RESUMEN
BACKGROUND: Optic neuritis (ON) is an inflammatory demyelinating condition of the optic nerve, with various causes. Its incidence is higher in children and young adults than in older adults of both genders, but is more common in women than in men. ON is rarely associated with mydriasis, and it is seldom triggered by vaccines against tetanus and diphtheria. CASE REPORT: A 36-year-old Caucasian woman presented with bilateral ON that had started 18 days after administration of a booster dose of the double adult vaccine (dT) against diphtheria and tetanus. Bilateral mydriasis persisted after treatment and clinical resolution of the ON. She experienced severe headache, blurred vision, decreased visual acuity in the right eye and bilateral mydriasis, a diagnosis confirmed by imaging tests. Treatment with oral corticosteroids resulted in rapid resolution of the neuritis; however, mydriasis persisted for several months. CONCLUSION: This study describes a very unusual case of bilateral ON associated with prolonged mydriasis after vaccination against tetanus and diphtheria that regressed after treatment with oral corticosteroids. Prolonged mydriasis was the manifestation that differed from the other cases previously described.
Asunto(s)
Midriasis , Neuritis Óptica , Humanos , Neuritis Óptica/inducido químicamente , Neuritis Óptica/etiología , Femenino , Adulto , Midriasis/inducido químicamente , Midriasis/etiología , Vacunación/efectos adversos , Resultado del Tratamiento , Vacuna contra Difteria y Tétanos/efectos adversosRESUMEN
BACKGROUND: Although the combination tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) is recommended at adolescence in developed countries, the tetanus and diphtheria toxoid vaccine (Td), which is less costly, is recommended instead in some parts of the world. A new Td, BR-TD-1001, was developed by a Korean manufacturer for distribution to endemic regions and for use in the initial step of novel Tdap development. METHODS: This phase 3, randomized, double-blind, multi-center trial, conducted in Korea, aimed to evaluate the immunogenicity and safety of BR-TD-1001. Healthy children aged 10 to 12 years were randomized 1:1 to receive either BR-TD-1001 or the control Td (Td-pur, GlaxoSmithKline). Antibodies were measured using enzyme-linked immunosorbent assay. RESULTS: A total of 218 subjects (BR-TD-1001, n = 108; control, n = 110) were enrolled and included in the safety analysis. Vaccine-mediated antibody responses were similar in both groups. We confirmed the non-inferiority of BR-TD-1001 against the control, Td; 100% of both groups achieved seroprotection against diphtheria and tetanus. Furthermore, there was no significant difference between groups in the proportion of participants who demonstrated boost responses against diphtheria and tetanus toxoids. The incidence of solicited local and systemic adverse events (AEs), unsolicited AEs, and serious AEs did not differ significantly between groups. CONCLUSION: The BR-TD-1001 satisfied the immunological non-inferiority criterion against diphtheria and tetanus, with a clinically acceptable safety profile. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04618939.
Asunto(s)
Vacuna contra Difteria y Tétanos/inmunología , Difteria/prevención & control , Tétanos/prevención & control , Anticuerpos Antibacterianos/sangre , Formación de Anticuerpos , Niño , Difteria/inmunología , Vacuna contra Difteria y Tétanos/administración & dosificación , Vacuna contra Difteria y Tétanos/efectos adversos , Método Doble Ciego , Ensayo de Inmunoadsorción Enzimática , Eritema/etiología , Femenino , Humanos , Masculino , Dolor/etiología , Dolor/patología , República de Corea , Tétanos/inmunologíaRESUMEN
The diversity of B cell subsets and their contribution to vaccine-induced immunity in humans are not well elucidated but hold important implications for rational vaccine design. Prior studies demonstrate that B cell subsets distinguished by immunoglobulin (Ig) isotype expression exhibit divergent activation-induced fates. Here, the antigen-specific B cell response to tetanus toxoid (TTd) booster vaccination was examined in healthy adults, using a dual-TTd tetramer staining flow cytometry protocol. Unsupervised analyses of the data revealed that prior to vaccination, IgM-expressing CD27+ B cells accounted for the majority of TTd-binding B cells. 7 days following vaccination, there was an acute expansion of TTd-binding plasmablasts (PB) predominantly expressing IgG, and a minority expressing IgA or IgM. Frequencies of all PB subsets returned to baseline at days 14 and 21. TTd-binding IgG+ and IgA+ memory B cells (MBC) exhibited a steady and delayed maximal expansion compared to PB, peaking in frequencies at day 14. In contrast, the number of TTd-binding IgM+IgD+CD27+ B cells and IgM-only CD27+ B cells remain unchanged following vaccination. To examine TTd-binding capacity of IgG+ MBC and IgM+IgD+CD27+ B cells, surface TTd-tetramer was normalised to expression of the B cell receptor-associated CD79b subunit. CD79b-normalised TTd binding increased in IgG+ MBC, but remained unchanged in IgM+IgD+CD27+ B cells, and correlated with the functional affinity index of plasma TTd-specific IgG antibodies, following vaccination. Finally, frequencies of activated (PD-1+ICOS+) circulating follicular helper T cells (cTFH), particularly of the CXCR3-CCR6- cTFH2 cell phenotype, at their peak expansion, strongly predicted antigen-binding capacity of IgG+ MBC. These data highlight the phenotypic and functional diversity of the B cell memory compartment, in their temporal kinetics, antigen-binding capacities and association with cTFH cells, and are important parameters for consideration in assessing vaccine-induced immune responses.
Asunto(s)
Vacuna contra Difteria y Tétanos/administración & dosificación , Inmunización Secundaria , Inmunoglobulinas/sangre , Memoria Inmunológica/efectos de los fármacos , Células B de Memoria/efectos de los fármacos , Toxina Tetánica/administración & dosificación , Antígenos CD79/metabolismo , Vacuna contra Difteria y Tétanos/efectos adversos , Vacuna contra Difteria y Tétanos/inmunología , Voluntarios Sanos , Humanos , Proteína Coestimuladora de Linfocitos T Inducibles/metabolismo , Células B de Memoria/inmunología , Células B de Memoria/metabolismo , Fenotipo , Receptor de Muerte Celular Programada 1/metabolismo , Células T Auxiliares Foliculares/inmunología , Células T Auxiliares Foliculares/metabolismo , Toxina Tetánica/efectos adversos , Toxina Tetánica/inmunología , Miembro 7 de la Superfamilia de Receptores de Factores de Necrosis Tumoral/metabolismoAsunto(s)
Vacuna contra Difteria y Tétanos/efectos adversos , Pitiriasis Liquenoide/etiología , Pitiriasis Liquenoide/patología , Corticoesteroides/uso terapéutico , Adulto , Antimetabolitos/uso terapéutico , Epidermis/patología , Humanos , Masculino , Necrosis , Pitiriasis Liquenoide/tratamiento farmacológicoAsunto(s)
Humanos , Masculino , Adulto , Pitiriasis Liquenoide/etiología , Pitiriasis Liquenoide/patología , Vacuna contra Difteria y Tétanos/efectos adversos , Pitiriasis Liquenoide/tratamiento farmacológico , Corticoesteroides/uso terapéutico , Epidermis/patología , Necrosis , Antimetabolitos/uso terapéuticoRESUMEN
OBJECTIVES: We aimed to assess the safety and immunogenicity of a diphtheria/tetanus vaccine booster dose in three different patient groups with rheumatic diseases on a variety of immunosuppressive/immunomodulatory medications compared with healthy controls (HCs). METHODS: We conducted a multi-centre prospective cohort study in Switzerland. We enrolled patients with RA, axial SpA/PsA, vasculitis (Behçet's disease, ANCA-associated vasculitis) and HCs. Diphtheria/tetanus vaccination was administered according to the Swiss vaccination recommendations. Blood samples were drawn before vaccination, and 1 month and 3 months afterwards. Antibody concentrations against vaccine antigens were measured by ELISA. Immunogenicity was compared between patient and medication groups. A mixed model was applied for multivariate analysis. Missing data were dealt with using multiple imputation. RESULTS: Between January 2014 and December 2015, we enrolled 284 patients with rheumatic diseases (131 RA, 114 SpA/PsA, 39 vasculitis) and 253 HCs. Of the patients, 89% were on immunosuppressive/immunomodulatory medication. Three months post-vaccination 100% of HCs vs 98% of patients were protected against tetanus and 84% vs 73% against diphtheria. HCs and SpA/PsA patients had significantly higher responses than RA and vasculitis patients. Assessing underlying diseases and medications in a multivariate model, rituximab was the only factor negatively influencing tetanus immunogenicity, whereas only MTX treatment had a negative influence on diphtheria antibody responses. No vaccine-related serious adverse events were recorded. CONCLUSION: Diphtheria/tetanus booster vaccination was safe. Tetanus vaccination was immunogenic; the diphtheria component was less immunogenic. Vaccine responses were blunted by rituximab and MTX. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, Identifier: NCT01947465.
Asunto(s)
Anticuerpos Antibacterianos/biosíntesis , Vacuna contra Difteria y Tétanos/efectos adversos , Inmunogenicidad Vacunal/efectos de los fármacos , Enfermedades Reumáticas/inmunología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Clostridium tetani/inmunología , Corynebacterium diphtheriae/inmunología , Difteria/prevención & control , Vacuna contra Difteria y Tétanos/inmunología , Femenino , Humanos , Inmunización Secundaria , Inmunogenicidad Vacunal/inmunología , Inmunosupresores/farmacología , Inmunosupresores/uso terapéutico , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Enfermedades Reumáticas/tratamiento farmacológico , Tétanos/prevención & control , Vacunación , Adulto JovenRESUMEN
BACKGROUND: When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction. METHODS: Subjects aged ≥50 years were randomized 1:1:1 to receive tetanus-diphtheria (Td) + 13-valent pneumococcal conjugate vaccine (PCV13; Group 1), PCV13 alone (Group 2), or Td alone (Group 3). After single or concomitant vaccination, enzyme-linked immunosorbent assay and opsonophagocytic assay (OPA) were performed to compare immunogenicity for Td and PCV13, respectively. RESULTS: A total of 448 subjects were available for the assessment. After concomitant administration, the non-inferiority criteria of geometric mean titer (GMT) ratios were met for tetanus, diphtheria, and all four pneumococcal serotypes (1, 5, 18C, and 19A). However, subjects in Group 3 (Td alone) were more likely to have a high IgG anti-tetanus antibody titer (≥ 0.5 U/mL) than those in Group 1 (Td + PCV13) (p < 0.01). As for the pneumococcal serotype 1, the OPA GMT was significantly higher in Group 1 (PCV13 + Td) compared to Group 2 (PCV13 alone) (p = 0.02). No serious adverse event occurred. CONCLUSIONS: Concomitant Td and PCV13 administration induced sufficient immunity without significant interference and showed good safety profiles. TRIALS REGISTRATION: NCT03552445 registered at http://www.clinicaltrials.gov on June 11, 2018 (retrospectively registered).
Asunto(s)
Vacuna contra Difteria y Tétanos , Difteria/prevención & control , Inmunogenicidad Vacunal , Infecciones Neumocócicas/prevención & control , Vacunas Neumococicas , Tétanos/prevención & control , Vacunación/métodos , Adulto , Anciano , Anciano de 80 o más Años , Vacuna contra Difteria y Tétanos/administración & dosificación , Vacuna contra Difteria y Tétanos/efectos adversos , Vacuna contra Difteria y Tétanos/inmunología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Vacunas Neumococicas/administración & dosificación , Vacunas Neumococicas/efectos adversos , Vacunas Neumococicas/inmunología , Estudios Retrospectivos , Streptococcus pneumoniae/inmunología , Vacunas Conjugadas/administración & dosificación , Vacunas Conjugadas/efectos adversos , Vacunas Conjugadas/inmunologíaRESUMEN
In our systematic research we identified four studies concerning the onset of neurological adverse events following vaccination and two excluding this association. A 33-year-old Italian man, belonging to the Italian Army was hospitalized because he suffered from vertigo, nausea and sudden right hearing loss not classified (NDD), that set in 24 h after the administration of tetanus-diphtheria and meningococcal vaccines. Some neurological events arising after vaccination are very difficult to treat. In our case, the functional recovery on low and medium frequencies was possible about 6 months after the morbid event.
Asunto(s)
Vacuna contra Difteria y Tétanos/efectos adversos , Pérdida Auditiva Sensorineural/etiología , Pérdida Auditiva Súbita/etiología , Vacunas Meningococicas/efectos adversos , Vacunación/efectos adversos , Adulto , Humanos , MasculinoRESUMEN
In light of waning immunity to pertussis following receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine, maintaining protection may require repeated Tdap vaccination. We evaluated the safety of repeated doses of tetanus-containing vaccine in 68 915 nonpregnant adolescents and adults in the Vaccine Safety Datalink population who had received an initial dose of Tdap. Compared with 7521 subjects who received a subsequent dose of tetanus toxoid, reduced diphtheria (Td) vaccine, the 61 394 subjects who received a subsequent dose of Tdap did not have significantly elevated risk of medical visits for seizure, cranial nerve disorders, limb swelling, pain in limb, cellulitis, paralytic syndromes, or encephalopathy/encephalitis/meningitis. These results suggest that repeated Tdap vaccination has acceptable safety relative to Tdap vaccination followed by Td vaccination.
Asunto(s)
Vacuna contra Difteria y Tétanos/efectos adversos , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/efectos adversos , Esquemas de Inmunización , Vacunación/efectos adversos , Adolescente , Adulto , Encefalopatías/inducido químicamente , Encefalopatías/epidemiología , Celulitis (Flemón)/inducido químicamente , Celulitis (Flemón)/epidemiología , Niño , Enfermedades de los Nervios Craneales/inducido químicamente , Enfermedades de los Nervios Craneales/epidemiología , Difteria/prevención & control , Vacuna contra Difteria y Tétanos/administración & dosificación , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificación , Extremidades , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Dolor Musculoesquelético/inducido químicamente , Dolor Musculoesquelético/epidemiología , Parálisis/inducido químicamente , Parálisis/epidemiología , Convulsiones/inducido químicamente , Convulsiones/epidemiología , Tétanos/prevención & control , Estados Unidos/epidemiología , Vacunación/métodos , Tos Ferina/prevención & control , Adulto JovenRESUMEN
Objectives: Pneumococcal, tetanus and influenza vaccinations are recommended for patients with cryopyrin-associated periodic syndromes (CAPS) when treated with immunosuppressive medication. The aim of this publication is to report the safety of pneumococcal and other vaccinations in CAPS patients. Methods: All CAPS patients followed in the ß-CONFIDENT (Clinical Outcomes and Safety Registry study of Ilaris patients) registry were analysed if they had received a vaccination. The ß-CONFIDENT registry is a global, long-term, prospective, observational registry, capturing and monitoring patients treated with canakinumab. Results: Sixty-eight CAPS patients had received a total of 159 vaccine injections, 107 injections against influenza, 19 pneumococcal vaccinations, 12 against tetanus/diphtheria antigens and 21 other vaccinations. Fourteen per cent of injections had elicited at least one vaccine reaction. All five vaccine-related serious adverse events were associated with pneumococcal vaccination. Vaccine reactions were observed in 70% of pneumococcal vaccinations, compared with 7% in influenza and 17% in tetanus/diphtheria vaccinations. The odds ratios to react to the pneumococcal vaccines compared with influenza and tetanus/diphtheria vaccines were 31.0 (95% CI: 8, 119) and 10.8 (95% CI: 2, 74). Vaccine reactions after pneumococcal vaccinations were more severe and lasted significantly longer (up to 3 weeks) compared with other vaccinations. In two patients, pneumococcal vaccination also elicited symptoms consistent with systemic inflammation due to CAPS reactivation. Conclusion: Pneumococcal vaccines, unlike other vaccines, frequently trigger severe local and systemic inflammation in CAPS patients. Clinicians must balance potential benefits of pneumococcal immunization against safety concerns. The 13-valent pneumococcal conjugate vaccine might be favourable over the polysaccharide vaccine in CAPS patients.
Asunto(s)
Síndromes Periódicos Asociados a Criopirina/complicaciones , Infecciones Oportunistas/complicaciones , Vacunación/efectos adversos , Adolescente , Adulto , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales/uso terapéutico , Anticuerpos Monoclonales Humanizados , Síndromes Periódicos Asociados a Criopirina/tratamiento farmacológico , Síndromes Periódicos Asociados a Criopirina/inmunología , Vacuna contra Difteria y Tétanos/efectos adversos , Femenino , Humanos , Inmunosupresores/efectos adversos , Inmunosupresores/uso terapéutico , Vacunas contra la Influenza/efectos adversos , Masculino , Persona de Mediana Edad , Infecciones Oportunistas/prevención & control , Vacunas Neumococicas/efectos adversos , Estudios Prospectivos , Sistema de Registros , Seguridad , Adulto JovenRESUMEN
BACKGROUND/PURPOSE: A new reduced-dose tetanus-diphtheria (Td) vaccine was developed in Korea, and phase I and II clinical trials were successfully undertaken. We conducted this double-blind, randomized, multicenter phase III clinical trial to assess the immunogenicity and safety of the new Td vaccine. METHODS: Healthy adolescents 11-12 years of age were enrolled and randomized to receive the new Td vaccine (study group) or a commercially available Td vaccine (control group). Blood samples were collected prior to and 4 weeks after the vaccination. Between the study and control groups, seroprotection rate, booster response, and geometric mean titer of antibodies against diphtheria and tetanus toxoids were compared after the vaccination. All solicited and unsolicited adverse events and serious adverse events during the 6-week study period were monitored. RESULTS: A total of 164 adolescents received vaccination, and 156 of them were evaluated to assess immunogenicity. The seroprotection rate and geometric mean titer for antibodies against diphtheria were significantly higher in the study group, whereas those against tetanus were significantly higher in the control group. However, all seroprotection rates against diphtheria and tetanus in the study and control groups were high: 100% against diphtheria and tetanus in the study group, and 98.7% against diphtheria and 100% against tetanus in the control group. No significant differences in the frequency of solicited and unsolicited adverse events were observed between the two vaccine groups. CONCLUSION: The new Td vaccine is highly immunogenic and safe, and this new Td vaccine can be effectively used for preventing diphtheria and tetanus.
Asunto(s)
Vacuna contra Difteria y Tétanos/administración & dosificación , Vacuna contra Difteria y Tétanos/inmunología , Difteria/prevención & control , Tétanos/prevención & control , Vacunación/métodos , Adolescente , Anticuerpos Antibacterianos/sangre , Niño , Difteria/inmunología , Toxoide Diftérico/inmunología , Vacuna contra Difteria y Tétanos/efectos adversos , Vacuna contra Difteria y Tétanos/sangre , Método Doble Ciego , Femenino , Humanos , Inmunogenicidad Vacunal/inmunología , Inyecciones Intramusculares , Masculino , República de Corea , Tétanos/inmunología , Toxoide Tetánico/inmunología , Resultado del TratamientoRESUMEN
Revaxis(®) is a vaccine against diphtheria, tetanus and poliomyelitis (dT-IPV). This vaccine should not be administered by the intradermal or intravenous route. Poor injection techniques and related consequences are rare. We report a case of bursitis associated with reactive glenohumeral effusion complicated by bone erosion occurring after injection of the dT-IPV vaccine. A 26 year old patient was admitted for painful left shoulder causing functional impairment. Control magnetic resonance imaging showed bone oedema on the upper outer part of the humeral head, with a slight cortical irregularity, indicating that the vaccine was injected in contact with the bone at this location, causing erosion. Outcome was favourable after intra-articular corticosteroids. Reports of articular or periarticular injury after vaccination are extremely rare, in view of the substantial number of vaccines administered every year. The potential complications of vaccination are well known to general practitioners but under-reported in the literature.
Asunto(s)
Resorción Ósea/inducido químicamente , Resorción Ósea/epidemiología , Bursitis/inducido químicamente , Bursitis/epidemiología , Vacuna contra Difteria y Tétanos/efectos adversos , Vacuna Antipolio de Virus Inactivados/efectos adversos , Adulto , Vacuna contra Difteria y Tétanos/administración & dosificación , Femenino , Humanos , Húmero/patología , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Articulación del Hombro/patología , Vacunas Combinadas/administración & dosificación , Vacunas Combinadas/efectos adversosRESUMEN
BR-TD-1001 was developed as a booster for the immunity maintenance of diphtheria and tetanus. The aim of this study was to evaluate the safety and immunogenicity of BR-TD-1001 (test vaccine) in comparison with placebo and an active comparator in healthy Korean adults. A randomized, double-blind, placebo-controlled, active comparator, phase I clinical trial was conducted. Fifty subjects were randomly assigned to one of 3 treatment groups in a ratio of 2:2:1, and were administered a single intramuscular dose of test vaccine, active comparator, or placebo, respectively. All subjects were monitored for 4 weeks after injection. The antibody titers of the patients 2 and 4 weeks after vaccination were compared with the baseline. The frequencies of all adverse events including adverse drug reactions in the test group were not statistically different from those of the other treatment groups (P = 0.4974, 0.3061). No serious adverse event occurred, and no subject was withdrawn from the study for safety. The seroprotection rates against both tetanus and diphtheria at 4 weeks after vaccination were over 0.95. For anti-tetanus antibody, the geometric mean titer in the test group was significantly higher than those of the other groups (P = 0.0364, 0.0033). The geometric mean titer of anti-diphtheria antibody in the test group was significantly higher than the value of the placebo (P = 0.0347) while it was not for the value of the active comparator (P = 0.8484). In conclusion, BR-TD-1001 was safe, well-tolerated, and showed sufficient immunogenicity as a booster for diphtheria and tetanus.
Asunto(s)
Toxoide Diftérico/efectos adversos , Toxoide Diftérico/inmunología , Vacuna contra Difteria y Tétanos/efectos adversos , Vacuna contra Difteria y Tétanos/inmunología , Inmunización Secundaria/métodos , Toxoide Tetánico/efectos adversos , Toxoide Tetánico/inmunología , Adulto , Anticuerpos Antibacterianos/sangre , Antitoxinas/sangre , Pueblo Asiatico , Toxoide Diftérico/administración & dosificación , Vacuna contra Difteria y Tétanos/administración & dosificación , Método Doble Ciego , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/patología , Voluntarios Sanos , Humanos , Inyecciones Intramusculares , Masculino , Placebos/administración & dosificación , Toxoide Tetánico/administración & dosificación , Resultado del Tratamiento , Adulto JovenRESUMEN
INTRODUCTION: This follow-up study assessed the 5-year persistence of vaccine-induced antibodies (Td-IPV or DT-IPV) and the immune response to a booster dose of DTaP-IPV. METHODS: This was an open-label, parallel-group (two arms), multicentre trial performed at 44 study sites in France. Children aged 11-13 years, of either sex, who received Td-IPV (Revaxis(®)) and DT-IPV (DT Polio(®)) vaccines at 6 years of age in one previous open-label trial with no further vaccination against diphtheria, tetanus, pertussis or poliomyelitis, were enrolled. All participants received a single intramuscular booster dose (0.5mL) of DTaP-IPV vaccine (Tetravac-Acellulaire(®)). Study endpoints were based on antibody persistence and post-booster immune responses. Safety was monitored throughout the study. Descriptive statistics were used for all analyses. RESULTS: Of the 758 children included in the previous study, 274 were included in this follow-up study; 129 had previously been vaccinated with Td-IPV, and 145 had previously received DT-IPV. At least 96.5% of participants in both groups presented an anti-diphtheria and anti-tetanus concentration ≥0.01IU/mL, and anti-poliovirus types 1-3 titres≥8 (1/dilution). Following vaccination with DTaP-IPV, anti-diphtheria and anti-tetanus antibody concentrations ≥0.1IU/mL and anti-poliovirus types 1-3 antibody titres ≥8 (1/dilution) were achieved in all participants. DTaP-IPV was well tolerated in this study. There were no serious adverse events during the study, and no participant withdrew because of adverse events. DISCUSSION: The present study confirmed the long-term immunity conferred by Td-IPV when given as a booster dose, and supports the use of Td-IPV as a second booster at 6 years of age in children previously vaccinated against diphtheria, tetanus and poliomyelitis types 1-3.
Asunto(s)
Anticuerpos Antibacterianos/sangre , Anticuerpos Antivirales/sangre , Vacuna contra Difteria y Tétanos/administración & dosificación , Vacuna contra Difteria y Tétanos/inmunología , Inmunización Secundaria , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacuna Antipolio de Virus Inactivados/inmunología , Adolescente , Niño , Preescolar , Vacuna contra Difteria y Tétanos/efectos adversos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Femenino , Estudios de Seguimiento , Francia , Humanos , Inyecciones Intramusculares , Masculino , Vacuna Antipolio de Virus Inactivados/efectos adversos , Resultado del TratamientoRESUMEN
In recipients primed with acellular pertussis diphtheria-tetanus combined vaccine (DTaP) an increased incidence of severe local reactions with extensive redness/swelling has been reported for each subsequent dose of diphtheria-tetanus based combination vaccine given as a booster. This has been attributed to residual active pertussis toxin (PT) in the primary vaccine. In this study, we investigated the possible contribution of the A-subunit enzymatic activity and the B-oligomer carbohydrate binding activity of residual PT in DTaP to local reactions in a murine model using Japanese DTaP batches produced before and after the introduction of a test for reversion of pertussis toxoid to toxin. Residual PT activity was correlated with the B-oligomer carbohydrate binding activity. The in vivo mouse footpad swelling model assay indicated that the B-oligomer carbohydrate binding activity and possibly other factors were associated with intensified sensitization to local reaction following diphtheria toxoid booster.
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Vacuna contra Difteria y Tétanos/administración & dosificación , Vacuna contra Difteria y Tétanos/efectos adversos , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/inmunología , Edema/inducido químicamente , Hiperemia/inducido químicamente , Inmunización Secundaria/efectos adversos , Animales , Femenino , Ratones Endogámicos BALB CRESUMEN
Complex regional pain syndrome type I (CRPS I) is a disorder of one or more extremities characterized by pain, abnormal sensitivity (allodynia), swelling, limited range of motion, vasomotor instability, fatigue and emotional distress. The symptoms may be aggravated by even minor activity or weather change. It is usually provoked by injury, surgery or injection but in a small proportion of patients CRPS I develops without a clear causative event. There are several literature reports on CRPS after rubella and hepatitis B vaccination. We present a case of CRPS I affecting the left arm after diphtheria and tetanus (Di-Te) vaccination in the left deltoid muscle in a young girl having experienced profound emotional stress before the vaccination procedure. History data on previous minor trauma at the site of vaccination or emotional stress may necessitate temporary vaccination delay due to their proneness to impaired local or systemic immune response and CRPS as a complication of vaccination. If a child or an adult has prominent swelling and severe pain after vaccination, the diagnosis of CRPS I should be considered and if confirmed, the multidisciplinary treatment should start as soon as possible.
Asunto(s)
Brazo , Vacuna contra Difteria y Tétanos/efectos adversos , Edema/etiología , Distrofia Simpática Refleja/etiología , Adolescente , Edema/inmunología , Femenino , Humanos , Distrofia Simpática Refleja/inmunologíaRESUMEN
We write to report two rare cases of retinal vasculitis following administration of vaccinations. Both patients received recent vaccinations (within 4 weeks and 2 months respectively) and presented with unilateral visual loss due to retinal arteriolar vasculitis. Investigations did not reveal any other causes of vasculitis. The first patient's ocular inflammation settled following periocular steroid injection, whereas the second patient required the additional use of oral corticosteroid. Both patients had improved vision following treatment. Vaccinations can cause an autoimmune reaction. Systemic vasculitis has previously been described, whereas ocular vasculitic involvement is also possible but extremely rare. When seeing a patient with visual loss due to retinal vasculitis of unknown aetiology, a history of any recent vaccinations should be elicited.
Asunto(s)
Vacunas contra la Influenza/efectos adversos , Vasculitis Retiniana/etiología , Vacunas/efectos adversos , Vacuna contra Difteria y Tétanos/efectos adversos , Vacunas contra la Hepatitis A/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Vacunas contra Poliovirus/efectos adversos , Radiografía , Vasos Retinianos/diagnóstico por imagen , Vacunas Tifoides-Paratifoides/efectos adversosRESUMEN
IMPORTANCE: Bullous pemphigoid (BP) has been previously described to develop after vaccination in 26 patients. Immunoblotting or enzyme-linked immunosorbent assays (ELISAs), which were performed for 7 of these patients, have always shown circulating autoantibodies against BP180 and/or BP230 antigens. A case of anti-laminin-332 mucous membrane pemphigoid (MMP) that developed shortly after a diphtheria tetanus vaccination is described, with a review of the literature on postvaccination BP. OBSERVATIONS: A 29-year-old man developed an acute eruption of oral and cutaneous blisters and erosions 2 days after receiving a diphtheria tetanus vaccination. The histopathological, immunohistochemical, immunofluorescent, ELISA, and immunoblotting assay results were compatible with anti-laminin-332 MMP. The serum autoantibodies reacted with the α3 and ß3 subunits of laminin-332. The disease was controlled by administering a combination of glucocorticosteroids and dapsone. CONCLUSIONS AND RELEVANCE: The development of acute MMP shortly after a diphtheria tetanus vaccination may have been serendipitous, a result of a nonspecific bystander activation of the immune system, or due to structural mimicry between domains of the toxoid molecule and a subunit of laminin-332.
Asunto(s)
Autoanticuerpos/sangre , Moléculas de Adhesión Celular/inmunología , Vacuna contra Difteria y Tétanos/efectos adversos , Erupciones por Medicamentos/inmunología , Penfigoide Benigno de la Membrana Mucosa/inmunología , Adulto , Humanos , Masculino , Penfigoide Benigno de la Membrana Mucosa/inducido químicamente , Penfigoide Benigno de la Membrana Mucosa/tratamiento farmacológico , KalininaRESUMEN
This phase II clinical trial was conducted to compare the immunogenicity and safety of a newly developed tetanus-reduced diphtheria (Td) vaccine (GC1107-T5.0 and GC1107-T7.5) and control vaccine. This study was also performed to select the proper dose of tetanus toxoid in the new Td vaccines. Healthy adolescents aged between 11 and 12 yr participated in this study. A total of 130 subjects (44 GC1107-T5.0, 42 GC1107-T7.5 and 44 control vaccine) completed a single dose of vaccination. Blood samples were collected from the subjects before and 4 weeks after the vaccination. In this study, all subjects (100%) in both GC1107-T5.0 and GC1107-T7.5 groups showed seroprotective antibody levels (≥ 0.1 U/mL) against diphtheria or tetanus toxoids. After the vaccination, the geometric mean titer (GMT) against diphtheria was significantly higher in Group GC1107-T5.0 (6.53) and GC1107-T7.5 (6.11) than in the control group (3.96). The GMT against tetanus was 18.6 in Group GC1107-T5.0, 19.94 in GC1107-T7.5 and 19.01 in the control group after the vaccination. In this study, the rates of local adverse reactions were 67.3% and 59.1% in GC1107-T5.0 and GC1107-7.5, respectively. No significant differences in the number of adverse reactions, prevalence and degree of severity of the solicited and unsolicited adverse reactions were observed among the three groups. Thus, both newly developed Td vaccines appear to be safe and show good immunogenicity. GC1107-T5.0, which contains relatively small amounts of tetanus toxoid, has been selected for a phase III clinical trial.
Asunto(s)
Vacuna contra Difteria y Tétanos/inmunología , Difteria/prevención & control , Tétanos/prevención & control , Anticuerpos Antibacterianos/sangre , Artralgia/etiología , Niño , Vacuna contra Difteria y Tétanos/efectos adversos , Método Doble Ciego , Femenino , Cefalea/etiología , Humanos , Masculino , Dolor/etiología , Resultado del Tratamiento , VacunaciónRESUMEN
Psoriasis is a common inflammatory disease with multiple known triggers. We report the case of a patient whose psoriasis was triggered by tetanus and diphtheria immunization (Td vaccine). To the best of our knowledge, this is the first reported case of psoriasis triggered by the Td vaccine. Authors speculate about the involved mechanisms.