Last update 23 Nov 2024
Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)
Last update 23 Nov 2024
Overview
Basic Info
Drug Type Prophylactic vaccine |
Synonyms Falciparum malaria vaccine, TMX 201 adjuvantbased Malaria vaccine Swiss TPH Institute/Telormedix |
Target |
Mechanism TLR7 modulators(Toll like receptor 7 modulators), Immunostimulants |
Therapeutic Areas |
Active Indication- |
Inactive Indication |
Originator Organization |
Active Organization- |
Inactive Organization |
Drug Highest PhasePendingPhase 1 |
First Approval Date- |
Regulation- |
Login to view timeline
Related
1
Clinical Trials associated with Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)A Randomized Placebo-Controlled Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Synthetic Peptides in Healthy Adult Volunteers
100 Clinical Results associated with Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)
Login to view more data
100 Translational Medicine associated with Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)
Login to view more data
100 Patents (Medical) associated with Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)
Login to view more data
62
Literatures (Medical) associated with Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)01 Dec 2024ACTA TROPICA
Characterisation of the erythrocyte invasion phenotype of FCB-2: A South American P. falciparum reference strain
Article
Author: Patarroyo, Manuel Alfonso ; Curtidor, Hernando ; Ararat-Sarria, Monica
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 2024Vaccine
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: Cummings, J F ; Wortmann, G ; Angov, E ; Kester, K E ; Holland, C A ; Tornieporth, N ; Soisson, L A ; Coyne, P ; Krzych, U ; Schaecher, K ; Ockenhouse, C F ; Polhemus, M E ; Heppner, D G ; Nielsen, R K ; Gasser, R A
BACKGROUND:
To 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.
METHODS:
A 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).
RESULTS:
Subjects 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.
CONCLUSION:
Co-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.
CLINICALTRIALS:
gov identifier: NCT01556945.
01 Oct 2023Med (New York, N.Y.)
Superior antibody immunogenicity of a viral-vectored RH5 blood-stage malaria vaccine in Tanzanian infants as compared to adults
Article
Author: Miura, Kazutoyo ; King, Lloyd D W ; Cho, Jee-Sun ; Nielsen, Carolyn M ; Draper, Simon J ; Milando, Florence ; Diouf, Ababacar ; Lawrie, Alison M ; Hodgson, Susanne H ; Mwamlima, Tunu G ; Nyaulingo, Gloria ; Mswata, Sarah ; Barrett, Jordan R ; Mtaka, Ivanny M ; Lilolime, Nasoro S ; Mwalimu, Bakari ; Athumani, Thabit ; Minassian, Angela M ; Themistocleous, Yrene ; Mohammed, Latipha ; Rashid, Mohammed ; Silk, Sarah E ; Payne, Ruth O ; Kalinga, Wilmina F ; Lweno, Omary ; Ali, Ali M ; Mpina, Maximillian ; Mkwepu, Fatuma ; Ahmed, Saumu ; Olotu, Ally I ; Long, Carole A ; Nugent, Fay L ; Simon, Beatus ; Wang, Lawrence T
BACKGROUND:
RH5 is a leading blood-stage candidate antigen for a Plasmodium falciparum vaccine; however, its safety and immunogenicity in malaria-endemic populations are unknown.
METHODS:
A phase 1b, single-center, dose-escalation, age-de-escalation, double-blind, randomized, controlled trial was conducted in Bagamoyo, Tanzania (NCT03435874). Between 12th April and 25th 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.
FINDINGS:
Vaccinations 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.
CONCLUSIONS:
The 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.
FUNDING:
Medical Research Council, London, UK.
1
News (Medical) associated with Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)100 Deals associated with Falciparum malaria vaccine (Swiss TPH Institute/Telormedix)
Login to view more data
R&D Status
10 top R&D records. to view more data
Login
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Malaria, Falciparum | Phase 1 | CH | - | |
| Malaria, Falciparum | Phase 1 | CH | - |
Login to view more data
Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Login to view more data
Translational Medicine
Boost your research with our translational medicine data.
login
or
Deal
Boost your decision using our deal data.
login
or
Core Patent
Boost your research with our Core Patent data.
login
or
Clinical Trial
Identify the latest clinical trials across global registries.
login
or
Approval
Accelerate your research with the latest regulatory approval information.
login
or
Regulation
Understand key drug designations in just a few clicks with Synapse.
login
or
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
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
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free