ANRS 0146s NovaaTen study aims to determine the vaccine responses in the participants of the ANRS EP46 Novaa trial 10 years after a primary anti-yellow fever vaccination

Start Date01 Nov 2024

Sponsor / Collaborator

ANRS, Emerging Infectious Diseases

[+3]

NCT06399003 / RecruitingPhase 3

A Phase III, Multi-Center, Randomized, Observer-Blind, Active Controlled Non-Inferiority Study to Evaluate the Immunogenicity and Safety of SIBP's MMR Vaccine Compared to GSK MMR Vaccine in Children, 9-11 Months of Age

To evaluate the Immunogenicity and Safety of Shanghai Institute of Biological Products Co., Ltd.'s Measles, Mumps and Rubella (MMR) Vaccine Compared to a Licensed and WHO Prequalified GSK MMR Vaccine in Healthy African Children, 9-11 Months of Age.

Start Date28 Jun 2024

Sponsor / Collaborator

Shanghai Institute of Biological Products Co., Ltd.

CTRI/2024/03/063471 / RecruitingPhase 2/3IIT

A Phase 2/3 Multicenter, Double blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity with STAMARIL in Adults - Nil

Start Date15 Mar 2024

Sponsor / Collaborator-

100 Clinical Results associated with 17D YF Vaccine(Sanofi Pasteur)

100 Translational Medicine associated with 17D YF Vaccine(Sanofi Pasteur)

100 Patents (Medical) associated with 17D YF Vaccine(Sanofi Pasteur)

340

Literatures (Medical) associated with 17D YF Vaccine(Sanofi Pasteur)

01 Nov 2024·Lancet Global Health

Schistosome and malaria exposure and urban–rural differences in vaccine responses in Uganda: a causal mediation analysis using data from three linked randomised controlled trials

Article

Author: Corstjens, Paul L A M ; van Dam, Govert J ; Kaleebu, Pontiano ; Kabami, Grace ; Amongin, Rebecca ; Kakande, Ayoub ; Webb, Emily L ; Natukunda, Agnes ; Tumusiime, Josephine ; Kayiwa, John ; Nassanga, Beatrice ; Nassuuna, Jacent ; Kabali, Joel ; Kukundakwe, Christine ; Nsubuga, Denis ; Kabagenyi, Joyce ; Zirimenya, Ludoviko ; Nkurunungi, Gyaviira ; Kabuubi, Prossy N ; Mutebe, Alex ; Oduru, Gloria ; Nkangi, Ronald ; Sewankambo, Moses ; Akello, Florence A ; Ninsiima, Caroline ; Kizza, Moses ; Kiwanuka, Samuel ; Katushabe, Charity ; Walusimbi, Bridgious ; Nayebare, Doreen ; Akurut, Hellen ; Driciru, Emmanuella ; Akello, Mirriam ; Wajja, Anne ; Apule, Barbara ; Nankabirwa, Christine ; Namusobya, Loyce ; Kiwudhu, Fred ; Nyanzi, Ruth ; Tumwesige, Pius ; Serubanja, Joel ; Cose, Stephen ; Amongi, Susan ; Namutebi, Milly ; Zziwa, Christopher ; Onen, Caroline ; Elliott, Alison M ; Kizindo, Robert ; Nakazibwe, Esther

BACKGROUND:

Vaccine immunogenicity and effectiveness vary geographically. Chronic immunomodulating parasitic infections including schistosomes and malaria have been hypothesised to be mediators of geographical variations.

METHODS:

We compared vaccine-specific immune responses between three Ugandan settings (schistosome-endemic rural, malaria-endemic rural, and urban) and did causal mediation analysis to assess the role of Schistosoma mansoni and malaria exposure in observed differences. We used data from the control groups of three linked randomised trials investigating the effects of intensive parasite treatment among schoolchildren. All participants received the BCG vaccine (week 0); yellow fever (YF-17D), oral typhoid (Ty21a), human papillomavirus (HPV; week 4); and HPV booster and tetanus-diphtheria (week 28). Primary outcomes were vaccine responses at week 8 and, for tetanus-diphtheria, week 52. We estimated the total effect (TE) of setting on vaccine responses and natural indirect effect (NIE) mediated through current or previous infection with S mansoni or malaria, and baseline vaccine-specific responses.

FINDINGS:

We included 239 (43%) participants from the schistosomiasis-endemic setting, 171 (30%) from the malaria-endemic setting, and 151 (27%) from the urban setting. At week 8, vaccine responses were lower in rural settings: schistosomiasis-endemic versus urban settings (TE geometric mean ratio for YF-17D plaque reduction neutralisation at 50% (PRNT₅₀) titres 0·58 [95% CI 0·37 to 0·91], for S Typhi O-lipopolysaccharide-specific IgG 0·61 [0·40 to 0·93], and for tetanus-specific IgG 0·33 [0·22 to 0·51]); malaria-endemic versus urban settings (YF-17D 0·70 [0·49 to 0·99], S Typhi O-lipopolysaccharide-specific IgG 0·29 [0·20 to 0·43], and tetanus-specific IgG 0·53 [-0·35 to 0·80]). However, we found higher BCG-specific IFNγ responses in the malaria-endemic versus urban setting (1·54 [1·20 to 1·98]). The estimated NIEs of setting on vaccine responses mediated through previous and current S mansoni and malaria were not statistically significant. For malaria-endemic versus urban settings, baseline vaccine-specific responses contributed to some but not all differences: S Typhi O-lipopolysaccharide-specific IgG at week 8 (57.9% mediated [38·6 to 77·2]) and week 52 (70·0% mediated [49·4 to 90·6]) and BCG at week 52 (46.4% mediated [-4·8 to 97·7]).

INTERPRETATION:

We found significant variation in vaccine response between urban and rural settings but could not confirm a causal role for schistosome or malaria exposure. Other exposures require consideration.

FUNDING:

UK Medical Research Council.

01 Nov 2024·Lancet Global Health

The effect of BCG revaccination on the response to unrelated vaccines in urban Ugandan adolescents (POPVAC C): an open-label, randomised controlled trial

Article

Author: Serubanja, Joel ; van Dam, Govert J ; Webb, Emily L ; Kakande, Ayoub ; Kaleebu, Pontiano ; Natukunda, Agnes ; Kabali, Joel ; Nassuuna, Jacent ; Zirimenya, Ludoviko ; Kabagenyi, Joyce ; Kukundakwe, Christine ; Kiwudhu, Fred ; Nkurunungi, Gyaviira ; Namusobya, Loyce ; Oduru, Gloria ; Mutebe, Alex ; Apule, Barbara ; Kabuubi, Prossy N ; Sewankambo, Moses ; Akello, Florence A ; Kizindo, Robert ; Katushabe, Charity ; Ninsiima, Caroline ; Kizza, Moses ; Walusimbi, Bridgious ; Nayebare, Doreen ; Akello, Mirriam ; Akurut, Hellen ; Elliott, Alison M ; Kiwanuka, Samuel ; Nkangi, Ronald ; Nassanga, Beatrice ; Driciru, Emmanuella ; Wajja, Anne ; Kayiwa, John ; Nankabirwa, Christine ; Namutebi, Milly ; Onen, Caroline ; Amongi, Susan ; Cose, Stephen ; Kabami, Grace ; Nyanzi, Ruth ; Amongin, Rebecca ; Tumusiime, Josephine ; Zziwa, Christopher ; Nakazibwe, Esther ; Tumwesige, Pius ; Nsubuga, Denis ; Corstjens, Paul L A M

BACKGROUND:

Immune responses induced by several important vaccines differ between populations, with reduced responses in low-income and rural settings compared with high-income and urban settings. BCG immunisation boosts immune responses to some unrelated vaccines in high-income populations. We aimed to test the hypothesis that BCG revaccination can enhance responses to unrelated vaccines in Ugandan schoolchildren.

METHODS:

We conducted an open-label, randomised controlled trial to compare the effects of BCG revaccination versus no BCG revaccination on the immunogenicity of subsequent unrelated vaccines among adolescents aged 13-17 years who are participants in an urban Ugandan birth cohort study, in which BCG vaccination was documented at birth. Participants were excluded if they had received any of the trial vaccines or related agents when aged 5 years or older. Computer-generated 1:1 randomisation was implemented in REDCap. Participants were excluded if they were concurrently enrolled in other trials; had a clinically significant history of immunodeficiency, or serious psychiatric conditions or moderate to severe acute illnesses; were taking immunosuppressive medications; had allergies to vaccine components, a predisposition towards developing keloid scarring; positive HIV tests or pregnancy tests; were female participants who were lactating; or if they planned to use investigational drugs, vaccines, blood products, or any combination thereof. Trial participants assigned to the BCG revaccination group received the live parenteral BCG-Russia vaccine (Serum Institute of India, Pune, India; 0·1 mL intradermally, right upper arm) at week 0. All participants received yellow fever vaccine (YF-17D; Sanofi Pasteur, Lyon, France; 0·5 mL intramuscularly, left upper arm), live oral typhoid vaccine (Ty21a; PaxVax, London, UK; one capsule per day taken for three alternate days), and quadrivalent virus-like particle human papillomavirus (HPV) vaccine (Merck, Rahway, NJ, USA; 0·5 mL intramuscularly, left upper arm) at week 4; and toxoid vaccines (tetanus-diphtheria; Serum Institute of India; 0·5 mL intramuscularly, left upper arm) and an HPV booster at week 28. An additional HPV vaccination at week 8 was provided to female participants older than 14 years who had not previously been vaccinated. The primary outcomes were yellow fever neutralising antibody titres at 4 weeks post-YF-17D vaccination, Salmonella enterica serovar Typhi (henceforth S Typhi) O-lipopolysaccharide (O:LPS)-specific IgG concentration at 4 weeks post-Ty21a vaccination, and HPV-16 and HPV-18 L1 protein-specific IgG concentration at 4 weeks post-HPV vaccination. Primary outcome assays were conducted at week 8, and at week 52 for tetanus-diphtheria. We conducted an intention-to-treat analysis comparing log-transformed outcomes between trial groups, with results back-transformed to geometric mean ratios (GMRs). The safety population comprised all randomly allocated participants. The trial was registered at the ISRCTN Registry (ISRCTN10482904) and is complete.

FINDINGS:

Between Aug 31 and Oct 12, 2020, we screened 376 potential participants for eligibility. We enrolled and randomly allocated 300 participants to the two groups (151 [50%] to the BCG group and 149 [50%] to the no BCG group). 178 (59%) of 300 participants were male and 122 (41%) were female. 142 (91%) of 151 participants in the BCG group and 139 (93%) of 149 in the no BCG group completed follow-up. There was no effect of BCG revaccination, compared with no BCG revaccination, on the response observed for any vaccine. Yellow fever plaque reduction neutralising reference tests (PRNT₅₀) titres (the reciprocal of the last plasma dilution that reduced by 50%) had a GMR of 0·95 (95% CI 0·75-1·19; p=0·62) and PRNT₉₀ (reciprocal of the last plasma dilution that reduced by 90%) had a GMR of 0·94 (0·74-1·19; p=0·60); IgG to S Typhi O:LPS was 0·99 (0·80-1·23; p=0·94); IgG to HPV-16 was 0·97 (0·69-1·35; p=0·85) and to HPV-18 was 1·03 (0·76-1·40; p=0·83); and toxoid-specific IgG for tetanus was 1·13 (0·87-1·47; p=0·36) and was 1·00 (0·87-1·16; p=0·97) for diphtheria. There were no serious adverse events in either group.

INTERPRETATION:

We found no evidence that BCG revaccination is an effective strategy to improve immunogenicity of other vaccines in this low-income, urban setting.

FUNDING:

UK Medical Research Council.

TRANSLATION:

For the Luganda translation of the abstract see Supplementary Materials section.

01 Nov 2024·Lancet Global Health

The effect of intermittent preventive treatment for malaria with dihydroartemisinin–piperaquine on vaccine-specific responses among schoolchildren in rural Uganda (POPVAC B): a double-blind, randomised controlled trial

Article

Author: Akello, Florence A ; Webb, Emily L ; van Dam, Govert J ; Oduru, Gloria ; Kakande, Ayoub ; Amongin, Rebecca ; Katushabe, Charity ; Kaleebu, Pontiano ; Natukunda, Agnes ; Nkurunungi, Gyaviira ; Nassuuna, Jacent ; Kiwudhu, Fred ; Zirimenya, Ludoviko ; Kabagenyi, Joyce ; Nsubuga, Denis ; Kabuubi, Prossy N ; Namusobya, Loyce ; Namusobya, Loyce K ; Mutebe, Alex ; Staedke, Sarah G ; Nankabirwa, Christine M ; Kabali, Joel ; Sewankambo, Moses ; Kizindo, Robert ; Ninsiima, Caroline ; Tumusiime, Josephine ; Kizza, Moses ; Nayebare, Doreen ; Akello, Mirriam ; Elliott, Alison M ; Kiwanuka, Samuel ; Nkangi, Ronald ; Akurut, Hellen ; Nassanga, Beatrice ; Kabami, Grace ; Wajja, Anne ; Kayiwa, John ; Apule, Barbara ; Nankabirwa, Christine ; Namutebi, Milly ; Kukundakwe, Christine ; Walusimbi, Bridgious ; Driciru, Emmanuella ; Cose, Stephen ; Nyanzi, Ruth ; Serubanja, Joel ; Amongi, Susan ; Onen, Caroline ; Zziwa, Christopher ; Tumwesige, Pius ; Nakazibwe, Esther ; Corstjens, Paul L A M

BACKGROUND:

Several important vaccines differ in immunogenicity and efficacy between populations. We hypothesised that malaria suppresses responses to unrelated vaccines and that this effect can be reversed-at least partially-by monthly malaria intermittent preventive treatment (IPT) in high-transmission settings.

METHODS:

We conducted an individually randomised, double-blind, placebo-controlled trial of the effect of malaria IPT with dihydroartemisinin-piperaquine on vaccine responses among schoolchildren aged 9-17 years in Jinja district, Uganda. Participants were recruited from two schools and did not have exposure to vaccines of interest after the age of 5 years, with the exception of human papillomavirus (HPV). Computer-generated 1:1 randomisation was implemented in REDCap. 3-day courses of dihydroartemisinin-piperaquine (dosage by weight) or placebo were administered monthly, including twice before the first vaccination. Trial participants were vaccinated with the live parenteral BCG vaccine (Serum Institute of India, Pune, India) at week 0; yellow fever vaccine (YF-17D; Sanofi Pasteur, Lyon, France); live oral typhoid vaccine (Ty21a; PaxVax, London, UK), and quadrivalent virus-like particle HPV vaccine (Merck, Rahway, NJ, USA) at week 4; and toxoid vaccines (tetanus-diphtheria; Serum Institute of India) and an HPV booster at week 28. An additional HPV vaccination at week 8 was provided to female participants older than 14 years who had not previously been vaccinated, and a tetanus-diphtheria booster was given after completion of the trial at week 52. Primary outcomes were vaccine responses at week 8 and, for tetanus-diphtheria, at week 52, and analysis was done in the intention-to-treat population. Malaria parasite prevalence at enrolment and during follow-up was determined retrospectively by PCR. The safety population comprised all randomly allocated participants. The trial was registered at the ISRCTN Registry (ISRCTN62041885) and is complete.

FINDINGS:

Between May 25 and July 14, 2021, we assessed 388 potential participants for eligibility. We enrolled and randomly allocated 341 participants to the two groups (170 [50%] to dihydroartemisinin-piperaquine and 171 [50%] to placebo); 192 (56%) were female and 149 (44%) participants were male. 145 (85%) participants in the dihydroartemisinin-piperaquine group and 140 participants (82%) in the placebo group were followed up until the week 52 endpoint. At enrolment, 109 (64%) of all participants in the dihydroartemisinin-piperaquine group and 99 (58%) of 170 participants in the placebo group had malaria; this reduced to 6% or lower at all follow-up visits in the dihydroartemisinin-piperaquine group. There was no effect of dihydroartemisinin-piperaquine versus placebo on primary outcomes: BCG-specific IFNγ ELISpot response had a geometric mean ratio (GMR) of 1·09 (95% CI 0·93-1·29), p=0·28; yellow fever neutralising antibody was 1·19 (0·91-1·54), p=0·20 for plaque reduction neutralising reference tests (PRNT₅₀) titres (the reciprocal of the last plasma dilution that reduced by 50%) and 1·24 (0·97-1·58), p=0·09 for PRNT₉₀ titres (reciprocal of the last plasma dilution that reduced by 90%); and IgG to Salmonella enterica serovar Typhi O-lipopolysaccharide was 1·09 (0·81-1·46), p=0·58, HPV-16 was 0·72 (0·44-1·77), p=0·19, HPV-18 was 0·71 (0·47-1·09), p=0·11; tetanus toxoid was 1·22 (0·91-1·62), p=0·18, and diphtheria toxoid was 0·97 (0·83-1·13), p=0·72. There was some evidence that dihydroartemisinin-piperaquine reduced waning of the yellow fever response.

INTERPRETATION:

IPT for malaria with dihydroartemisinin-piperaquine did not improve peak vaccine responses, despite reducing malaria prevalence. Possible longer-term effects on response waning should be further explored.

FUNDING:

UK Medical Research Council.

TRANSLATION:

For the Luganda translation of the abstract see Supplementary Materials section.

News (Medical) associated with 17D YF Vaccine(Sanofi Pasteur)

12 Sep 2024

·www.biospace.com

QIAGEN and Bio-Manguinhos/Fiocruz collaborate to enhance malaria and dengue detection in Brazil’s national screening programs

Advanced PCR-based screening platform deployed nationwide across 30 laboratories provides new capabilities to detect malaria, HIV, HCV, and HBV in blood donations // Advanced capabilities support epidemiological surveillance of ongoing dengue outbreak in Brazil with unique chemistry developed by QIAGEN and Bio-Manguinhos/Fiocruz // Partnership highlights QIAGEN’s commitment to custom and OEM solutions, technology transfer and long-term support Venlo, the Netherlands, Rio de Janeiro, Brazil, Sept. 12, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the expansion of its strategic partnership with Bio-Manguinhos/Fiocruz, the leading provider of vaccines and diagnostics to the Brazilian Ministry of Health. The partnership, initiated in 2009, supported Bio-Manguinhos/Fiocruz with reagents and instruments for testing samples for HIV and hepatitis C virus. With the expansion of this collaboration, Bio-Manguinhos is now able to launch an advanced PCR-based molecular screening platform to detect malaria alongside HIV, hepatitis B and C virus (HCV and HBV), a capability previously unavailable in Brazil’s blood donation program. It also supports epidemiological surveillance of Brazil’s ongoing dengue epidemic by composing Bio-Manguinhos/Fiocruz dengue molecular kits based on unique chemistry developed by QIAGEN and Bio-Manguinhos/Fiocruz. QIAGEN will supply critical molecular biology technologies, custom solutions, and comprehensive training to facilitate Brazil’s public health initiative. The advanced Brazilian Nucleic Acid Test (NAT Plus) platform, leveraging QIAGEN’s PCR reagents, was recently rolled out as part of Brazil’s national blood screening program. Initiated in 2010, this is the largest blood donation safety initiative in the country’s history. Every year, five million blood donations are performed in Brazil, with 70% conducted by public blood banks. This latest advancement improves transfusional safety by detecting malaria and closing the “diagnostic window” between the time of infection and laboratory diagnosis. It is currently operational in 30 laboratories and is critical to safeguarding blood supplies in regions where these diseases are not endemic. QIAGEN and Bio-Manguinhos have been partnering since 2009 to equip Brazil’s national blood screening program with advanced molecular testing solutions. “QIAGEN’s support has been crucial to achieving our public health goals, especially in enabling malaria and dengue screening,” said Antonio Gomes Pinto Ferreira, IVD Reagents Director of Bio-Manguinhos/Fiocruz. “Their team helped us develop and scale an epidemiological solution that significantly enhances our blood screening capabilities and improves public safety.” “QIAGEN is committed to working side-by-side with technology partners, like Bio-Manguinhos/Fiocruz, to develop high-impact solutions”, said Salim Essakali, Head of Strategic Partnerships & OEM Division at QIAGEN. “This partnership exemplifies how combining QIAGEN’s biotechnology expertise, life science tools and operational capabilities can improve public health outcomes within Brazil’s national blood screening program”. The NAT Plus platform supports health surveillance within the blood transfusion system, engaging over 300 trained professionals across 14 hemotherapy centers and processing 3.5 million samples annually. Bio-Manguinhos/Fiocruz’s ZCD-typing kit can now also detect and discriminate samples of zika, chikungunya and dengue, and type the latter, which supports epidemiological surveillance programs in Brazil. Under the terms of this agreement, QIAGEN’s solutions will be included in the screening kits and private labeled under the Bio-Manguinhos’s brand. Since its inception, QIAGENs Strategic Partnerships & OEM Division has supported over 400 global partners in molecular diagnostics, life science research, infectious disease testing, and oncology with state-of-the-art manufacturing facilities, integrated quality management systems and a comprehensive catalogue of customizable products and services. About QIAGEN Strategic Partnerships QIAGEN Strategic Partnerships accelerates the process of bringing innovative brands, products, and capabilities to the market by providing tailored solutions and comprehensive support for companies in the life sciences research, biotechnology, and diagnostics sectors. The program offers QIAGEN’s strategic partners access to customized solutions, contract bulk manufacturing, volume packaging, shipping and expert support across all aspects of comprehensive workflows. These workflows include sample preparation, assay development for next-generation sequencing (NGS), precision and custom enzymes, quantitative or digital PCR, bioinformatic analysis solutions, and technical, regulatory, and compliance consultation services. By leveraging QIAGEN’s extensive life science expertise and operational capabilities, strategic partners can develop and deploy high-impact solutions effectively and efficiently. Learn more about QIAGEN Strategic Partnerships here: About QIAGEN QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of March 31, 2024, QIAGEN employed more than 5,900 people in over 35 locations worldwide. Further information can be found at . About Bio-Manguinhos/Fiocruz Founded in 1976, Bio-Manguinhos is a Fiocruz’s Institute responsible for research, innovation, development and the production of vaccines, in vitro diagnostics and biotherapeutics aimed at primarily meeting the demands of national public health. Bio-Manguinhos/Fiocruz is one of the largest production centers in Latin America, at Fiocruz’ Manguinhos Campus, contributing to the self-sufficiency efforts to supply essential vaccines, biotherapeutics and in vitro diagnostics for the Brazilian Ministry of Health. The Institute also contributes with the public health of several countries, mainly by the export of the yellow fever vaccine, pre-qualified by WHO. Further information can be found at . Forward-Looking Statement Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, collaborations, markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of QIAGEN’s new products and the integration of acquired technologies and businesses; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission. Source: QIAGEN N.V. Category: Corporate CONTACT: John Gilardi QIAGEN N.V. +49 2103 29 116711 ir@qiagen.com Domenica Martorana QIAGEN N.V. +49 2103 29 11244 ir@qiagen.com Thomas Theuringer QIAGEN N.V. +49 2103 29 11826 pr@qiagen.com Lisa Spechht QIAGEN N.V. +49 2103 29 14181 pr@qiagen.com

VaccineClinical Study

08 Jun 2024

·www.drugs.com

This Travel Season, Know Your Risks for Yellow Fever

SATURDAY, June 8, 2024 -- If tropical lands like South America or Africa are your travel destinations, getting yourself protected against yellow fever before you go is imperative, an expert says. What is yellow fever? According to Dr. Jill Weatherhead , an assistant professor of tropical medicine and infectious diseases at Baylor College of Medicine in Houston, it's a viral illness endemic to tropical zones that's spread to humans through the bites of infected mosquitos. Most folks bitten and infected may not show any symptoms. But others will develop symptoms within a week of the bite. “These symptoms include fever, chills, headaches, back pain and myalgias [aches],” Weatherhead said in a Baylor news release. In some people, "the virus can progress to severe disease," she added. "One in seven people will develop severe yellow fever, which includes high fever or jaundice, which is the yellowing of the skin that is associated with inflammation of the liver or hemorrhagic shock where bleeding can happen.” For folks unfortunate to develop full-blown disease, there's very little doctors can do since no known antiviral is effective against the illness. The best that can be done is what health care workers call "supportive care." There are two key methods of preventing yellow fever before it starts, however: Vaccination and mosquito avoidance. “A yellow fever vaccine is available and recommended for all persons nine months and older traveling to yellow fever-endemic regions, with some exceptions," Weatherhead said. "Additionally, some countries might require you to have the vaccination before you enter, and there may be some restrictions on going into a country if you have been to a yellow fever-endemic area." Once in an area where mosquitoes carrying the yellow fever virus might be found, a few simple steps can help you avoid getting bitten. They're basically the same measures you would use back home: wear long sleeves and long pants and use a bug repellant with DEET. If you find yourself infected with yellow fever, "make sure you are hydrated and are controlling your fevers to help alleviate symptoms," Weatherhead said. "Acetaminophen would be the medication of choice. Avoid using anti-inflammatories like aspirin and other NSAIDs that could impact your platelets. Seeking medical care as soon as possible can be lifesaving.” SOURCE: Baylor College of Medicine, news release, June 6, 2024 Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Vaccine

26 Mar 2024

·www.fiercepharma.com

Caring Cross, Brazil's Fiocruz team up to produce cell and gene therapies at a fraction of their cost in the US

Maryland non-profit Caring Cross and Brazil's Fundacao Oswaldo Cruz (Fiocruz) plan to develop and manufacture cell and gene therapies at one-tenth of their cost in the U.S. Maryland non-profit Caring Cross has unveiled a partnership with the Brazilian government that's designed to provide access to advanced cell and gene therapies for diseases like leukemia, lymphoma and HIV infection—and in the process provide a manufacturing model that demonstrates how to reduce the cost of these treatments in the United States and Europe. Caring Cross and Fundacao Oswaldo Cruz (Fiocruz)—a foundation funded by the Brazilian Ministry of Health—plan to develop and manufacture the medicines at a fraction of their cost in the U.S. Co-founded by cell and gene therapy manufacturing trailblazers Boro Dropulic, Ph.D. and Rimas Orentas, Caring Cross’ mission is to organize and support a community of healthcare professionals, scientists, engineers, advocates and business leaders to accelerate the development of advanced medicines and make them available for all patients around the world. The program with Brazil is the first of its kind anywhere in the world, Dropulic and Orentas said in an interview with Fierce Pharma. “We’re pioneering something quite new in terms of teaching an organization, that is directly linked to the Ministry of Health, how to manufacture CAR-T cells and the vectors themselves,” said Dropulic, the executive director of Caring Cross. “We will start first in Rio de Janeiro at the Fiocruz campus—in collaboration with INCA, which is their equivalent of the NCI (National Cancer Institute)—to run clinical trials for leukemia and lymphoma.” Dropulic knows the drill. He founded Lentigen, which developed the lentiviral vector used by Novartis to produce the first FDA-approved cell therapy product, Kymriah, in 2017. Dropulic directed Lentigen’s CDMO business model before launching Caring Cross in 2021. The effort in Brazil will include the development of a product for HIV, which is currently in clinical trials in the U.S. A candidate to cure sickle cell disease and beta thalassemia could enter the clinic later this year. Under the plan, the therapies will be available for free for patients, with an approximate cost of $35,000 per dose covered by the Brazilian public health system. Dropulic and Orentas believe an approved product could be available within three years. Caring Cross aims to slash production costs with its point-of-care manufacturing model. Development and manufacturing can be executed entirely in modular units which are 56 by 13 feet and can be set up anywhere. “When you make these products at the point of care or close to a hospital, you significantly decrease these logistical costs,” Dropulic said. Orentas added that it’s already dawned on the managed care systems in countries such as Spain, Germany and Denmark that the way gene therapies are produced in the U.S. is “not sustainable.” Even with the high cost of doing business in the U.S., Caring Cross believes it could deliver CAR-T therapies for around $80,000, Orentas said. In the U.S., cell and gene therapy prices currently range from hundreds of thousands of dollars to millions of dollars. Caring Cross's Brazilian partner has "biomanufacturing expertise" and "an experienced workforce," Orentas said. Fiocruz is the world’s largest producer of the yellow fever vaccine. It also served as Brazil’s home base for production of its AstraZeneca-partnered COVID vaccine. Meanwhile, through its for-profit CDMO spinout, Vector BioMed, Caring Cross is developing technologies to improve the accessibility of CAR-T and other therapies.

$Caring Cross, Brazil's Fiocruz team up to produce cell and gene therapies at a fraction of their cost in the US$

VaccineGene TherapyCell Therapy

100 Deals associated with 17D YF Vaccine(Sanofi Pasteur)

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KEGG	Wiki	ATC	Drug Bank
D06347	17D YF Vaccine(Sanofi Pasteur)	J07BL01	-

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Indication	Country/Location	Organization	Date
Yellow Fever	US	Sanofi Pasteur, Inc.	09 Dec 1999

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis