Clinical Research Directory

Preoperative Pneumococcal and Influenza Vaccination to Prevent Postoperative Pulmonary Infection in Patients Undergoing Lung Resection for Pulmonary Nodules or Lung Cancer

Postoperative pneumonia (POP) affects 4%-24% of lung cancer surgery patients, increasing mortality, stay, costs and worsening prognosis, especially in older patients. Perioperative immunosuppression and synergistic influenza/pneumococcal infection support perioperative vaccination, which may also induce trained immunity; thoracic surgery data are lacking. This multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial will enroll \~1278 patients aged ≥50 undergoing anatomical lung resection for pulmonary nodules or lung cancer, randomized 1:1 to vaccination or no vaccination, with 180-day follow-up. Randomization uses a computer-generated, site-stratified block sequence, concealed via central IWRS or sealed envelopes. An unblinded team handles screening, randomization and vaccination data; surgeons and assessors are blinded. No site may exceed 50% of enrollment. Vaccination group receives 23-valent pneumococcal polysaccharide and quadrivalent influenza vaccines intramuscularly in separate arms 14-28 days preoperatively. Controls receive no vaccine/placebo, with surgery scheduled 14-28 days after randomization. Concomitant indicated treatments are permitted and recorded. Primary endpoint is POP per modified CDC/NHSN criteria: new/progressive imaging infiltrate (excluding atelectasis, edema, embolism, tumor), plus ≥1 clinical sign (fever \>38 °C, WBC ≤4000 or ≥12,000/mm³, or altered mental status if ≥70 years) and ≥2 respiratory signs. Findings on days 3-5 are excluded unless persistent/worsening. Microbiology is confirmatory, not required.

Comparative Immunologic Mechanisms and Microbiome Interactions Following Different Influenza Vaccine Formulations in Older Adults

This prospective, randomized, open-label clinical study aims to evaluate the immunogenicity and underlying immune mechanisms of different influenza vaccine formulations in adults aged ≥65 years. Additionally, the study investigates the role of the gut microbiome in modulating vaccine-induced immune responses and durability.

A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019, 2019-2020, 2020-2021, and 2021-2022).

Estimate the Safety and Effectiveness of Adjuvanted Influenza Vaccine Among Asian Elderly People When Compared to Non-adjuvanted Vaccines

To compare the immunogenicity, cellular immune response, and safety between adjuvanted (aIIV4) and non-adjuvanted (IIV4) seasonal influenza vaccines in the Taiwanese elderly population with chronic medical conditions.

Vaccination Nudges From Pharmacists

The goal of this individual-level pragmatic randomized policy trial is to learn about the impact of behavioural nudges via mailed letters on increasing influenza and travel vaccination uptake in Alberta, Canada. The primary outcome is the proportion of adults receiving influenza and/or travel vaccination. The secondary outcome is the number of stroke events in the 6 months following vaccination. As such, this research aims to answer two key questions: 1. Do behavioural nudges increase influenza and travel vaccination in Alberta? 2. If yes, is there a decrease in the number of stroke events in the 6 months following vaccination? The two-arm individual level pragmatic randomized trial design includes two letter dimensions, a letter (a "nudge") with an influenza and cardiovascular risk reduction message and a letter with a travel vaccination benefit message, yielding the following groups: Letter with an influenza and cardiovascular risk reduction message Letter with a travel vaccination benefit message

Characterizing the Human Airway Immune Response to FluMist Vaccination

The goal of this clinical trial is to measure the immune response in the blood, nose, and lungs after participants receive either the FDA-approved inactivated influenza vaccine or the FDA-approved intranasal FluMist vaccine. The study will evaluate immune responses in groups of healthy, non-pregnant, volunteers between the ages of 18 and 40. The main purpose of the study is to measure the change in influenza vaccine-specific antibodies in the lower lungs and nose between vaccination and 14 days after participants receive the vaccine. All participants will be randomized to receive one of the two seasonal flu vaccines and will have blood and back of the nose swabs collected throughout the study. Some study participants will choose to undergo optional bronchoscopy procedures and will be included in the part of the study looking at lower lung immune responses.

Vaccine Chatbot for Improving Influenza Vaccination Uptake

This study aims to assess the impact of a vaccine chatbot on improving influenza vaccination uptake among children aged between 6 and 59 months through a cluster randomized trial. Specifically, the main questions it seeks to answer are whether an AI-enabled vaccine chatbot will increase the uptake of influenza vaccine among children and their family members, and how it will influence parents' literacy and confidence towards influenza vaccine. It will explore the potential role of vaccine chatbot on vaccination services. A cluster randomization will be used to assign children to the intervention and control groups. Parents of children in the intervention group will be invited to use the influenza vaccine chatbot online through WeChat, the mostly widely used social media platform in mainland China, or any web browsers. They can ask any questions related to the influenza vaccine and receive validated answers from the chatbot immediately. The intervention will last one and a half months, with invitations sent every ten days to reinforce the engagement. The control group will not use the chatbot during the intervention duration. After the intervention, the uptake, literacy, and confidence towards influenza vaccine will be compared between the intervention and control groups to evaluate the impact of vaccine chatbot.