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 BioNets recombinant aP Pertagen4 and TdaP Boostagen4 vaccines, alongside the chemically-detoxified Tdap vaccine Adacel4 in adults who participated in a prior phase IIIII 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 vaccines impact on reducing the severity and occurrence of postherpetic neuralgia in adults 40 years and older.

Researchers are evaluating the effects of a self-administered acupressure intervention on cough and related symptoms in lung cancer survivors. The study aims to see if acupressure can reduce cough, lessen a symptom group involving dyspnea, cough, and fatigue, and improve overall symptom burden, functional capacity, and quality of life for these patients. This is a randomized controlled trial focusing on supportive care for lung cancer survivors. Participants are randomly assigned to either an 8-week acupressure program or an education group. Those in the acupressure group attend two training sessions at the hospital during the first week to learn proper techniques. They then perform acupressure daily on 15 specific points at least twice a day and during coughing episodes. The education group receives a booklet about lung cancer, cough causes, and management strategies. Trainers follow up with acupressure participants twice weekly to support and assess their practice. Participants will keep diaries recording their acupressure practice and symptoms. They are assessed at four times before treatment, after 1 week, after 8 weeks, and 8 weeks post-intervention. Researchers evaluate cough severity, cough-related quality of life, the dyspnea-cough-fatigue symptom cluster, fatigue, symptom burden, functional capacity, and health-related quality of life. The study runs from baseline through an 8-week intervention and an 8-week follow-up period, with ongoing monitoring via diaries and trainer contacts.

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 devices 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 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 studying differences in lung and nasal fluid and tissue samples between healthy people and those with a history of lung infections to understand susceptibility to respiratory infections. This observational research involves both adults and children enrolled in National Institutes of Health NIH protocols, aiming to analyze immune function and inflammatory responses in these groups. The study will collect various specimens and bedside measurements to explore new pathways related to infectious diseases. Participants may undergo procedures such as bronchoscopy with bronchoalveolar lavage, bronchial brushings, endobronchial biopsies, nasal mucosal scrape biopsies, sputum induction, and collection of exhaled breath condensate. Additional measurements include nasal nitric oxide production, nasal potential difference, exhaled aerosol mask sampling, cough aerosol collection, exhaled particle collection, and Lung Clearance Index LCI testing. These samples and data will be stored or transferred to laboratories for detailed investigation. Participants will have medical history reviews, physical exams, blood and urine tests, ECGs, and chest X-rays as part of assessments. Some may undergo treadmill stress tests if over 45 with chest symptoms. Specimens collected through various methods will help researchers compare immune responses. The trial includes healthy volunteers and patients with infection susceptibility, with procedures designed to monitor safety and collect detailed respiratory data over time.

Researchers are evaluating a digital empowerment model for lung cancer screening aimed at detecting lung cancer earlier and reducing deaths from respiratory diseases. This single-arm cluster randomized trial is conducted in Guangzhou, focusing on community health service centers. The study assesses the effectiveness and cost-effectiveness of low-dose CT LDCT screening combined with AI technology and digital health platforms to improve early lung cancer diagnosis. The intervention includes low-dose CT screenings performed at primary healthcare institutions, supported by an AI-based full-lung model that assists in interpreting CT images. Community health centers use a digital platform called Fei Anxin to manage resident information and coordinate screening efforts. Participants with detected lung nodules are referred to hospitals for further examination. The study expects to enroll about 16,000 participants and collects individual data through questionnaires and digital tools. Participants will undergo lung cancer screening and complete health questionnaires. Screening and diagnostic data are gathered via digital platforms and hospitals. Researchers will measure the proportion of early-stage lung cancer detected within one year after intervention implementation, along with secondary outcomes like follow-up rates, diagnosis rates, false positive rates, and complications related to CT screening and diagnostic tests. The study runs from June 2024 through June 2025 and involves ongoing monitoring and data collection throughout this period.

This trial investigates whether intramuscular steroid injections can effectively treat unexplained chronic cough, a condition thought to involve nerve and larynx inflammation. The study compares steroid injections against placebo in a randomized, single-blind design to determine if steroid treatment reduces cough severity and improves symptoms. Researchers aim to find an accessible, evidence-based treatment option for patients with this challenging condition. Participants are randomly assigned to receive either a triamcinolone steroid injection or a saline placebo injection into the deltoid muscle. The study focuses on the systemic effects of steroids, based on theories that neuroinflammation drives chronic cough and that treatment site may not be critical. The trial duration includes a 4-week period after injection to evaluate symptom changes. During participation, patients complete questionnaires including the Leicester Cough Questionnaire and visual analog scales to assess cough severity and improvement. Researchers also record a simple yesno response to symptom change and monitor any adverse reactions. Data collected over 4 weeks will help determine the treatments impact, with safety and effectiveness measured carefully throughout the study.