The Phase 1 clinical trial was conducted by The King Abdullah International Medical Research Centre (KAIMRC), in the Kingdom of Saudi Arabia (KSA), in partnership with the University of Oxford. Vaccitech retains commercial rights to this vaccine.
The ChAdOx1 MERS vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses, which continued through the six–month follow–up period.
Study published online in The Lancet Microbe (https://www.thelancet.com/journals/lanmic/article/PIIS2666–5247(21)00193–2/fulltext).
OXFORD, United Kingdom, Nov. 04, 2021 (GLOBE NEWSWIRE) — Vaccitech plc (NASDAQ: VACC), a clinical–stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer, today announced the publication in The Lancet Microbe of the first Phase 1 clinical trial conducted in the Middle East evaluating the safety and tolerability of the ChAdOx1 MERS (Middle Eastern Respiratory Syndrome) vaccine candidate. The study builds on the first Phase 1 clinical trial of ChAdOx1 MERS conducted in the United Kingdom and published in Lancet ID last year.
The Phase 1 trial is part of a collaboration between the University of Oxford's Jenner Institute and the King Abdullah International Medical Research Center (KAIMRC). It is the first vaccine clinical trial to be conducted within the Kingdom of Saudi Arabia. Vaccitech retains commercial rights to the vaccine.
"The high fatality rate of diagnosed MERS–CoV makes it one of the most dangerous coronaviruses communicable between humans," says Naif Alharbi, KAIMRC, DPhil, vaccinologist and co–principal investigator on the MERS vaccine trial. "Research into robust preventative measures for a virus with pandemic potential is a global health imperative. The completion of our trial is the latest achievement for KAIMRC's world–leading MERS research and supports advancing the ChAdOx1 MERS vaccine candidate into its next phase of development. This multi–partner experience has also set the stage for more MERS vaccine clinical development in KSA, improving both research and regulatory expertise."
Dame Sarah Gilbert Ph.D., co–founder of Vaccitech said, "This was the first phase I trial of any vaccine conducted in KSA, and it is fitting that it was a trial of a vaccine against MERS. The results provide further evidence on the tolerability and immunogenicity profile of this vaccine candidate and pave the way for its further development."
Tom Evans, M.D., Chief Scientific Officer of Vaccitech added, "These important trial results, collected by scientists at the Jenner and KAIMRC, have the potential to progress us toward a much–needed vaccine for MERS. Their publication also builds on the already extensive dataset which supports our ChAdOx platform for prophylactic, pandemic preparedness, and therapeutic uses."
Twenty–four healthy adult volunteers aged 18 to 50 years received one of three single doses of ChAdOx1 MERS (at dose levels of 5 x 109 viral particles (VP), 2.5 x 1010 VP and 5 x 1010 VP). The primary objective was to assess safety and tolerability. Secondary objectives included evaluation of cellular and humoral immunogenicity from baseline through six months. The trial showed that ChAdOx1 MERS was generally well tolerated with most adverse events either mild or moderate. The most common adverse event was headache (58% of volunteers) followed by muscle pain (54%). The vaccine candidate induced robust antibody and T cell immune responses in all volunteers. Antibodies peaked at day 28 and T cell responses peaked at day 14, both of which were maintained until the end of follow–up at six months. The results of the study support advancing the vaccine candidate into Phase 2 development.
There have been more than 2,500 cases of MERS reported globally to the World Health Organization (WHO), including 886 deaths. The MERS case fatality rate is 34%, an order of magnitude greater than the rate reported for the COVID–19 coronavirus, SARS–CoV–2. The WHO lists MERS–CoV as a priority pathogen for vaccine development due to its threat to global health security.
Notes to editors:
About the trial and KAIMRC
The trial took place at King Abdullah International Medical Research Center (KAIMRC) and King Abdulaziz Medical City (KAMC). Both are part of the Ministry of National Guard Health Affairs (Saudi NGHA). KAMC in Riyadh has been recognised as a distinguished healthcare provider in Saudi Arabia and the region, with a bed capacity of 1501, and commenced its operations in May 1983. Since then, it has continued expanding, while providing services for a rapidly growing patient population in all of its catchment areas. Recently KAIMRC and KAMC have received approval for a Phase 1 clinical trial unit from the national regulator (Saudi FDA).
First identified in 2012 in Saudi Arabia, MERS is a viral respiratory illness caused by the highly pathogenic MERS coronavirus (MERS–CoV). MERS–CoV is likely a zoonotic bat virus, with the dromedary camel implicated as the major animal host for spread to humans. Human to human transmission via droplets and contact can occur, especially in nosocomial settings, which lack robust infection control practices. MERS–CoV leads to severe disease of the lower respiratory tract, with a high symptomatic case fatality rate of ~34%. More than 2,500 cases of MERS have now been reported from 27 countries, including 12 Eastern Mediterranean countries. Globally, as of June 2021, MERS has now been responsible for 886 deaths with eight new cases of MERS reported from January 1, 2021, to May 3, 2021, in Saudi Arabia and UAE.
About Vaccitech plc
Vaccitech is a clinical–stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer. The company's proprietary platform comprises proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, as well as the well–validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable tolerability profiles and without the ability to replicate in humans. The combination of a ChAdOx prime treatment with subsequent MVA boost has consistently generated significantly higher magnitudes of CD8+ T cells compared with other technologies and approaches. The company has a broad pipeline of both clinical and preclinical stage therapeutic programs in solid tumors and viral infections and prophylactic viral vaccine programs. Vaccitech co–invented a COVID–19 vaccine with the University of Oxford, now approved for use in many territories and exclusively licensed worldwide to AstraZeneca through Oxford University Innovation, or OUI. Vaccitech is entitled to receive a share of the milestones and royalty income received by OUI from AstraZeneca.
Forward Looking Statement
This press release contains forward–looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding: the Company's business plans and objectives, including the timing and advancement of the Company's programs, such as the clinical trial of ChAdOx1 MERS (VTP–500) and the continued development of ChAdOx1 MERS, the potential therapeutic effects and expected patient population of ChAdOx1 MERS and the Company's use of capital, expenses and other financial results. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue" and similar expressions are intended to identify forward–looking statements, although not all forward–looking statements contain these identifying words. Any forward–looking statements in this press release are based on management's current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward–looking statements contained in this press release, including, without limitation: the success, cost and timing of the Company's product development activities and planned and ongoing clinical trials, the Company's ability to execute on its strategy, regulatory developments, the Company's ability to fund its operations and the impact that the current COVID–19 pandemic will have on the Company's clinical trials and preclinical studies and other risks identified in the Company's filings with the Securities and Exchange Commission (the "SEC"), including its Quarterly Report on Form 10–Q for the first quarter of 2021 and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward–looking statements, which speak only as of the date they are made. The Company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward–looking statements.
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