Influenza virosomes represent an innovative human-compatible antigen delivery system that has already proven its suitability for subunit vaccine design. The aim of the study was to proof the concept that virosomes can also be used to elicit high titers of antibodies against synthetic peptides derived from the circumsporozoite protein and from the apical-membrane-antigen 1 and that the formulations are safe in humans.

Start Date01 Nov 2003

Sponsor / Collaborator

Swiss Tropical & Public Health Institute

100 Clinical Results associated with Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)

100 Translational Medicine associated with Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)

100 Patents (Medical) associated with Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)

Literatures (Medical) associated with Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)

01 Dec 2024·Acta Tropica

Characterisation of the erythrocyte invasion phenotype of FCB-2: A South American P. falciparum reference strain

Article

Author: Curtidor, Hernando ; Ararat-Sarria, Monica ; Patarroyo, Manuel Alfonso

The extent of parasite adaptive capability involved in erythrocyte invasion represents a significant challenge for the development of a Plasmodium falciparum vaccine. The parasite's geographical and populational origin may influence such adaptive behaviour; in vitro culture-adapted parasite strains are typically used for such studies. Previous studies have reported invasion phenotypes in strains from Africa and Asia and, to a lesser extent, from Latin America. This study was aimed at expanding the pool of characterised parasite strains from Latin America by describing the invasion phenotype of the P. falciparum Colombia Bogotá 2 (FCB2) strain. The FCB2 genome was sequenced and erythrocyte invasion ligand sequences were analysed and compared to other previously reported ones. RT-PCR was used for assessing Pfeba family erythrocyte invasion ligands and reticulocyte binding homologue (Pfrh) gene transcription. A flow cytometry-based erythrocyte invasion assay (using enzymatically-treated erythrocytes) was used for determining the FCB2 strain's invasion phenotype. The P. falciparum FCB2 genome sequence was analysed, bearing in mind that prolonged in vitro parasite culture may affect its genome sequence and, in some cases, lead to the deletion of certain genes; it was demonstrated that all erythrocyte invasion ligand gene sequences studied here were preserved. Comparative analysis showed that the target genome sequences were conserved whereas transcriptional analysis highlighted Pfebas and Pfrhs gene expression. Erythrocyte invasion analysis demonstrated that the FCB2 strain has a sialic acid-resistant invasion phenotype.

01 Apr 2024·Vaccine

A phase IIa, randomized, double-blind, safety, immunogenicity and efficacy trial of Plasmodium falciparum vaccine antigens merozoite surface protein 1 and RTS,S formulated with AS02 adjuvant in healthy, malaria-naïve adults

Article

Author: Kester, K E ; Angov, E ; Ockenhouse, C F ; Coyne, P ; Wortmann, G ; Holland, C A ; Polhemus, M E ; Nielsen, R K ; Krzych, U ; Gasser, R A ; Schaecher, K ; Soisson, L A ; Cummings, J F ; Heppner, D G ; Tornieporth, N

BACKGROUNDTo improve the efficacy of Plasmodium falciparum malaria vaccine RTS,S/AS02, we conducted a study in 2001 in healthy, malaria-naïve adults administered RTS,S/AS02 in combination with FMP1, a recombinant merozoite surface-protein-1, C-terminal 42kD fragment.METHODSA double-blind Phase I/IIa study randomized N = 60 subjects 1:1:1:1 to one of four groups, N = 15/group, to evaluate safety, immunogenicity, and efficacy of intra-deltoid half-doses of RTS,S/AS02 and FMP1/AS02 administered in the contralateral (RTS,S + FMP1-separate) or same (RTS,S + FMP1-same) sites, or FMP1/AS02 alone (FMP1-alone), or RTS,S/AS02 alone (RTS,S-alone) on a 0-, 1-, 3-month schedule. Subjects receiving three doses of vaccine and non-immunized controls (N = 11) were infected with homologous P. falciparum 3D7 sporozoites by Controlled Human Malaria Infection (CHMI).RESULTSSubjects in all vaccination groups experienced mostly mild or moderate local and general adverse events that resolved within eight days. Anti-circumsporozoite antibody levels were lower when FMP1 and RTS,S were co-administered at the same site (35.0 µg/mL: 95 % CI 20.3-63), versus separate arms (57.4 µg/mL: 95 % CI 32.3-102) or RTS,S alone (62.0 µg/mL: 95 % CI: 37.8-101.8). RTS,S-specific lymphoproliferative responses and ex vivo ELISpot CSP-specific interferon-gamma (IFN-γ) responses were indistinguishable among groups receiving RTS,S/AS02. There was no difference in antibody to FMP1 among groups receiving FMP1/AS02. After CHMI, groups immunized with a RTS,S-containing regimen had ∼ 30 % sterile protection against parasitemia, and equivalent delays in time-to-parasitemia. The FMP1/AS02 alone group showed no sterile immunity or delay in parasitemia.CONCLUSIONCo-administration of RTS,S and FMP1/AS02 reduced anti-RTS,S antibody, but did not affect tolerability, cellular immunity, or efficacy in a stringent CHMI model. Absence of efficacy or delay of patency in the sporozoite challenge model in the FMP1/AS02 group did not rule out efficacy of FMP1/AS02 in an endemic population. However, a Phase IIb trial of FMP1/AS02 in children in malaria-endemic Kenya did not demonstrate efficacy against natural infection.CLINICALTRIALSgov identifier: NCT01556945.

01 Oct 2023·Med

Superior antibody immunogenicity of a viral-vectored RH5 blood-stage malaria vaccine in Tanzanian infants as compared to adults

Article

Author: Payne, Ruth O ; Lawrie, Alison M ; Kalinga, Wilmina F ; Long, Carole A ; Nielsen, Carolyn M ; Lweno, Omary ; Mwalimu, Bakari ; Themistocleous, Yrene ; Lilolime, Nasoro S ; Milando, Florence ; Hodgson, Susanne H ; Mswata, Sarah ; Minassian, Angela M ; Mpina, Maximillian ; Silk, Sarah E ; Mkwepu, Fatuma ; Ahmed, Saumu ; King, Lloyd D W ; Mwamlima, Tunu G ; Mohammed, Latipha ; Miura, Kazutoyo ; Simon, Beatus ; Ali, Ali M ; Cho, Jee-Sun ; Nugent, Fay L ; Olotu, Ally I ; Mtaka, Ivanny M ; Barrett, Jordan R ; Draper, Simon J ; Wang, Lawrence T ; Nyaulingo, Gloria ; Diouf, Ababacar ; Athumani, Thabit ; Rashid, Mohammed

BACKGROUNDRH5 is a leading blood-stage candidate antigen for a Plasmodium falciparum vaccine; however, its safety and immunogenicity in malaria-endemic populations are unknown.METHODSA phase 1b, single-center, dose-escalation, age-de-escalation, double-blind, randomized, controlled trial was conducted in Bagamoyo, Tanzania (NCT03435874). Between 12^th April and 25^th October 2018, 63 healthy adults (18-35 years), young children (1-6 years), and infants (6-11 months) received a priming dose of viral-vectored ChAd63 RH5 or rabies control vaccine. Sixty participants were boosted with modified vaccinia virus Ankara (MVA) RH5 or rabies control vaccine 8 weeks later and completed 6 months of follow-up post priming. Primary outcomes were the number of solicited and unsolicited adverse events post vaccination and the number of serious adverse events over the study period. Secondary outcomes included measures of the anti-RH5 immune response.FINDINGSVaccinations were well tolerated, with profiles comparable across groups. No serious adverse events were reported. Vaccination induced RH5-specific cellular and humoral responses. Higher anti-RH5 serum immunoglobulin G (IgG) responses were observed post boost in young children and infants compared to adults. Vaccine-induced antibodies showed growth inhibition activity (GIA) in vitro against P. falciparum blood-stage parasites; their highest levels were observed in infants.CONCLUSIONSThe ChAd63-MVA RH5 vaccine shows acceptable safety and reactogenicity and encouraging immunogenicity in children and infants residing in a malaria-endemic area. The levels of functional GIA observed in RH5-vaccinated infants are the highest reported to date following human vaccination. These data support onward clinical development of RH5-based blood-stage vaccines to protect against clinical malaria in young African infants.FUNDINGMedical Research Council, London, UK.

News (Medical) associated with Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)

22 Jun 2023

·www.prnewswire.com

Global Cancer Vaccine Partnering Terms and Agreements Analysis Report/Directory 2023: Access Over 350 Cancer Vaccine Deals - Disclosed Headlines, Upfronts, Milestones and Royalties

DUBLIN, June 22, 2023 /PRNewswire/ -- The "Global Cancer Vaccine Partnering Terms and Agreements 2010-2023" report has been added to ResearchAndMarkets.com's offering. The Global Cancer Vaccine Partnering Terms and Agreements 2010-2023 report provides comprehensive access to available deals and contract documents for over 350 cancer vaccine deals. Trends in cancer vaccine partnering deals Disclosed headlines, upfronts, milestones and royalties by stage of development Cancer vaccine partnering contract documents Top cancer vaccine deals by value This report provides details of the latest cancer vaccine agreements announced in the life sciences since 2010. The report takes the reader through a comprehensive review cancer vaccine deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering cancer vaccine partnering deals. The report presents financial deal term values for cancer vaccine deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals. The middle section of the report explores the leading dealmakers in the cancer vaccine partnering field; both the leading deal values and most active cancer vaccine dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market. One of the key highlights of the report is that over 350 online deal records of actual cancer vaccine deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal. In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. The initial chapters of this report provide an orientation of cancer vaccine dealmaking. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in cancer vaccine dealmaking since 2010, including details of headline, upfront, milestone and royalty terms. Chapter 3 provides a review of the leading cancer vaccine deals since 2010. Deals are listed by headline value. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 4 provides a comprehensive listing of the top 25 most active companies in cancer vaccine dealmaking with a brief summary followed by a comprehensive listing of cancer vaccine deals announced by that company, as well as contract documents, where available. Chapter 5 provides a comprehensive and detailed review of cancer vaccine partnering deals signed and announced since Jan 2010, where a contract document is available in the public domain. Each deal title links via Weblink to an online version of the deal record and contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive and detailed review of cancer vaccine partnering deals signed and announced since Jan 2010. The chapter is organized by specific cancer vaccine technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand. A comprehensive series of appendices is provided organized by cancer vaccine partnering company A-Z, stage of development, deal type, and therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand. The report also includes numerous tables and figures that illustrate the trends and activities in cancer vaccine partnering and dealmaking since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of cancer vaccine technologies and products. Key benefits In-depth understanding of cancer vaccine deal trends since 2010 Access to headline, upfront, milestone and royalty data Detailed access to actual cancer vaccine contracts entered into by leading biopharma companies Identify most active cancer vaccine dealmakers since 2010 Insight into terms included in a cancer vaccine partnering agreement, with real world examples Understand the key deal terms companies have agreed in previous deals Undertake due diligence to assess suitability of your proposed deal terms for partner companies In Global Cancer Vaccine Partnering Terms and Agreements 2010-2023, the available deals are listed by: Company A-Z Headline value Stage of development at signing Deal component type Specific therapy target Technology type Analyzing actual contract agreements allows assessment of the following: What are the precise rights granted or optioned? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sale sand payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Companies Mentioned 2A 3D Medicines A*STAR Bioprocessing Technology Institute Aura Biosciences Averion AV Therapeutics Beth Israel Deaconess Medical Center BGI CureLab Oncology CureVac Cyplasin Biomedical CYTLIMIC Daiichi Sankyo Dainippon Sumitomo Pharma Dalton Pharma Services Exiqon ExpreS2ion Biotechnologies Federal Ministry of Education and Research (BMBF) Flaskworks Georgia Health Sciences University GeoVax German Cancer Research Center Hookipa Pharma Human Vaccines Project iBio Icahn School of Medicine at Mount Sinai Ichor Medical Systems Leukaemia & Lymphoma Research LG Life Sciences Ligand Pharmaceuticals Massachusetts Life Sciences Center Mayo Clinic National Research Council Canada National Surgical Adjuvant Breast and Bowel Project OncoQR OncoSec Medical Oncotherapy Science PsiOxus Therapeutics Pulmotec PX Biosolutions Qiagen Radboud University Nijmegen Medical Centre Selecta Biosciences Selexis Sellas Clinicals Holding Seres Therapeutics Telormedix Teva Pharmaceutical Industries VGX International Vinnova ViroMed Vivalis VLP Therapeutics VLST Corporation Y-mAbs Therapeutics Yale University Yamaguchi University For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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100 Deals associated with Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)

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Indication	Highest Phase	Country/Location	Organization	Date
Malaria, Falciparum	Phase 1	CH	Swiss Tropical & Public Health Institute	-
Malaria, Falciparum	Phase 1	CH	Telormedix SA	-

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