Evaluating the Long Term Immunogenicity of adenoviral and MVA vectored Ebola vaccine schedules and response to late boosting with AD26.ZEBOV vaccine: an open-label clinical trial - Re-evaluating Optimal Vaccine Schedules Against Ebola (REVOLVE)

开始日期2018-11-28

申办/合作机构-

PACTR201503001057193 / CompletedN/AIIT

A Randomized Trial to Evaluate Ebola Vaccine Efficacy and Safety in Guinea, West Africa-Part A: A Randomized Trial of Ring Vaccination to Evaluate Ebola Vaccine Efficacy and Safety in Guinea, West Africa. Part B- Safety and immunogenicity of VSV¿G/ZEBOV-GP among Frontline Workers

开始日期2015-03-07

申办/合作机构

World Health Organization (United States)

100 项与 Ebola vaccine (Etubics corporation) 相关的临床结果

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100 项与 Ebola vaccine (Etubics corporation) 相关的转化医学

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100 项与 Ebola vaccine (Etubics corporation) 相关的专利（医药）

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项与 Ebola vaccine (Etubics corporation) 相关的文献（医药）

2024-12-31·Expert Review of Vaccines

Lessons from a decade of adult vaccine rollout in low- and middle-income countries: a scoping review

Review

作者: Gerste, Amelia K ; Baidya, Anurima ; DeLuca, Andrea N ; Buis, Joeri S ; Kerkhoff, Andrew D ; Georgewill, Onimitein ; Gill, Michelle M ; Limaye, Rupali J ; Majidulla, Arman ; Pelzer, Puck T ; Jerene, Degu

INTRODUCTIONThe historical focus of vaccines on child health coupled with the advent of novel vaccines targeting adult populations necessitates exploring strategies for adult vaccine implementation.AREAS COVEREDThis scoping review extracts insights from the past decade's experiences introducing adult vaccines in low- and middle-income countries. Among 25 papers reviewed, 19 focused on oral cholera vaccine, 2 on Meningococcal A vaccines, 2 on tetanus toxoid vaccine, 1 on typhoid vaccine, and 1 on Ebola vaccine. Aligned with WHO's Global Framework for New TB Vaccines for Adults and Adolescents, our findings center on vaccine availability, accessibility, and acceptance.EXPERT OPINIONAvailability findings underscore the importance of understanding disease burden for prioritization, multi-sectoral collaboration during planning, and strategic resource allocation and coordination. Accessibility results highlight the benefits of leveraging existing health infrastructure and adequately training healthcare workers, and contextually tailoring vaccine delivery approaches to reach challenging sub-groups like working male adults. Central to fostering acceptance, resonant sensitization, and communication campaigns engaging the communities and utilizing trusted local leaders countered rumors and increased awareness and uptake. As we approach the introduction of a new adult TB vaccine, insights from this review equips decision-makers with key evidence-based recommendations to support successful and equitable vaccinations targeting adults.

2024-10-01·Journal of Infection

Replication, safety and immunogenicity of the vectored Ebola vaccine rVSV-ΔG-ZEBOV-GP in a sub-Saharan African paediatric population: A randomised controlled, open-label trial in children aged 1-12 years living in Lambaréné, Gabon

Article

作者: Kavishna, Ranmali ; Agnandji, Selidji T ; Velavan, Thirumalaisamy P ; Harandi, Ali M ; Musangomunei, Fungai P ; Olubiyi, Bisola F ; Rothenberger, Sylvia ; Nakaya, Helder I ; Siegrist, Claire-Anne ; Kabwende, Anita L ; Medaglini, Donata ; Kokou, Kossiwa ; Mahmoudou, Saidou ; Engler, Olivier ; Alabi, Ayodele ; Nakka, Sravya S ; Kremsner, Peter G ; Bie-Ondo, Juste C

BACKGROUNDUnlike adults, children experienced stronger and longer vector replication in plasma and shedding in saliva following rVSVΔG-ZEBOV-GP vaccination. The resulting risks of immunosuppression or immune hyperactivation leading to increased Adverse Events (AEs) and altered antibody responses are concerns that have been addressed in the present manuscript.METHODSChildren aged 1-12 years living in Gabon received either rVSVΔG-ZEBOV-GP (ERVEBO®) vaccine or the varicella-zoster virus (VZV) vaccine (VZV). The concentration of rVSVΔG vector in blood and saliva, the occurrence of AEs up to day 28; the anti-rVSVΔG-ZEBOV-GP and anti-VZV IgG antibody titres, neutralising and avidity functions of anti-rVSVΔG-ZEBOV-GP by day 365; were assessed in serum. (PACTR202005733552021) FINDINGS: In the rVSVΔG-ZEBOV-GP group, 70% and 7% of children had > 0 copies/ml of rVSVΔG respectively in plasma by day 3 and in saliva by day 14 after vaccination, with no detection on day 28. Significantly higher but transient AEs occurred in the rVSVΔG-ZEBOV-GP group. Both vaccines induced seroconversion on day 28 and sustainable IgG antibody titres by day 365. Avidity and neutralisation functions of the anti-rVSVΔG-ZEBOV-GP antibodies peaked at day 28 and were maintained by day 365.INTERPRETATIONThe replication and shedding do not affect the favourable risk-benefit balance of the rVSVΔG-ZEBOV-GP in children.FUNDINGThis trial is funded by the Innovative Medicines Initiative 2 (IMI 2) Joint Undertaking (grant number: 116068). The Biomedicine and Social Sciences research team of CERMEL is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP-TMA-SF-1946-VARSAF).

2024-09-04·The American Journal of Tropical Medicine and Hygiene

Healthcare Providers’ and Frontline Workers’ Experiences of an Ebola Vaccine Trial in the Boende Health District of the Democratic Republic of the Congo

Article

作者: Mitashi, Patrick ; Zola Matuvanga, Trésor ; Muhindo-Mavoko, Hypolite ; Salloum, Maha ; Larivière, Ynke ; Matangila, Junior ; Milolo, Solange ; Maketa, Vivi ; Van Geertruyden, Jean-Pierre ; Bolombo, Freddy Bikioli ; Osang’ir, Bernard Isekah ; Esanga, Emmanuel ; Van Damme, Pierre ; Lemey, Gwen ; Paviotti, Antea

ABSTRACT.This study explored the experiences of healthcare providers (HCPs) and frontline workers who were involved in an Ebola vaccine trial in the Democratic Republic of the Congo. The researchers interviewed a total of 99 participants (HCPs and frontline workers) living and working in the Boende health district during the period of the study, from February to March 2022. These individuals included a mix of trial participants and non-trial participants (staff of the trial, local health authorities, and head nurses of health centers). In-depth individual interviews, as well as focus group discussions (FGDs), were used to understand interviewees’ experiences and perceptions. The data were analyzed to identify the main themes. The findings unveiled a multitude of positive experiences among interviewees/FGD participants. The commitment of the trial investigators to improve the study site and to equip the volunteers with necessary skills and knowledge greatly contributed to a positive trial experience. However, some interviewees felt that the reimbursement for time and travel expenses during their trial visits was insufficient in comparison with their expectations. Additionally, there were expressions of worry about the frequency of blood draws during scheduled trial visits. Our findings emphasize the critical importance of addressing and continuously considering the perspectives and concerns of trial participants before designing and implementing vaccine trials. By actively incorporating their inputs, researchers can mitigate concerns and tailor communication strategies, potentially enhancing the overall success and impact of the vaccine trial.

项与 Ebola vaccine (Etubics corporation) 相关的新闻（医药）

2023-09-08

·Pharmaceutical Technology

EC expands indication approval for Merck’s Ebola vaccine

Ervebois is indicated for active immunisation of the paediatric population against Zaire ebolavirus-caused Ebola virus disease. Credit: Novikov Aleksey / Shutterstock.com. The European Commission (EC) has granted expanded indication approval for Merck’s Ebola Zaire vaccine, Ervebo, to include children aged one year or above. Ervebois is indicated for active immunisation of the paediatric population against the Zaire ebolavirus-caused Ebola virus disease. Recommended Reports Reports LOA and PTSR Model - meningococcal [serotype A, C, W-135, X and Y] vaccine GlobalData Reports LOA and PTSR Model - Genital Herpes Vaccine in Genital Herpes GlobalData View all The live recombinant viral vaccine comprises a vesicular stomatitis virus (VSV) backbone with the VSV envelope glycoprotein removed and replaced with the Zaire ebolavirus’s (Kikwit 1995 strain) envelope glycoprotein. The latest approval comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency gave its approval in July 2023. The vaccine is currently approved in the European Union for active immunisation in those aged 18 years or above. Merck Research Laboratories global clinical development senior vice-president and chief medical officer Dr Eliav Barr stated: “The European Commission’s expanded approval of Ervebo for children one year of age and older is an important milestone for the prevention of disease caused by Zaire ebolavirus. “When outbreaks of Ebola virus disease occur, they can quickly become a public health crisis. We are proud to play a role, alongside the global public health community, in helping to prepare for potential outbreaks of Zaire ebolavirus.” The US Food and Drug Administration approved the expanded indication of Ervebo for usage in children aged 12 months and above in August 2023. In a bid to support planning and response activities for future outbreaks, the company signed an agreement with the United Nations International Children’s Emergency Fund in January 2021, under which a global Ebola vaccine stockpile is being created using Ervebo.

上市批准疫苗

2023-02-02

·FierceBiotech

Inovio hopes Ebola vaccine booster data can provide a shot in the arm

Inovio is in need of good news from the clinic after its early efforts to develop a COVID-19 vaccine ran into trouble. A day after imposing a second round of layoffs, Inovio revealed a small data set for its Ebola vaccine booster, which the company hopes could someday also boost its fortunes. INO-4201 was tested in a phase 1b study in 46 healthy volunteers who had previously received Merck & Co.’s Ebola vaccine Ervebo three to seven years prior. The 36 participants who received the shot responded, with boosted neutralizing titers maintained 24 weeks later. Patients received a 1-mg dose, which was injected intradermally followed by electroportation using Inovio's Cellectra device. Cellectra is a hand-held device that uses a brief electrical pulse to allow plasmids to enter cells through temporary pores. Inovio is working with Global Urgent and Advanced Research and Development, or GuardRX, through funding from the U.S. Defense Advanced Research Projects Agency, or DARPA, and Geneva University Hospitals. The company expects to reveal more data in a peer-reviewed journal at a later date. The Pennsylvania biotech is in need of good news from the clinic, after its early efforts to develop a COVID-19 vaccine ran into trouble in 2021 while other companies got to the finish line faster. With that disappointment, Inovio's tough times continued, culminating in two rounds of layoffs, most recently on Wednesday when 11% of the workforce was let go. In the strategic reorganization announced this week, Inovio said its lead programs were treatments for HPV-associated diseases. This includes recurrent respiratory papillomatosis candidate INO-3107 and VGX-3100 for cervical high-grade squamous intraepithelial lesions. The company is expecting data from both programs in the third quarter. Editor's note: This story was updated at 3:06 p.m. ET on Feb. 2, 2023, to correct that Wednesday's layoffs involved 11% of staff.