Open-Label Phase 3 Clinical Study to Investigate Safety and Immunogenicity of a Single VLA2001 Booster Vaccination in Volunteers Aged ≥18 Years, After Priming With Another Inactivated COVID-19 Vaccine

Data from some studies indicate the decline in the effectiveness of the authorized COVID-19 vaccines due to antibody waning following vaccination and the emergence of different variants. These findings support the need to increase vaccination and booster campaigns to protect the adult population against infection. Valneva developed the VLA2001 vaccine, a highly purified, whole virus SARS-CoV-2 vaccine produced on Vero cells and inactivated with β-propiolactone. VLA2001 will be adjuvanted with the licensed adjuvant cytosine phospho-guanine (CpG) 1018 (produced by Dynavax, contained in HEPLISAV-B®) in combination with aluminum hydroxide. On April 14, 2022, VLA2001 was granted Conditional Marketing Authorization (CMA) by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom for primary immunization in adults 18 to 50 years of age. This follows the emergency use authorization granted by the Bahraini NHRA in March 2022. As a substantial population has received a primary vaccination series with authorized vaccines, a booster dose to extend the duration and protection may be required.This study aims to investigate the safety, tolerability, and immunogenicity of the VLA2001 vaccine as a booster dose to adults 18 years and older who were primed with another licensed inactivated COVID-19 vaccine at least 6 months prior to enrollment.

Start Date01 Dec 2022

Sponsor / Collaborator

Centro De Estudios en Infectología Pediátrica

NCT04405843

/ CompletedPhase 2/3

Randomized, Placebo Controlled, Double Blind Clinical Trial to Evaluate the Efficacy of Molecule D11AX22 in Adults Patients From Valle Del Cauca, Colombia With Early Stages of SARS COV2 / COVID-19

Double blind, placebo controlled, randomized clinical trial to evaluate the efficacy of ivermectin in preventing progression of disease in adult patients with early stages of COVID-19

Start Date14 Jul 2020

Sponsor / Collaborator

Centro De Estudios en Infectología Pediátrica

100 Clinical Results associated with Centro De Estudios en Infectología Pediátrica

0 Patents (Medical) associated with Centro De Estudios en Infectología Pediátrica

Literatures (Medical) associated with Centro De Estudios en Infectología Pediátrica

16 Dec 2024·The Journal of Infectious Diseases

Efficacy and Safety of a Tetravalent Dengue Vaccine (TAK-003) in Children With Prior Japanese Encephalitis or Yellow Fever Vaccination

Article

Author: Biswal, Shibadas ; Wallace, Derek ; Dietze, Reynaldo ; Fan, Huihao ; LeFevre, Inge ; Pujitha Wickramasinghe, V ; López-Medina, Eduardo ; Escudero, Ian ; Gunasekera, Dulanie ; Fernando, Asvini ; Rivera, Luis ; Fernando, LakKumar ; Tuboi, Suely ; Brose, Manja ; Rauscher, Martina ; Moreira, Edson Duarte ; Lopez, Pio ; Fernando, Asvini D ; Velásquez, Hector ; Saez-Llorens, Xavier ; Luz, Kleber ; Lloyd, Eric ; Bravo, Lulu ; Wickramasinghe, V Pujitha ; Yu, Delia ; Rodriguez-Arenales, Edith Johanna ; Borja-Tabora, Charissa ; Borkowski, Astrid ; Venâncio da Cunha, Rivaldo ; Vargas, Luis Martinez ; Tricou, Vianney ; da Cunha, Rivaldo Venâncio ; Sirivichayakul, Chukiat ; Jimeno, Jose ; Alera, Maria Theresa ; Hutagalung, Yanee ; Watanaveeradej, Veerachai ; Kosalaraksa, Pope ; Reynales, Humberto ; Oliveira, Ana Lucia ; Espinoza, Felix ; Folschweiller, Nicolas ; Manacharoen, Onanong

AbstractBackgroundWe explored the impact of prior yellow fever (YF) or Japanese encephalitis (JE) vaccination on the efficacy of Takeda's dengue vaccine candidate, TAK-003.MethodsChildren 4–16 years of age were randomized 2:1 to receive TAK-003 or placebo and were under active febrile surveillance. Symptomatic dengue was confirmed by serotype-specific reverse-transcription polymerase chain reaction. YF and JE vaccination history was recorded.ResultsOf the 20 071 children who received TAK-003 or placebo, 21.1% had a YF and 23.9% had a JE vaccination history at randomization. Fifty-seven months after vaccination, vaccine efficacy (95% confidence interval) was 55.7% (39.7%–67.5%) in those with YF vaccination, 77.8% (70.8%–83.1%) for JE vaccination, and 53.5% (45.4%–60.4%) for no prior YF/JE vaccination. Regional differences in serotype distribution confound these results. The apparent higher vaccine efficacy in the JE vaccination subgroup could be largely explained by serotype-specific efficacy of TAK-003. Within 28 days of any vaccination, the proportions of participants with serious adverse events in the YF/JE prior vaccination population were comparable between the TAK-003 and placebo groups.ConclusionsThe available data do not suggest a clinically relevant impact of prior JE or YF vaccination on TAK-003 performance. Overall, TAK-003 was well-tolerated and efficacious in different epidemiological settings.Clinical Trials Registration. NCT02747927.

01 Jul 2023·Journal of Pediatric Infectious Diseases

Effect of Antibiotics and Gut Microbiota on the Development of Sepsis in Children with Hematopoietic Stem Cell Transplants

Author: Benavides, Iván Darío ; López-Medina, Eduardo ; Portilla, Carlos A. ; Potes, Daniela ; Rivera-Franco, Nelson ; Ramirez, Oscar ; Castillo, Andrés

Abstract Objective To describe the association between antibiotic use, gut microbiota composition, and the development of sepsis in pediatric patients undergoing hematopoietic stem cell transplantation (HSCT) to treat acute lymphoblastic leukemia. Methods A cohort of pediatric patients was followed up between days −30 (pre-HSCT) and +30 (post-HSCT), and sequential stool samples were collected for analysis of the taxonomic composition of bacterial communities by comparing the sequences of the 16s ribosomal RNA gene. Clinically, patients were divided into those with or without sepsis according to their clinical and laboratory data. Gut microbiota was categorized as potentially pathogenic or commensal and was described according to antibiotic use in patients with and without sepsis. Results A cohort of eight patients provided 34 stool samples at different time points during their pre- and post-HSCT periods. There was a greater diversity in the microbial composition in patients who did not develop sepsis. In contrast, patients who developed sepsis had low microbiota diversity, a slight dominance of the genus Bacteroides and order Enterobacterales, and a low abundance of the genus Akkermansia. The use of antibiotics was associated with a low relative abundance of commensal bacteria, a high relative abundance of potentially pathogenic microbiota, and a risk of sepsis. Conclusion Our results suggest that gut microbiota sequencing in pediatric HSCT recipients could predict the clinical course and guide direct interventions to improve patient outcomes. Accordingly, short-spectrum, tailored antibiotic therapy could be provided to patients with fever pre- and post-HSCT to prevent dysbiosis and reduce the risk of sepsis.

02 Jan 2023·Human Vaccines & Immunotherapeutics

Safety and immunogenicity of SCB-2019, an adjuvanted, recombinant SARS-CoV-2 trimeric S-protein subunit COVID-19 vaccine in healthy 12–17 year-old adolescents

Article

Author: Montellano, May Emmeline B ; Smolenov, Igor ; Buntinx, Erik ; Hu, Branda ; Salvani-Bautista, Milagros ; Baccarini, Carmen ; Huang, Yung ; Borja-Tabora, Charissa ; Velasquez, Hector ; Lopez, Pio ; Carlos, Josefina ; Rodriquez, Edith Johana ; Alberto, Edison R ; Han, Htay Htay ; Li, Ping ; Bravo, Lulu ; Rodriguez, Camilo A

We previously demonstrated the efficacy of the COVID-19 vaccine candidate, SCB-2019, in adults in the SPECTRA phase 2/3 efficacy study. We extended the study to include 1278 healthy 12-17-year-old adolescents in Belgium, Colombia, and the Philippines who received either two doses of SCB-2019 or placebo 21 days apart, to assess immunogenicity as neutralizing antibodies against prototype SARS-CoV-2 and variants of concern, and safety and reactogenicity as solicited and unsolicited adverse events with a comparator group of young adults (18-25 years). In participants with no evidence of prior SARS-CoV-2 infection SCB-2019 immunogenicity in adolescents was non-inferior to that in young adults; respective geometric mean neutralizing titers (GMT) against prototype SARS-CoV-2 14 days after the second vaccination were 271 IU/mL (95% CI: 211-348) and 144 IU/mL (116-178). Most adolescents (1077, 84.3%) had serologic evidence of prior SAR-CoV-2 exposure at baseline; in these seropositive adolescents neutralizing GMTs increased from 173 IU/mL (135-122) to 982 IU/mL (881-1094) after the second dose. Neutralizing titers against Delta and Omicron BA SARS-CoV-2 variants were also increased, most notably in those with prior exposure. SCB-2019 vaccine was well tolerated with generally mild or moderate, transient solicited and unsolicited adverse events that were comparable in adolescent vaccine and placebo groups except for injection site pain - reported after 20% of SCB-2019 and 7.3% of placebo injections. SCB-2019 vaccine was highly immunogenic against SARS-CoV-2 prototype and variants in adolescents, especially in those with evidence of prior exposure, with comparable immunogenicity to young adults. Clinical trial registration: EudraCT 2020-004272-17; ClinicalTrials.gov NCT04672395.

100 Deals associated with Centro De Estudios en Infectología Pediátrica

100 Translational Medicine associated with Centro De Estudios en Infectología Pediátrica

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