Search results for " vaccines"
showing 10 items of 472 documents
INfluenza Vaccine Indication during therapy with Immune checkpoint inhibitors: A multicenter prospective observational study (INVIDIa-2)
2021
BackgroundUntil now, no robust data supported the efficacy, safety and recommendation for influenza vaccination in patients with cancer receiving immune checkpoint inhibitors (ICIs).MethodsThe prospective multicenter observational INfluenza Vaccine Indication During therapy with Immune checkpoint inhibitors (INVIDIa-2) study investigated the clinical effectiveness of influenza vaccination in patients with advanced cancer receiving ICIs, enrolled in 82 Italian centers from October 2019 to January 2020. The primary endpoint was the time-adjusted incidence of influenza-like illness (ILI) until April 30, 2020. Secondary endpoints regarded ILI severity and vaccine safety.ResultsThe study enrolle…
Phase I trial of thymidylate synthase poly-epitope peptide (TSPP) vaccine in advanced cancer patients.
2015
Thymidylate synthase (TS) poly-epitope peptide (TSPP) is a 27-mer peptide vaccine containing the amino acidic sequences of three epitopes with HLA-A2.1-binding motifs of TS, an enzyme overexpressed in cancer cells, which plays a crucial role in DNA repair and replication. Based on the results of preclinical studies, we designed a phase Ib trial (TSPP/VAC1) to investigate, in a dose escalation setting, the safety and the biological activity of TSPP vaccination alone (arm A) or in combination with GM-CSF and IL-2 (arm B) in cancer patients. Twenty-one pretreated metastatic cancer patients, with a good performance status (ECOG ≤ 1) and no severe organ failure or immunological disease, were enr…
Long-term pertussis-specific immune responses to a combined diphtheria, tetanus, tricomponent acellular pertussis and hepatitis B vaccine in pre-term…
2002
Abstract Immunoglobulin G (IgG) antibody titres against pertussis antigens, Bordetella pertussis-specific proliferation and cytokine production by peripheral blood mononuclear cells (PBMCs) were evaluated at the age of 5–6 years in 13 children who had been pre-term infants with a gestational age (GA) of ≤31 weeks, 10 who had been pre-term infants with a GA of 32–37 weeks, and 15 who had been term infants with a GA of 38–42 weeks. All of the infants had been immunised with a combined diphtheria, tetanus, tricomponent acellular pertussis and hepatitis B vaccine (DTaP–HBV) at 3, 5, and 11 months of post-natal age. Our results show that the long-term immune responses induced by primary pertussi…
Reactogenicity and Immunogenicity at Preschool Age of a Booster Dose of Two Three-Component Diphtheria-Tetanus-Acellular Pertussis Vaccines in Childr…
2001
Objectives.To determine the reactogenicity and immunogenicity of a fourth dose of 2 three-component acellular pertussis vaccines combined with diphtheria-tetanus-acellular pertussis (DTaP) when administered at preschool age to children primed in infancy with 3 doses of the same DTaP and who had received a diphtheria-tetanus (DT) dose at the age of 12 months.Setting.Local health units of 4 Italian regions.Study Design.Three thousand five hundred twenty-two children, who had been randomized in the first year of life to be immunized with a DTaP vaccine by either SmithKline Beecham or Chiron Biocine, were offered a booster of the same vaccine or, if refusing, a DT vaccine at the age of 5 to 6 y…
Factors Associated with Influenza Vaccination of Hospitalized Elderly Patients in Spain
2016
Vaccination of the elderly is an important factor in limiting the impact of influenza in the community. The aim of this study was to investigate the factors associated with influenza vaccination coverage in hospitalized patients aged ≥ 65 years hospitalized due to causes unrelated to influenza in Spain. We carried out a cross-sectional study. Bivariate analysis was performed comparing vaccinated and unvaccinated patients, taking in to account sociodemographic variables and medical risk conditions. Multivariate analysis was performed using multilevel regression models. We included 1038 patients: 602 (58%) had received the influenza vaccine in the 2013-14 season. Three or more general practit…
French organization for the pharmacovigilance of COVID-19 vaccines: A major challenge.
2021
International audience; In this special issue, we present the main highlights of the first weeks of pharmacovigilance monitoring of coronavirus disease 2019 (COVID-19) vaccines in this unprecedented situation in France: the deployment of a vaccination during an epidemic period with the aim of vaccinating the entire population and the intense pharmacovigilance and surveillance of these vaccines still under conditional marketing authorizations. In this unprecedented situation, the cross approach and interaction between the French pharmacovigilance network and French National Agency for the Safety of Medicines and Health Products (ANSM) has been optimized to provide a real-time safety related …
The effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) on hepatitis B vaccination in haemodialysis patients.
1996
Haemodialysis patients often fail to respond to hepatitis B vaccination. In this pilot study, 15 patients previously non-responsive to at least three 40 micrograms doses of hepatitis B vaccine were given 0.5, 5 or 10 micrograms kg-1 granulocyte-macrophage colony-stimulating factor (GM-CSF) subcutaneously 24 h prior to booster vaccination with a hepatitis B vaccine. Seven of the 15 patients developed antibody to hepatitis B surface antigen (HBsAb) (35-7240 IU L-1) upon initial vaccination with GM-CSF and two of four individuals responded with low HBsAb titres of 15 and 60 IU L-1 when revaccinated with hepatitis B surface antigen (HBsAg) and twice the dose of GM-CSF. The application of GM-CSF…
Overview of the benefitsand potential issues of the nonavalent HPV vaccine
2017
HPV-related diseases affect anogenital and oropharyngeal regions, heavily affecting the psychosexual dimension of both male and female individuals. HPV vaccination programs based on a bivalent or quadrivalent vaccine have opened broad perspectives for primary prevention. A nonavalent HPV vaccine (9vHPV), covering nine genotypes (HPV6, HPV11, HPV16, HPV18, HPV31, HPV33, HPV45, HPV52, and HPV58), might provide further improvement in terms of direct protection. In the present report, efficacy and safety data from 9vHPV vaccine development programs are examined. Efficacy data come from a pivotal trial, which was conducted among women aged 16–26 years randomly assigned to receive either the 9vHP…
Safety, reactogenicity and immunogenicity of a combined hexavalent tetanus, diphtheria, acellular pertussis, hepatitis B, inactivated poliovirus vacc…
2003
Safety, reactogenicity and immunogenicity of GSK Biologicals` hexavalent DTPa-HBV-IPV/Hib vaccine (Infanrix(R)hexa) was assessed when used for primary vaccination at 3, 4 and 5 months of age (N = 2163), compared to the separate administration of DTPa-IPV/Hib and HBV vaccines (N = 720). A similar safety and reactogenicity profile was demonstrated for both vaccine regimens, as well as a good immune response for all antigen components. By offering protection against six diseases in it series of single injections, the hexavalent DTPa-HBV-IPV/Hib vaccine was shown to be a safe, well tolerated and immunogenic alternative to primary immunization with licensed separately administered vaccines. (C) …
Immunogenicity and reactogenicity of a Haemophilus influenzae type b tetanus conjugate vaccine when administered separately or mixed with concomitant…
1998
With an increasing number of new vaccines available for routine childhood immunization, combination vaccines are needed in order to maintain or achieve a high compliance with recommended immunization programmes. In a prospective, randomized, comparative, multi-centre study, 822 healthy infants were enrolled to receive three doses of either a candidate or a commercially available Haemophilus influenzae type b (Hib) vaccine concomitantly with diphtheria-, tetanus- acellular pertussis (DTaP) vaccine. Study subjects were randomly allocated to one of the following groups: (1) separate, or (2) mixed injection of DTaP and candidate Hib vaccine, or (3) separate injection of DTaP and commercial Hib …