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1.
Nat Immunol ; 24(4): 560, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36959298
2.
Nature ; 595(7866): 289-294, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-34194041

RESUMEN

The global decline in malaria has stalled1, emphasizing the need for vaccines that induce durable sterilizing immunity. Here we optimized regimens for chemoprophylaxis vaccination (CVac), for which aseptic, purified, cryopreserved, infectious Plasmodium falciparum sporozoites (PfSPZ) were inoculated under prophylactic cover with pyrimethamine (PYR) (Sanaria PfSPZ-CVac(PYR)) or chloroquine (CQ) (PfSPZ-CVac(CQ))-which kill liver-stage and blood-stage parasites, respectively-and we assessed vaccine efficacy against homologous (that is, the same strain as the vaccine) and heterologous (a different strain) controlled human malaria infection (CHMI) three months after immunization ( https://clinicaltrials.gov/ , NCT02511054 and NCT03083847). We report that a fourfold increase in the dose of PfSPZ-CVac(PYR) from 5.12 × 104 to 2 × 105 PfSPZs transformed a minimal vaccine efficacy (low dose, two out of nine (22.2%) participants protected against homologous CHMI), to a high-level vaccine efficacy with seven out of eight (87.5%) individuals protected against homologous and seven out of nine (77.8%) protected against heterologous CHMI. Increased protection was associated with Vδ2 γδ T cell and antibody responses. At the higher dose, PfSPZ-CVac(CQ) protected six out of six (100%) participants against heterologous CHMI three months after immunization. All homologous (four out of four) and heterologous (eight out of eight) infectivity control participants showed parasitaemia. PfSPZ-CVac(CQ) and PfSPZ-CVac(PYR) induced a durable, sterile vaccine efficacy against a heterologous South American strain of P. falciparum, which has a genome and predicted CD8 T cell immunome that differs more strongly from the African vaccine strain than other analysed African P. falciparum strains.


Asunto(s)
Anticuerpos Neutralizantes/inmunología , Hígado/inmunología , Hígado/parasitología , Vacunas contra la Malaria/inmunología , Plasmodium falciparum/efectos de los fármacos , Plasmodium falciparum/inmunología , Vacunas Atenuadas/inmunología , Adulto , Animales , Formación de Anticuerpos/inmunología , Ensayo de Inmunoadsorción Enzimática , Femenino , Humanos , Inmunoglobulina G/sangre , Inmunoglobulina G/inmunología , Estadios del Ciclo de Vida/inmunología , Malaria/sangre , Malaria/inmunología , Malaria/parasitología , Malaria/prevención & control , Vacunas contra la Malaria/administración & dosificación , Vacunas contra la Malaria/efectos adversos , Vacunas contra la Malaria/química , Masculino , Persona de Mediana Edad , Plasmodium falciparum/crecimiento & desarrollo , Linfocitos T/citología , Linfocitos T/inmunología , Linfocitos T/metabolismo , Factores de Tiempo , Vacunación/efectos adversos , Vacunas Atenuadas/administración & dosificación , Vacunas Atenuadas/efectos adversos , Vacunas Atenuadas/química
3.
N Engl J Med ; 388(16): 1451-1464, 2023 Apr 20.
Artículo en Inglés | MEDLINE | ID: mdl-37018474

RESUMEN

BACKGROUND: Whether vaccination during pregnancy could reduce the burden of respiratory syncytial virus (RSV)-associated lower respiratory tract illness in newborns and infants is uncertain. METHODS: In this phase 3, double-blind trial conducted in 18 countries, we randomly assigned, in a 1:1 ratio, pregnant women at 24 through 36 weeks' gestation to receive a single intramuscular injection of 120 µg of a bivalent RSV prefusion F protein-based (RSVpreF) vaccine or placebo. The two primary efficacy end points were medically attended severe RSV-associated lower respiratory tract illness and medically attended RSV-associated lower respiratory tract illness in infants within 90, 120, 150, and 180 days after birth. A lower boundary of the confidence interval for vaccine efficacy (99.5% confidence interval [CI] at 90 days; 97.58% CI at later intervals) greater than 20% was considered to meet the success criterion for vaccine efficacy with respect to the primary end points. RESULTS: At this prespecified interim analysis, the success criterion for vaccine efficacy was met with respect to one primary end point. Overall, 3682 maternal participants received vaccine and 3676 received placebo; 3570 and 3558 infants, respectively, were evaluated. Medically attended severe lower respiratory tract illness occurred within 90 days after birth in 6 infants of women in the vaccine group and 33 infants of women in the placebo group (vaccine efficacy, 81.8%; 99.5% CI, 40.6 to 96.3); 19 cases and 62 cases, respectively, occurred within 180 days after birth (vaccine efficacy, 69.4%; 97.58% CI, 44.3 to 84.1). Medically attended RSV-associated lower respiratory tract illness occurred within 90 days after birth in 24 infants of women in the vaccine group and 56 infants of women in the placebo group (vaccine efficacy, 57.1%; 99.5% CI, 14.7 to 79.8); these results did not meet the statistical success criterion. No safety signals were detected in maternal participants or in infants and toddlers up to 24 months of age. The incidences of adverse events reported within 1 month after injection or within 1 month after birth were similar in the vaccine group (13.8% of women and 37.1% of infants) and the placebo group (13.1% and 34.5%, respectively). CONCLUSIONS: RSVpreF vaccine administered during pregnancy was effective against medically attended severe RSV-associated lower respiratory tract illness in infants, and no safety concerns were identified. (Funded by Pfizer; MATISSE ClinicalTrials.gov number, NCT04424316.).


Asunto(s)
Infecciones por Virus Sincitial Respiratorio , Vacunas contra Virus Sincitial Respiratorio , Infecciones del Sistema Respiratorio , Femenino , Humanos , Lactante , Recién Nacido , Embarazo , Anticuerpos Antivirales , Enfermedades Transmisibles/terapia , Método Doble Ciego , Inyecciones Intramusculares , Infecciones por Virus Sincitial Respiratorio/epidemiología , Infecciones por Virus Sincitial Respiratorio/prevención & control , Vacunas contra Virus Sincitial Respiratorio/administración & dosificación , Vacunas contra Virus Sincitial Respiratorio/efectos adversos , Vacunas contra Virus Sincitial Respiratorio/uso terapéutico , Virus Sincitiales Respiratorios , Resultado del Tratamiento , Vacunación/efectos adversos , Vacunación/métodos , Eficacia de las Vacunas , Vacunas Combinadas/administración & dosificación , Vacunas Combinadas/efectos adversos , Vacunas Combinadas/uso terapéutico , Infecciones del Sistema Respiratorio/epidemiología , Infecciones del Sistema Respiratorio/prevención & control
4.
Annu Rev Med ; 74: 65-74, 2023 01 27.
Artículo en Inglés | MEDLINE | ID: mdl-35850494

RESUMEN

Billions of individuals worldwide have benefited from the unprecedented large-scale rollout of COVID-19 vaccines. Given the sheer number of people that have received these vaccines, it is not surprising that rare side effects are reported that were not previously detected in the phase III vaccine trials. This review addresses one rare complication called SARS-CoV-2 vaccination-induced thrombotic thrombocytopenia (VITT). It occurs in approximately 1/50,000 to 1/100,000 recipients of the adenovirus vector-based COVID-19 vaccines made by AstraZeneca-Oxford or Johnson & Johnson. Information on VITT syndrome was disseminated quickly via social media and publications after it was first discovered. Initial observations associating VITT with specific patient populations, thrombus locations, and outcomes associated with heparin therapy have since been refined with additional clinical experience. In this review, we discuss what is currently known about the incidence, pathophysiology, diagnosis, and treatment of VITT.


Asunto(s)
COVID-19 , Trombocitopenia , Trombosis , Vacunas , Humanos , Vacunas contra la COVID-19/efectos adversos , SARS-CoV-2 , COVID-19/prevención & control , Vacunación/efectos adversos , Trombocitopenia/inducido químicamente
5.
Hepatology ; 80(5): 1147-1157, 2024 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-38358465

RESUMEN

BACKGROUND AND AIMS: Since the introduction of SARS-CoV-2 vaccines, several cases of vaccine-induced immune thrombocytopenia and thrombosis (VITT) have been described, especially cerebral vein thrombosis. We aimed to retrospectively collect all new cases of acute onset first or recurrent splanchnic vein thrombosis (SVT) following a recent SARS-CoV-2 vaccination within the Vascular Liver Disease Group network. APPROACH AND RESULTS: New cases of SVT were identified from April 2021 to April 2022; follow-up was completed on December 31, 2022. Criteria to define VITT were derived from previous studies. Data from a pre-COVID cohort of patients with SVT (N=436) were used for comparison of clinical presentation, etiology, and outcome. Twenty-nine patients were identified with SVT occurring with a median of 11 days (range 2-76) after the first (48%), second (41%), or third (10%) vaccination (ChAdOx1 nCov-19 (n=12) or BNT162b2 (n=14), other (n=3) Only 2 patients(7%) fulfilled criteria for definite VITT. Twenty (69%) had SVT at multiple sites, including 4 (14%) with concomitant extra-abdominal thrombosis. Only 28% had an underlying prothrombotic condition, compared to 52% in the pre-COVID SVT cohort ( p =0.01). Five patients (17%) underwent bowel resection for mesenteric ischemia, compared with 3% in pre-COVID SVT ( p <0.001). Two patients died shortly after diagnosis (7%). CONCLUSIONS: Although definite VITT was rare, in 72% of cases, no other cause for SVT could be identified following SARS-CoV-2 vaccination. These cases were different from patients with nonvaccine-related SVT, with lower incidence of prothrombotic conditions, higher rates of bowel ischemia, and poorer outcome. Although SVT after SARS-CoV-2 vaccination is rare in absolute terms, these data remain relevant considering ongoing revaccination programs.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Trombosis de la Vena , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Vacuna BNT162/efectos adversos , ChAdOx1 nCoV-19/efectos adversos , COVID-19/prevención & control , COVID-19/complicaciones , Vacunas contra la COVID-19/efectos adversos , Estudios Retrospectivos , Circulación Esplácnica , Vacunación/efectos adversos , Trombosis de la Vena/etiología , Trombosis de la Vena/prevención & control
6.
FASEB J ; 38(13): e23814, 2024 Jul 15.
Artículo en Inglés | MEDLINE | ID: mdl-38959046

RESUMEN

As we enter a new era of mRNA-based therapeutics, evidence on genetic or environmental factors that might predispose to unknown off-target side effects, gains in importance. Among these factors, exercise appears likely to have influenced otherwise cryptic cases of early-onset postvaccination myocarditis. And the existence of a distinct late-onset myocarditis is now being recognized. Here, three case-history reports suggest crypticity (the author's own case), unless provoked by a preexisting cardiac morbidity (one case), or by immune checkpoint blockade to enhance anticancer autoimmunity (several cases). These reports are supported by noninvasive fluorodeoxyglucose-based cardiac scan comparisons of multiple vaccinated and unvaccinated subjects. In pre-pandemic decades, applications for funds by the leading innovator in mRNA-based therapeutics seldom gained peer-review approval. Thus, at the start of the pandemic, the meager data on such side effects could justify only emergency approval. We must do better.


Asunto(s)
COVID-19 , Miocarditis , Vacunación , Humanos , COVID-19/prevención & control , COVID-19/inmunología , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/inmunología , Miocarditis/etiología , SARS-CoV-2/inmunología , Vacunación/efectos adversos
7.
PLoS Biol ; 20(5): e3001643, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35639676

RESUMEN

Ensuring high vaccination and even booster vaccination coverage is critical in preventing severe Coronavirus Disease 2019 (COVID-19). Among the various COVID-19 vaccines currently in use, the mRNA vaccines have shown remarkable effectiveness. However, systemic adverse events (AEs), such as postvaccination fatigue, are prevalent following mRNA vaccination, and the underpinnings of which are not understood. Herein, we found that higher baseline expression of genes related to T and NK cell exhaustion and suppression were positively correlated with the development of moderately severe fatigue after Pfizer-BioNTech BNT162b2 vaccination; increased expression of genes associated with T and NK cell exhaustion and suppression reacted to vaccination were associated with greater levels of innate immune activation at 1 day postvaccination. We further found, in a mouse model, that altering the route of vaccination from intramuscular (i.m.) to subcutaneous (s.c.) could lessen the pro-inflammatory response and correspondingly the extent of systemic AEs; the humoral immune response to BNT162b2 vaccination was not compromised. Instead, it is possible that the s.c. route could improve cytotoxic CD8 T-cell responses to BNT162b2 vaccination. Our findings thus provide a glimpse of the molecular basis of postvaccination fatigue from mRNA vaccination and suggest a readily translatable solution to minimize systemic AEs.


Asunto(s)
COVID-19 , Animales , Vacuna BNT162 , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Fatiga/etiología , Humanos , Células Asesinas Naturales , Ratones , ARN Mensajero/genética , Vacunación/efectos adversos
8.
Circ Res ; 132(10): 1338-1357, 2023 05 12.
Artículo en Inglés | MEDLINE | ID: mdl-37167355

RESUMEN

SARS-CoV-2 vaccine-associated myocarditis/myocardial injury should be evaluated in the contexts of COVID-19 infection, other types of viral myocarditis, and other vaccine-associated cardiac disorders. COVID-19 vaccine-associated myocardial injury can be caused by an inflammatory immune cell infiltrate, but other etiologies such as microvascular thrombosis are also possible. The clinical diagnosis is typically based on symptoms and cardiac magnetic resonance imaging. Endomyocardial biopsy is confirmatory for myocarditis, but may not show an inflammatory infiltrate because of rapid resolution or a non-inflammatory etiology. Myocarditis associated with SARS-COVID-19 vaccines occurs primarily with mRNA platform vaccines, which are also the most effective. In persons aged >16 or >12 years the myocarditis estimated crude incidences after the first 2 doses of BNT162b2 and mRNA-1273 are approximately 1.9 and 3.5 per 100 000 individuals, respectively. These rates equate to excess incidences above control populations of approximately 1.2 (BNT162b2) and 1.9 (mRNA-1273) per 100 000 persons, which are lower than the myocarditis rate for smallpox but higher than that for influenza vaccines. In the studies that have included mRNA vaccine and SARS-COVID-19 myocarditis measured by the same methodology, the incidence rate was increased by 3.5-fold over control in COVID-19 compared with 1.5-fold for BNT162b2 and 6.2-fold for mRNA-1273. However, mortality and major morbidity are less and recovery is faster with mRNA vaccine-associated myocarditis compared to COVID-19 infection. The reasons for this include vaccine-associated myocarditis having a higher incidence in young adults and adolescents, typically no involvement of other organs in vaccine-associated myocarditis, and based on comparisons to non-COVID viral myocarditis an inherently more benign clinical course.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Lesiones Cardíacas , Miocarditis , Adolescente , Humanos , Adulto Joven , Vacuna nCoV-2019 mRNA-1273 , Vacuna BNT162 , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Lesiones Cardíacas/etiología , Miocarditis/epidemiología , Miocarditis/etiología , SARS-CoV-2 , Vacunación/efectos adversos
9.
Rev Med Virol ; 34(3): e2538, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38658176

RESUMEN

Serious adverse events following vaccination include medical complications that require hospitalisation. The live varicella vaccine that was approved by the Food and Drug Administration in the United States in 1995 has an excellent safety record. Since the vaccine is a live virus, adverse events are more common in immunocompromised children who are vaccinated inadvertently. This review includes only serious adverse events in children considered to be immunocompetent. The serious adverse event called varicella vaccine meningitis was first reported in a hospitalised immunocompetent child in 2008. When we carried out a literature search, we found 15 cases of immunocompetent children and adolescents with varicella vaccine meningitis; the median age was 11 years. Eight of the children had received two varicella vaccinations. Most of the children also had a concomitant herpes zoster rash, although three did not. The children lived in the United States, Greece, Germany, Switzerland, and Japan. During our literature search, we found five additional cases of serious neurological events in immunocompetent children; these included 4 cases of progressive herpes zoster and one case of acute retinitis. Pulses of enteral corticosteroids as well as a lack of herpes simplex virus antibody may be risk factors for reactivation in immunocompetent children. All 20 children with adverse events were treated with acyclovir and recovered; 19 were hospitalised and one child was managed as an outpatient. Even though the number of neurological adverse events remains exceedingly low following varicella vaccination, we recommend documentation of those caused by the vaccine virus.


Asunto(s)
Vacuna contra la Varicela , Meningitis Viral , Adolescente , Niño , Preescolar , Femenino , Humanos , Masculino , Aciclovir/uso terapéutico , Antivirales/uso terapéutico , Varicela/prevención & control , Varicela/virología , Vacuna contra la Varicela/administración & dosificación , Vacuna contra la Varicela/efectos adversos , Vacuna contra la Varicela/inmunología , Herpesvirus Humano 3/inmunología , Meningitis Viral/virología , Enfermedades del Sistema Nervioso/virología , Enfermedades del Sistema Nervioso/etiología , Vacunación/efectos adversos , Activación Viral/efectos de los fármacos
11.
Eur Heart J ; 45(32): 2983-2991, 2024 Aug 21.
Artículo en Inglés | MEDLINE | ID: mdl-38993069

RESUMEN

BACKGROUND AND AIMS: Concerns about the safety of coronavirus disease 2019 (COVID-19) vaccines in patients with atrial fibrillation/flutter (AF/AFL) have arisen due to reports of thrombo-embolic events following COVID-19 vaccination in the general population. This study aimed to evaluate the risk of thrombo-embolic events after COVID-19 vaccination in patients with AF/AFL. METHODS: This was a modified self-controlled case-series study using a comprehensive nationwide-linked database provided by the National Health Insurance Service in South Korea to calculate incidence rate ratios (IRRs) of thrombo-embolic events. The study population included individuals aged ≥12 years who were either vaccinated (e.g. one or two doses) or unvaccinated during the period from February to December 2021. The primary outcome was a composite of thrombo-embolic events, including ischaemic stroke, transient ischaemic attack, and systemic thromboembolism. The risk period was defined as 0-21 days following COVID-19 vaccination. RESULTS: The final analysis included 124 127 individuals with AF/AFL. The IRR of thrombo-embolic events within 21 days after COVID-19 vaccination, compared with that during the unexposed control period, was 0.93 [95% confidence interval (CI) 0.77-1.12]. No significant risk variations were noted by sex, age, or vaccine type. However, patients without anticoagulant therapy had an IRR of 1.88 (95% CI 1.39-2.54) following vaccination. CONCLUSIONS: In patients with AF/AFL, COVID-19 vaccination was generally not associated with an increased risk of thrombo-embolic events. However, careful individual risk assessment is required when advising vaccination for those not on oral anticoagulant, as these patients exhibited an increased risk of thrombo-embolic events post-vaccination.


Asunto(s)
Fibrilación Atrial , Vacunas contra la COVID-19 , COVID-19 , Tromboembolia , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Fibrilación Atrial/epidemiología , Aleteo Atrial/epidemiología , COVID-19/prevención & control , COVID-19/epidemiología , COVID-19/complicaciones , Vacunas contra la COVID-19/efectos adversos , Incidencia , República de Corea/epidemiología , Tromboembolia/prevención & control , Tromboembolia/epidemiología , Tromboembolia/etiología , Vacunación/efectos adversos
12.
Eur Heart J ; 45(15): 1327-1335, 2024 Apr 14.
Artículo en Inglés | MEDLINE | ID: mdl-38365960

RESUMEN

BACKGROUND AND AIMS: The SARS-CoV-2 mRNA vaccines are associated with an increased risk of myocarditis. This association appears to be strongest in male adolescents and younger males and after the second dose. The aim was to evaluate the risk of myocarditis following SARS-CoV-2 mRNA booster vaccination in 12-to-39-year-olds. METHODS: A multinational cohort study was conducted using nationwide register data in Denmark, Finland, Norway, and Sweden and comprising all 8.9 million individuals residing in each of the four countries. Participants were followed for an inpatient diagnosis of myocarditis. In each of the four countries, Poisson regression was used to estimate adjusted incidence rate ratios (IRRs) of myocarditis comparing vaccination schedules, with associated 95% confidence intervals (CIs). Country-specific results were combined in meta-analyses. RESULTS: A total of 8.9 million residents were followed for 12 271 861 person-years and 1533 cases of myocarditis were identified. In 12-to-39-year-old males, the 28-day acute risk period following the third dose of BNT162b2 or mRNA-1273 was associated with an increased incidence rate of myocarditis compared to the post-acute risk period 28 days or more after the second dose [IRR 2.08 (95% CI 1.31-3.33) and 8.89 (2.26-35.03), respectively]. For females, the corresponding IRR was only estimable for BNT162b2, 3.99 (0.41-38.64). The corresponding absolute risks following the third dose of BNT162b2 and mRNA-1273 in males were 0.86 (95% CI 0.53-1.32) and 1.95 (0.53-4.99) myocarditis events within 28 days per 100 000 individuals vaccinated, respectively. In females, the corresponding absolute risks following the third dose of BNT162b2 were 0.15 (0.04-0.39) events per 100 000 individuals vaccinated. No deaths occurred within 30 days of vaccine-related cases. CONCLUSIONS: The results suggest that a booster dose is associated with increased myocarditis risk in adolescents and young adults. However, the absolute risk of myocarditis following booster vaccination is low.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Miocarditis , Adolescente , Adulto , Niño , Femenino , Humanos , Masculino , Adulto Joven , Vacuna nCoV-2019 mRNA-1273 , Vacuna BNT162 , Estudios de Cohortes , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Miocarditis/inducido químicamente , Miocarditis/epidemiología , Vacunación/efectos adversos , Inmunización Secundaria/efectos adversos
13.
J Allergy Clin Immunol ; 153(6): 1711-1720, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38520423

RESUMEN

BACKGROUND: There is growing evidence that the coronavirus disease 2019 (COVID-19) vaccination can affect the regulation of the immune system, leading to the development of autoimmune diseases. However, the autoimmune adverse events (AEs) after COVID-19 vaccination remain largely unclear. OBJECTIVE: We sought to investigate the autoimmune AEs after COVID-19 vaccination from a population-based cohort in South Korea. METHODS: A total of 4,203,887 participants, representing 50% of the population residing in Seoul, were recruited from the National Health Insurance Service database and then divided into 2 groups on the basis of COVID-19 vaccination. The cumulative incidence, hazard ratios (HRs), and 95% CIs of autoimmune AEs were assessed following COVID-19 vaccination. RESULTS: The incidence of vitiligo has been observed to be significantly higher in the vaccination group compared with the no vaccination group. The cumulative incidence of vitiligo began to show a significant difference starting 2 weeks after vaccination, and it reached 2.2% in the vaccination group and 0.6% in the no vaccination group by 3 months after COVID-19 vaccination. Vitiligo (HR, 2.714; 95% CI, 1.777-4.146) was an increased risk among autoimmune AEs. Furthermore, the risk of vitiligo was the highest for heterologous vaccination (HR, 3.890; 95% CI, 2.303-6.573) compared with using cDNA vaccine (HR, 2.861; 95% CI, 1.838-4.453) or mRNA vaccine (HR, 2.475; 95% CI, 1.607-3.813). CONCLUSIONS: Vitiligo as an autoimmune AE was noted to be substantially higher in the COVID-19-vaccinated group compared with the controls. Therefore, the occurrence of vitiligo could be considered as one of the significant AEs post-COVID-19 vaccination.


Asunto(s)
Enfermedades Autoinmunes , Vacunas contra la COVID-19 , COVID-19 , Vitíligo , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedades Autoinmunes/inducido químicamente , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Incidencia , República de Corea/epidemiología , Seúl/epidemiología , Vacunación/efectos adversos , Vitíligo/inducido químicamente
14.
J Infect Dis ; 230(2): e353-e362, 2024 Aug 16.
Artículo en Inglés | MEDLINE | ID: mdl-38133639

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.


Asunto(s)
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 adversos
15.
J Infect Dis ; 230(3): e591-e600, 2024 Sep 23.
Artículo en Inglés | MEDLINE | ID: mdl-38513368

RESUMEN

BACKGROUND: Solid organ transplant recipients (SOTRs) are at high risk for severe COVID-19. METHODS: This open-label, phase 3b trial evaluated mRNA-1273 in 137 kidney and 77 liver SOTRs and 20 immunocompetent participants. In part A, SOTRs received three 100-µg doses of mRNA-1273; immunocompetent participants received 2 doses. In part B, an additional 100-µg dose was offered ≥4 months after the primary series. Here, we report interim trial results. RESULTS: mRNA-1273 was well-tolerated in SOTRs. Four serious adverse events were considered vaccine related by the investigator in 3 SOTRs with preexisting comorbidities. No vaccine-related biopsy-proven organ rejection events or deaths were reported. mRNA-1273 elicited modest neutralizing antibody responses after dose 2 and improved responses after dose 3 in SOTRs. Post-dose 3 responses among liver SOTRs were comparable to post-dose 2 responses in immunocompetent participants. Post-additional dose responses were increased in SOTRs, regardless of primary series vaccination. In liver SOTRs, post-additional dose responses were ∼3-fold higher versus post-dose 2 but lower than immunocompetent participant responses. Most kidney SOTRs received multiple immunosuppressants and had reduced antibody responses versus liver SOTRs. CONCLUSIONS: mRNA-1273 was well-tolerated, and dose 3 and the additional dose improved antibody responses among SOTRs. CLINICAL TRIALS REGISTRATION: NCT04860297.


Asunto(s)
Vacuna nCoV-2019 mRNA-1273 , Anticuerpos Neutralizantes , Anticuerpos Antivirales , Vacunas contra la COVID-19 , COVID-19 , Trasplante de Órganos , SARS-CoV-2 , Receptores de Trasplantes , Humanos , Vacuna nCoV-2019 mRNA-1273/administración & dosificación , Vacuna nCoV-2019 mRNA-1273/inmunología , Masculino , Femenino , Persona de Mediana Edad , COVID-19/prevención & control , COVID-19/inmunología , Adulto , Anticuerpos Neutralizantes/sangre , Anticuerpos Antivirales/sangre , Anciano , SARS-CoV-2/inmunología , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/inmunología , Vacunas contra la COVID-19/administración & dosificación , Trasplante de Órganos/efectos adversos , Inmunogenicidad Vacunal , Trasplante de Hígado/efectos adversos , Trasplante de Riñón/efectos adversos , Vacunación/efectos adversos , Huésped Inmunocomprometido
16.
Emerg Infect Dis ; 30(4): 775-778, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38526214

RESUMEN

Given its enhanced genetic stability, novel oral poliovirus vaccine type 2 was deployed for type 2 poliovirus outbreak responses under World Health Organization Emergency Use Listing. We evaluated the safety profile of this vaccine. No safety signals were identified using a multipronged approach of passive and active surveillance.


Asunto(s)
Poliovirus , Poliovirus/genética , Vacuna Antipolio Oral/efectos adversos , Uganda/epidemiología , Vacunación/efectos adversos , Inmunización
17.
Emerg Infect Dis ; 30(11): 2313-2322, 2024 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-39378869

RESUMEN

We conducted a self-controlled case series study to investigate the association between COVID-19 vaccination and facial palsy (FP) in South Korea. We used a large immunization registry linked with the national health information database. We included 44,564,345 patients >18 years of age who received >1 dose of COVID-19 vaccine (BNT162b2, mRNA-1273, ChAdOx1 nCoV-19, or Ad.26.COV2.S) and had an FP diagnosis and corticosteroid prescription within 240 days postvaccination. We compared FP incidence in a risk window (days 1-28) with a control window (the remainder of the 240-day observation period, excluding any risk windows). We found 5,211 patients experienced FP within the risk window and 10,531 experienced FP within the control window. FP risk increased within 28 days postvaccination, primarily after first and second doses and was observed for both mRNA and viral vaccines. Clinicians should carefully assess the FP risk-benefit profile associated with the COVID-19 vaccines and monitor neurologic signs after vaccination.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Parálisis Facial , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Vacuna nCoV-2019 mRNA-1273/efectos adversos , Vacuna BNT162/efectos adversos , ChAdOx1 nCoV-19/efectos adversos , COVID-19/prevención & control , COVID-19/epidemiología , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/administración & dosificación , Parálisis Facial/inducido químicamente , Parálisis Facial/epidemiología , Incidencia , República de Corea/epidemiología , Factores de Riesgo , Vacunación/efectos adversos
18.
BMC Immunol ; 25(1): 35, 2024 Jun 19.
Artículo en Inglés | MEDLINE | ID: mdl-38898409

RESUMEN

BACKGROUND: For the past three years, the pandemic has had a major effect on global public health, mainly on those with underlying medical conditions, such as people living with Multiple Sclerosis. Vaccination among this group is of great importance, and the long-term impacts of vaccination and its safety on the health of these patients will continue to be revealed. Therefore, risks related to vaccination and immune response need to be assessed. The objective here was to characterize the immune response, short-term safety, and the effects of multiple variables on these factors after COVID-19 vaccination (mainly Sinopharm) among people with Multiple Sclerosis. We assessed the short-term safety and humoral SARS-COV-2 anti-RBD IgG response using a data collection form and Immunoassay, respectively. RESULTS: No severe adverse events or MS relapse was observed. Myalgia/body pain (26.7%), low-grade fever (22.2%), and mild headache (15.6%) were the most common adverse events. The use and type of vaccine influenced the frequency of side effects with a p-value < 0.0001. Regarding immune response, patients on rituximab and fingolimod had a lower antibody titer compared to other medications. With a significant difference, hybrid immunity (p-value: 0.047) and type of DMTs (p-value: 0.017) affected the humoral response. CONCLUSION: There is a low incidence of serious adverse effects, MS worsening or relapse after COVID-19 vaccination, and mainly, side effects are similar to that of the general population. It appears that treatment with various disease-modifying therapies does not induce or worsen the post-vaccination side effects, although some, including Rituximab and fingolimod, may affect the immunity induced after vaccination.


Asunto(s)
Anticuerpos Antivirales , Vacunas contra la COVID-19 , COVID-19 , Inmunidad Humoral , Esclerosis Múltiple , SARS-CoV-2 , Humanos , Esclerosis Múltiple/inmunología , Esclerosis Múltiple/tratamiento farmacológico , COVID-19/inmunología , COVID-19/prevención & control , SARS-CoV-2/inmunología , Femenino , Anticuerpos Antivirales/inmunología , Anticuerpos Antivirales/sangre , Masculino , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/inmunología , Adulto , Persona de Mediana Edad , Rituximab/efectos adversos , Rituximab/uso terapéutico , Inmunoglobulina G/sangre , Inmunoglobulina G/inmunología , Vacunación/efectos adversos , Inmunosupresores/efectos adversos , Inmunosupresores/uso terapéutico
19.
Clin Immunol ; 259: 109882, 2024 02.
Artículo en Inglés | MEDLINE | ID: mdl-38158168

RESUMEN

We identified 3620 autoimmune-related adverse events among 223.2 million US residents using Vaccine Adverse Events Reporting System and the COVID-19 Data Tracker. This study is the first to quantify the cumulative incidence of autoimmune and auto-inflammatory adverse events after COVID-19 vaccination. We reported autoimmune and auto-inflammatory adverse events across 6 major classes of medical conditions and stratified by age, sex, and manufacturer.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Humanos , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Estados Unidos/epidemiología , Vacunación/efectos adversos
20.
Curr Opin Rheumatol ; 36(2): 148-153, 2024 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-37976046

RESUMEN

PURPOSE OF REVIEW: We review the latest guidelines and note special considerations for systemic lupus erythematosus (SLE) patients when approaching vaccination against SARS-CoV-2, influenza, pneumococcus, herpes zoster, and potentially respiratory syncytial virus (RSV) vaccine in the future. RECENT FINDINGS: SLE patients have unique infectious risks due to newer treatments and the nature of the disease itself. It is important to balance the benefit of additional protective immunity from updated vaccines against the possible risk of disease activity exacerbations. SUMMARY: It is important to continuously evaluate the safety and immunogenicity of updated vaccines specifically for SLE patients. Additionally, the newly approved RSV vaccine should be considered for this population to reduce severe respiratory illness.


Asunto(s)
Lupus Eritematoso Sistémico , Vacunación , Humanos , Vacunación/efectos adversos
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