RESUMEN
OBJECTIVE: To analyze the effect of breastfeeding on reducing Pentavalent vaccination pain in infants and to identify the necessary breastfeeding interval for antinociceptive action. METHOD: Open parallel randomized clinical trial. Ninety mother-infant dyads participated, distributed into intervention group 1 (n = 30), which breastfed five minutes before vaccination; intervention group 2 (n = 30), which breastfed five minutes before and during vaccination; and control group (n = 30), which did not breastfeed. The outcome variable was the pain level measured by the FLACC Scale. Data analysis was conducted using descriptive and inferential statistics, applying Fisher's Exact, Kolmogorov-Smirnov, Kruskal-Wallis and Dunn's multiple comparison tests, with 0.05 significance level. RESULTS: Pain induced by the Pentavalent vaccine was reduced in intervention groups 1 and 2 (mean pain of 6.06 versus 3.83, respectively) compared to the control group (mean of pain of 7.43), which was significant for intervention group 2 (p < 0.001), indicating that, to achieve lower levels of pain, breastfeeding should be carried out before and during vaccination. CONCLUSION: Longer breastfeeding, conducted five minutes before and during vaccination, reduces the pain induced by the Pentavalent vaccine. No vaccination risks were identified to outweigh the benefits. These results endorse that health professionals should encourage breastfeeding at least five minutes before and during vaccine injection for an antinociception effect. Brazilian Clinical Trials Registry: RBR-9vh37wr.
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Lactancia Materna , Dolor , Humanos , Lactante , Femenino , Masculino , Dolor/etiología , Dolor/prevención & control , Vacunación/efectos adversos , Adulto , Vacunas Combinadas/efectos adversos , Vacunas Combinadas/administración & dosificación , Vacunas contra Hepatitis B/administración & dosificación , Vacunas contra Hepatitis B/efectos adversos , Vacunas contra Haemophilus/administración & dosificación , Vacunas contra Haemophilus/efectos adversos , Factores de Tiempo , Dimensión del Dolor , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vacuna Antipolio de Virus Inactivados/administración & dosificaciónRESUMEN
OBJECTIVES: This study aims to evaluate the safety of a new inactivated poliomyelitis vaccine (Sabin strains) (sIPV) for large-scale use in primary and booster immunizations, whether simultaneously administered with other vaccines or not and to explore the persistence of all vaccines at approximately six months after vaccination. METHOD: A total of 3200 infants were recruited into this study, including 2000 infants aged 2-3 months randomly assigned (1:1) into the "sIPV basic" or the "sIPV+DTaP" group for primary immunization of sIPV. Another 1200 children aged 18 months old and above were randomly assigned (2:2:1:1) into the "sIPV booster," "sIPV+HepA-I," "sIPV+MMR", or "sIPV+HepA-L" group for booster immunization of sIPV. Adverse events within 30 days of each vaccination dose in all participants were self-reported by guardians using a WeChat mini-program. Approximately 200 blood samples were collected at 5-7 months after the final vaccination to test for antibodies against poliovirus and other viruses. RESULTS: 3198 participants in total were included in the safety study, including 1999 infants aged 2-3 months old and 1199 children aged 18-26 months old. For primary immunization, the incidence of adverse reactions in the "sIPV basic" and the "sIPV+DTaP" group were 3.19 and 6.21% (P = 0.001), respectively. For booster immunization, the incidences of adverse reaction for the "sIPV booster" group were 2.25%, while the incidence for the "sIPV +others" group in total was 2.50% (P = 0.788). Most adverse reactions were mild. Fever was the most common symptom in all groups. No vaccine-related serious adverse events (SAEs) were observed in this study. The seropositivity rates of antibodies in the "sIPV basic" and the "sIPV+DTaP" group were 92.31 and 100% against type 1 poliovirus (P = 0.031); 96.15% and 98.57% against type 2 poliovirus (P = 0.575); 98.08% and 91.43% against type 3 poliovirus (P = 0.237), respectively. Regarding booster vaccination with sIPV, whether co-administered with other vaccines or not, the seropositivity rates of antibodies against the three types of polioviruses were all 100%. Seropositivity rates of antibodies against hepatitis A, measles, mumps, and rubella were all no <77%, except for pertussis, which was <30%. CONCLUSION: sIPV demonstrated good safety and immune persistence for primary and booster vaccinations, whether administered singly or simultaneously. Antibodies against hepatitis A, measles, mumps and rubella were not disrupted by the co-vaccination. However, the seropositivity rates and geometric mean concentrations (GMCs) of antibodies against pertussis indicate the necessity for a booster dose.
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Anticuerpos Antivirales , Inmunización Secundaria , Poliomielitis , Vacuna Antipolio de Virus Inactivados , Humanos , Vacuna Antipolio de Virus Inactivados/inmunología , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacuna Antipolio de Virus Inactivados/efectos adversos , Lactante , Inmunización Secundaria/métodos , Masculino , China , Femenino , Anticuerpos Antivirales/sangre , Poliomielitis/prevención & control , Poliomielitis/inmunología , Poliovirus/inmunología , Esquemas de Inmunización , Vacunación/métodos , Vacunas Combinadas/inmunología , Vacunas Combinadas/administración & dosificación , Vacunas Combinadas/efectos adversosRESUMEN
BACKGROUND: This field efficacy study was designed to determine the efficacy of a new bivalent vaccine containing porcine circovirus type 2d (PCV2d) and Mycoplasma hyopneumoniae at three independent pig farms. METHODS: Three pig farms were selected based on their history of subclinical PCV2 infection and enzootic pneumonia. Each farm housed a total of 40, 18-day-old pigs that were randomly allocated to 1 of 2 treatment groups. Pigs were administered a 2.0 mL dose of the bivalent vaccine intramuscularly at 21 days of age in accordance with the manufacturer's recommendations, whereas unvaccinated pigs were administered a single dose of phosphate-buffered saline at the same age. RESULTS: Clinically, the average daily weight gain of vaccinated groups was significantly higher (p < 0.05) than those of unvaccinated animals during the growing (70-112 days of age), finishing (112-175 days of age) and overall (3-175 days of age) stages of production. Vaccinated animals elicited neutralizing anti-PCV2 antibodies and PCV2d-specific interferon-γ secreting cells (IFN-γ-SC), which reduced the amount of PCV2d genomic copies in blood and reduced lymphoid lesions severity when compared with unvaccinated animals. Similarly, vaccinated animals elicited M. hyopneumoniae-specific IFN-γ-SC, which reduced the amount of M. hyopneumoniae in the larynx and reduced lung lesions severity. CONCLUSIONS: The result of the field trial demonstrated that the bivalent vaccine was efficacious in the protection of swine herds suffering from subclinical PCV2d infection and enzootic pneumonia.
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Vacunas Bacterianas , Infecciones por Circoviridae , Circovirus , Mycoplasma hyopneumoniae , Neumonía Porcina por Mycoplasma , Vacunas Virales , Animales , Circovirus/inmunología , Mycoplasma hyopneumoniae/inmunología , Infecciones por Circoviridae/veterinaria , Infecciones por Circoviridae/prevención & control , Porcinos , Neumonía Porcina por Mycoplasma/prevención & control , Vacunas Virales/inmunología , Vacunas Virales/administración & dosificación , Vacunas Bacterianas/inmunología , Vacunas Bacterianas/administración & dosificación , Vacunas Combinadas/inmunología , Enfermedades de los Porcinos/prevención & control , Enfermedades de los Porcinos/virología , Enfermedades de los Porcinos/microbiología , Distribución Aleatoria , Sus scrofa , Infecciones AsintomáticasRESUMEN
Hemorrhagic fever with renal syndrome (HFRS) and tick-borne encephalitis (TBE) are the most common viral diseases in Russia. HFRS is caused by six different types of hantaviruses: Hantaan, Amur, Seoul, Puumala, Kurkino, and Sochi, which are transmitted to humans through small mammals of the Muridae and Cricetidae families. TBE is caused by viruses belonging to five different phylogenetic subtypes. The similarities in the ecology of HFRS and TBE pathogens is presented here. Hantavirus-infected small mammals can transmit the virus to uninfected animals, and ticks can also transmit hantavirus to other ticks and mammals. Hantavirus transmission from ticks to humans is possible only hypothetically based on indirect data. Over the past 23 years, 164,582 cases of HFRS (4.9 per 105 people) and 71,579 cases of TBE (2.5 per 105 people) were registered in Russia. The mortality rate was 0.4% (668 cases) in HFRS and 1.6% deaths (1136 cases) in TBE. There were 4030 HFRS (2.5%) and 9414 TBE (13%) cases in children under 14 years old. HFRS and TBE cases were registered in 42 out of 85 Russian regions; in 18-only HFRS, in 13-only TBE, and 12 had no reported cases. The prospects of applying a combined vaccine for HFRS and TBE prevention are shown in this paper.
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Encefalitis Transmitida por Garrapatas , Fiebre Hemorrágica con Síndrome Renal , Vacunas Virales , Encefalitis Transmitida por Garrapatas/prevención & control , Encefalitis Transmitida por Garrapatas/epidemiología , Encefalitis Transmitida por Garrapatas/virología , Encefalitis Transmitida por Garrapatas/transmisión , Federación de Rusia/epidemiología , Fiebre Hemorrágica con Síndrome Renal/epidemiología , Fiebre Hemorrágica con Síndrome Renal/prevención & control , Fiebre Hemorrágica con Síndrome Renal/virología , Humanos , Animales , Vacunas Virales/inmunología , Vacunas Virales/administración & dosificación , Orthohantavirus/inmunología , Orthohantavirus/genética , Virus de la Encefalitis Transmitidos por Garrapatas/inmunología , Virus de la Encefalitis Transmitidos por Garrapatas/genética , Vacunas Combinadas/inmunología , Vacunas Combinadas/administración & dosificación , Garrapatas/virologíaRESUMEN
L'Organisation panaméricaine de la santé (OPS) publie quatre fois par an le Bulletin d'Immunisation en anglais, français, portugais et espagnol. Son objectif est de faciliter l'échange d'idées et d'informations sur les programmes de vaccination dans la région des Amériques et au-delà. Il est publié depuis 1979 en anglais et en espagnol, les versions française et portugaise ayant débuté en 2001 et 2019, respectivement. Le numéro de juin 2024 du bulletin trimestriel Bulletin d'Immunisation traite des sujets suivants: Semaine de la vaccination dans les Amériques 2024 : « Agis maintenant pour protéger ton avenir #Vaccine-toi »; Décès du Dr Cuauhtémoc Ruiz Matus, chef de l'Unité d’immunisation de l’OPS de 2007 à 2022 ; L'OPS lance de nouvelles pages web pour aider les pays à accroître la demande de vaccins ; Lancement du tableau de bord de la vaccination tout au long de la vie dans les Amériques; Considérations importantes pour l'introduction du vaccin hexavalent (DTwP-HepB-Hib-VPI) (avec vaccin anticoquelucheux à germes entiers) ; Dix ans après la disparition de Ciro de Quadros, nous présentons ici des extraits d'une conversation entre Donald Henderson, Ciro de Quadros et Jon Andrus datant de 2013; Application de l’approche du parcours de vie aux programmes nationaux de vaccination ; Prix des vaccins achetés par l’intermédiaire du Fonds renouvelable de l’OPS, 2024 (prix en US$) ; et Prix des seringues achetées par l'intermédiaire du Fonds renouvelable de l'OPS, 2024 (prix en dollars US).
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Inmunización , Vacunas , Vacunación , Enfermedades Prevenibles por Vacunación , Acontecimientos que Cambian la Vida , Vacunas Combinadas , AméricasRESUMEN
A Organização Pan-Americana da Saúde (OPAS) publica o Boletim de Imunização quatro vezes por ano em inglês, francês, português e espanhol. Seu objetivo é facilitar o intercâmbio de ideias e informações sobre programas de imunização na Região das Américas e fora dela. Ele é publicado desde 1979 em inglês e espanhol, com versões em francês e português iniciadas em 2001 e 2019, respectivamente. A edição de marzo de 2024 do Boletim de Imunização aborda os seguintes tópicos: Semana de Vacinação nas Américas 2024: “Proteja o futuro: vacine-se”; Nota de falecimento do Dr. Cuauhtémoc Ruiz Matus, chefe da Unidade de Imunização de 2007 a 2022 ; OPAS lança novas páginas em seu site para ajudar os países a aumentar a demanda por vacinas; Lançamento do painel de controle de imunização ao longo do curso de vida na Região das Américas; Considerações importantes sobre a introdução da vacina hexavalente (DTPw-HepB-Hib-VIP) (com o componente pertússis de células inteiras); Dez anos após o falecimento de Ciro de Quadros, apresentamos trechos de uma conversa entre ele, Donald Henderson e Jon Andrus, em 2013; Explorando o uso da abordagem de curso de vida nos programas nacionais de imunização; Preços de vacinas compradas por meio do Fundo Rotativo da OPAS, 2024 (preços em dólares dos Estados Unidos); Preços de seringas compradas por meio do Fundo Rotativo da OPAS, 2024 (preços em dólares dos Estados Unidos).
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Inmunización , Vacunas , Vacunación , Enfermedades Prevenibles por Vacunación , Acontecimientos que Cambian la Vida , Vacunas Combinadas , AméricasRESUMEN
La Organización Panamericana de la Salud (OPS) publica cuatro veces al año el Boletín de Inmunización en español, francés, inglés y portugués. Su propósito es facilitar el intercambio de ideas e información sobre los programas de inmunización en la Región de las Américas y más allá. Se publica desde 1979 en inglés y español, con versiones en francés y portugués a partir de 2001 y 2019, respectivamente.
Asunto(s)
Inmunización , Vacunas , Vacunación , Enfermedades Prevenibles por Vacunación , Acontecimientos que Cambian la Vida , Vacunas Combinadas , AméricasRESUMEN
The Pan American Health Organization (PAHO) publishes the Immunization Newsletter four times a year in English, French, Portuguese, and Spanish. Its purpose is to facilitate the exchange of ideas and information on immunization programs in the Region of the Americas and beyond. It has been published since 1979 in English and Spanish, with French and Portuguese versions beginning in 2001 and 2019, respectively.
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Inmunización , Vacunas , Vacunación , Enfermedades Prevenibles por Vacunación , Acontecimientos que Cambian la Vida , Vacunas Combinadas , AméricasRESUMEN
Transmission-blocking vaccines interrupting malaria transmission within mosquitoes represent an ideal public health tool to eliminate malaria at the population level. Plasmodium falciparum and P. vivax account for more than 90% of the global malaria burden, co-endemic in many regions of the world. P25 and P48/45 are two leading candidates for both species and have shown promising transmission-blocking activity in preclinical and clinical studies. However, neither of these target antigens as individual vaccines has induced complete transmission inhibition in mosquitoes. In this study, we assessed immunogenicity of combination vaccines based on P25 and P48/45 using a DNA vaccine platform to broaden vaccine specificity against P. falciparum and P. vivax. Individual DNA vaccines encoding Pvs25, Pfs25, Pvs48/45 and Pfs48/45, as well as various combinations including (Pvs25 + Pvs48/45), (Pfs25 + Pfs48/45), (Pvs25 + Pfs25), and (Pvs48/45 + Pfs48/45), were evaluated in mice using in vivo electroporation. Potent antibody responses were induced in mice immunized with individual and combination DNA vaccines, and specific antibody responses were not compromised when combinations of DNA vaccines were evaluated against individual DNA vaccines. The anti-Pvs25 IgG from individual and combination groups revealed concentration-dependent transmission-reducing activity (TRA) in direct membrane feeding assays (DMFA) using blood from P. vivax-infected donors in Brazil and independently in ex vivo MFA using Pvs25-transgenic P. berghei. Similarly, anti-Pfs25 and anti-Pfs48/45 IgGs from mice immunized with Pfs25 and Pfs48/45 DNA vaccines individually and in various combinations revealed antibody dose-dependent TRA in standard membrane feeding assays (SMFA) using culture-derived P. falciparum gametocytes. However, antibodies induced by immunization with Pvs48/45 DNA vaccines were ineffective in DMFA and require further vaccine construct optimization, considering the possibility of induction of both transmission-blocking and transmission-enhancing antibodies revealed by competition ELISA. These studies provide a rationale for combining multiple antigens to simultaneously target transmission of malaria caused by P. falciparum and P. vivax.
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Anticuerpos Antiprotozoarios , Vacunas contra la Malaria , Malaria Falciparum , Malaria Vivax , Plasmodium falciparum , Plasmodium vivax , Vacunas de ADN , Vacunas contra la Malaria/inmunología , Vacunas contra la Malaria/administración & dosificación , Animales , Malaria Falciparum/prevención & control , Malaria Falciparum/transmisión , Malaria Falciparum/inmunología , Plasmodium falciparum/inmunología , Plasmodium falciparum/genética , Plasmodium vivax/inmunología , Plasmodium vivax/genética , Malaria Vivax/prevención & control , Malaria Vivax/transmisión , Malaria Vivax/inmunología , Ratones , Vacunas de ADN/inmunología , Vacunas de ADN/administración & dosificación , Anticuerpos Antiprotozoarios/inmunología , Anticuerpos Antiprotozoarios/sangre , Femenino , Vacunas Combinadas/inmunología , Vacunas Combinadas/administración & dosificación , Antígenos de Protozoos/inmunología , Antígenos de Protozoos/genética , Proteínas Protozoarias/inmunología , Proteínas Protozoarias/genética , Ratones Endogámicos BALB C , HumanosRESUMEN
Influenza A Virus (IAV) and Respiratory Syncytial Virus (RSV) are both responsible for millions of severe respiratory tract infections every year worldwide. Effective vaccines able to prevent transmission and severe disease, are important measures to reduce the burden for the global health system. Despite the strong systemic immune responses induced upon current parental immunizations, this vaccination strategy fails to promote a robust mucosal immune response. Here, we investigated the immunogenicity and efficacy of a mucosal adenoviral vector vaccine to tackle both pathogens simultaneously at their entry site. For this purpose, BALB/c mice were immunized intranasally with adenoviral vectors (Ad) encoding the influenza-derived proteins, hemagglutinin (HA) and nucleoprotein (NP), in combination with an Ad encoding for the RSV fusion (F) protein. The mucosal combinatory vaccine induced neutralizing antibodies as well as local IgA responses against both viruses. Moreover, the vaccine elicited pulmonary CD8+ and CD4+ tissue resident memory T cells (TRM) against the immunodominant epitopes of RSV-F and IAV-NP. Furthermore, the addition of Ad-TGFß or Ad-CCL17 as mucosal adjuvant enhanced the formation of functional CD8+ TRM responses against the conserved IAV-NP. Consequently, the combinatory vaccine not only provided protection against subsequent infections with RSV, but also against heterosubtypic challenges with pH1N1 or H3N2 strains. In conclusion, we present here a potent combinatory vaccine for mucosal applications, which provides protection against two of the most relevant respiratory viruses.
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Anticuerpos Antivirales , Inmunidad Mucosa , Virus de la Influenza A , Vacunas contra la Influenza , Ratones Endogámicos BALB C , Infecciones por Virus Sincitial Respiratorio , Vacunas contra Virus Sincitial Respiratorio , Animales , Ratones , Infecciones por Virus Sincitial Respiratorio/prevención & control , Infecciones por Virus Sincitial Respiratorio/inmunología , Vacunas contra la Influenza/inmunología , Vacunas contra la Influenza/administración & dosificación , Vacunas contra Virus Sincitial Respiratorio/inmunología , Vacunas contra Virus Sincitial Respiratorio/administración & dosificación , Anticuerpos Antivirales/inmunología , Virus de la Influenza A/inmunología , Femenino , Infecciones por Orthomyxoviridae/inmunología , Infecciones por Orthomyxoviridae/prevención & control , Virus Sincitiales Respiratorios/inmunología , Anticuerpos Neutralizantes/inmunología , Anticuerpos Neutralizantes/sangre , Vacunas Combinadas/inmunología , Vacunas Combinadas/administración & dosificación , Humanos , Adenoviridae/inmunología , Adenoviridae/genética , Vectores GenéticosRESUMEN
To fully understand the safety of DTaP-IPV/Hib vaccination, we evaluated the differences between DTaP-IPV/Hib co-administration and separate administration of the DTaP, IPV and Hib vaccines (DTaP+IPV+Hib) based on adverse events following immunization (AEFI). All AEFI reported in Hebei Province, China, between 2020 and 2022 were included in this study. The risk difference (RD%), relative risk (RR), and Chi-square value were used to compare the differences in reported rates of AEFI between the DTaP-IPV/Hib and DTaP+IPV+Hib groups. From 2020 to 2022, 130 AEFI cases were reported in Hebei Province after DTaP-IPV/Hib vaccination, corresponding to an AEFI reported rate of 66.9/million doses, which was significantly lower than that for DTaP+IPV+Hib (9836 AEFI with a reported rate of 637.8/million doses). The overall reported rate of non-severe AEFI for DTaP+IPV+Hib vaccines was 9.5 times that of DTaP-IPV/Hib vaccination [95% confidence interval (CI): 8.0, 11.3]. Meanwhile, the reported rate of AEFI among infants aged 0-1 y was 9.8 times higher for DTaP+IPV+Hib than for DTaP-IPV/Hib (95% CI: 8.2, 11.7). DTaP+IPV+Hib vaccination also resulted in higher risks of high fever, localized redness and swelling, localized induration, and allergic rash compared with DTaP-IPV/Hib vaccination. The risk of AEFI, which were mostly mild reaction, was higher after vaccination with DTaP+IPV+Hib than after DTaP-IPV/Hib vaccination.
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Vacuna contra Difteria, Tétanos y Tos Ferina , Vacunas contra Haemophilus , Vacuna Antipolio de Virus Inactivados , Vacunas Combinadas , Humanos , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Haemophilus/administración & dosificación , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Lactante , Vacunas Combinadas/efectos adversos , Vacunas Combinadas/administración & dosificación , China/epidemiología , Femenino , Masculino , Vacunación/efectos adversos , Infecciones por Haemophilus/prevención & control , Esquemas de Inmunización , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/efectos adversos , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificaciónRESUMEN
OBJECTIVES: The pathogenic microorganisms that cause intestinal diseases can significantly jeopardize people's health. Currently, there are no authorized treatments or vaccinations available to combat the germs responsible for intestinal disease. METHODS: Using immunoinformatics, we developed a potent multi-epitope Combination (combo) vaccine versus Salmonella and enterohemorrhagic E. coli. The B and T cell epitopes were identified by performing a conservancy assessment, population coverage analysis, physicochemical attributes assessment, and secondary and tertiary structure assessment of the chosen antigenic polypeptide. The selection process for vaccine development included using several bioinformatics tools and approaches to finally choose two linear B-cell epitopes, five CTL epitopes, and two HTL epitopes. RESULTS: The vaccine had strong immunogenicity, cytokine production, immunological properties, non-toxicity, non-allergenicity, stability, and potential efficacy against infections. Disulfide bonding, codon modification, and computational cloning were also used to enhance the stability and efficacy of expression in the host E. coli. The vaccine's structure has a strong affinity for the TLR4 ligand and is very durable, as shown by molecular docking and molecular modeling. The results of the immunological simulation demonstrated that both B and T cells had a heightened response to the vaccination component. CONCLUSIONS: The comprehensive in silico analysis reveals that the proposed vaccine will likely elicit a robust immune response against pathogenic bacteria that cause intestinal diseases. Therefore, it is a promising option for further experimental testing.
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Epítopos de Linfocito B , Epítopos de Linfocito T , Vacunología , Humanos , Epítopos de Linfocito T/inmunología , Vacunología/métodos , Epítopos de Linfocito B/inmunología , Vacunas Combinadas/inmunología , Genómica/métodos , Escherichia coli Enterohemorrágica/inmunología , Salmonella/inmunología , Animales , Biología Computacional/métodos , Simulación del Acoplamiento Molecular , Vacunas contra Escherichia coli/inmunología , Infecciones por Escherichia coli/prevención & control , Infecciones por Escherichia coli/inmunología , Infecciones por Salmonella/inmunología , Infecciones por Salmonella/prevención & control , Antígenos Bacterianos/inmunología , Desarrollo de Vacunas/métodos , Vacunas Bacterianas/inmunologíaAsunto(s)
Vacunas contra Haemophilus , Vacunas contra Hepatitis B , Padres , Vacuna Antipolio de Virus Inactivados , Humanos , China , Vacunas contra Haemophilus/economía , Vacunas contra Hepatitis B/economía , Vacunas contra Hepatitis B/administración & dosificación , Estudios Transversales , Padres/psicología , Vacuna Antipolio de Virus Inactivados/economía , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacunas Combinadas/economía , Aceptación de la Atención de Salud/psicología , Encuestas y Cuestionarios , Vacunación/economía , Vacunación/psicología , Vacuna contra Difteria, Tétanos y Tos Ferina/economía , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , LactanteRESUMEN
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
In the post-COVID-19 era, the co-circulation of respiratory viruses, including influenza, SARS-CoV-2, and respiratory syncytial virus (RSV), continues to have significant health impacts and presents ongoing public health challenges. Vaccination remains the most effective measure for preventing viral infections. To address the concurrent circulation of these respiratory viruses, extensive efforts have been dedicated to the development of combined vaccines. These vaccines utilize a range of platforms, including mRNA-based vaccines, viral vector vaccines, and subunit vaccines, providing opportunities in addressing multiple pathogens at once. This review delves into the major advancements in the field of combined vaccine research, underscoring the strategic use of various platforms to tackle the simultaneous circulation of respiratory viruses effectively.
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COVID-19 , Infecciones por Virus Sincitial Respiratorio , SARS-CoV-2 , Humanos , Infecciones por Virus Sincitial Respiratorio/prevención & control , Infecciones por Virus Sincitial Respiratorio/inmunología , COVID-19/prevención & control , COVID-19/inmunología , SARS-CoV-2/inmunología , SARS-CoV-2/genética , Vacunas contra la COVID-19/inmunología , Vacunas Combinadas/inmunología , Vacunas Combinadas/administración & dosificación , Desarrollo de Vacunas , Vacunas Virales/inmunología , Gripe Humana/prevención & control , Gripe Humana/inmunología , Vacunas contra Virus Sincitial Respiratorio/inmunología , Vacunación , AnimalesAsunto(s)
Meningitis Meningocócica , Vacunas Meningococicas , Humanos , Nigeria/epidemiología , Vacunas Meningococicas/administración & dosificación , Meningitis Meningocócica/prevención & control , Vacunas Neumococicas/administración & dosificación , Lactante , Vacunas Combinadas/administración & dosificación , Vacunación , Programas de InmunizaciónRESUMEN
PURPOSE: Compared with monotherapy, combination therapy with multiple antihypertensive drugs has demonstrated superior efficacy in the management of hypertension. The aim of this study was to explore the efficacy of multitarget combined vaccines in achieving simultaneous antihypertensive and target organ protection effects. METHODS: Our team has developed ATRQß-001 and ADRQß-004 vaccines targeting Ang II type 1 receptor (AT1R) and α1D-adrenergic receptor (α1D-AR), respectively. In NG-nitroarginine methyl ester ( l -NAME) + abilities spontaneously hypertensive rats (SHRs) model, SHRs were simultaneously inoculated with ATRQß-001 and ADRQß-004 vaccines. Histological and biochemical analyses were performed to evaluate the antihypertensive effects and target organ protection of the ATRQß-001 and ADRQß-004 combined vaccines in comparison with those of the single vaccine. RESULTS: Both ATRQß-001 and ADRQß-004 vaccines induced robust antibody production, resulting in persistent high antibody titers in rats. Notably, the combined administration of both vaccines significantly decreased SBP in SHRs compared with treatment with a single vaccine, both before and after l -NAME administration. Furthermore, the combined vaccine regimen demonstrated superior efficacy in protecting against vascular remodeling, myocardial hypertrophy and fibrosis, and kidney injury in SHRs. Mechanistically, the combined vaccines exhibited significantly downregulated the expression of angiotensin II type 1 receptor (AT1R) and α1D-adrenergic receptor (α1D-AR). Importantly, no apparent immune-related adverse effects were observed in animals immunized with the combined vaccines. CONCLUSION: Preliminary findings from this investigation suggest that co-administration of the novel ATRQß-001 and ADRQß-004 vaccines holds potential as a groundbreaking therapeutic strategy for managing hypertension.