Impfstoffentwicklung
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Der Fokus der Forschungsgruppe ist die Erforschung neuer Impfstoffe und neuer Impfstoffprinzipien: Insbesondere widmet sie sich der Entwicklung von Messenger-RNA-Impfstoffen (mRNA) in einer langjährigen Kooperation mit der Firma CureVac.
Das Tropeninstitut führt regelmäßig Impfstoffstudien durch, zum Beispiel im Bereich COVID-19, Dengue oder Tollwut.
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LeitungDr. med. Mirjam SchunkFunktionsoberärztin, stellv. AmbulanzleitungStudienkoordinationKaroline LöffelStudy CoordinatorMarieluise MolnarStudy nurseManuela ZwerenzStudy CoordinatorÄrztliches TeamDr. med. Kristina HuberFachärztin für Allgemeinmedizin, DTM&H+49 (0)89 4400-59894ÜplcbSlug ZfjinpvimefulhvfiuyziJusmiYuka Nadai-GeldmacherAssistenzärztinØfogeTgmglxiämvgyzipvim-fulhvfiuyziJu miDr. med. Rahel SpindlerFachärztin für Innere Medizin, Ambulanzärztin+49 (0)89 4400-59850Dr. med. Andreas ZederFacharzt für Innere MedizinStudienteamSophia FerschMTLA, Study Nurse+49 (0)89 4400-59850cüözlgs,wipcyzvim fulhvfiuyziu-miDr. rer. nat. Otto GeisenbergerUnit Head Project ManagementPD Dr. rer. nat. Christof GeldmacherUnit Head - Forschungsgruppe "Infection and Immunity"Dr. rer. nat. Kathrin HeldUnit Head - Forschungsgruppe "Infection and Immunity"Dr. rer. nat. Susanne VejdaLeitung QualitätsmanagementClaudia Bräu-HebergerCTA, ForschungSabine RappeMTLA, ForschungAngelika ThomschkeCTAFuxiälog Kzüvcyzoivinmeful_vfiuyziuemni
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Laufende Studien
- Hepatitis B-Impfstudie: TherVacB_Phase1a: Open Phase 1a Trial to Assess the Safety and Immunogenicity of a Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate in Healthy Volunteers
- Corona-Impfstudie: D1701-VrV-101 (2021-005219-30): A Phase 1, Dose Ranging Study Assessing the Safety, Tolerability, Immunogenicity of Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV-2 Spike and Nucleocapsid Glycoproteins.
- Dengue-Impfstudie: V181-003 (2020-004501-30): A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Three Different Potency Levels of V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [live, attenuated]) in Healthy Adults.
- Gelbfieber-Impfstudie (Rekrutierung abgeschlossen): VYF03 (2020-005566-33): Phase 2, controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to Stamaril® in Adults.
Abgeschlossene Studien
- CV-NCOV-004 (2020-003998-22): Phase 2b/3, randomized, observer-blinded, placebo-controlled, multicenter clinical study evaluating the efficacy and safety of investigational SARS-CoV-2 mRNA vaccine CVnCoV in adults 18 years and older.
- CV-NCOV-001 (2020-001286-36): Phase 1/2a, partially blind, placebo-controlled, dose-escalation, first-inhuman, clinical trial to evaluate the safety, reactogenicity and immunogenicityafter 1 and 2 doses of the investigational SARS-CoV-2 mRNA vaccine CVnCoV. administered intramuscularly in healthy adults.
- CV-7202-104 (2017-002856-10): a non-randomized, open label, controlled, dose-escalation, phase I clinical trial to evaluate the safety, reactogenicity and immunogenicity of one or two administrations of candidate rabies mRNA vaccine CV7202 in healthy adult subjects.
- CV-7201-102 (2013-00217117): Phase I Safety and Immunogenicity Trial of an investigational RNActive® Rabies Vaccine (CV7201).
- Rabi_JE V49_23E1 (2015-000382-31): open label, multicenter study to evaluate long-term immunogenicity and boosterability of immune responses in adults who received different primary vaccination regimens of pre-exposure prophylaxis.
- Rabi_JE V49_23(2011-005173-23): a multicenter, observer blind, phase III study on the safety and immunogenicity of a rabies vaccine and Japanese encephalitis vaccine, applied simultaneously or single in different time intervals.
- MenHep V59_38(2011-000475-14): a randomized, unblinded, phase III b study on the safety and immunogenicity of a conjugate meningococcal ACWY vaccine applied simultaneously with different travel medicine relevant vaccines.
- MenHep V59_53 (2011-001333-17): a randomized, unblinded, phase III b study on the safety and immunogenicity of a Hep A/B vaccine applied simultaneously with a conjugate meningococcal ACWY vaccine.
- H1N1 V111_02 (2009-013671-21): A Randomized, Single-blind, Dose-Ranging, Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and Non Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects 18 or More Years of Age.
- H1N1 V110_03 (2008-003871-32): a single-blind, randomized, dose-finding study on the immunogenicity, reactogenicity and safty of different formulations of adjuvant and non adjuvant, cell based, monovalent sub-unit vaccine (influenza /H1N1 of porcine origin).
- ETEC ELT 301 (2008-008726-75): a double-blind, randomized, placebo-controlled phase III study on the immunogenicity and reactogenicity of a novel travel diarrhea vaccine.
- V87P13 (2008-003871-32): a randomized, placebo-controlled, observer blind, phase III multi-center study on the safety, tolerability and immunogenicity of two doses of a monovalent A/H5N1 influenza vaccine adjuvanted with MF59 (FLUAD-H5N1) for adults.
- V101P1 (2007-002712-25): a randomized placebo-controlled, phase III multi-center study on the safety and immunogenicity of a tetravalent influenza vaccine for adults.
- JEIC51-310 (2007-002771-14): a double-blind, randomized, phase III study on the comparison of three different charges of IC51 (JE-PIV) vaccine for Japanese Encephalitis.
- JEIC51-309 (2006-002076-18): a double-blind, randomized, phase III study on the comparison of three different charges of IC51 (JE-PIV) vaccine for Japanese Encephalitis.
- JEIC51-303 (2005-000253-29): a phase III follow-up study on the long-term immunogenicity of IC51 (JE-PIV) for Japanese Encephalitis.
- H5N1-008 & 011 (2006-001281-16): A phase III, observer-blind, randomised study to evaluate the safety and immunogenicity of one and two administrations of pandemic monovalent (H5N1) influenza vaccine.
- JEIC51-302 (2005-000100-14): a phase III, double blind, randomized, placebo controlled study on the safety and immunogenicity of a vaccine for Japanese Encephalitis.
- POX-MVA 007 (NCT 00189917): multicenter phase I study pilot study on the safety and immunogenicity of MVA-BN™ smallpox vaccine.
- HIV-POL-001 (NCT00386633): Phase I study on safety and tolerability of a recombinant MVA vaccine expressing the HIV-1 nef gene (MVA-Nef) administered by three subcutaneous injections to patients with asymptomatic HIV infection.
Boostrix ®- dTpa-019 (263855): multicenter phase III study on the immunogenicity and rectogenicity of a new dTpa-IPV combination vaccine.
TypHA-006 (270362): multicenter phase III study on the immunogenicity and rectogenicity of a typhoid Vi-polysaccharide/Hepatitis A combination vaccine.
HBV-269 (103860): double blind multicenter phase II study on the safety, immunogenicity & reactogenicity of a new hepatitis B vaccine.