Publications by authors named "Villafana T"
Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infection (LRTI) in infants worldwide. Nirsevimab, an extended half-life monoclonal antibody against RSV, is approved in China for the prevention of RSV lower respiratory tract disease in infants; however, global nirsevimab trials did not enroll Chinese infants. To inform the investigation of nirsevimab for the prevention of RSV LRTI in Chinese infants, this Phase I, randomized, placebo-controlled trial evaluated the pharmacokinetics (PK) and safety of nirsevimab in healthy Chinese adults.
View Article and Find Full Text PDFBackground: Nirsevimab is an extended half-life, highly potent neutralizing monoclonal antibody against the respiratory syncytial virus (RSV) fusion protein, with efficacy in preventing RSV-associated medically attended (MA) lower respiratory tract infection (LRTI) in infants and medically vulnerable children (aged ≤24 months). This post-hoc exploratory analysis examined the incidence of LRTI from RSV and other respiratory pathogens during a 2:1 randomized, double-blind, placebo-controlled, phase 3 study of nirsevimab, in healthy-term and late-preterm (i.e.
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- The MEDLEY trial investigated the effectiveness of nirsevimab, a new monoclonal antibody for RSV, compared to the older treatment palivizumab in preterm infants and those with specific health conditions.
- Nirsevimab was given as a single dose, while palivizumab was administered as five monthly doses, with both treatments' antibody levels monitored over two RSV seasons.
- Results showed that nirsevimab produced approximately 10 times higher and more lasting neutralizing antibody levels against RSV than palivizumab.
Article Synopsis
- The MUSIC trial tested nirsevimab, a monoclonal antibody designed to treat severe RSV infections in immunocompromised children under 24 months, assessing its safety and how the body processes the drug over time.
- Out of the 100 participants with various immunocompromising conditions, most experienced minimal side effects, with three deaths occurring that were unrelated to the treatment.
- Findings showed that nirsevimab was generally well tolerated, with serum levels indicating potential effectiveness in preventing RSV infections similar to those in healthy infants, though some children had increased drug clearance that may affect efficacy.
Article Synopsis
- Nirsevimab is a long-lasting monoclonal antibody designed to prevent RSV-related respiratory issues in vulnerable infants and children, and its effectiveness was tested against the standard treatment, palivizumab, in a clinical trial called MEDLEY.
- The trial included two RSV seasons where participants received either nirsevimab or palivizumab, with ongoing assessments of RSV infections and antibody responses through nasal swabs.
- The results showed that while certain substitutions in RSV isolates developed resistance to palivizumab, no changes were found that affected nirsevimab's ability to neutralize RSV, indicating its potential superiority in preventing RSV infections.
A better understanding of the long-term safety, efficacy, and immunogenicity of COVID-19 vaccines is needed. This phase 3, randomized, placebo-controlled study for AZD1222 (ChAdOx1 nCoV-19) primary-series vaccination enrolled 32,450 participants in the USA, Chile, and Peru between August 2020 and January 2021 (NCT04516746). Endpoints included the 2-year follow-up assessment of safety, efficacy, and immunogenicity.
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- Nirsevimab is approved in the US for preventing RSV in neonates and infants, particularly during their first RSV season, based on safety data from three clinical trials involving different populations.
- In the studies, participants were given a single dose of nirsevimab or a comparator treatment, with safety data showing that most adverse events (AEs) were mild to moderate and largely unrelated to the treatment.
- The conclusion indicated that nirsevimab has a favorable safety profile for preventing RSV disease, regardless of the infants' gestational age or pre-existing conditions.
Article Synopsis
- AZD2816 is a variant-specific COVID-19 vaccine designed to improve immunity against the SARS-CoV-2 beta variant while still resembling the original AZD1222 vaccine.
- The study involved unvaccinated adults in a randomized, multinational trial across several countries, primarily assessing the safety and effectiveness of administering different schedules of the two vaccines over a period of 180 days.
- Results indicated comparable safety profiles and immune responses to both vaccines, with slight variations in the rates of adverse events and antibody responses among the different groups.
Article Synopsis
- Nirsevimab is a monoclonal antibody approved for RSV prevention in infants across several regions, including Canada, the EU, Great Britain, and the USA.
- A population pharmacokinetics model was developed to study how factors like body weight and age affect the drug's clearance rate in infants.
- The findings suggest a weight-based dosing strategy for nirsevimab to effectively meet the needs of all infants during their first RSV season, regardless of health status or prematurity.
Article Synopsis
- The Phase 3 MELODY trial evaluated the effectiveness of nirsevimab in preventing RSV in children during their second RSV season.
- Results showed that there was no increase in medically attended RSV lower respiratory infections or disease severity in children who received nirsevimab compared to those who received a placebo.
- The clinical trial is registered at Clinicaltrials.gov under NCT03979313, confirming its scientific validity.
Article Synopsis
- The study evaluated the efficacy and safety of AZD2816, a new COVID-19 vaccine variant, compared to the existing AZD1222 vaccine as booster shots for individuals who had previously received two doses of either vaccine.
- Conducted across 23 sites in the UK and Poland, the mixed methods approach included random assignment of nearly 1,400 adult participants and ensured blinding of participants and research staff regarding the groups.
- Results showed that both vaccines had similar safety profiles, with high percentages of participants reporting mild side effects, and demonstrated acceptable levels of antibody production against the virus.
Article Synopsis
- * Analysis showed that RSV A and B infections occurred at similar rates, with some noteworthy substitutions in their fusion proteins affecting susceptibility to nirsevimab.
- * Despite some binding site changes, over 99% of RSV isolates from the trials remained sensitive to nirsevimab, indicating its continued effectiveness.
Safety of Re-dosing Nirsevimab Prior to RSV Season 2 in Children With Heart or Lung Disease.
J Pediatric Infect Dis Soc
August 2023
Article Synopsis
- A study on children with congenital heart disease or chronic lung disease found that 200 mg nirsevimab is as safe as palivizumab for RSV prevention.
- Nirsevimab showed effective serum levels that could help protect healthy infants from severe RSV disease.
- The results suggest that nirsevimab could also be effective for children at high risk of severe RSV during their second RSV season.
COVID-19 vaccine efficacy (VE) has been observed to vary against antigenically distinct SARS-CoV-2 variants of concern (VoC). Here we report the final analysis of VE and safety from COV005: a phase 1b/2, multicenter, double-blind, randomized, placebo-controlled study of primary series AZD1222 (ChAdOx1 nCoV-19) vaccination in South African adults aged 18-65 years. South Africa's first, second, and third waves of SARS-CoV-2 infections were respectively driven by the ancestral SARS-CoV-2 virus (wild type, WT), and SARS-CoV-2 Beta and Delta VoCs.
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- - Nirsevimab is a monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) by maintaining high levels of neutralizing antibodies (NAbs) after administration, as shown in the MELODY clinical trials.
- - Analysis of over 2,000 infants revealed that preterm infants had lower baseline RSV antibody levels compared to full-term infants, but nirsevimab significantly boosted NAb levels, remaining high for up to a year.
- - Despite its protective effects against RSV, nirsevimab still allowed infants to develop their immune response to the virus, indicating it can both prevent RSV disease and promote future immunity.
In the phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine conducted in the U.S., Chile, and Peru, anti-spike binding IgG concentration (spike IgG) and pseudovirus 50% neutralizing antibody titer (nAb ID50) measured four weeks after two doses were assessed as correlates of risk and protection against PCR-confirmed symptomatic SARS-CoV-2 infection (COVID-19).
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- Breakthrough SARS-CoV-2 infections in vaccinated individuals generally lead to milder disease compared to unvaccinated people, highlighting the benefits of vaccination during the pandemic.
- In a study involving AZD1222 (ChAdOx1 nCoV-19) vaccinees, results showed they experienced lower incidence, shorter duration of symptoms, and reduced viral loads compared to placebo recipients.
- Vaccinated individuals exhibited strong immune responses, including increased antibody production and T-cell responses, which were linked to better control of the virus and reduced transmission potential.
Efficacy of nirsevimab against respiratory syncytial virus lower respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital heart disease and chronic lung disease: a pooled analysis of randomised controlled trials.
Lancet Child Adolesc Health
March 2023
Article Synopsis
- Nirsevimab is a monoclonal antibody shown to protect healthy infants from RSV-related lower respiratory tract infections in two clinical trials (phase 2b and MELODY), demonstrating safety similar to the existing drug palivizumab!* -
- Infants were dosed based on weight (50 mg for those <5 kg and 100 mg for ≥5 kg) and both the pooled efficacy and safety of nirsevimab were analyzed, particularly in infants at higher risk for severe RSV infections due to health conditions or preterm birth.* -
- The primary goal was to determine the incidence of RSV LRTI requiring medical attention within 150 days post-injection, with secondary focuses on hospital admissions and very
There is currently no licensed vaccine for respiratory syncytial virus (RSV). Here, we assess the effect of RSV fusion protein (F) conformation on B cell responses in a post hoc comparison of samples from the DS-Cav1 [prefusion (pre-F)] and MEDI7510 [postfusion (post-F)] vaccine clinical trials. We compared the magnitude and quality of the serological and B cell responses across time points and vaccines.
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- The study examines the use of intranasal ChAdOx1 nCoV-19 vaccine in healthy adults, focusing on safety and immune responses against SARS-CoV-2.
- Participants received varying doses, with some also getting intramuscular mRNA vaccines as part of the trial.
- Results showed mild side effects but inconsistent mucosal antibody responses, with weaker systemic responses compared to traditional intramuscular vaccination.
Article Synopsis
- - The study evaluated the safety, efficacy, and immune response of the AZD1222 COVID-19 vaccine in a phase 3 trial with 21,634 participants receiving the vaccine and 10,816 receiving a placebo.
- - Results showed the vaccine had a 67.0% effectiveness at preventing symptomatic COVID-19 in participants with no prior SARS-CoV-2 infection, and maintained lower incidence rates of COVID-19 over 6 months post-vaccination.
- - The AZD1222 vaccine was found to be safe and well tolerated, with effective immune responses observed, although there was a decrease in immunity by Day 180 post-vaccination.