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Vaccine Preventable Diseases clinical trials

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NCT ID: NCT06333275 Recruiting - Clinical trials for Vaccine Immunity in CAR-T Cell Therapy Recipients

Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy

IMCAR
Start date: November 14, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about vaccine immunity in patients with B-cell malignancies treated by chimeric antigen receptor T-cell therapies (CAR-T). The main questions it aims to answer are: - Do CAR-T cell therapy recipients lose vaccine protection against common vaccine-preventable pathogens - Are current re-vaccination recommendations sufficient in restoring vaccine-protection - Is this restored vaccine-protection after CAR-T cell therapy lost faster than usual - Do clinical or immunological factors predict vaccine response after CAR-T cell therapy

NCT ID: NCT06202703 Recruiting - Clinical trials for Vaccine-Preventable Diseases

Fine Needle aSpiration of Lymph nodEs to Study vAccine-induced Immunity

SEA
Start date: April 15, 2023
Phase: N/A
Study type: Interventional

Rationale Causing a wide range of infectious diseases, including pneumonia, otitis media and meningitis, S. pneumoniae represents an important global health problem. Pneumococcal vaccines are clinically effective in preventing invasive pneumococcal disease, but the underlying immune response is likely to differ due to the inclusion of T cell epitopes in the conjugate, but not purified polysaccharide vaccine. However, these differences remain scantly studied. Lymph node fine needle aspiration (FNA) has been recently described to study vaccine-induced germinal centre responses in depth and represents a promising tool to study the underlying immune mechanisms of pneumococcal vaccines. Insight into the underlying immune mechanisms of vaccines could improve future vaccine design, e.g. by refining dosing intervals. Objective Determine timing of peak germinal centre B cell frequency following pneumococcal vaccination. Main trial endpoints The main trial endpoint is represented by the frequency of germinal centre B cells (BGC) in lymph node aspirates at various time points after vaccination, as measured by spectral flow cytometry. Both total BGC cells and S. pneumoniae polysaccharide-specific BGC frequencies will be determined. Trial design Pilot intervention study without a comparator. Trial population Healthy individuals between the age of 20 - 40 Interventions Subjects will be vaccinated once with Prevenar13. FNA of the draining lymph node will be performed and blood will be drawn at baseline, followed by weekly collection during the first four weeks, every other week between weeks 4 - 8 and a final collection time point after 12 weeks, resulting in a total of 8 sampling time points over the course of three months. Draining lymph node size will be assessed by ultrasound every other day during the first two weeks and then alongside lymph node FNA for the remainder of the study.

NCT ID: NCT06137755 Recruiting - Herpes Zoster Clinical Trials

Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above

Start date: March 15, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-VZV-001.

NCT ID: NCT06104345 Recruiting - Cholera Clinical Trials

Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines

Start date: October 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to explore the coadministration of oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines in healthy volunteers aged 18-65 years. The main question it aims to answer is: • Does coadministration impact the immune responses to Vivotif® and Dukoral® vaccines Participants will: - receive either oral typhoid fever (Vivotif®) or oral cholera (Dukoral®) vaccines or both simultaneously - give blood samples for immunogenicity analyses - participate in adverse event follow up Researchers will compare those receiving only one of the vaccines to those receiving both simultaneously to see if coadministration has an impact on antigen-specific responses measured with: - ELISPOT (plasmablast responses specific to Salmonella typhi, Vibrio Cholerae and Enterotoxigenic Escherichia coli) - ELISA (antibodies in lymphocyte supernatants (ALS) and serum antibodies specific to vaccine antigens)

NCT ID: NCT06088745 Recruiting - Herpes Zoster Clinical Trials

A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine

Start date: September 28, 2023
Phase: Phase 3
Study type: Interventional

This clinical trial is to study protective efficacy and safety of a recombinant herpes zoster vaccine (LZ901) and sponsored by Beijing Luzhu Biotechnology Co., Ltd. It is a phase Ⅲ, randomized, double-blind, placebo-controlled in healthy people aged 40 years and older. The study is to protect adults against shingles (herpes zoster / varicella zoster virus(VZV)). There will be about 26000 participators who will receive two-dose injection at the upper arm. LZ901 vaccine is made up of a tetramer of VZV glycoprotein E (VZV gE-Fc) and adsorbed with aluminum hydroxide adjuvant. This adjuvant can raise the immune response to a lot of antigens. It is the most widely used and safe adjuvant in various types of vaccines worldwide.

NCT ID: NCT06074237 Recruiting - Vaccine Refusal Clinical Trials

Improving Vaccine Counseling Skills Among Residents Using Educational Modules and Standardized Patient Encounters

Start date: April 25, 2024
Phase: N/A
Study type: Interventional

Unfortunately, only 40% of US pediatric residency programs reported in a survey that vaccine safety and counseling training is provided to residents. The success of a residency curriculum focused on communication strategies with patients hesitant to receive the influenza vaccine has been demonstrated, finding a decreased rate of vaccination refusal in the post curricular period. In a recent 2020 study, it demonstrated the positive impact of an online vaccine curriculum on resident vaccine knowledge and self-reported confidence in counseling vaccine hesitant patients. Providers have the potential to impact a substantial pediatric patient population. The outpatient clinics where the residents included in this study care for patients had 9942 pediatric visits in 2021. Each visit is an opportunity to talk with families about vaccines, address concerns and to administer vaccines when needed. The hypothesize is that interactive educational interventions using the online training modules combined with the standardized patient encounters will increase resident vaccine knowledge and confidence, and enhance communication and counseling skills, thereby improving vaccination rates of Human Papilloma Virus (HPV), Influenza, Measles/Mumps/Rubella (MMR) and Coronavirus (COVID-19) in the Beaumont residency clinics.

NCT ID: NCT06065176 Recruiting - COVID-19 Clinical Trials

The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection

BEEHIVE
Start date: November 22, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to find out how well two different 2023-2024 updated COVID-19 vaccines protect people from COVID-19 (the disease caused by the SARS-CoV-2 virus), and to determine if getting a 2023-2024 updated vaccine provides better protection from COVID-19 than not getting a vaccine. If the participant chooses to get a 2023-2024 updated COVID-19 vaccine as part of this study, they will have a 50/50 chance of receiving either the Novavax or Pfizer mRNA vaccine. If the participant decides not to get a 2023-2024 updated COVID-19 vaccine, the participant can still participate in other study activities. STUDY ACTIVITIES: - An online enrollment survey - An in-person enrollment visit - Weekly online surveys for 20 weeks - Weekly COVID-19 tests for 20 weeks - Additional online surveys if you have COVID-19 symptoms or tested positive for COVID-19. - Additional COVID-19 tests if you have COVID-19 symptoms or tested positive. - Online survey questions in the middle and at the end of the study

NCT ID: NCT05984849 Recruiting - COVID-19 Clinical Trials

Playing Games to Learn About Children's Vaccines Project

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

This proposed study aims to conduct timely research that promotes vaccine confidence and vaccination of two strongly recommended vaccines with suboptimal uptake rates: Human papillomavirus (HPV) and COVID-19 in vulnerable and underserved youth aged 11-14.

NCT ID: NCT05750017 Recruiting - Herpes Zoster Clinical Trials

A Study to Evaluate Safety and Tolerability of a Recombinant Herpes Zoster Vaccine

Start date: March 23, 2023
Phase: Phase 1
Study type: Interventional

This clinical trial is to study the safety and tolerability of a recombinant herpes zoster vaccine (LZ901) and sponsored by Beijing Luzhu Biotechnology Co., Ltd. It is a phase I, randomized, double-blind, placebo-controlled, dose escalation study in healthy people aged 50 to 70 years inclusive. The study is to protect adults against shingles (herpes zoster / varicella zoster virus(VZV)). There will be about 66 participators who will receive two-dose injection at the upper arm. LZ901 vaccine is made up of a tetramer of VZV glycoprotein E (VZV gE-Fc) and adsorbed with aluminum hydroxide adjuvant. This adjuvant can raise the immune response to a lot of antigens. It is the most widely used and safe adjuvant in various types of vaccines worldwide. In this study: 1. The participation is voluntary. 2. Before the study, participants will receive some tests for screening. If qualified, investigators will officially invite them to join this study. 3. The study vaccine is LZ901 with two different dose levels (50μg/0.5 mL, 100μg/0.5 mL). The placebo, which is saline solution, has no active drug. Participants will receive one of three as above mentioned. 4. Participants will be enrolled in one of four cohorts. If participants are enrolled in Cohorts 1 or 2, they will receive LZ901. If participants are enrolled in Cohorts 3 or 4, they will have a 2 out of 3 chance (66%) of receiving LZ901 and 1 out of 3 chance (33%) of receiving placebo. 5. In Cohort 3 and 4, the study staff and participants will not know which study treatment participants will be receiving. However, the study doctor can get this information in case of an emergency. 6. Participants will stay at the clinic for 30 minutes after each vaccination to observe if there are any uncomfortable. 7. This study will last about 8 months and will include about 8 study visits to the clinic. During this period, participants will receive a follow-up phone call and/or email by the study staff to follow the condition closely for safety, and record on diary/contact card. 8. Participants will receive some tests during the study, include safety tests such as physical examination, vital signs measurements, blood tests, urinalysis. Participants will be measured the levels of specific antibodies to see if the vaccine works well. This study is for research purposes only. Participants may not receive any direct benefits from participating in this study but have a chance to be in a study that may help others in the future.

NCT ID: NCT05604911 Recruiting - Clinical trials for Kidney Transplant; Complications

Herpes Virus Infections in Kidney Transplant Patients

HINT
Start date: January 1, 2023
Phase:
Study type: Observational

Kidney transplant recipients are at increased risk of infections, including Varicella-zoster virus (VZV) infections. Vaccination against VZV is routinely offered to all kidney transplant recipients and candidates in Denmark. In this exploratory observational study, the VZV specific immune response in kidney transplant candidates and recipients will be characterized at different time points in relation to transplantation, vaccination and infections. More knowledge on the immune reaction to transplantation, VZV vaccination and VZV infections may provide improved strategies for prevention and treatment of VZV infections in kidney transplant candidates and recipients.