Pertussis (Whooping Cough)

Researchers are conducting a phase IV, open-label, non-randomized study to compare the immune response and safety of a second booster dose of Pertagen4 vaccine with Adacel4 vaccine, given 10 years after the first booster. The study also aims to evaluate the long-term persistence of antibodies from BioNet's recombinant aP (Pertagen4) and TdaP (Boostagen4) vaccines, alongside the chemically-detoxified Tdap vaccine (Adacel4) in adults who participated in a prior phase II/III trial (TDA202). Participants who received one dose of Boostagen4, Pertagen4, or Adacel4 in the initial TDA202 study and completed a 1-year follow-up will be invited about 10 years later for this follow-up study. After consenting and screening for health status, participants will provide blood samples before and 28 days after receiving a second booster dose — either Pertagen4 or Adacel4 — administered by trained staff. The study will monitor immediate reactions for 30 minutes post-vaccination and collect diary records of side effects for 7 to 28 days. Participants will have assessments including medical history review, physical exams, and antibody testing via blood samples at enrollment and 28 days after vaccination. Safety monitoring will continue through the study, with phone check-ins to support diary completion. Blood samples will be analyzed to measure antibody levels against pertussis, tetanus, and diphtheria toxins to understand immune responses and vaccine safety over time.

This research aims to evaluate the immune response, safety, and consistency between different batches of the LBVD vaccine compared to the combined use of Pentavalent and Inactivated Poliomyelitis vaccines in healthy infants aged 6 to 8 weeks. The study is divided into two stages: Stage 1 compares LBVD with licensed control vaccines, and Stage 2 confirms that LBVD is not inferior to control vaccines and assesses consistency across three lots of LBVD. Participants receive a three-dose primary vaccination series at 6, 10, and 14 weeks of age. The LBVD vaccine is administered as an intramuscular injection into the thigh. The control group receives co-administration of Pentavalent and Inactivated Polio vaccines. Stage 1 focuses on initial comparisons, while Stage 2 includes multiple LBVD lots to evaluate lot-to-lot consistency. Throughout the study, infants will be monitored for immune protection levels and antibody concentrations four weeks after completing the vaccination series. Safety is tracked by observing immediate reactions within 30 minutes, solicited side effects within 7 days, and other adverse events within 4 weeks post-vaccination. The study follows infants from 6 weeks through 8 weeks of age, including all vaccine administrations and safety assessments.

Researchers are evaluating the combination of Adebrelimab with carboplatin or cisplatin plus etoposide chemotherapy and concurrent radiotherapy as a first treatment for patients with extensive-stage oligometastatic small cell lung cancer. This Phase II open-label study aims to assess the safety and effectiveness of this regimen in this patient group. The trial is led by Nanfang Hospital, Southern Medical University and focuses on patients with limited metastatic lesions and organs affected. Participants will first receive Adebrelimab intravenously along with carboplatin or cisplatin and etoposide for two cycles during the induction phase. Next, participants undergo concurrent chemoradiotherapy, including thoracic radiation and stereotactic body radiation therapy (SBRT) to metastases, combined with one to two cycles of chemotherapy. Following this, they will receive one to two additional cycles of Adebrelimab combined with chemotherapy, and then continue on Adebrelimab alone as maintenance therapy until disease progression, unacceptable side effects, or withdrawal from the study. During the study, participants will be closely monitored through clinical assessments, imaging, and laboratory tests to track progression-free survival and other measures such as overall survival and response rates, with follow-up lasting up to approximately 30 months. Safety will be monitored by recording adverse events throughout the treatment and maintenance phases. The total participation time includes induction, concurrent chemoradiotherapy, maintenance, and follow-up periods to fully evaluate treatment outcomes and tolerability.

Researchers are evaluating the protective efficacy and safety of a recombinant herpes zoster vaccine called LZ901 in healthy adults aged 40 years and older. This phase 3, randomized, double-blind, placebo-controlled trial aims to protect participants against shingles caused by the varicella zoster virus. The vaccine contains a tetramer of VZV glycoprotein E combined with an aluminum hydroxide adjuvant known to enhance immune response and widely used in vaccines worldwide. Participants will receive two doses of either the LZ901 vaccine or a placebo (aluminum hydroxide adjuvant) injected into the upper arm on day 0 and day 29. Around 26,000 participants will be enrolled, including a subgroup of about 3,000 to assess the consistency of immune response across three vaccine batches and monitor persistence of immunity up to 36 months. The study includes four groups: treatment main, placebo main, treatment immunization, and placebo immunization groups. Participants will undergo up to 24 visits depending on their group, including on-site and in-person visits for screening, vaccination, and follow-up assessments. Researchers will monitor vaccine efficacy 30 days after full immunization, track adverse events from immediate to 12 months post-vaccination, and evaluate immune response through antibody tests at multiple time points. The study also explores the vaccine's impact on reducing the severity and occurrence of postherpetic neuralgia in adults 40 years and older.

Researchers are conducting a Phase 1, open-label, randomized crossover study to evaluate how the study drug ibuzatrelvir is absorbed into the bloodstream of healthy adults. The trial compares the amount of ibuzatrelvir in blood after taking different tablet formulations, including the original and new tablets, both with and without food. The study also assesses the safety and tolerability of the medication. Participants will take a single dose of ibuzatrelvir in four different ways across four dosing periods: the original tablet fasted, the new tablet fasted, the new tablet dispersed in water fasted, and the new tablet fed. Each dosing period lasts 2 to 3 days, and participants will stay in the clinical research unit for 9 nights and 10 days to complete all dosing and procedures. The study uses a crossover design where each participant receives all treatment types in varied sequences. During the study, participants will have blood and urine samples collected for safety and to measure drug levels, with up to 40 blood draws for pharmacokinetics. They will also undergo up to 8 ECGs to monitor heart activity. Participants must fast overnight before most doses. After the inpatient stay, a follow-up phone call will occur 28 to 35 days after the last dose. Total participation lasts about 10 to 11 weeks.

Researchers are evaluating the effects of acupressure on cough and related symptoms such as shortness of breath and fatigue in lung cancer survivors. This randomized controlled trial aims to see if acupressure can reduce these symptoms, improve symptom burden, and enhance health-related quality of life and functional ability in patients with lung cancer. The study addresses the significant impact that cough and its related symptoms have on lung cancer survivors' quality of life and overall survival. Participants are randomly assigned to one of two groups: one group receives an 8-week acupressure intervention, while the other receives an educational booklet about lung cancer, cough causes, and management. The acupressure group attends two hospital training sessions in the first week to learn the technique, then performs acupressure daily on 15 specific points twice a day and during coughing episodes as needed. The education group receives the booklet after baseline assessment and will be offered acupressure later after the study ends. Participants keep diaries of their acupressure practice and symptoms and are assessed four times: before starting (baseline), after one week, after eight weeks, and eight weeks after the intervention ends. Researchers measure cough, quality of life related to cough, symptom clusters, fatigue, shortness of breath, symptom burden, functional capacity, and overall health-related quality of life. Follow-up continues for 16 weeks to monitor lasting effects and safety throughout the study period.

Researchers are evaluating the ability of the AeviceMD, a wearable medical device, to detect wheezing in both children and adults. Wheezing, cough, and breathlessness are common respiratory symptoms usually identified manually by healthcare professionals through listening to lung sounds. The study aims to find out if AeviceMD can detect wheezes as accurately as a physician and to explore its potential for remote lung sound monitoring. During the study, participants will have the AeviceMD device placed on them to record lung sounds and detect wheezes. The device's findings will be compared with assessments made by physicians through traditional auscultation. The study includes two groups: patients diagnosed with acute asthma exacerbations and patients with other non-cardiac and non-pulmonary complaints. Participants will undergo lung sound recordings both onsite with a physician and remotely, with the results compared between the AeviceMD device and medical professionals. The primary outcome is the detection of wheeze within 60 seconds, while the secondary outcome involves identifying respiratory sounds within 150 seconds. The study is observational and will continue until December 2026, involving children aged 3 years and older.

Researchers are evaluating a new hexavalent vaccine containing diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and a reduced dose of inactivated poliovirus vaccine (IPV) antigens in healthy infants and toddlers. This study compares the immunogenicity and safety of this reduced IPV dose vaccine to the licensed full-dose SIIPL HEXASIILae vaccine. The study aims to support global polio eradication by improving IPV availability and affordability through antigen dose reduction. The study is an observer-blind, randomized, active-controlled, multi-center Phase III trial involving 1,557 infants aged 6 to 8 weeks. Participants will be randomized in a 2:1 ratio to receive either the reduced IPV hexavalent vaccine or the full-dose HEXASIILae vaccine. Both groups will receive a three-dose primary vaccination series at 6, 10, and 14 weeks, followed by a booster between 12 and 24 months of age. The vaccines are given to actively immunize infants against six diseases. Participants will be monitored closely for immune response and safety. Safety and immunogenicity data will be collected up to 28 days after the third vaccination dose. After primary vaccination, infants will be followed every three months from 6 to 21 months of age until they receive the booster dose. A final safety and immunogenicity assessment will be done 28 days after the booster. The study will measure the vaccine's ability to produce an immune response without significant adverse effects over the study period ending in May 2026.

Researchers are investigating the best approach to treat low-risk patients with isolated subsegmental pulmonary embolism (SSPE), a type of blood clot in small lung arteries. The study aims to determine whether monitoring patients without anticoagulation is as safe and effective as giving anticoagulant medication. This is important because many patients currently receive anticoagulants that carry a risk of bleeding, but it is unclear if all patients with isolated SSPE need this treatment. Patients in the trial are randomly assigned to one of two groups. One group receives the anticoagulant drug rivaroxaban, starting with 15 mg twice daily for 21 days, then 20 mg once daily for a total of 90 days. The other group receives a placebo matching the same schedule. The trial compares clinical surveillance without anticoagulation to anticoagulation treatment to assess safety and effectiveness. Participants will be followed for 90 days after randomization to monitor for recurrent venous thromboembolism, significant bleeding events, and overall survival. Researchers will track these outcomes through clinical assessments and safety monitoring. This study is designed to evaluate if careful monitoring alone is a safe alternative to anticoagulation in selected patients with isolated SSPE, potentially reducing bleeding risks from treatment.

Researchers are examining fluid and tissue samples from the lungs and noses of healthy individuals and people with a history of lung infections to identify differences that may relate to susceptibility to certain infections. This observational study includes healthy volunteers and patients aged 5 to 75 years who are followed at the National Institutes of Health (NIH). The goal is to better understand immune function and pathways involved in respiratory infections by comparing samples from these groups. Participants may undergo various procedures including bronchoscopy with bronchoalveolar lavage, bronchial brushings, and endobronchial biopsies in adults; nasal mucosal biopsies and brushings; sputum induction; measurement of nasal nitric oxide and nasal potential difference; collection of exhaled breath condensate, aerosol samples, and cough aerosols; and Lung Clearance Index testing. These samples will be analyzed for cellular and acellular components in specialized laboratories. During the study, participants will have medical history reviews, physical exams, blood and urine tests, chest X-rays, electrocardiograms, and treadmill stress tests if indicated. Bronchoscopy procedures involve sedation and numbing for comfort while collecting samples from the airways. Researchers will measure immune function differences and monitor various respiratory and physiological parameters over time. Participants will also provide informed consent and arrange for transportation home after procedures, with the total participation involving multiple sample collections and assessments.