RESUMEN
BACKGROUND: Respiratory syncytial virus (RSV) fusion protein stabilized in the prefusion conformation (RSVPreF3) was under investigation as a maternal vaccine. METHODS: This phase 2, randomized, placebo-controlled, single-dose, multicenter study enrolled healthy, nonpregnant women, randomized 1:1:1:1:1 to 5 parallel groups studying RSVPreF3 (60 or 120 µg) coadministered with diphtheria, tetanus, and acellular pertussis vaccine (dTpa) or placebo, and dTpa coadministered with placebo. Safety and humoral immune responses were assessed. An extension phase also assessed a RSVPreF3 120 µg vaccination 12-18 months after first vaccination. RESULTS: The safety profile of RSVPreF3 was unaffected by dose or dTpa coadministration. Solicited and unsolicited adverse events (AEs) were evenly distributed across study groups. Injection-site pain was higher following the second vaccination versus the first vaccination. Medically attended AEs were rare (<5% overall). Both RSVPreF3 dose levels (alone and with dTpa) were immunogenic, increasing levels of RSV-A neutralizing antibody ≥8-fold and anti-RSVPreF3 IgG antibody ≥11-fold at 1 month postvaccination, which persisted at 12-18 months postvaccination; modest 2-fold increases were observed with a second RSVPreF3 vaccination. CONCLUSIONS: This study indicates RSVPreF3 coadministration with dTpa induces robust immune responses and is well tolerated, regardless of the RSVPreF3 dose level used. CLINICAL TRIALS REGISTRATION: NCT04138056.
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Anticuerpos Antivirales , Infecciones por Virus Sincitial Respiratorio , Vacunas contra Virus Sincitial Respiratorio , Humanos , Femenino , Adulto , Anticuerpos Antivirales/sangre , Infecciones por Virus Sincitial Respiratorio/prevención & control , Infecciones por Virus Sincitial Respiratorio/inmunología , Vacunas contra Virus Sincitial Respiratorio/inmunología , Vacunas contra Virus Sincitial Respiratorio/efectos adversos , Vacunas contra Virus Sincitial Respiratorio/administración & dosificación , Adulto Joven , Virus Sincitial Respiratorio Humano/inmunología , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Inmunogenicidad Vacunal , Adolescente , Proteínas Virales de Fusión/inmunología , Proteínas Virales de Fusión/administración & dosificación , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/efectos adversos , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/inmunología , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificación , Vacunación/efectos adversosRESUMEN
BACKGROUND: In many countries, infant vaccination with acellular pertussis (aP) vaccines has replaced use of more reactogenic whole-cell pertussis (wP) vaccines. Based on immunological and epidemiological evidence, we hypothesised that substituting the first aP dose in the routine vaccination schedule with wP vaccine might protect against IgE-mediated food allergy. We aimed to compare reactogenicity, immunogenicity, and IgE-mediated responses of a mixed wP/aP primary schedule versus the standard aP-only schedule. METHODS AND FINDINGS: OPTIMUM is a Bayesian, 2-stage, double-blind, randomised trial. In stage one, infants were assigned (1:1) to either a first dose of a pentavalent wP combination vaccine (DTwP-Hib-HepB, Pentabio PT Bio Farma, Indonesia) or a hexavalent aP vaccine (DTaP-Hib-HepB-IPV, Infanrix hexa, GlaxoSmithKline, Australia) at approximately 6 weeks old. Subsequently, all infants received the hexavalent aP vaccine at 4 and 6 months old as well as an aP vaccine at 18 months old (DTaP-IPV, Infanrix-IPV, GlaxoSmithKline, Australia). Stage two is ongoing and follows the above randomisation strategy and vaccination schedule. Ahead of ascertainment of the primary clinical outcome of allergist-confirmed IgE-mediated food allergy by 12 months old, here we present the results of secondary immunogenicity, reactogenicity, tetanus toxoid IgE-mediated immune responses, and parental acceptability endpoints. Serum IgG responses to diphtheria, tetanus, and pertussis antigens were measured using a multiplex fluorescent bead-based immunoassay; total and specific IgE were measured in plasma by means of the ImmunoCAP assay (Thermo Fisher Scientific). The immunogenicity of the mixed schedule was defined as being noninferior to that of the aP-only schedule using a noninferiority margin of 2/3 on the ratio of the geometric mean concentrations (GMR) of pertussis toxin (PT)-IgG 1 month after the 6-month aP. Solicited adverse reactions were summarised by study arm and included all children who received the first dose of either wP or aP. Parental acceptance was assessed using a 5-point Likert scale. The primary analyses were based on intention-to-treat (ITT); secondary per-protocol (PP) analyses were also performed. The trial is registered with ANZCTR (ACTRN12617000065392p). Between March 7, 2018 and January 13, 2020, 150 infants were randomised (75 per arm). PT-IgG responses of the mixed schedule were noninferior to the aP-only schedule at approximately 1 month after the 6-month aP dose [GMR = 0·98, 95% credible interval (0·77 to 1·26); probability (GMR > 2/3) > 0·99; ITT analysis]. At 7 months old, the posterior median probability of quantitation for tetanus toxoid IgE was 0·22 (95% credible interval 0·12 to 0·34) in both the mixed schedule group and in the aP-only group. Despite exclusions, the results were consistent in the PP analysis. At 6 weeks old, irritability was the most common systemic solicited reaction reported in wP (65 [88%] of 74) versus aP (59 [82%] of 72) vaccinees. At the same age, severe systemic reactions were reported among 14 (19%) of 74 infants after wP and 8 (11%) of 72 infants after aP. There were 7 SAEs among 5 participants within the first 6 months of follow-up; on blinded assessment, none were deemed to be related to the study vaccines. Parental acceptance of mixed and aP-only schedules was high (71 [97%] of 73 versus 69 [96%] of 72 would agree to have the same schedule again). CONCLUSIONS: Compared to the aP-only schedule, the mixed schedule evoked noninferior PT-IgG responses, was associated with more severe reactions, but was well accepted by parents. Tetanus toxoid IgE responses did not differ across the study groups. TRIAL REGISTRATION: Trial registered at the Australian and New Zealand Clinical 207 Trial Registry (ACTRN12617000065392p).
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Vacuna contra Difteria, Tétanos y Tos Ferina , Esquemas de Inmunización , Inmunoglobulina E , Humanos , Lactante , Método Doble Ciego , Inmunoglobulina E/inmunología , Inmunoglobulina E/sangre , Femenino , Masculino , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Australia , Vacunas Combinadas/inmunología , Vacunas Combinadas/efectos adversos , Vacunas Combinadas/administración & dosificación , Vacuna contra la Tos Ferina/inmunología , Vacuna contra la Tos Ferina/efectos adversos , Vacuna contra la Tos Ferina/administración & dosificación , Hipersensibilidad a los Alimentos/inmunología , Hipersensibilidad a los Alimentos/prevención & control , Vacuna Antipolio de Virus Inactivados/inmunología , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacunas contra Haemophilus/inmunología , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Haemophilus/administración & dosificación , Tos Ferina/prevención & control , Tos Ferina/inmunología , Inmunogenicidad Vacunal , Anticuerpos Antibacterianos/sangre , Anticuerpos Antibacterianos/inmunologíaRESUMEN
We assessed the safety of hexavalent vaccine diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, hepatitis b, and haemophilus influenzae b conjugate vaccine in the Vaccine Adverse Event Reporting System. Five hundred-one reports of adverse events (AEs) were identified; 21 (4.2%) were serious. Most frequently reported AEs were fever (10.2%) and injection site erythema (5.4%). AEs reported were consistent with findings from prelicensure studies.
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Vacuna contra Difteria, Tétanos y Tos Ferina , Vacunas contra Haemophilus , Humanos , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Hepatitis B/efectos adversos , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vacunas Combinadas/efectos adversos , Vacunas ConjugadasRESUMEN
INTRODUCTION: Underimmunization of CHD children is a public health concern in China. This study aimed to analyze the vaccination status of CHD children to provide additional evidence on optimal vaccination strategies and to make suggestions to promote appropriate vaccination services for these children. METHODS: This cross-sectional study evaluated 155 CHD children who received at least one vaccine at Peking University First Hospital. Vaccine-specific immunization rates were calculated. A telephone questionnaire survey was conducted that covered the following: the prognosis, reasons for delayed vaccinations and getting vaccination in the hospital. All statistical analyses were performed using the SPSS version 22 software. RESULTS: The left-to-right shunt group involved 138 children, while the other type CHD group involved 17. The vaccination rate was the highest for MPSV-AC (87.1%) and the lowest for DTaP (40.1%). The most frequent reason for vaccination in the hospital was refusal from community health centers (61.5%). No participant reported vaccine-related adverse effects. CONCLUSIONS: The age-appropriate vaccine-specific immunization rates in CHD children are low, with the lowest for DTaP. Refusal of community health centers was the primary reason. Our findings support that clinically stable CHD children may be safely vaccinated on a schedule similar to that of ordinary children in China. IMPACT: From our investigation, we found that the age-appropriate vaccine-specific immunization rates in children with CHD in China are low, with the lowest for diphtheria and tetanus toxoid and acellular pertussis. Refusal of community health centers to vaccinate was the primary reason for the low rates. We believe our study provides additional evidence on optimal vaccination strategies for children with CHD and it can be used to develop strategies to promote appropriate vaccination services for these children.
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Cardiopatías Congénitas , Tos Ferina , Humanos , Niño , Lactante , Estudios Transversales , Vacunación , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , HospitalesRESUMEN
BACKGROUND: Persistent itching subcutaneous granulomas related to aluminium-containing vaccines are poorly recognised in health care. They are often associated with aluminium hypersensitivity. CASE PRESENTATION: An intensely itching subcutaneous nodule appeared on the left thigh of a 17-month-old girl at the injection site for an aluminium adsorbed diphtheria-tetanus-pertussis-polio-HiB vaccine given at 3, 5 and 12 months. Ultrasound suggested a vascular malformation among other differential diagnoses. An MR investigation under general anaesthesia was planned, but the diagnosis was confirmed prior to this by a positive epicutaneous test with aluminium. INTERPRETATION: Despite a typical history of an itchy vaccination granuloma, the child underwent a thorough hospital workup to rule out malignancy. The diagnosis was delayed for two years. Vaccination granulomas have a good prognosis but can persist for many years. It is important to recognise the condition early in primary health care to avoid unnecessary anxiety and investigations.
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Aluminio , Vacuna contra Difteria, Tétanos y Tos Ferina , Aluminio/efectos adversos , Niño , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Femenino , Granuloma/inducido químicamente , Granuloma/patología , Humanos , Lactante , Prurito/patología , Vacunación/efectos adversosRESUMEN
BACKGROUND: The third dose of diphtheria-tetanus-pertussis vaccine (DTP3) is used to monitor immunization programs. DTP has been associated with higher female mortality. METHODS: We updated previous literature searches for DTP studies of mortality by sex. We examined the female/male (F/M) mortality rate ratio (MRR) with increasing number of doses of DTP and for subsequent doses of measles vaccine (MV) after DTP and of DTP after MV. RESULTS: Eight studies had information on both DTP1 and DTP3. The F/M MRR was 1.17 (95% confidence interval [CI], .88-1.57) after DTP1 and increased to 1.66 (95% CI, 1.32-2.09) after DTP3. Following receipt of MV, the F/M MRR declined to 0.63 (95% CI, .42-.96). In 11 studies the F/M MRR increased to 1.73 (95% CI, 1.33-2.27) when DTP-containing vaccine was administered after MV. CONCLUSIONS: F/M MRR increased with increasing doses of DTP. After MV, girls had lower mortality than boys. With DTP after MV, mortality increased again for girls relative to boys. No bias can explain these changes in F/M MRR. DTP does not improve male survival substantially in situations with herd immunity to pertussis and higher F/M MRR after DTP may therefore reflects an absolute increase in female mortality.
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Vacuna contra Difteria, Tétanos y Tos Ferina , Mortalidad , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Femenino , Humanos , Lactante , Masculino , Vacuna Antisarampión/efectos adversosRESUMEN
Neisseria meningitidis is a major cause of meningitis and septicaemia. A MenB vaccine (4CMenB) was licensed by the European Medicines Agency in January 2013. Here we describe the blood transcriptome and proteome following infant immunisations with or without concomitant 4CMenB, to gain insight into the molecular mechanisms underlying post-vaccination reactogenicity and immunogenicity. Infants were randomised to receive control immunisations (PCV13 and DTaP-IPV-Hib) with or without 4CMenB at 2 and 4 months of age. Blood gene expression and plasma proteins were measured prior to, then 4 h, 24 h, 3 days or 7 days post-vaccination. 4CMenB vaccination was associated with increased expression of ENTPD7 and increased concentrations of 4 plasma proteins: CRP, G-CSF, IL-1RA and IL-6. Post-vaccination fever was associated with increased expression of SELL, involved in neutrophil recruitment. A murine model dissecting the vaccine components found the concomitant regimen to be associated with increased gene perturbation compared with 4CMenB vaccine alone with enhancement of pathways such as interleukin-3, -5 and GM-CSF signalling. Finally, we present transcriptomic profiles predictive of immunological and febrile responses following 4CMenB vaccine.
Asunto(s)
Fiebre/genética , Inmunidad/genética , Vacunas Meningococicas/inmunología , Animales , Análisis Químico de la Sangre , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Femenino , Fiebre/sangre , Fiebre/epidemiología , Fiebre/etiología , Perfilación de la Expresión Génica , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Haemophilus/inmunología , Interacciones Huésped-Patógeno/genética , Interacciones Huésped-Patógeno/inmunología , Humanos , Incidencia , Lactante , Masculino , Infecciones Meningocócicas/prevención & control , Vacunas Meningococicas/efectos adversos , Ratones , Ratones Endogámicos C57BL , Análisis por Micromatrices , Vacunas Neumococicas/efectos adversos , Vacunas Neumococicas/inmunología , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vacuna Antipolio de Virus Inactivados/inmunología , Proteoma/análisis , Transcriptoma , Vacunación/efectos adversos , Vacunas Conjugadas/efectos adversos , Vacunas Conjugadas/inmunologíaRESUMEN
BACKGROUND: Globally, the use of single DTaP-IPV/Hib vaccines that combine DTaP-IPV and Hib is widespread, but in Japan vaccination is usually concomitant at separate sites. The immunogenicity and safety of a primary vaccination series and booster of a combined pentavalent DTaP-IPV/Hib vaccine were evaluated and compared to separate administration of DTaP-IPV and Hib in Japanese infants. METHODS: Healthy Japanese infants were administered DTaP-IPV/Hib (Group A: N = 207) or DTaP-IPV + Hib (Group B: N = 207) by the subcutaneous (SC) or DTaP-IPV/Hib by the intramuscular (IM) route (Group C: N = 10). All subjects received a 3-dose primary vaccination series and a booster. Non-inferiority (Group A versus Group B) was tested post-primary series and subsequent post hoc analyses were performed for anti-Hib. Safety was assessed by parental reports. RESULTS: Non-inferiority for SC administration of Group A versus Group B for the primary series was demonstrated for antibody responses to all antigens except Hib using the threshold of 1.0 µg/mL. Post hoc analyses for anti-Hib demonstrated non-inferiority for the primary series response using 0.15 µg/mL, and for pre-booster antibody persistence and the booster response using 0.15 µg/mL and 1.0 µg/mL. The immune response was similar for each antigen following SC or IM administration. There were no safety concerns in any group, and a lower incidence of injection sites for the IM route was observed as expected. CONCLUSIONS: These data show the good immunogenicity and safety profile of the DTaP-IPV/Hib vaccine as a 3-dose infant primary series followed by a booster in the second year of life in Japan.
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Cápsulas Bacterianas/inmunología , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/inmunología , Vacunas contra Haemophilus/inmunología , Inmunización Secundaria/métodos , Inmunogenicidad Vacunal , Vacuna Antipolio de Virus Inactivados/inmunología , Anticuerpos Antibacterianos/sangre , Anticuerpos Antibacterianos/inmunología , Niño , Preescolar , Difteria/inmunología , Difteria/microbiología , Difteria/prevención & control , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificación , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/efectos adversos , Femenino , Vacunas contra Haemophilus/administración & dosificación , Vacunas contra Haemophilus/efectos adversos , Haemophilus influenzae tipo b/inmunología , Voluntarios Sanos , Humanos , Esquemas de Inmunización , Incidencia , Lactante , Reacción en el Punto de Inyección/epidemiología , Reacción en el Punto de Inyección/inmunología , Inyecciones Intramusculares , Inyecciones Subcutáneas , Japón , Masculino , Meningitis por Haemophilus/inmunología , Meningitis por Haemophilus/microbiología , Meningitis por Haemophilus/prevención & control , Poliomielitis/inmunología , Poliomielitis/microbiología , Poliomielitis/prevención & control , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacuna Antipolio de Virus Inactivados/efectos adversos , Tétanos/inmunología , Tétanos/microbiología , Tétanos/prevención & control , Vacunas Conjugadas/administración & dosificación , Vacunas Conjugadas/efectos adversos , Vacunas Conjugadas/inmunología , Tos Ferina/inmunología , Tos Ferina/microbiología , Tos Ferina/prevención & controlRESUMEN
Vaccines are an essential tool for the prevention of infectious diseases. However, false ideas and rumours with no scientific foundation about their possible negative effects may dissuade people from being vaccinated, with the consequent risks for the health of the population. The objective of this article is to evaluate the origin and the arguments of some of the most frequent mistaken ideas and rumours about the possible adverse effects of vaccines. Some clearly established adverse effects are presented, as well as false beliefs about various vaccines and potential harm to health. Vaccines, like any drug, can cause adverse effects, but the possible adverse effects of vaccination programs are clearly lower than their individual (vaccinated) and collective benefits (those vaccinated and those who cannot be vaccinated for medical reasons). The possible adverse effects attributable to vaccines should be detected by powerful and well-structured pharmacovigilance systems.
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Conocimientos, Actitudes y Práctica en Salud , Inmunización/psicología , Vacunas/efectos adversos , Inmunidad Adaptativa , Asma/etiología , Trastorno del Espectro Autista/etiología , Enfermedades Autoinmunes/etiología , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Formaldehído/efectos adversos , Gastroenteritis/prevención & control , Gastroenteritis/virología , Síndrome de Guillain-Barré/etiología , Humanos , Hipersensibilidad/etiología , Inmunización/efectos adversos , Recién Nacido , Vacunas contra la Influenza/efectos adversos , Vacuna contra el Sarampión-Parotiditis-Rubéola/efectos adversos , Narcolepsia/etiología , Neoplasias/etiología , Farmacovigilancia , Vacuna Antipolio de Virus Inactivados/efectos adversos , Conservadores Farmacéuticos/efectos adversos , Infecciones por Rotavirus/prevención & control , Vacunas contra Rotavirus/efectos adversos , Timerosal/efectos adversos , Zinc/efectos adversosRESUMEN
Background: Immunization of pregnant women with tetanus-diphtheria-acellular pertussis vaccine (Tdap) provides protection against pertussis to the newborn infant. Methods: In a randomized, controlled, observer-blind, multicenter clinical trial, we measured the safety and immunogenicity of Tdap during pregnancy and the effect on the infant's immune response to primary vaccination at 2, 4, and 6 months and booster vaccination at 12 months of age. A total of 273 women received either Tdap or tetanus-diphtheria (Td) vaccine in the third trimester and provided information for the safety analysis and samples for the immunogenicity analyses; 261 infants provided serum for the immunogenicity analyses. Results: Rates of adverse events were similar in both groups. Infants of Tdap recipients had cord blood levels that were 21% higher than maternal levels for pertussis toxoid (PT), 13% higher for filamentous hemagglutinin (FHA), 4% higher for pertactin (PRN), and 7% higher for fimbriae (FIM). These infants had significantly higher PT antibody levels at birth and at 2 months and significantly higher FHA, PRN, and FIM antibodies at birth and 2 and 4 months, but significantly lower PT and FHA antibody levels at 6 and 7 months and significantly lower PRN and FIM antibody levels at 7 months than infants whose mothers received Td. Differences persisted prebooster at 12 months for all antigens and postbooster 1 month later for PT, FHA, and FIM. Conclusions: This study demonstrated that Tdap during pregnancy results in higher levels of antibodies early in infancy but lower levels after the primary vaccine series. Clinical Trials Registration: NCT00553228.
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Anticuerpos Antibacterianos/sangre , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/inmunología , Adulto , Difteria/prevención & control , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificación , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/efectos adversos , Femenino , Humanos , Recién Nacido , Embarazo , Tétanos/prevención & control , Tos Ferina/prevención & control , Adulto JovenRESUMEN
Bullous pemphigoid is the most common autoimmune blistering disorder in the elderly. It affects people aged 70 years or older. Clinically it is characterized by intensely pruritic eruption consisting of widespread tense blisters on an erythematous background. It is associated with cellular and humoral responses against hemidesmosomal components of the skin and mucous membranes. In contrast, infantile bullous pemphigoid is exceedingly rare disease and presents with some unique features like favorable prognosis, possible association with vaccination, and primary involvement of acral surfaces. Herein, we present a case of 4,5-month-old infant with neonatal pemphigoid, successfully treated with a combination of intravenous immunoglobulins and pulse methylprednisolone.
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Antiinflamatorios/uso terapéutico , Inmunoglobulinas Intravenosas/uso terapéutico , Factores Inmunológicos/uso terapéutico , Metilprednisolona/uso terapéutico , Penfigoide Ampolloso/tratamiento farmacológico , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Quimioterapia Combinada , Femenino , Vacunas contra Haemophilus/efectos adversos , Humanos , Lactante , Penfigoide Ampolloso/etiología , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vacunas Combinadas/efectos adversosRESUMEN
INTRODUCTION: Adverse events following immunization (AEFI) may follow the use of any vaccine. There is thus a need for documentation of the types and prevalence of AEFIs for each vaccine and early identification of new events or those occurring at rates higher than expected. When one vaccine replaces another, it is important to document the safety of the new vaccine as well as compare to that of the old. In this study, we aimed to document the AEFIs following the use of pentavalent vaccine recently introduced into the National Programme on Immunization and compare with those of diphtheria-tetanus-pertussis (DTwP) vaccine which it replaced. METHODS: This was a retrospective cohort study on infants with at least 2 immunization visits who commenced immunization between June 2011 and May 2013 at the Child Welfare Clinic of Institute of Child Health, University of Benin, Nigeria. At every visit for immunization, the caregiver is asked about any reaction that followed the previous immunization, and this is documented in immunization registers which data were reviewed for this study. RESULTS: There were 2475 doses of DTwP and pentavalent vaccines administered to 946 children. Adverse events following immunizations were reported following 487 (19.7%) doses. The prevalence of AEFIs following pentavalent vaccine (22.1%) was significantly higher than that following DTwP (13.5%) P < .0001. Significantly more AEFIs followed the first dose of either vaccine compared to subsequent doses P < .0001. The commonest AEFI reported for either vaccine was fever. CONCLUSION: Adverse events following immunization following pentavalent vaccine although higher than that following DTwP was within expected levels.
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Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Vacunas contra Hepatitis B/efectos adversos , Vacunación/efectos adversos , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Femenino , Vacunas contra Hepatitis B/administración & dosificación , Humanos , Esquemas de Inmunización , Lactante , Masculino , Nigeria/epidemiología , Estudios Retrospectivos , Vacunación/métodosRESUMEN
PURPOSE: The need to develop methods for studying the safety of childhood immunization schedules has been recognized by the Institute of Medicine and Department of Health and Human Services. The recommended childhood immunization schedule includes multiple vaccines in a visit. A key concern is safety of concomitant (same day) versus separate day vaccination. This paper addresses a methodological challenge for observational studies using a self-controlled design to investigate the safety of concomitant vaccination. METHODS: We propose a process for distinguishing which of several concomitantly administered vaccines is responsible for increased risk of an adverse event while adjusting for confounding due to relationships between effect modifying risk factors and concomitant vaccine combinations. We illustrate the approach by re-examining the known increase in risk of seizure 7 to 10 days after measles-mumps-rubella (MMR) vaccination and evaluating potential independent or modifying effects of other vaccines. RESULTS: Initial analyses suggested that DTaP had both an independent and potentiating effect on seizure. After accounting for the relationship between age at vaccination and vaccine combination, there was little evidence for increased risk of seizure with same day administration of DTaP and MMR; incidence rate ratio, 95% confidence interval 1.2 (0.9-1.6), P value = θ.226. CONCLUSION: We have shown that when using a self-controlled design to investigate safety of concomitant vaccination, it can be critically important to adjust for time-invariant effect modifying risk factors, such as age at time of vaccination, which are structurally related to vaccination patterns due to recommended immunization schedules.
Asunto(s)
Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Esquemas de Inmunización , Vacuna contra el Sarampión-Parotiditis-Rubéola/efectos adversos , Convulsiones/epidemiología , Vacunación/efectos adversos , Factores de Edad , Factores de Confusión Epidemiológicos , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Registros Electrónicos de Salud/estadística & datos numéricos , Femenino , Humanos , Lactante , Masculino , Vacuna contra el Sarampión-Parotiditis-Rubéola/administración & dosificación , Estudios Observacionales como Asunto/métodos , Proyectos de Investigación , Convulsiones/inducido químicamente , Factores de Tiempo , Vacunación/métodosRESUMEN
BACKGROUND: The new combination of DTwP-HB-Hib vaccines has been developed in Indonesia following World Health Organization (WHO) recommendation and integrated into national immunization program. The aims of the study were to measure 1) antibody persistence 12-18 months after a primary series, 2) immune response and safety after a booster dose of DTwP-HB-Hib. METHODS: This was a multi-center, open-labeled, prospective, interventional study. Subjects who had received complete primary dose of DTwP-HB-Hib vaccine from the previous phase III trial were recruited in this trial. Subjects were given one dose of DTwP-HB-Hib (Pentabio®) booster at age 18-24 months old. Diphtheria, tetanus, pertussis, hepatitis B, Hemophilus influenza type B antibodies were measured before and after booster to determine antibody persistence and immune response. Vaccine adverse events were assessed immediately and monitored until 28 days after the booster recorded with parent's diary cards. RESULTS: There were 396 subjects who completed the study. Increased proportion of seroprotected subjects from pre-booster to post-booster were noted in all vaccine antigens: 74.5 to 99.7% for diphtheria; 100 to 100% for tetanus; 40.4 to 95.5% for pertussis; 90.2 to 99.5% for hepatitis B; and 97.7 to 100% for Hib. Common systemic adverse events (AEs) were irritability (23.7-25%) and fever (39.9-45.2%). Local AEs such as redness, swelling, and induration were significantly less common in the thigh group (7.7, 11.3, and 7.1%) than in the deltoid group (28.9, 30.7, and 25%) (P < 0.001). Most AEs were mild and resolved spontaneously within three-day follow-up period. CONCLUSIONS: Booster of DTwP-HB-Hib vaccine at age 18-24 months is required to achieve and maintain optimal protective antibody. The vaccine is safe and immunogenic to be used for booster vaccination. TRIAL REGISTRATION: NCT02095314 (retrospectively registered, March 24, 2014).
Asunto(s)
Formación de Anticuerpos/inmunología , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Vacunas contra Haemophilus/inmunología , Vacunas contra Hepatitis B/inmunología , Inmunización Secundaria , Vacunación , Niño , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Edema/etiología , Femenino , Fiebre/etiología , Estudios de Seguimiento , Vacunas contra Haemophilus/administración & dosificación , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Hepatitis B/administración & dosificación , Vacunas contra Hepatitis B/efectos adversos , Humanos , Inmunización Secundaria/efectos adversos , Lactante , Masculino , Estudios Prospectivos , Vacunación/efectos adversosRESUMEN
Persistent itching nodules related to aluminium-adsorbed vaccines are well known in children with frequent positive patch tests to aluminium when tested. We report two cases of children with persistent postvaccination nodules who presented with atypical eruptions after aluminium patch tests.
Asunto(s)
Aluminio/efectos adversos , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Hepatitis B/efectos adversos , Vacuna Neumocócica Conjugada Heptavalente/efectos adversos , Vacuna Antipolio de Virus Inactivados/efectos adversos , Prurito/etiología , Aluminio/inmunología , Exantema/etiología , Femenino , Humanos , Lactante , Pruebas del Parche/métodos , Vacunas Combinadas/efectos adversosRESUMEN
Immune Thrombocytopenia Purpura (ITP) secondary to vaccinations is rare, especially after autologous hematopoietic stem cell transplantation (HSCT). A 31-yearold female received autologous HSCT for relapsed Hodgkin Disease, with platelet engraftment at Day+14. One week after receiving second scheduled vaccinations, she developed severe thrombocytopenia (3x109/L) associated with pharyngeal hematoma. Bone marrow (BM) examinations were consistent with ITP, possibly secondary to Influenza vaccine. Platelet increment was poor despite high dose corticosteroids, intravenous immunoglobulin (IVIG), Danazol and Eltrombopag. A repeated BM biopsy was in agreement with ITP. Re-treatment with tapering doses of prednisolone resulted in stable platelet counts at 120x109/L a year later.
Asunto(s)
Trasplante de Células Madre Hematopoyéticas/efectos adversos , Púrpura Trombocitopénica Idiopática/etiología , Vacunas/efectos adversos , Adulto , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Femenino , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Hepatitis B/efectos adversos , Enfermedad de Hodgkin/cirugía , Humanos , Vacunas contra la Influenza/efectos adversos , Vacunas Neumococicas/efectos adversos , Trasplante Autólogo/efectos adversosRESUMEN
BACKGROUND: Nowadays whooping cough (pertussis) represents one of the most prevalent vaccine-preventable diseases in Western countries; even more, it is currently on rise. In many countries, the use of acellular pertussis adult vaccine in combination with tetanus and diphtheria toxoids (Tdap) is recommended for women during pregnancy to protect newborns in the first months of life, when they are too young to be vaccinated. In Italy, vaccination of women during the third trimester of pregnancy is included in the national immunization programme (PNPV 2017-2019), though up to now, this vaccination strategy has not been efficiently implemented. OBJECTIVE: In view of the public health importance of pertussis, particularly in young infants, we undertook this review to summarise the existing evidence on immunogenicity, effectiveness, safety and uptake of pertussis vaccine in expectant mothers to protect newborns from pertussis. CONCLUSION: There is an increasing evidence that supports the safety, immunogenicity and effectiveness of Triaxis® e Boostrix® pertussis vaccination during pregnancy to protect infants before they receive their primary immunisations. In particular, both vaccines showed 90% effectiveness in the reduction of pertussis disease and hospitalization in newborns, with 95% effectiveness in the reduction of deaths. In Italy, the implementation of antenatal vaccination against pertussis is needed to narrow the gap between the recommendation of the PNPV and the prevention strategies actually offered by the public health system. To reach a good level of vaccine coverage, providers' recommendations are critical. Hence, extensive education of vaccine givers and all primary and secondary healthcare professionals who have any contact with pregnant women is needed.
Asunto(s)
Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Vacunación/métodos , Tos Ferina/prevención & control , Adulto , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificación , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/efectos adversos , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/inmunología , Femenino , Humanos , Programas de Inmunización , Inmunogenicidad Vacunal , Recién Nacido , Enfermedades del Recién Nacido/microbiología , Enfermedades del Recién Nacido/prevención & control , Italia , Embarazo , Tercer Trimestre del Embarazo , Vacunación/efectos adversos , Tos Ferina/inmunologíaRESUMEN
BACKGROUND: The most important factors that affect the incidence of vaccine-related complications are the constituent biological components of the vaccine, injection site reactions, age and sex. The aim of this study is to determine the incidence rate of adverse events following immunization with pentavalent vaccine (DTPw-Hep B-Hib (PRP-T) vaccine (pentavac) (adsorbed) is manufactured by Serum Institute of India ltd), which was introduced in Iran in November 2014. It is important to monitor vaccine-related adverse events because of the role of vaccine safety in immunization program success. METHODS: This study was a mixed cohort study that included 1119 children less than 1 year of age. In 2015, the children were referred to Hamadan health centers to receive pentavalent vaccine at 2, 4 and 6 months of age. The data were collected from the parents of the children using a questionnaire that was administered either face-to-face or by telephone. The cumulative incidence of side effects and risk ratio was reported with 95% confidence intervals (CI). Chi-squared tests and logistic regressions were used to investigate the association between the variables. RESULTS: The cumulative incidence rate of pentavalent-related adverse events during 48 h following immunization was estimated to be 15.8% for swelling, 10.9% for redness, 44.2% for pain, 12.6% for mild fever, 0.1% for high fever, 20.0% for drowsiness, 15.0% for loss of appetite, 32.9% for irritability, 4.6% for vomiting and 5.5% for persistent crying. There is no evidence for the occurrence of convulsion and encephalopathy among children who receive pentavalent vaccines. CONCLUSION: Further large studies with long time follow up are required to address rare events include convulsions, encephalopathy or persistent crying. However, Findings urge immunization programs to use pentavalent vaccinations and to continue implementing the current immunization program in children under 1 year of age.
Asunto(s)
Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacunas contra Haemophilus/efectos adversos , Programas de Inmunización/estadística & datos numéricos , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vacunación/efectos adversos , Factores de Edad , Estudios de Cohortes , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Relación Dosis-Respuesta Inmunológica , Femenino , Vacunas contra Haemophilus/administración & dosificación , Humanos , Incidencia , Lactante , Recién Nacido , Irán , Masculino , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Encuestas y Cuestionarios , Vacunación/estadística & datos numéricos , Vacunas Combinadas/administración & dosificación , Vacunas Combinadas/efectos adversosRESUMEN
PURPOSE: In March 1992, eight infants who had died within 36 hours of receiving whole-cell pertussis vaccine (diphtheria, tetanus, and whole-cell pertussis [DTwP]) prompted the Taiwan health authorities to suspend its use. We conducted an investigation of vaccination and sudden unexplained infant death (SUID) and repeated it more recently after Taiwan switched to acellular pertussis vaccine (diphtheria, tetanus, and acellular pertussis [DTaP]) in 2010. METHODS: All SUIDs aged 31-364 days during 1990-1992 and 1996-2013 were selected from the death registration databases. The case-control investigation matched each case to two controls on clinic, sex, and birth date, whereas the follow-up self-controlled case series study compared risk of death during the 30-day post-vaccination risk periods with those in the control periods within the same case. RESULTS: Sudden unexplained infant death was associated with never receiving DTwP (odds ratio 2.28, 95% confidence interval 1.25-4.15) in the case-control investigation. The odds ratios within 0-1, 2-7, 8-14, and 15-30 days of DTwP administration were 1.18, 0.26, 0.50, and 0.77. In the 1996-2013 self-controlled case series studies, this temporal shift between DTwP and SUID was consistently observed for female (incidence rate ratio 1.70, 0.75, 1.01, and 0.84) but not male or DTaP recipients. A pooled analysis showed significant risk within 2 days of receiving DTwP in female infants (incidence rate ratio 1.66, 95% confidence interval 1.05-2.60). CONCLUSIONS: Being unvaccinated and recent receipt of DTwP in female infants was significantly associated with SUID; the latter was consistent with a temporal shift pattern without overall increase in risk. The currently used pertussis vaccine, DTaP, did not increase risk of SUID. Copyright © 2016 John Wiley & Sons, Ltd.
Asunto(s)
Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificación , Muerte Súbita del Lactante/epidemiología , Estudios de Casos y Controles , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Lactante , Masculino , Riesgo , Muerte Súbita del Lactante/etiología , Taiwán/epidemiología , Factores de Tiempo , Vacunación/efectos adversos , Vacunación/métodosRESUMEN
In 2011, the 7-valent conjugated pneumococcal vaccine (PCV7) was replaced by the 10-valent vaccine (PCV10) and universal hepatitis B vaccination has been introduced in the Netherlands. A questionnaire study was conducted to assess the tolerability of DTaP-IPV-Hib + PCV7 (PCV7-cohort), DTaP-IPV-Hib + PCV10 (PCV10-cohort), and DTaP-IPV-Hib-HepB + PCV10 (HepB-cohort). Parents were asked to report in questionnaires local reactions and systemic adverse events (AEs) before and after vaccination of their infant at 2, 3, 4, and 11 months of age. For 29.0 and 29.4% infants of the PCV7-cohort, at least one local reaction was reported in the week after the first dose of DTaP-IPV (left leg) and PCV-7 vaccination (right leg). Significantly more infants from the PCV10-cohort (45.1%, p < 0.001 and 44.6%, p < 0.001) and HepB-cohort (42.6%, p < 0.001 and 41.9%, p < 0.001) reported at least one local reaction. This effect was less pronounced after the successive doses. Most of the infants experienced at least one systemic AE, and after dose 4, this was higher for infants in the PCV10-cohort (65.9%, p = 0.047) and HepB-cohort (70.6%, p = 0.000) compared to the PCV7-cohort (62.3%). CONCLUSION: Addition of antigens to a vaccine resulted in a higher reactogenicity, but the AEs were in general mild and transient. What is Known: ⢠Assessment of adverse events is crucial for achieving the highest safety in immunization programs, in order to inform public health actions and maintain public confidence in immunization programs. What is New: ⢠Newly introduced vaccines DTaP-IPV-Hib-HepB and PCV10 are generally safe and well tolerated in infants. ⢠These results are useful for information purposes and for monitoring variations in rates of AEs in the general population or in the target group over time.