A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Rift Valley Fever Virus (RVFV) Vaccine ChAdOx1 RVF Among Healthy Adult Volunteers in Uganda

Randomised, single blind, placebo - controlled, dose-escalation, phase I clinical trial recruiting healthy adults aged 18-50 years

开始日期2022-05-31

申办/合作机构

University of Oxford

NCT04754776 / Completed早期临床1期IIT

A Phase I Study to Determine the Safety & Immunogenicity of the Candidate Rift Valley Fever Virus (RVFV) Vaccine ChAdOx1 RVF in UK Healthy Adult Volunteers

Phase I open label, non-randomised dose escalation study on healthy UK volunteers aged from 18 to 50 years to assess the safety and immunogenicity of ChAdOx1 RVF

开始日期2021-06-11

申办/合作机构

University of Oxford

100 项与 ChAdOx1 RVF 相关的临床结果

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100 项与 ChAdOx1 RVF 相关的转化医学

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100 项与 ChAdOx1 RVF 相关的专利（医药）

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项与 ChAdOx1 RVF 相关的文献（医药）

2023-08-01·The Lancet. Infectious diseases

Safety and immunogenicity of a ChAdOx1 vaccine against Rift Valley fever in UK adults: an open-label, non-randomised, first-in-human phase 1 clinical trial.

Article

作者: Charleston, Bryan ; Jenkin, Daniel ; Hill, Adrian V S ; Bowden, Thomas A ; Gilbert, Sarah C ; Platt, Abigail ; Warimwe, George M ; Lawrie, Alison ; Gitonga, John N ; Wright, Daniel ; Kaleebu, Pontiano ; Karanja, Henry K ; Ewer, Katie J ; Tran, Nguyen ; Turner, Cheryl ; Boyd, Amy ; Mugo, Daisy ; Folegatti, Pedro M ; Poulton, Ian

BACKGROUNDRift Valley fever is a viral epidemic illness prevalent in Africa that can be fatal or result in debilitating sequelae in humans. No vaccines are available for human use. We aimed to evaluate the safety and immunogenicity of a non-replicating simian adenovirus-vectored Rift Valley fever (ChAdOx1 RVF) vaccine in humans.METHODSWe conducted a phase 1, first-in-human, open-label, dose-escalation trial in healthy adults aged 18-50 years at the Centre for Clinical Vaccinology and Tropical Medicine, Oxford, UK. Participants were required to have no serious comorbidities or previous history of receiving an adenovirus-based vaccine before enrolment. Participants were non-randomly allocated to receive a single ChAdOx1 RVF dose of either 5 × 10⁹ virus particles (vp), 2·5 × 10¹⁰ vp, or 5 × 10¹⁰ vp administered intramuscularly into the deltoid of their non-dominant arm; enrolment was sequential and administration was staggered to allow for safety to be assessed before progression to the next dose. Primary outcome measures were assessment of adverse events and secondary outcome measures were Rift Valley fever neutralising antibody titres, Rift Valley fever GnGc-binding antibody titres (ELISA), and cellular response (ELISpot), analysed in all participants who received a vaccine. This trial is registered with ClinicalTrials.gov (NCT04754776).FINDINGSBetween June 11, 2021, and Jan 13, 2022, 15 volunteers received a single dose of either 5 × 10⁹ vp (n=3), 2·5 × 10¹⁰ vp (n=6), or 5 × 10¹⁰ vp (n=6) ChAdOx1 RVF. Nine participants were female and six were male. 14 (93%) of 15 participants reported solicited local adverse reactions; injection-site pain was the most frequent (13 [87%] of 15). Ten (67%) of 15 participants (from the 2·5 × 10¹⁰ vp and 5 × 10¹⁰ vp groups only) reported systemic symptoms, which were mostly mild in intensity, the most common being headache (nine [60%] of 15) and fatigue (seven [47%]). All unsolicited adverse events reported within 28 days were either mild or moderate in severity; gastrointestinal symptoms were the most common reaction (at least possibly related to vaccination), occurring in four (27%) of 15 participants. Transient decreases in total white cell, lymphocyte, or neutrophil counts occurred at day 2 in some participants in the intermediate-dose and high-dose groups. Lymphopenia graded as severe occurred in two participants in the 5 × 10¹⁰ vp group at a single timepoint, but resolved at the subsequent follow-up visit. No serious adverse events occurred. Rift Valley fever neutralising antibodies were detectable across all dose groups, with all participants in the 5 × 10¹⁰ vp dose group having high neutralising antibody titres that peaked at day 28 after vaccination and persisted through the 3-month follow-up. High titres of binding IgG targeting Gc glycoprotein were detected whereas those targeting Gn were comparatively low. IFNγ cellular responses against Rift Valley fever Gn and Gc glycoproteins were observed in all participants except one in the 5 × 10¹⁰ vp dose group. These IFNγ responses peaked at 2 weeks after vaccination, were highest in the 5 × 10¹⁰ vp dose group, and tended to be more frequent against the Gn glycoprotein.INTERPRETATIONChAdOx1 RVF was safe, well tolerated, and immunogenic when administered as a single dose in this study population. The data support further clinical development of ChAdOx1 RVF for human use.FUNDINGUK Department of Health and Social Care through the UK Vaccines Network, Oak Foundation, and the Wellcome Trust.TRANSLATIONFor the Swahili translation of the abstract see Supplementary Materials section.

npj Vaccines1区 · 医学

Safety and efficacy of ChAdOx1 RVF vaccine against Rift Valley fever in pregnant sheep and goats

1区 · 医学

ArticleOA

作者: Kortekaas, Jeroen ; Clark, Madeleine H A ; Warimwe, George M ; Charleston, Bryan ; Stedman, Anna ; Wichgers Schreur, Paul J ; van Keulen, Lucien ; Francis, Michael J ; Wright, Daniel ; Hill, Adrian V S ; Gilbert, Sarah C

AbstractRift Valley fever virus (RVFV) is a zoonotic mosquito-borne virus that was first discovered in Kenya in 1930 and has since spread to become endemic in much of Africa and the Arabian Peninsula. Rift Valley fever (RVF) causes recurrent outbreaks of febrile illness associated with high levels of mortality and poor outcomes during pregnancy—including foetal malformations, spontaneous abortion and stillbirths—in livestock, and associated with miscarriage in humans. No vaccines are available for human use and those licensed for veterinary use have potential drawbacks, including residual virulence that may contraindicate their use in pregnancy. To address this gap, we previously developed a simian adenovirus vectored vaccine, ChAdOx1 RVF, that encodes RVFV envelope glycoproteins. ChAdOx1 RVF is fully protective against RVF in non-pregnant livestock and is also under development for human use. Here, we now demonstrate that when administered to pregnant sheep and goats, ChAdOx1 RVF is safe, elicits high titre RVFV neutralizing antibody, and provides protection against viraemia and foetal loss, although this protection is not as robust for the goats. In addition, we provide a description of RVFV challenge in pregnant goats and contrast this to the pathology observed in pregnant sheep. Together, our data further support the ongoing development of ChAdOx1 RVF vaccine for use in livestock and humans.

项与 ChAdOx1 RVF 相关的新闻（医药）

2021-02-26

·BioSpace

Canada to receive 2 million doses of AstraZeneca's COVID-19 vaccine manufactured by the Serum Institute of India

GATINEAU, QC, Feb. 26, 2021 /CNW/ - The Government of Canada is taking steps to ensure more people in Canada are vaccinated more quickly, and continues to work to give Canadians access to safe and effective COVID-19 vaccines as soon as possible. Following Health Canada's authorization of the AstraZeneca ChAdOx1 COVID-19 vaccine, the Honourable Anita Anand, Minister of Public Services and Procurement, announced today that Canada has secured 2 million doses of the AstraZeneca COVID-19 vaccine through an agreement with Verity Pharmaceuticals Canada Inc./Serum Institute of India. AstraZeneca has licensed the manufacture of its ChAdOx1 vaccine to the Serum Institute. The first 500,000 doses will be delivered to Canada in the coming weeks and will quickly be ready for distribution to the provinces and territories. The remaining 1.5 million doses will arrive by mid-May. The 2 million doses secured through this agreement are in addition to the 20 million doses already secured through an earlier agreement with AstraZeneca. Health Canada's authorization of the AstraZeneca vaccine allows the Government of Canada to advance its work with AstraZeneca to finalize delivery schedules for the 20 million doses. This announcement further solidifies Canada's plan to be able to provide a vaccine to everyone in Canada for whom these COVID-19 vaccines are recommended, by the end of September. Quotes "The Government of Canada continues to do everything possible to protect Canadians from COVID-19. This includes securing a highly diverse and extensive portfolio of vaccines and taking all necessary measures to ready the country to receive them. We remain fully on track to ensure that there will be a sufficient supply so that every eligible Canadian who wants a vaccine will have access to one by the end of September. I am grateful for the collaboration of our partners in India to finalize this agreement, and I look forward to continuing to work closely together in the weeks ahead." The Honourable Anita Anand Minister of Public Services and Procurement Quick facts AstraZeneca has licensed the manufacture of its ChAdOx1 vaccine to the Serum Institute, which distributes it under the brand name COVISHIELD. The Government of Canada has signed agreements with the following companies to secure access to their COVID-19 vaccines and vaccine candidates: Pfizer, which will supply a minimum of 40 million doses and up to 76 million doses of its messenger RNA (mRNA) vaccine developed with BioNTech, BNT162b2. The Pfizer-BioNTech COVID-19 vaccine was approved by Health Canada on December 9, 2020. Canada will receive 4 million doses of the Pfizer-BioNTech COVID-19 vaccine before the end of March, and more than 1.5 million doses in the first half of April. Moderna, which will supply 44 million doses of its mRNA vaccine, mRNA-1273. The Moderna COVID-19 vaccine was approved on December 23, 2020. During the week of March 8, Canada is expecting more than 460,000 doses of the Moderna vaccine, and another 846,000 during the week of March 22. These deliveries mean we will have received over 2 million doses in the first quarter. AstraZeneca, which will supply 20 million doses of its viral vector vaccine, ChAdOx1. The AstraZeneca COVID-19 vaccine was approved on February 26, 2021. Verity Pharmaceuticals Canada Inc./Serum Institute of India (in collaboration with AstraZeneca Canada Inc.), which will supply 2 million doses of the ChAdOx1 viral vector vaccine. The Verity Pharmaceuticals Canada Inc./Serum Institute of India (in collaboration with AstraZeneca Canada Inc.) COVID-19 vaccine was approved on February 26, 2021. Medicago, which will supply up to 76 million doses of its virus-like particle vaccine candidate. Sanofi and GlaxoSmithKline, which will supply up to 72 million doses of their protein subunit vaccine candidate. oohnson & Johnson, which will supply up to 38 million doses of its viral vector vaccine candidate, Ad26.COV2.S. Novavax, which will supply up to 76 million doses of its protein subunit vaccine candidate, NVX-CoV2373. The authorization of AstraZeneca's COVID-19 vaccine also allows the Government of Canada to access its allocation of doses from the COVAX facility. Associated links Coronavirus disease (COVID-19): Canada's response Procuring vaccines for COVID-19 Supplying Canada's response to COVID-19 Follow us on Twitter Follow us on Facebook SOURCE Public Services and Procurement Canada

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100 项与 ChAdOx1 RVF 相关的药物交易

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