ABSTRACT
Human Papillomavirus (HPV) prophylactic vaccination has proven effective in preventing new infections, but it does not treat existing HPV infections or associated diseases. Hence, there is still an important reservoir of HPV in adults, as vaccination programs are mainly focused on young women. The primary objective of this non-randomized, open-label trial is to evaluate if a 3-dose regimen of Gardasil-9 in HPV16/18-positive women could reduce the infective capacity of their body fluids. We aim to assess if vaccine-induced antibodies could neutralize virions present in the mucosa, thus preventing the release of infective particles and HPV transmission to sexual partners. As our main endpoint, the E1^E4-HaCaT model will be used to assess the infectivity rate of cervical, anal and oral samples, obtained from women before and after vaccination. HPV DNA positivity, virion production, seroconversion, and the presence of antibodies in the exudates, will be evaluated to attribute infectivity reduction to vaccination. Our study will recruit two different cohorts (RIFT-HPV1 and RIFT-HPV2) of non-vaccinated adult women. RIFT-HPV1 will include subjects with an HPV16/18 positive cervical test and no apparent cervical lesions or cervical lesions eligible for conservative treatment. RIFT-HPV2 will include subjects with an HPV16/18 positive anal test and no apparent anal lesions or anal lesions eligible for conservative treatment, as well as women with an HPV16/18 positive cervical test and HPV-associated vulvar lesions. Subjects complying with inclusion criteria for both cohorts will be recruited to the main cohort, RIFT-HPV1. Three doses of Gardasil-9 will be administered intramuscularly at visit 1 (0 months), visit 2 (2 months) and visit 3 (6 months). Even though prophylactic HPV vaccines would not eliminate a pre-existing infection, our results will determine if HPV vaccination could be considered as a new complementary strategy to prevent HPV-associated diseases by reducing viral spread. Trial registration: https://clinicaltrials.gov/ct2/show/NCT05334706.
Subject(s)
Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 , Human papillomavirus 16 , Human papillomavirus 18 , Papillomavirus Infections , Humans , Female , Papillomavirus Infections/prevention & control , Papillomavirus Infections/virology , Papillomavirus Infections/immunology , Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18/administration & dosage , Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18/immunology , Human papillomavirus 16/immunology , Human papillomavirus 18/immunology , Adult , Young Adult , Adolescent , Antibodies, Viral/immunology , Papillomavirus Vaccines/administration & dosage , Papillomavirus Vaccines/immunology , DNA, Viral , Vaccination/methods , Cervix Uteri/virologyABSTRACT
3D printed LEGO®-like designs are an attractive approach for the development of compartmental delivery systems due to their potential for dose personalisation through the customisation of drug release profiles. Additive manufacturing technologies such as Fused Deposition Modelling (FDM) are ideal for the printing of structures with complex geometries and various sizes. This study is a paradigm for the fabrication of 3D printed LEGO® -like tablets by altering the design of the modular units and the filament composition for the delivery of different drug substances. By using a combination of placebo and drug loaded compartments comprising of immediate release (hydroxypropyl cellulose) and pH dependant polymers (hypromellose acetate succinate) we were able to customise the release kinetics of melatonin and caffeine that can potentially be used for the treatment of sleep disorders. The LEGO® -like compartments were designed to achieve immediate release of melatonin followed by variable lag times and controlled release of caffeine.
Subject(s)
Melatonin , Sleep Wake Disorders , Humans , Caffeine/chemistry , Printing, Three-Dimensional , Tablets/chemistry , Drug Liberation , Technology, PharmaceuticalABSTRACT
The development of personalised paediatric dosage forms using 3D printing technologies has gained significant interest over the last few years. In the current study extruded filaments of the highly bitter Diphenhydramine Hydrochloride (DPH) were fabricated by using suitable hydrophilic carries such as hydroxypropyl cellulose (Klucel ELFTM) and a non-ionic surfactant (Gelucire 48/16TM) combined with sweetener (Sucralose) and strawberry flavour grades. The thermoplastic filaments were used to print 3D fruit-chew designs by Fused Deposition Modelling (FDM) technology. Physicochemical characterisation confirmed the formation of glass solution where DPH was molecularly dispersed within the hydrophilic carriers. DPH was released rapidly from the 3D printed fruit-chew designs with >85% within the first 30 min. Trained panellists performed a full taste and sensory evaluation of the sweetener intensity and the strawberry aroma. The evaluation showed complete taste masking of the bitter DPH and revealed a synergistic effect of the sweetener and the strawberry flavour with enhanced sweet strawberry, fruity and aftertaste perception. The findings of the study can be used for the development of paediatric dosage forms with enhanced organoleptic properties, palatability and medication adherence.
ABSTRACT
No disponible
Subject(s)
Humans , Electronic Health Records/trends , Informed Consent , Advance Directives , Forms and Records Control/trends , Electronic Prescribing , Medical Order Entry Systems/trends , Image Enhancement , Attitude to ComputersABSTRACT
Considerando la experiencia acumulada y el trabajo desarrollado por los comités de prevención y control de la infección hospitalaria en el país, se decide crear similar organización en hogares de ancianos e impedidos físicos y mentales de Ciudad de La Habana. Se considera el adiestramiento y preparación de enfermeras vigilantes epidemiológicas y la elaboración del Reglamento que regirá la organización y funciones de estos comités refrendado por la asesoría jurídica de la Dirección Provincial de Salud en Ciudad de La Habana
Subject(s)
Humans , Cross Infection/prevention & control , Disabled Persons , Homes for the Aged , Intellectual Disability , NursingABSTRACT
Considerando la experiencia acumulada y el trabajo desarrollado por los comités de prevención y control de la infección hospitalaria en el país, se decide crear similar organización en hogares de ancianos e impedidos físicos y mentales de Ciudad de La Habana. Se considera el adiestramiento y preparación de enfermeras vigilantes epidemiológicas y la elaboración del Reglamento que regirá la organización y funciones de estos comités refrendado por la asesoría jurídica de la Dirección Provincial de Salud en Ciudad de La Habana (AU)
