Andrew W. Lee
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View article: Efficacy of monoclonal antibodies and maternal vaccination for prophylaxis of respiratory syncytial virus disease
Efficacy of monoclonal antibodies and maternal vaccination for prophylaxis of respiratory syncytial virus disease Open
Background Respiratory syncytial virus (RSV) is a leading cause of respiratory tract infection in infants and young children. The level of serum neutralizing antibodies (SNAs) is often used as a measure of protection against respiratory sy…
View article: 167. Phase 3, Randomized, Controlled Trial Evaluating Safety, Efficacy, and Pharmacokinetics (PK) of Clesrovimab in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease
167. Phase 3, Randomized, Controlled Trial Evaluating Safety, Efficacy, and Pharmacokinetics (PK) of Clesrovimab in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease Open
Background Clesrovimab is an investigational, long-acting monoclonal antibody for the prevention of RSV lower respiratory tract infection (LRI) in infants, including those at high risk of severe RSV disease due to serious comorbidity or pr…
View article: 166. A Phase 2b/3 Study to Evaluate the Efficacy and Safety of an Investigational Respiratory Syncytial Virus (RSV) Antibody, Clesrovimab, in Healthy Preterm and Full-Term Infants
166. A Phase 2b/3 Study to Evaluate the Efficacy and Safety of an Investigational Respiratory Syncytial Virus (RSV) Antibody, Clesrovimab, in Healthy Preterm and Full-Term Infants Open
Background Clesrovimab is an investigational, long-acting monoclonal antibody (mAb) targeting site IV of the fusion protein for the prevention of RSV lower respiratory tract infection in infants. Methods This phase 2b/3 double-blind, rando…
View article: A Phase 1b/2a Trial of a Half-life Extended Respiratory Syncytial Virus Neutralizing Antibody, Clesrovimab, in Healthy Preterm and Full-term Infants
A Phase 1b/2a Trial of a Half-life Extended Respiratory Syncytial Virus Neutralizing Antibody, Clesrovimab, in Healthy Preterm and Full-term Infants Open
Background Clesrovimab is an investigational monoclonal antibody with an extended half-life targeting site IV of the respiratory syncytial virus (RSV) fusion protein for the prevention of RSV disease in infants. Methods In this phase 1b/2a…
View article: Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults
Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults Open
Background The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine indicated for the prevention of Ebola virus disease (EVD) caused by Zaire ebolavirus in individuals 12 month…
View article: Real-Time Monitoring of Infectious Disease Outbreaks with a Combination of Google Trends Search Results and the Moving Epidemic Method: A Respiratory Syncytial Virus Case Study
Real-Time Monitoring of Infectious Disease Outbreaks with a Combination of Google Trends Search Results and the Moving Epidemic Method: A Respiratory Syncytial Virus Case Study Open
The COVID-19 pandemic has disrupted the seasonal patterns of several infectious diseases. Understanding when and where an outbreak may occur is vital for public health planning and response. We usually rely on well-functioning surveillance…
View article: A phase I randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a live-attenuated quadrivalent dengue vaccine in flavivirus-naïve and flavivirus-experienced healthy adults
A phase I randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a live-attenuated quadrivalent dengue vaccine in flavivirus-naïve and flavivirus-experienced healthy adults Open
Dengue (DENV) is a mosquito-borne virus with four serotypes causing substantial morbidity in tropical and subtropical areas worldwide. V181 is an investigational, live, attenuated, quadrivalent dengue vaccine. In this phase 1 double-blind,…
View article: 636. A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Quadrivalent Dengue Vaccine (V181)
636. A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Quadrivalent Dengue Vaccine (V181) Open
Background Dengue (DENV) is a mosquito-borne virus with four serotypes causing substantial morbidity in tropical and subtropical areas worldwide. A dengue vaccine that can be given to both seronegative and seropositive populations remains …
View article: Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis™) in premature infants
Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis™) in premature infants Open
Background: Immune immaturity may put premature infants at increased risk for infections. DTaP-IPV-Hib-HepB vaccine (Vaxelis™), a hexavalent vaccine studied in >6,800 children, has acceptable safety and immunogenicity profiles gener…
View article: Intravenous Fibrinolysis for Central Retinal Artery Occlusion
Intravenous Fibrinolysis for Central Retinal Artery Occlusion Open
Background and Purpose: Central retinal artery occlusion results in sudden, painless, usually permanent loss of vision in the affected eye. There is no proven, effective treatment to salvage visual acuity and a clear, unmet need for an eff…
View article: A double-blind, randomized, multicenter, controlled study to evaluate the immunogenicity, safety, and tolerability of varicella vaccine (VARIVAX™) passage extension 34 (PE34) process administered concomitantly with measles, mumps, and rubella vaccine (M-M-R™ II)
A double-blind, randomized, multicenter, controlled study to evaluate the immunogenicity, safety, and tolerability of varicella vaccine (VARIVAX™) passage extension 34 (PE34) process administered concomitantly with measles, mumps, and rubella vaccine (M-M-R™ II) Open
The varicella vaccine passage extension (VAR-PE) process was undertaken to extend the availability of varicella zoster virus (VZV)-containing vaccines. This study (V210-A03; NCT03239873) assessed the immunogenicity, safety, and tolerabilit…
View article: 2702. Infants Vaccinated with a Fully-Liquid DTaP-IPV-Hib-HepB Vaccine Are Protected During the High-Risk Period for Haemophilus Influenzae Type B Disease
2702. Infants Vaccinated with a Fully-Liquid DTaP-IPV-Hib-HepB Vaccine Are Protected During the High-Risk Period for Haemophilus Influenzae Type B Disease Open
Background DTaP-IPV-Hib-HepB is a fully-liquid, combination vaccine (Vaxelis™) approved for vaccination in infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib). Saf…
View article: Safety and immunogenicity of VAQTA® in children 12-to-23 months of age with and without administration of other US pediatric vaccines
Safety and immunogenicity of VAQTA® in children 12-to-23 months of age with and without administration of other US pediatric vaccines Open
Safety and immunogenicity data from 5 clinical trials conducted in the US in children 12-to-23 months old where HAVi was administered alone or concomitantly with other pediatric vaccines (M-M-R®II, Varivax®, TRIPEDIA®, Prevnar®, ProQuad®, …
View article: Concomitant use of VAQTA® with PedvaxHIB® and Infanrix® in 12 to 17 month old children
Concomitant use of VAQTA® with PedvaxHIB® and Infanrix® in 12 to 17 month old children Open
Open-label, multicenter, randomized study (NCT00289913) evaluated immunogenicity, safety, and tolerability of Vaqta (hepatitis A vaccine) administered with PedvaxHIB (Haemophilus b conjugate vaccine [Meningococcal protein conjugate]) & Inf…