A Phase 2a Study to Evaluate ALS-008176 in the Virus Challenge Model
Respiratory Syncytial Virus InfectionsThis study is designed to compare the antiviral effect of ALS-008176 compared to a placebo control in the respiratory syncytial virus challenge model.
Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)
RSV InfectionThe primary objective is to evaluate the suitability of the challenge model in measuring the efficacy of MEDI-557 compared to placebo in healthy adult participants for the reduction in the incidence of RSV through 12 days post-RSV challenge with the RSV Memphis-37 strain.
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers...
Drug SafetyRespiratory Syncytial Virus InfectionsThe purpose of this study is to determine the range of single inhaled doses of a new dry powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.
Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine
Respiratory Syncytial Virus InfectionsA Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in healthy adults (18 to 49 years of age). Study Objectives: Primary: To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations. Secondary: To assess and compare the immunogenicity (neutralizing antibody and total anti-F antibody) of the 6 RSV-F protein particle vaccine formulations To confirm the "dose sparing" and "value added" effects of the aluminum phosphate adjuvant
Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
BronchiolitisRespiratory Syncytial Virus InfectionsThe purpose of this study is to evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. We are using two different medications and comparing the difference in lung function after each medication. We will also be taking a nasal wash sample for VEGF. We will be using this in comparing how infants respond to the aerosol medications as well. We hope to help standardize medications used for infants with bronchiolitis and RSV.
Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients
Respiratory Syncytial Virus InfectionsThe purpose of this study is to test the safety and effectiveness of ribavirin, administered as an aerosol, in preventing progression of upper respiratory tract RSV infection to RSV pneumonia in bone marrow and peripheral blood transplant recipients.
Prevention of RSV Infections in Bone Marrow Transplant Recipients
Respiratory Syncytial Virus InfectionRespiratory Syncytial Virus (RSV) infections are very common and widespread. By age 5, virtually everyone has been infected and developed antibodies against some strain of the virus. RSV infections happen during adulthood, leading to common cold syndromes. In Bone Marrow Transplant recipients the disease is much more severe, usually progressing to pneumonia. This phenomenon is associated with mortality rates around 60-80%. RSV Polyclonal Immunoglobulin (Respigam® (Registered Trademark)) has been approved by the Food and Drug Administration and recommended by the American Academy of Pediatrics for prophylaxis of RSV disease in premature babies and children born with bronchopulmonary dysplasia. Furthermore, it has been used to treat RSV pneumonia in children and Bone Marrow Transplant recipients with encouraging results and no complications. Currently, no preventive strategies are available when approaching this infection among bone marrow transplant patients. We intend to prevent our bone marrow transplant patients from developing RSV pneumonia by employing the strategy already used in premature babies, i.e., by passive immunization with Respigam® (Registered Trademark). Our goal to evaluate the efficacy and safety of this strategy in such immunocompromised population. We believe that this will be a more reasonable approach than waiting for the infection to settle in and only then treating it, because optimal therapy is not currently available.
Phase 2a Study of MVA-BN-RSV Vaccination and RSV Challenge in Healthy Adults
RSV InfectionA Phase 2a, Randomised, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Immunogenicity and Efficacy of the Recombinant MVA-BN®-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Participants
Respiratory Syncytial Virus - RSV Protocol
Bone Marrow Transplant InfectionInfection in Marrow Transplant Recipients4 moreThe goal of this clinical research study is to learn if ribavirin can help to control RSV in patients with immune systems that have been weakened by a stem cell transplant. Researchers also want to compare the effectiveness of the drug when it is given by mouth to when it is inhaled. The safety of the drug in both methods of delivery will be studied. Ribavirin is designed to prevent the RSV virus from making more copies of itself in the body.
ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers
HealthyRSV InfectionThe overall aims of the study are: To provide additional information on the pharmacokinetics of ALX-0171 by measuring (i) local (bronchoalveolar lavage fluid (BALF)) and systemic (plasma) concentrations of ALX-0171 after oral inhalation, and (ii) systemic (plasma) and urine concentrations after intravenous administration. To further determine the safety and local and systemic tolerability of ALX-0171. To further evaluate local (induced sputum) and/or systemic (serum) immunogenicity of ALX-0171, by analysing the potential occurrence of anti-drug antibodies (ADA).