Germán Áñez
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View article: Analysis of Antibody Markers as Immune Correlates of Risk of Severe COVID-19 in the PREVENT-19 Efficacy Trial of the NVX-CoV2373 Recombinant Protein Vaccine
Analysis of Antibody Markers as Immune Correlates of Risk of Severe COVID-19 in the PREVENT-19 Efficacy Trial of the NVX-CoV2373 Recombinant Protein Vaccine Open
Background We previously showed that ancestral-specific anti-Spike binding IgG concentration and 50% inhibitory dilution neutralizing antibody titer (nAb-ID50) measured at 2 weeks postdose 2 (∼peak) were inverse correlates of risk (CoRs) o…
View article: Safety and immunogenicity of four sequential doses of NVX-CoV2373 in adults and adolescents: A phase 3, randomized, placebo-controlled trial (PREVENT-19)
Safety and immunogenicity of four sequential doses of NVX-CoV2373 in adults and adolescents: A phase 3, randomized, placebo-controlled trial (PREVENT-19) Open
NVX-CoV2373 elicited robust and durable humoral immune responses to ancestral SARS-CoV-2 as a 3rd and 4th dose after the primary series in adults and adolescents. Cross-reactivity to relevant variants provides insight into potential protec…
View article: Evaluating the Test-Negative Design for COVID-19 Vaccine Effectiveness Using Randomized Trial Data
Evaluating the Test-Negative Design for COVID-19 Vaccine Effectiveness Using Randomized Trial Data Open
Importance The test-negative design (TND) has been widely used to assess postmarketing COVID-19 vaccine effectiveness but requires further evaluation for this application. Objective To determine whether the TND reliably evaluates vaccine e…
View article: Safety and immunogenicity of four sequential doses of NVX-CoV2373 in adults and adolescents: a phase 3, randomized, placebo-controlled trial (PREVENT-19)
Safety and immunogenicity of four sequential doses of NVX-CoV2373 in adults and adolescents: a phase 3, randomized, placebo-controlled trial (PREVENT-19) Open
Background NVX-CoV2373, a recombinant SARS-CoV-2 spike (rS) protein vaccine with Matrix-M™ adjuvant, has been authorized for use in adults and adolescents. PREVENT-19 ( NCT04611802 /2019nCoV-301), a pivotal phase 3, randomized, placebo-con…
View article: Correction: Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in adolescents and adults: phase III randomized study
Correction: Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in adolescents and adults: phase III randomized study Open
100% [95% CI 97.9, 100]'.
View article: Safety, efficacy, and immunogenicity of the NVX-CoV2373 vaccine
Safety, efficacy, and immunogenicity of the NVX-CoV2373 vaccine Open
In clinical trials, NVX-CoV2373 showed tolerable reactogenicity and favorable safety profiles characterized by mostly mild-to-moderate adverse events of short duration and by low rates of severe and serious adverse events comparable to tho…
View article: Immunogenicity of NVX-CoV2373 in PREVENT-19: A Phase 3, Randomized, Placebo-Controlled Trial in Adults in the United States and Mexico
Immunogenicity of NVX-CoV2373 in PREVENT-19: A Phase 3, Randomized, Placebo-Controlled Trial in Adults in the United States and Mexico Open
Background NVX-CoV2373, an adjuvanted, recombinant SARS-CoV-2 spike (rS) protein vaccine, consistently demonstrated protective efficacy against COVID-19 in clinical trials and has received regulatory authorizations or approvals worldwide. …
View article: NVX-CoV2373 vaccine efficacy against hospitalization: A post hoc analysis of the PREVENT-19 phase 3, randomized, placebo-controlled trial
NVX-CoV2373 vaccine efficacy against hospitalization: A post hoc analysis of the PREVENT-19 phase 3, randomized, placebo-controlled trial Open
PREVENT-19, the pivotal phase 3 trial of the Novavax adjuvanted, recombinant spike protein COVID-19 vaccine (NVX-CoV2373), demonstrated that the vaccine was well tolerated and efficacious (vaccine efficacy, VE = 90%) for the prevention of …
View article: Safety, Immunogenicity, and Efficacy of the NVX-CoV2373 COVID-19 Vaccine in Adolescents
Safety, Immunogenicity, and Efficacy of the NVX-CoV2373 COVID-19 Vaccine in Adolescents Open
Importance Greater than 20% of cases and 0.4% of deaths from COVID-19 occur in children. Following demonstration of the safety and efficacy of the adjuvanted, recombinant spike protein vaccine NVX-CoV2373 in adults, the PREVENT-19 trial im…
View article: NVX-CoV2373 Vaccine Efficacy Against Hospitalization: A<i>post hoc</i>analysis of the PREVENT-19 phase 3, randomized, placebo-controlled trial
NVX-CoV2373 Vaccine Efficacy Against Hospitalization: A<i>post hoc</i>analysis of the PREVENT-19 phase 3, randomized, placebo-controlled trial Open
PREVENT-19, the pivotal phase 3 trial of the Novavax adjuvanted, recombinant spike protein COVID-19 vaccine (NVX-CoV2373) demonstrated that the vaccine was safe and efficacious (vaccine efficacy, VE= 90%) for the prevention of symptomatic …
View article: Immunogenicity and Safety of a Quadrivalent Meningococcal Tetanus Toxoid-Conjugate Vaccine (MenACYW-TT) Administered Concomitantly with Pneumococcal Conjugate Vaccine in Healthy Toddlers in the Russian Federation: a Phase III Randomized Study
Immunogenicity and Safety of a Quadrivalent Meningococcal Tetanus Toxoid-Conjugate Vaccine (MenACYW-TT) Administered Concomitantly with Pneumococcal Conjugate Vaccine in Healthy Toddlers in the Russian Federation: a Phase III Randomized Study Open
Relevance. Invasive meningococcal disease (IMD) has high morbidity and mortality, with infants and young children among those at greatest risk. Materials & Methods . A phase III, open-label, randomized study in toddlers aged 12–23 months …
View article: LB746. Safety and Immunogenicity of a Booster Dose of Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) in Adults from the PREVENT-19 Trial in the United States
LB746. Safety and Immunogenicity of a Booster Dose of Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) in Adults from the PREVENT-19 Trial in the United States Open
Background Novavax COVID-19 Vaccine, Adjuvanted (5 µg recombinant spike protein/50 µg Matrix-MTM adjuvant; NVX-CoV2373) has received regulatory authorizations for use in adults ≥ 18 years globally. Methods Participants from PREVENT-19 (NCT…
View article: Prospective surveillance of Zika virus at the end of the Americas’ outbreak: An unexpected outcome
Prospective surveillance of Zika virus at the end of the Americas’ outbreak: An unexpected outcome Open
Objective The French Polynesia Zika virus (ZIKV) outbreak (2013–2014) broadened the known manifestations of ZIKV disease (ZVD) to include neural and congenital syndromes. A subsequent epidemic in the Americas (2015–2016) caused >685,000…
View article: Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: A Randomized, Phase 3 Trial
Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: A Randomized, Phase 3 Trial Open
BACKGROUND Over 20% of cases and 0.4% of deaths from Covid-19 occur in children. Following demonstration of safety and efficacy of the adjuvanted, recombinant spike protein vaccine NVX-CoV2373 in adults, the PREVENT-19 trial enrolled adole…
View article: Immune Correlates Analysis of the PREVENT-19 COVID-19 Vaccine Efficacy Clinical Trial
Immune Correlates Analysis of the PREVENT-19 COVID-19 Vaccine Efficacy Clinical Trial Open
In the randomized, placebo-controlled PREVENT-19 phase 3 trial conducted in the U.S. and Mexico of the NVX-CoV2373 adjuvanted, recombinant spike protein nanoparticle vaccine, anti-spike binding IgG concentration (spike IgG) and pseudovirus…
View article: Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico Open
NVX-CoV2373 was safe and effective for the prevention of Covid-19. Most breakthrough cases were caused by contemporary variant strains. (Funded by Novavax and others; PREVENT-19 ClinicalTrials.gov number, NCT04611802.).
View article: 03. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered as a Booster Dose in Adults and Adolescents Vaccinated Against Meningococcal Disease 3 - 6 Years Earlier
03. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered as a Booster Dose in Adults and Adolescents Vaccinated Against Meningococcal Disease 3 - 6 Years Earlier Open
Background Booster doses of meningococcal conjugate vaccines may induce long-term protection against invasive meningococcal disease. MenACYW-TT [MenQuadfi®] is a quadrivalent meningococcal conjugate vaccine, licensed for use in ages 2 year…
View article: Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico Open
BACKGROUND Vaccination using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein antigen has been effective in the prevention of coronavirus disease 2019 (Covid-19). NVX-CoV2373 is an adjuvanted, recombinant S pr…
View article: Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study
Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study Open
The quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) was assessed as a booster in this Phase III trial (NCT02752906). Quadrivalent meningococcal conjugate vaccine (MCV4)-primed individuals aged ≥15 y (n = 810) were …
View article: Differential Pattern of Soluble Immune Markers in Asymptomatic Dengue, West Nile and Zika Virus Infections
Differential Pattern of Soluble Immune Markers in Asymptomatic Dengue, West Nile and Zika Virus Infections Open
Infections with dengue virus (DENV), West Nile virus (WNV) and Zika virus (ZIKV) usually present similar mild symptoms at early stages, and most infections (~80%) are asymptomatic. However, these infections may progress to severe disease w…
View article: 2725. Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Adolescents and Adults
2725. Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Adolescents and Adults Open
Background The MenACYW-TT conjugate vaccine is a quadrivalent meningococcal vaccine that contains tetanus toxoid as carrier protein. Vaccine is intended for global use in all age groups (i.e., individuals 6 weeks of age and older). This Ph…
View article: Use of a Blockade-of-Binding ELISA and Microneutralization Assay to Evaluate Zika Virus Serostatus in Dengue-Endemic Areas
Use of a Blockade-of-Binding ELISA and Microneutralization Assay to Evaluate Zika Virus Serostatus in Dengue-Endemic Areas Open
Zika virus (ZIKV) serological diagnostics are compromised in areas where dengue viruses (DENV) co-circulate because of their high levels of protein sequence homology. Here, we describe the characterization of a Zika blockade-of-binding ELI…
View article: Collaborative study to establish World Health Organization international reference reagents for dengue virus Types 1 to 4 RNA for use in nucleic acid testing
Collaborative study to establish World Health Organization international reference reagents for dengue virus Types 1 to 4 RNA for use in nucleic acid testing Open
BACKGROUND Dengue is the most important reemerging mosquito‐borne viral disease worldwide. Caused by dengue virus (DENV), a member of the genus Flavivirus in the Flaviviridae family, dengue can be asymptomatic (approx. 80% of cases) or sym…
View article: Genetic Variability of West Nile Virus in U.S. Blood Donors from the 2012 Epidemic Season
Genetic Variability of West Nile Virus in U.S. Blood Donors from the 2012 Epidemic Season Open
West Nile virus (WNV) is an arbovirus maintained in nature in a bird-mosquito enzootic cycle which can also infect other vertebrates including humans. WNV is now endemic in the United States (U.S.), causing yearly outbreaks that have resul…
View article: Distribution of Dengue Virus Types 1 and 4 in Blood Components from Infected Blood Donors from Puerto Rico
Distribution of Dengue Virus Types 1 and 4 in Blood Components from Infected Blood Donors from Puerto Rico Open
DENV was present in all tested components from most donors, and viral RNA was not preferentially distributed in any of the tested components. Infectious DENV was also present in similar proportions in cultured plasma, clot and CCWB samples…
View article: Complete Genome Sequences of Dengue Virus Type 1 to 4 Strains Used for the Development of CBER/FDA RNA Reference Reagents and WHO International Standard Candidates for Nucleic Acid Testing
Complete Genome Sequences of Dengue Virus Type 1 to 4 Strains Used for the Development of CBER/FDA RNA Reference Reagents and WHO International Standard Candidates for Nucleic Acid Testing Open
Dengue virus (DENV), a member of the Flaviviridae family, is the most common and clinically significant arbovirus in the world and is endemic in more than 100 countries. Here, we report the complete sequences of four DENV serotypes used in…
View article: Standardized methods to generate mock (spiked) clinical specimens by spiking blood or plasma with cultured pathogens
Standardized methods to generate mock (spiked) clinical specimens by spiking blood or plasma with cultured pathogens Open
The development of diagnostic platforms for detection of low prevalence pathogens such as biothreat or emerging agents is challenged by the lack of clinical specimens for performance evaluation. This deficit can be overcome using mock clin…