Gonzalo Pérez Marc

• PhD. MD. MSc
• Principal Investigator at Fundación Infant

Background RSV is an important cause of lower respiratory tract illness (LRTI) in older adults. RSVpreF is a bivalent stabilized prefusion F vaccine containing antigens against RSV-A and RSV-B. In this phase 3 trial in ≥60-year-olds, RSVpreF demonstrated vaccine efficacy (VE) of 88.9% and 77.8% against RSV-associated LRTI with ≥3 symptoms at the en...

Background In May 2023, the FDA approved RSVpreF [ABRYSVO™] for prevention of lower respiratory tract infection (LRTI) caused by RSV in adults ≥60 years of age. Here we present the vaccine efficacy (VE) data from the pivotal phase 3 global RENOIR study (NCT05035212) for an understanding of VE persistence through 2 RSV seasons and its impact on heal...

Background The RSV Vaccine Efficacy Study in Older Adults Immunized Against RSV Disease (RENOIR) is a phase 3, multicenter, randomized, double-blinded, placebo-controlled study that demonstrated vaccine efficacy (VE) of bivalent RSVpreF vaccine to prevent lower respiratory tract illness (LRTI) caused by RSV in adults ≥ 60 years of age over two RSV...

OBJECTIVE To describe preterm birth frequency and newborn and infant outcomes overall and among preterm children in the MATISSE (Maternal Immunization Study for Safety and Efficacy) trial of maternal vaccination with bivalent respiratory syncytial virus (RSV) prefusion F protein–based vaccine (RSVpreF) to protect infants against severe RSV-associat...

OBJECTIVE To evaluate descriptive efficacy data, exploratory immunogenicity data, and safety follow-up through study completion from the global, phase 3 MATISSE (Maternal Immunization Study for Safety and Efficacy) maternal vaccination trial of bivalent respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVpreF). METHODS MATISSE was a...

Background The mRNA-1345 vaccine demonstrated efficacy against RSV disease with acceptable safety in adults ≥60 years in the ConquerRSV trial. Here, humoral immunogenicity results from the trial are presented. Methods This phase 2/3 trial randomly assigned adults (≥60 years) to mRNA-1345 50-µg encoding prefusion F (preF) glycoprotein (n = 17,793)...

Background: This study (ARVAC-F2-3-002) assessed the immunogenicity, safety, and tolerability of a recombinant booster vaccine (ARVAC) containing the receptor binding domain of the SARS-CoV-2 Spike protein in three different versions: Gamma (ARVACGamma), Omicron BA.4/5 (ARVACOmicron), and Gamma/Omicron Bivalent (ARVACBivalent). Methods: Randomized,...

(ES) En el presente artículo nos proponemos argumentar en favor de una concepción procesual de la identidad de la persona enferma. Para ello, recorreremos algunas de las principales respuestas que ha dado la filosofía a la pregunta por la identidad personal, así como ciertas propuestas sobre cómo concebir la enfermedad y la identidad de la persona...

Background: Respiratory syncytial virus (RSV) can cause substantial morbidity and mortality among older adults. An mRNA-based RSV vaccine, mRNA-1345, encoding the stabilized RSV prefusion F glycoprotein, is under clinical investigation. Methods: In this ongoing, randomized, double-blind, placebo-controlled, phase 2-3 trial, we randomly assigned,...

Background RENOIR is a phase 3 randomized, double-blinded, placebo-controlled study evaluating Vaccine Efficacy (VE) to prevent lower respiratory tract illness (LRTI) in adults ≥ 60 years of age during 2 RSV seasons in Northern and Southern Hemisphere countries (NCT05035212). End of RSV Season 1 (EoS1) analysis demonstrated VE of 88.9% for RSV-asso...

Background Respiratory Syncytial Virus (RSV)-related disease poses an economic burden due to a substantial amount of health care utilization (HCU). RENOIR is a phase 3 global, multicenter, randomized, double-blinded, placebo-controlled study evaluating vaccine efficacy (VE) in adults ≥60 years of age during two RSV seasons in Northern and Southern...

Background: Whether vaccination during pregnancy could reduce the burden of respiratory syncytial virus (RSV)-associated lower respiratory tract illness in newborns and infants is uncertain. Methods: In this phase 3, double-blind trial conducted in 18 countries, we randomly assigned, in a 1:1 ratio, pregnant women at 24 through 36 weeks' gestati...

Background: Respiratory syncytial virus (RSV) infection causes considerable illness in older adults. The efficacy and safety of an investigational bivalent RSV prefusion F protein-based (RSVpreF) vaccine in this population are unknown. Methods: In this ongoing, phase 3 trial, we randomly assigned, in a 1:1 ratio, adults (≥60 years of age) to rec...

Background Outpatient monoclonal antibodies are no longer effective and antiviral treatments for COVID-19 disease remain largely unavailable in many countries worldwide. Although treatment with COVID-19 convalescent plasma is promising, clinical trials among outpatients have shown mixed results. Methods We conducted an individual participant data...

Background. Monoclonal antibody and antiviral treatments for COVID-19 disease remain largely unavailable worldwide, and existing monoclonal antibodies may be less active against circulating omicron variants. Although treatment with COVID-19 convalescent plasma (CCP) is promising, randomized clinical trials (RCTs) among outpatients have shown mixed...

Background Respiratory syncytial virus (RSV) is an important cause of disease in older adults and is associated with high morbidity and mortality, especially in those with high-risk conditions. Illness can vary from mild upper respiratory tract symptoms to more severe lower respiratory tract disease. After over 50 years of research, there is now ho...

What is this summary about? This is a summary of an article about part of a clinical study for the BNT162b2 COVID-19 vaccine, also called the Pfizer-BioNTech vaccine. The article was published in the New England Journal of Medicine in September 2021. The part of the study described in the article began in July 2020 and is ongoing. This means that t...

BACKGROUND Coronavirus-like particles (CoVLP) that are produced in plants and display the prefusion spike glycoprotein of the original strain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are combined with an adjuvant (Adjuvant System 03 [AS03]) to form the candidate vaccine. METHODS In this phase 3, multinational, randomized, pl...

Background: Coronavirus-like particles (CoVLP) that are produced in plants and display the prefusion spike glycoprotein of the original strain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are combined with an adjuvant (Adjuvant System 03 [AS03]) to form the candidate vaccine. Methods: In this phase 3, multinational, randomized...

Background: SARS-CoV-2 infected individuals ≥60 years old have the highest hospitalization rates and represent >80% fatalities. Within this population, those in long-term facilities represent >50% of the total COVID-19 related deaths per country. Among those without symptoms, the rate of pre-symptomatic illness is unclear, and potential predictors...

Background Several COVID-19 vaccines are currently being deployed but supply constraints, concerns over durability of immune responses, solidifying vaccine hesitancy/resistance and vaccine efficacy in the face of emerging variants mean that new vaccines continue to be needed to fight the ongoing pandemic. The vaccine described here is an enveloped,...

BACKGROUND BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approve...

Background: SARS-CoV-2 infected individuals ≥60 years old have the highest hospitalization rates and represent >80% fatalities. Within this population, those in long-term facilities represent >50% of the total COVID-19 related deaths per country. Among those without symptoms, the rate of pre-symptomatic illness is unclear, and potential predictors...

Background: BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. BNT162b2 is highly efficacious against COVID-19 and is currently authorized for emergency use or conditional approval worldwide. At the time of authorization, data beyond 2...

Efforts to best protect the world from SARS-CoV-2 as variants emerge and despite limited vaccine supply are ongoing. One strategy that may maximize vaccine quantities and expedite immunization campaigns involves providing single mRNA vaccine doses to individuals with previous COVID-19. In this issue of the JCI two independent studies, Levi et al. a...

Breast milk provides microorganisms that colonize the gut and program the immune system to develop oral tolerance. Between the 6 months of exclusive breastfeeding and the recommended 2 years of prolonged breastfeeding, complementary feeding leads to a progressive reduction in the entry of live microorganisms into the gut ecosystem. This is because...

Background Therapies to interrupt the progression of early coronavirus disease 2019 (Covid-19) remain elusive. Among them, convalescent plasma administered to hospitalized patients has been unsuccessful, perhaps because antibodies should be administered earlier in the course of illness. Methods We conducted a randomized, double-blind, placebo-cont...

(Abstracted from N Engl J Med 2020;383:426–439) Respiratory syncytial virus (RSV) is a leading cause of hospitalizations of infants with lower respiratory tract infections. In 2015, approximately 3.2 million children younger than 5 years were hospitalized because of RSV-associated lower respiratory infection, and 118,000 died in hospital.

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods Download a PDF of the Research Summary. In an ongoing multinational, placebo-controlled,...

Background Therapies to interrupt progression of early COVID-19 remain elusive. Among them, convalescent plasma in hospitalized patients was unsuccessful, perhaps because antibody should be administered earlier. We advanced plasma infusions to the first 72 hours of symptoms to arrest COVID-19 progression. Methods A randomized, double-blind, placeb...

Background: RSV is the dominant cause of severe lower respiratory tract infection (LRTI) in infants, with most severe disease concentrated in younger infants. Methods: healthy pregnant women 280/7 to 360/7 weeks gestation, with expected delivery near the start of the RSV season, were randomized to a single intramuscular dose of RSV F-protein nano...

El dolor no se puede explicar. Su comprensión no es posible si no lo es desde la más ingrata de las posiciones: su padecimiento. Así, en el intento por explicar sus múltiples apariciones, significados y mecanismos, surge como imprescindible el desarrollo de una filosofía del dolor. El acercamiento a estas cuestiones por parte de la medicina occiden...

Pain cannot be explained. It may only be understood from the most unpleasant of positions: suffering it. Thus, in the attempt to account for its multiple occurrences, meanings and mechanisms, developing a philosophy of pain appears to be essential. The approach to these issues by traditional occidental medicine has not considered the particular lan...