View clinical trials related to Monkeypox.
Filter by:The goal of this observational study is to describe possible physical and psychological sequelae after an mpox infection and to evaluate the longevity of B- and T-cell immune responses in former mpox patients and vaccine recipients. The main questions it aims to answer are: - Are there any physical or pschological sequelae after mpox infection? - Is the humoral and/or cellular immune response to MPOX (or vaccinia) virus) durable? - Do the patients develop strong local immunity in comparison to systemic immunity? - How long is the virus still detectable in semen, saliva or the ano-rectal region? Participants will answer a questionnaire, samples with blood, saliva and semen as well as anal swabs will be collected. Follow-up visits 8, 16 and 24 months after infection or vaccination are planned. A healthy control group will be recruited in our HIV-PrEP clinic.
The Aim: Study immunogenicity, confirm the safety and tolerability of different schedules of vaccination with "live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus" using a complex of clinical and laboratory-instrumental techniques. The research tasks are to: 1. To study the immunological activity of a single VAC∆6 vaccine dose of 1x10⁷ plaque-forming units (PFU). 2. To study the immunological activity of two VAC∆6 vaccine doses (given 28 days apart) of 1x10⁶ PFU. 3. Assess the safety of different VAC∆6 vaccination schedules using a set of clinical and laboratory-instrumental techniques (thermometry, measurement of blood pressure, heart and lung auscultation, ECG, common blood and urine tests, biochemical, immunological and virological studies). 4. Assess the reactogenicity of different VAC∆6 vaccination schedules (number of local and systemic reactions, the percentage of those vaccinated with systemic and local reactions of various severity degrees). 5. To identify VAC∆6 vaccine-associated adverse events. 6. Study cell-mediated immunity induced by different VAC∆6 vaccination schedules. 7. Determine the presence of the virus in specific skin formations (crusts, pustules), saliva, blood and urine. 8. Evaluate the protective efficacy of one and two doses of the studied VAC∆6 vaccine.
The study is a prospective cohort that evaluates the clinical and immune-metabolic variables that may be linked to the risk and severity of the infection or even hospitalization or death in patients infected with the Mpox virus in Brazil. The expectation is to include at least 80 patients over six months, with a follow-up of 90 days from inclusion, through contact via decentralized visits.
The aim of the clinical study is to study the safety and tolerability of the live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus, in intracutaneous administration. The research tasks are to: - evaluate the safety of various schemes for the use of the VAC∆6 vaccine using a set of clinical and laboratory-instrumental methods (thermometry, blood pressure registration, auscultation of the heart and lungs, electrocardiography (ECG), complete blood count and common urine test, biochemical, immunological, and virological studies); - evaluate the reactogenicity of various schemes for the use of the VAC∆6 vaccine (taking into account the number of local and systemic reactions, the percentage of those vaccinated with various degrees of manifestation of systemic and local reactions); - evaluate the possibility of virus shedding into the environment by volunteers; - evaluate the immunological efficacy of various vaccine administration schemes; - identify the development of undesirable reactions to the administration of the vaccine; - evaluate the cellular immune response to the introduction of various schemes for the use of the vaccine; - evaluate preliminary efficacy data in order to select an optimal scheme for the administration of the vaccine to make a decision on conducting Phase II clinical trials in an extended group of volunteers.
A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.
This study is a Phase 2 randomized, open-label, non-placebo controlled, multi-site clinical trial that will evaluate two ID regimens for MVA-BN vaccine compared to the standard SC regimen in healthy, vaccinia-naïve adults 18 to 50 years of age, inclusive, (Stage 1). In Stage 2 of the study, the standard SC regimen will be evaluated in adolescents ages 12 through 17 years, inclusive, and compared to the standard SC regimen in adults ages 18 to 50, inclusive. In Stage 2, approximately 210 healthy, vaccinia-naïve adults will be enrolled in a comparator arm (Arm 4) and will be given the standard, licensed regimen of 1x10^8 MVA-BN administered SC on Day 1 and 29 and will be combined with adults from Arm 3 (Stage 1) to be the comparator for the primary endpoint, non-inferiority testing. Approximately 210 healthy, vaccinia-naïve adolescents will be enrolled and given 1x10^8 MVA-BN administered SC on Days 1 and 29 (Arm 5). The study will have a set target enrollment of at least 25% adolescents ages 12 to 14 years to ensure that adequate numbers of younger adolescents are enrolled. The primary objectives are 1.) To determine if peak humoral immune responses in adults ages 18-50 years following an ID regimen of 2 x 10^7 TCID50 MVA-BN are non-inferior to the licensed regimen of 1 x 10^8 TCID50 MVA-BN administered SC; 2.) To determine if peak humoral immune responses in adults ages 18-50 years following an ID regimen of 1 x 10^7 TCID50 MVA-BN are non-inferior to the licensed regimen of 1 x 10^8 TCID50 MVA-BN administered SC.
The goal of this observational study is to monitor and assess the safety profile of the MVA-BN vaccine among staff and study personnel of the PALM-007 study in the Democratic Republic of the Congo. The main questions it aims to answer are: - To estimate the incidence of serious adverse events (SAEs) in all individuals vaccinated with the MVA-BN vaccine - To estimate the incidence of adverse events (AEs) after each dose of MVA-BN vaccine. Participants will receive two doses of vaccine and will be actively followed up to the 28th day after their last dose of MVA-BN vaccine.
Colorectal cancer tissue sections were obtained according to the inclusion criteria. The formalin was used to immersed all cancer specimens. And tissues were cut to 5 μm thickness and placed on glass slides before staining. Endogenous peroxidase activity was inhibited and blocked by de-paraffinizing, rehydrating, and using 5% bovine serum albumin at 37ºC for 30 min. The treated sections were incubated with anti-FOS (promab 30360) at 4ºC overnight and washed three times with PBS. After that, it is required that incubation with secondary anti-peroxidation sunflower at 37ºC for 30 minutes. After washing three times again with PBS, the sections were developed in diaminobenzidine and microscopic images were made by light microscopy.
The goal of this study is to assess the immune response, tolerance, and safety of the low-dose intradermal (forearm) mpox vaccine in people who are HIV+ compared to people who are HIV-, and compared to the standard-dose subcutaneous (upper arm) vaccine. The resulting data will fill knowledge gaps, inform public health practices, and address community concerns about the absence of data for low-dose intradermal mpox vaccinations in people living with HIV.
The study team will create an online module via the REDCap platform. The module will include around 5 videos and several infographics covering the topics of symptoms, transmission, prevention, vaccination, and treatment of the monkeypox virus. Surveys assessing the primary and secondary study endpoints will be given to participants before and after the module. The purpose of the study is to assess the efficacy and acceptability of an educational presentation on monkeypox in a cohort of individuals recruited from Rainbow Health and to secondarily assess participant risk perception, intention to vaccinate, and confidence in public health initiatives.