CoVac-1 / University Hospital Tuebingen - LARVOL DELTA

B-pVAC-SARS-CoV-2: Study to Prevent COVID-19 Infection in Adults With Bcell/ Antibody Deficiency (clinicaltrials.gov) - P1/2 | N=54 | Completed | Sponsor: University Hospital Tuebingen | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • BCL2 • IFNG

Development of a peptide-based vaccine for the induction of SARS-CoV-2-specific T cells in cancer patients with disease- or treatment-induced antibody deficiency (DGHO 2021) - P1 | "This favorable safety and efficacy profile indicates CoVac-1 as a promising vaccine candidate for the induction of broad T cell immunity in patients with antibody deficiency and will be evaluated in an upcoming study in this high-risk population (B-pVAC-SARS-CoV -2, EudraCT No. 2021-001070-38)."

Clinical • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Novel Coronavirus Disease • Oncology • Respiratory Diseases • CD8

[VIRTUAL] A peptide-based vaccine to induce SARS-CoV-2-specific T cells in cancer patients with disease- or treatment-induced antibody deficiency (CIMT 2021) - P1 | "Thus, CoVac-1 represents a promising vaccine candidate for the induction of broad T cell immunity in the high-risk population of patients with antibody deficiency, which will be evaluated in an upcoming study (B-pVAC-SARS-CoV-2, EudraCT- Nr. 2021-001070-38)."

Clinical • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Novel Coronavirus Disease • Oncology • Respiratory Diseases • CD8

B-pVAC-SARS-CoV-2: Study to Prevent COVID-19 Infection in Adults With Bcell/ Antibody Deficiency (clinicaltrials.gov) - P1/2 | N=54 | Active, not recruiting | Sponsor: University Hospital Tuebingen | Trial completion date: Aug 2022 ➔ Apr 2023 | Trial primary completion date: Mar 2022 ➔ Aug 2022

Trial completion date • Trial primary completion date • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • BCL2 • IFNG

"新型コロナウイルスに対する新たなワクチンであるCoVac-1は、多くの白血病やリンパ腫患者などのB細胞欠損患者の93％で、T細胞性免疫応答を誘導したことが、4月に開催された #aacr22 で発表された。 https://t.co/X3b7KwfRiI #リンパ腫　#白血病" (@cancer_ref)

Oncology

Safety and immunogenicity of a self-amplifying RNA vaccine against COVID-19: COVAC1, a phase I, dose-ranging trial. (PubMed, EClinicalMedicine) - "A phase I first-in-human dose-ranging trial of a saRNA COVID-19 vaccine candidate LNP-nCoVsaRNA, was conducted at Imperial Clinical Research Facility, and participating centres in London, UK, between 19 June to 28 October 2020. Participants received two intramuscular (IM) injections of LNP-nCoVsaRNA at six different dose levels, 0.1-10.0μg, given four weeks apart. Modifications to optimise humoral responses are required to realise its potential as an effective vaccine against SARS-CoV-2. This study was co-funded by grants and gifts from the Medical Research Council UKRI (MC_PC_19076), and the National Institute Health Research/Vaccine Task Force, Partners of Citadel and Citadel Securities, Sir Joseph Hotung Charitable Settlement, Jon Moulton Charity Trust, Pierre Andurand, Restore the Earth."

Clinical • Journal • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

B-pVAC-SARS-CoV-2: Study to Prevent COVID-19 Infection in Adults With Bcell/ Antibody Deficiency (clinicaltrials.gov) - P1/2; N=54; Active, not recruiting; Sponsor: University Hospital Tuebingen; Recruiting ➔ Active, not recruiting; Trial completion date: Mar 2022 ➔ Aug 2022

Clinical • Enrollment closed • Trial completion date • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • BCL2 • IFNG

A Clinical Trial of COVAC-1 in Generally Healthy Adults (clinicaltrials.gov) - P1; N=48; Not yet recruiting; Sponsor: University of Saskatchewan

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A COVID-19 peptide vaccine for the induction of SARS-CoV-2 T cell immunity. (PubMed, Nature) - "Furthermore, vaccine-induced T- cell responses were unaffected by current SARS-CoV-2 variants of concern (VOC). Together, CoVac-1 showed a favourable safety profile and induced broad, potent and VOC-independent T- cell responses, supporting the presently ongoing evaluation in a phase II trial for patients with B cell/antibody deficiency."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8 • IFNG

B-pVAC-SARS-CoV-2: Study to Prevent COVID-19 Infection in Adults With Bcell/ Antibody Deficiency (clinicaltrials.gov) - P1/2; N=68; Recruiting; Sponsor: University Hospital Tuebingen

Clinical • New P1/2 trial • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • BCL2 • IFNG

pVAC: Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: University Hospital Tuebingen

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease