an outbreak of pandemic influenza occur in the near term, using H5N1 as a proxy for the pandemic virus, the total available doses for the global population within six months of an out break would be only 1.2 billion courses or 2.4 billion doses. In addition, current stockpiles of pandemic influenza vaccine are limited. However, promising developments are occurring with respect to global capacity, technological innovation, and global conviction that offer potential solutions to the problem of pandemic influenza vaccine supply for the world's population.


Assuntos
Surtos de Doenças/prevenção & controle , Vacinas contra Influenza/imunologia , Influenza Humana/prevenção & controle , Humanos , Vacinas contra Influenza/economia , Vacinas contra Influenza/provisão & distribuição , Vacinação
6.
Vaccine ; 27(19): 2540-7, 2009 Apr 28.
Artigo em Inglês | MEDLINE | ID: mdl-19124057

RESUMO

Combination vaccines improve parental and provider satisfaction and schedule compliance by decreasing the number of injections. In a Phase 2, randomized, double-blind, multicenter study, we compared four formulations of a liquid, hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B virus (DTaP-IPV-Hib-HBV) vaccine in 708 infants immunized at 2, 3, 4, and 12-14 months of age. The formulations contained identical DTaP and IPV components, differing in the contents of Hib polyribosylribitol phosphate (PRP) conjugate component (tetanus-toxoid [PRP-T, 12microg] or Neisseria meningitidis outer-membrane-protein-complex [PRP-OMPC, 3microg or 6microg]), and in hepatitis B surface antigen (HBsAg, 10microg or 15microg). A minimum acceptable postdose 3 antibody response rate was defined by the lower limit of the 95% confidence interval exceeding a prespecified target. Rates of adverse events (AEs) were similar among groups, with a trend for increased solicited injection-site reactions (pain, redness, swelling) with increasing PRP-OMPC and HBsAg concentration. Serious AEs reported by eight subjects were not considered to be vaccine related. All PRP-OMPC formulations met prespecified acceptability criteria for postdose 3 immunogenicity for all antigens: PRP, HBsAg, pertussis, diphtheria, tetanus and polio. Apart from the Hib response, the postdose 3 responses obtained with the PRP-T formulation met the acceptability criterion for each antigen. Postdose 4 responses were acceptable for all antigens in all formulations. All vaccine formulations were well tolerated. The three PRP-OMPC formulations met prespecified immunogenicity criteria, and the one with the lowest PRP-OMPC concentration was selected for further optimization of immunogenicity.


Assuntos
Vacina contra Difteria, Tétano e Coqueluche/efeitos adversos , Vacina contra Difteria, Tétano e Coqueluche/imunologia , Vacinas Anti-Haemophilus/efeitos adversos , Vacinas Anti-Haemophilus/imunologia , Vacinas contra Hepatite B/efeitos adversos , Vacinas contra Hepatite B/imunologia , Vacina Antipólio de Vírus Inativado/efeitos adversos , Vacina Antipólio de Vírus Inativado/imunologia , Anticorpos Antibacterianos/sangue , Anticorpos Antivirais/sangue , Química Farmacêutica , Vacina contra Difteria, Tétano e Coqueluche/administração & dosagem , Feminino , Vacinas Anti-Haemophilus/administração & dosagem , Vacinas contra Hepatite B/administração & dosagem , Humanos , Imunização Secundária , Lactente , Masculino , Vacina Antipólio de Vírus Inativado/administração & dosagem , Vacinas Combinadas/administração & dosagem , Vacinas Combinadas/efeitos adversos , Vacinas Combinadas/imunologia , Vacinas Conjugadas/administração & dosagem , Vacinas Conjugadas/efeitos adversos , Vacinas Conjugadas/imunologia
7.
Hum Vaccin ; 5(2): 92-7, 2009 02.
Artigo em Inglês | MEDLINE | ID: mdl-18690015

RESUMO

BACKGROUND: Merck has developed a manufacturing process modification for RECOMBIVAX HB. Three lots of modified process hepatitis B vaccine (mpHBV) were studied in a randomized, blinded trial to demonstrate similarity of the three lots of mpHBV and noninferiority to RECOMBIVAX HB (control vaccine) with regard to immunogenicity. RESULTS: Month 7 SPRs for the mpHBV groups ranged from 97.8 to 98.9% (98.2% for the mpHBV groups combined). The seroprotection rate (SPR) for the control group was 98.5%. The estimated geometric mean titer (GMT) was 1761 mIU/mL for the mpHBV groups combined and 1108 mIU/mL for the control group. The GMT ratio (mpHBV/control) was 1.6 [95% confidence interval (CI): 1.2 to 2.1], indicating superiority of mpHBV compared with control. The percentages of subjects reporting any adverse experience (AE), injection-site AEs, or systemic AEs were similar across the four vaccination groups. There were no serious AEs. METHODS: Healthy 20-to 35-year-old subjects (N = 860) received a 1-mL intramuscular dose [10 mcg hepatitis B surface antigen (HBsAg)] of mpHBV from 1 of 3 lots or control at Day 1, and Months 1 and 6. Serum antibody to HBsAg (anti-HBs) was assayed Predose 1 and 1 month Postdose 3 (Month 7) using a quantitative hepatitis B antibody assay (Ortho VITROS ECi assay). Anti-HBs GMTs and SPRs (% of subjects with an anti-HBs titer > or =10 mIU/mL) were compared at Month 7. After each dose, injection-site AEs and oral temperature were recorded for 5 days; systemic AEs were recorded for 15 days. CONCLUSIONS: The SPRs for the mpHBV groups and the control group were high; responses were consistent across the mpHBV groups. The mpHBV and control vaccines were generally well tolerated.


Assuntos
Anticorpos Anti-Hepatite B/sangue , Vacinas contra Hepatite B/efeitos adversos , Vacinas contra Hepatite B/imunologia , Adulto , Feminino , Humanos , Masculino , Vacinas Sintéticas/efeitos adversos , Vacinas Sintéticas/imunologia , Adulto Jovem
8.
Pediatr Infect Dis J ; 26(12): 1099-104, 2007 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-18043445

RESUMO

BACKGROUND: Premature infants seem to be at greater risk of hospitalization from rotavirus gastroenteritis than term infants. Safety and efficacy of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine were assessed in premature infants enrolled in the large-scale, blinded, placebo-controlled rotavirus efficacy and safety trial (REST). METHODS: Healthy infants 6-12 weeks of chronologic age at study entry were randomized to receive 3 oral doses of pentavalent rotavirus vaccine or placebo at 4- to 10-week intervals. Infants born at < or =36 weeks of gestational age were eligible if thriving at the time of enrollment. Safety and efficacy were retrospectively assessed in these premature infants comparing vaccine with placebo recipients. Cases of rotavirus gastroenteritis were defined as forceful vomiting and/or > or =3 watery or looser-than-normal stools within a 24-hour period, accompanied by detection of rotavirus antigen in the stool. RESULTS: A total of 2070 infants between 25 and 36 gestational weeks received at least 1 dose of vaccine or placebo; 1005 vaccine recipients and 1061 placebo recipients were evaluable for safety. Serious adverse events occurred in 55 vaccine recipients (5.5%) and 62 placebo recipients (5.8%). In a nested substudy of 308 premature infants evaluable for detailed safety (154 in each group), the frequencies of fever, diarrhea, vomiting, and irritability were comparable between vaccine and placebo recipients. Overall, 3 doses of the pentavalent vaccine reduced the rate of hospitalizations and emergency department visits in premature infants due to rotavirus gastroenteritis by 100% (95% CI: 82.2-100) compared with placebo. The vaccine also prevented 73.0% (95% CI: -2.2-95.2) of rotavirus gastroenteritis cases of any severity. CONCLUSIONS: In this post hoc analysis of healthy premature infants, the pentavalent rotavirus vaccine was generally well-tolerated and substantially reduced rotavirus-attributable hospitalizations and emergency department visits compared with placebo. Overall, vaccine safety and efficacy seemed to be generally comparable to the results in the REST study population as a whole. These results support vaccinating healthy premature infants on the same schedule as term infants.


Assuntos
Gastroenterite/prevenção & controle , Doenças do Prematuro/prevenção & controle , Vírus Reordenados/imunologia , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus , Rotavirus/imunologia , Animais , Bovinos , Gastroenterite/virologia , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro/virologia , Rotavirus/classificação , Infecções por Rotavirus/virologia , Vacinas contra Rotavirus/administração & dosagem , Vacinas contra Rotavirus/efeitos adversos , Resultado do Tratamento
9.
Lancet ; 369(9574): 1693-702, 2007 May 19.
Artigo em Inglês | MEDLINE | ID: mdl-17512854

RESUMO

BACKGROUND: Vulval and vaginal cancers among younger women are often related to infection with human papillomavirus (HPV). These cancers are preceded by high-grade vulval intraepithelial neoplasia (VIN2-3) and vaginal intraepithelial neoplasia (VaIN2-3). Our aim was to do a combined analysis of three randomised clinical trials to assess the effect of a prophylactic quadrivalent HPV vaccine on the incidence of these diseases. METHODS: 18 174 women (16-26 years) were enrolled and randomised to receive either quadrivalent HPV6/11/16/18 L1 virus-like-particle vaccine or placebo at day 1, and months 2 and 6. Individuals underwent detailed anogenital examination at day 1, 1 month after dose three, and at 6-12-month intervals for up to 48 months. Suspect genital lesions were biopsied and read by a panel of pathologists and vaccine HPV type-specific DNA testing was done. The primary endpoint was the combined incidence of VIN2-3 or VaIN2-3 associated with HPV16 or HPV18. Primary efficacy analyses were done in a per-protocol population. FINDINGS: The mean follow-up time was 3 years. Among women naive to HPV16 or HPV18 through 1 month after dose three (per-protocol population; vaccine n=7811; placebo n=7785), the vaccine was 100% effective (95% CI 72-100) against VIN2-3 or VaIN2-3 associated with HPV16 or HPV18. In the intention-to-treat population (which included 18 174 women who, at day 1, could have been infected with HPV16 or HPV18), vaccine efficacy against VIN2-3 or VaIN2-3 associated with HPV16 or HPV18 was 71% (37-88). The vaccine was 49% (18-69) effective against all VIN2-3 or VaIN2-3, irrespective of whether or not HPV DNA was detected in the lesion. The most common treatment-related adverse event was injection-site pain. INTERPRETATION: Prophylactic administration of quadrivalent HPV vaccine was effective in preventing high-grade vulval and vaginal lesions associated with HPV16 or HPV18 infection in women who were naive to these types before vaccination. With time, such vaccination could result in reduced rates of HPV-related vulval and vaginal cancers.


Assuntos
Papillomaviridae/imunologia , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus , Displasia do Colo do Útero/prevenção & controle , Neoplasias do Colo do Útero/prevenção & controle , Adolescente , Adulto , Feminino , Humanos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto
10.
Pediatr Infect Dis J ; 26(3): 221-7, 2007 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-17484218

RESUMO

BACKGROUND: A live pentavalent rotavirus vaccine (PRV) containing 5 human-bovine (WC3) reassortants expressing human serotypes G1, G2, G3, G4 and P1A[8] was evaluated in a blinded, placebo-controlled study. Possible interactions between PRV and concomitantly administered licensed pediatric vaccines were investigated in a United States-based nested substudy (Concomitant Use Study) of the Rotavirus Efficacy and Safety Trial. METHODS: From 2002 to 2003, healthy infants approximately 6 to 12 weeks of age at entry were randomized to receive either 3 oral doses of PRV or placebo at 4- to 10-week intervals. Subjects were also to receive combined Haemophilus influenzae type b and hepatitis B vaccine (2 doses), diphtheria and tetanus toxoids and acellular pertussis vaccine (3 doses), inactivated poliovirus vaccine (2 doses) and pneumococcal conjugate vaccine (3 doses) on the same day; oral poliovirus vaccine was not administered. Immunogenicity was assessed by measuring antibody responses to PRV and antigens contained in the licensed vaccines. Cases of rotavirus gastroenteritis were defined by forceful vomiting and/or -3 watery or looser-than-normal stools within a 24-hour period, and detection of rotavirus antigen in the stool. Safety was assessed by reporting of adverse events using diary cards. RESULTS: The Concomitant Use Study enrolled 662 subjects in the PRV group and 696 subjects in the placebo group. For the 17 antigens in the concomitantly administered vaccines, antibody responses were similar in PRV and placebo recipients, except for moderately diminished antibody responses to the pertactin component of pertussis vaccine. Efficacy of PRV against rotavirus gastroenteritis of any severity was 89.5% (95% CI = 26.5-99.8%). PRV was generally well tolerated when given concomitantly with the prespecified vaccines. CONCLUSIONS: In this study, antibody responses to the concomitantly administered vaccines were generally similar in PRV and placebo recipients. PRV was efficacious and well tolerated when given concomitantly with pediatric vaccines licensed in the United States.


Assuntos
Vírus Reordenados/imunologia , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus/administração & dosagem , Vacinas contra Rotavirus/imunologia , Rotavirus/imunologia , Administração Oral , Animais , Anticorpos Antivirais/sangue , Bovinos , Vacina contra Difteria, Tétano e Coqueluche/administração & dosagem , Vacina contra Difteria, Tétano e Coqueluche/efeitos adversos , Vacina contra Difteria, Tétano e Coqueluche/imunologia , Método Duplo-Cego , Esquema de Medicação , 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 , Lactente , Masculino , Vacinas Pneumocócicas/administração & dosagem , Vacinas Pneumocócicas/efeitos adversos , Vacinas Pneumocócicas/imunologia , Vacina Antipólio de Vírus Inativado/administração & dosagem , Vacina Antipólio de Vírus Inativado/efeitos adversos , Vacina Antipólio de Vírus Inativado/imunologia , Vacinas contra Rotavirus/efeitos adversos , Estados Unidos
11.
Pediatrics ; 119(1): 11-8, 2007 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-17200266

RESUMO

BACKGROUND: Rotavirus is the leading cause of dehydrating acute gastroenteritis in infants worldwide. Previous studies of a live pentavalent human-bovine reassortant rotavirus vaccine have shown it to be efficacious across a range of potencies. OBJECTIVE: Our goal was to evaluate the efficacy, immunogenicity, and safety of pentavalent rotavirus vaccine at the end of shelf life in healthy infants. PATIENTS AND METHODS: During 2002-2004, 1312 healthy infants approximately 6 to 12 weeks old from the United States (47%) and Finland (53%) were randomly assigned to receive 3 oral doses of vaccine (vaccine at approximately 1.1 x 10(7) infectious U per dose) or placebo approximately 4 to 10 weeks apart. Infants were to be followed for acute gastroenteritis through 1 rotavirus season after vaccination and for adverse events postvaccination. RESULTS: Three doses of pentavalent rotavirus vaccine at the end of shelf life demonstrated efficacy against rotavirus gastroenteritis caused by human G-serotypes included in the vaccine (G1-G4). Efficacy against severe rotavirus gastroenteritis was 100%, and efficacy against any rotavirus gastroenteritis regardless of severity was 72.5%. A threefold rise in G1 serum neutralizing was observed in 57% and in anti-rotavirus immunoglobulin A in 96% of pentavalent rotavirus vaccine recipients. No statistically significant increase in vomiting, diarrhea, or irritability was observed among pentavalent rotavirus vaccine recipients compared with placebo recipients within the 7-day period from each dose. A statistically significant increase in fevers (> or = 100.5 degrees F, rectal equivalent) was observed among pentavalent rotavirus vaccine recipients compared with placebo recipients after dose 1. CONCLUSIONS: This pentavalent human-bovine rotavirus vaccine was generally well tolerated, efficacious, and immunogenic at the end of shelf life.


Assuntos
Vacinas contra Rotavirus/imunologia , Vacinação , Doença Aguda , Anticorpos Antivirais/sangue , Método Duplo-Cego , Fezes/virologia , Feminino , Gastroenterite/prevenção & controle , Gastroenterite/virologia , Hospitalização , Humanos , Imunoglobulina A/sangue , Lactente , Masculino , Rotavirus/imunologia , Rotavirus/isolamento & purificação , Infecções por Rotavirus/prevenção & controle , Infecções por Rotavirus/virologia , Vacinas contra Rotavirus/efeitos adversos
12.
N Engl J Med ; 354(1): 23-33, 2006 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-16394299

RESUMO

BACKGROUND: Rotavirus is a leading cause of childhood gastroenteritis and death worldwide. METHODS: We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned to receive three oral doses of live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, and P[8] or placebo at 4-to-10-week intervals in a blinded fashion. Active surveillance was used to identify subjects with serious adverse and other events. RESULTS: The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4). The vaccine reduced hospitalizations and emergency department visits related to G1-G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 94.5 percent (95 percent confidence interval, 91.2 to 96.6 percent). In a nested substudy, efficacy against any G1-G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination was 74.0 percent (95 percent confidence interval, 66.8 to 79.9 percent); efficacy against severe gastroenteritis was 98.0 percent (95 percent confidence interval, 88.3 to 100 percent). The vaccine reduced clinic visits for G1-G4 rotavirus gastroenteritis by 86.0 percent (95 percent confidence interval, 73.9 to 92.5 percent). CONCLUSIONS: This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.)


Assuntos
Gastroenterite/prevenção & controle , Intussuscepção/etiologia , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus , Vacinas Atenuadas , Administração Oral , Animais , Anticorpos Antivirais/sangue , Bovinos , Diarreia Infantil/prevenção & controle , Diarreia Infantil/virologia , Método Duplo-Cego , Feminino , Febre/etiologia , Gastroenterite/virologia , Hemorragia Gastrointestinal/etiologia , Recursos em Saúde/estatística & dados numéricos , Hospitalização , Humanos , Imunoglobulina A/sangue , Lactente , Masculino , Vírus Reordenados , Risco , Rotavirus/classificação , Rotavirus/imunologia , Vacinas contra Rotavirus/administração & dosagem , Vacinas contra Rotavirus/efeitos adversos , Vacinas contra Rotavirus/imunologia , Vacinas Atenuadas/administração & dosagem , Vacinas Atenuadas/efeitos adversos , Vacinas Atenuadas/imunologia
13.
Vaccine ; 21(3-4): 181-7, 2002 Dec 13.
Artigo em Inglês | MEDLINE | ID: mdl-12450692

RESUMO

BACKGROUND: In a previous clinical trial comparing COMVAX with its monovalent components, PedvaxHIB and RECOMBIVAX HB, one of 92 comparisons of post-vaccination adverse experiences revealed a higher rate of unusual, high-pitched crying following the second, but not the first or third doses of COMVAX compared with two monovalent control vaccines. Rates of prolonged crying were similar between groups at each visit. OBJECTIVES: To compare the frequencies of unusual, high-pitched crying between recipients of COMVAX plus placebo and recipients of PedvaxHIB plus RECOMBIVAX HB following the second vaccine doses (primary) and to summarize the frequency of unusual, high-pitched crying and prolonged crying after each vaccination visit. DESIGN: We enrolled 1215 healthy infants in a randomized, double blind, placebo-controlled study. Participating infants received study vaccines at 2 and 4 months of age and other routine childhood vaccines at 6-7 weeks and 3 months of age. Crying was evaluated via questionnaire at the time of enrollment (baseline) and daily from days 0 to 2 after each injection. RESULTS: Reports of unusual, high-pitched crying and prolonged crying were uncommon (<1%) prior to the first vaccination visit and were comparable in both treatment groups. After each injection, rates of unusual, high-pitched crying (range: 4.26-6.96%) and prolonged crying (range: 0-1.36%) appeared similar between treatment groups and for each vaccination visit. Crying resolved in all infants; no neurological impairment was reported. CONCLUSION: This study found no statistically significant differences in rates of unusual, high-pitched crying and prolonged crying in infants vaccinated with COMVAX plus placebo compared with infants vaccinated with its monovalent components, PedvaxHIB and RECOMBIVAX HB.


Assuntos
Proteínas da Membrana Bacteriana Externa/administração & dosagem , Choro , Vacinas Anti-Haemophilus/administração & dosagem , Vacinas contra Hepatite B/administração & dosagem , Esquemas de Imunização , Polissacarídeos Bacterianos/administração & dosagem , Vacinação/psicologia , Vacinas Sintéticas/administração & dosagem , Método Duplo-Cego , Humanos , Lactente , Segurança , Vacinação/efeitos adversos , Vacinas Combinadas/administração & dosagem
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