A phase 3, randomised, observer-blinded, placebo controlled-trial evaluating the safety and immunogenicity of investigational SARS-CoV-2 mRNA vaccine CVnCoV in adult healthcare workers in Mainz (Germany).

Autor:	Kowalzik F; Children's Hospital, University Medical Center of the Johannes Gutenberg-Universität Mainz, Langenbeckstr. 1, D-55131, Mainz, Germany., Teschner D; Department of Hematology, and Medical Oncology, University Medical Center of the Johannes Gutenberg-Universität Mainz, Langenbeckstr. 1, D-55131, Mainz, Germany.; Department of Internal Medicine II, University Hospital Würzburg, Oberdürrbacher Straße 6, D-97080, Würzburg, Germany., Mesquita M; CureVac SE, Tübingen, Germany., Jensen C; Children's Hospital, University Medical Center of the Johannes Gutenberg-Universität Mainz, Langenbeckstr. 1, D-55131, Mainz, Germany., Schreiner D; Children's Hospital, University Medical Center of the Johannes Gutenberg-Universität Mainz, Langenbeckstr. 1, D-55131, Mainz, Germany., Kronfeld K; Interdisciplinary Center for Clinical Trials (IZKS), University Medical Center of the Johannes Gutenberg-Universität Mainz, Langenbeckstr. 1, D-55131, Mainz, Germany., Tubic-Grozdanis M; Pharmacy Department, University Medical Center of the Johannes Gutenberg-Universität Mainz, Langenbeckstr. 1, D-55131, Mainz, Germany., Cheatham-Seitz D; CureVac SE, Tübingen, Germany., Hettich F; CureVac SE, Tübingen, Germany., Quintini G; CureVac SE, Tübingen, Germany., Schoenborn-Kellenberger O; CureVac SE, Tübingen, Germany., Codó P; CureVac SE, Tübingen, Germany., von Eisenhart-Rothe P; CureVac SE, Tübingen, Germany., Mann P; CureVac SE, Tübingen, Germany., Oostvogels L; CureVac SE, Tübingen, Germany., Gehring S; Children's Hospital, University Medical Center of the Johannes Gutenberg-Universität Mainz, Langenbeckstr. 1, D-55131, Mainz, Germany.
Jazyk:	angličtina
Zdroj:	Vaccine: X [Vaccine X] 2024 Jun 20; Vol. 19, pp. 100512. Date of Electronic Publication: 2024 Jun 20 (Print Publication: 2024).
DOI:	10.1016/j.jvacx.2024.100512
Abstrakt:	Background: CV-NCOV-005 was conducted to generate additional safety and immunogenicity data for the former CVnCoV SARS-CoV-2 mRNA vaccine candidate in healthcare workers (HCW). Methods: Randomised, observer blinded, placebo-controlled, phase 3 trial performed at the University Medical Center Mainz, Germany. HCWs aged ≥18 years with no history of SARS-CoV-2 infection/positive serology were randomly assigned to receive two doses of CVnCoV, or two doses of placebo (0.9% NaCl). The primary objectives were to expand the safety database of CVnCoV and assess antibody responses against SARS-CoV-2. Primary safety and reactogenicity outcomes included solicited adverse events (AEs) within 7 days after each dose and unsolicited AEs within 28 days after each dose, with safety follow-up for 13 months after first vaccination. Since HCWs became eligible to receive an authorised vaccine during enrolment and efficacy results from HERALD CVnCoV trial were made available on 30 th of June 2021, this study was unblinded and converted to an open label design. Results: Most participants in the CVnCoV group reported at least one solicited AE, a relatively high number being Grade 3 (43.3% in CVnCoV group and 6.4% in placebo group). Most AEs were short in duration and did not affect vaccine compliance. The percentage of participants with unsolicited AEs up to 28 days after any dose was slightly higher in CVnCoV group (37.0%) compared with placebo group (31.2%). IgG binding antibodies against the receptor binding domain of the SARS-CoV-2 spike protein were observed after vaccination, with higher seroconversion rates and antibody levels after the second dose. Conclusion: No safety concerns for CVnCoV were identified up to 1 year post second dose. IgG responses against SARS-CoV-2 were observed after two doses, with a higher seroconversion rate and antibody levels observed after second vaccination.Study registration: ClinicalTrials.gov NCT04674189, study period: 23 rd of December 2020 to 8 th of June 2022. Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Philipp Mann reports a relationship with CureVac SE that includes: equity or stocks. Lidia Oostvogels reports a relationship with CureVac SE that includes: employment and equity or stocks. Frank Kowalzik reports a relationship with CureVac SE that includes: funding grants. Gianluca Quintini reports a relationship with CureVac SE that includes: employment and equity or stocks. Margarida Mesquita reports a relationship with CureVac SE that includes: employment and equity or stocks. Oliver Schoenborn-Kellenberger reports a relationship with CureVac SE that includes: consulting or advisory. Paula Codo reports a relationship with CureVac SE that includes: equity or stocks. Philipp von Eisenhart-Rothe reports a relationship with CureVac SE that includes: employment, equity or stocks, and funding grants. Daniel Teschner reports a relationship with CureVac SE that includes: funding grants. Daniel Teschner reports a relationship with ACI that includes: consulting or advisory. Daniel Teschner reports a relationship with BioNTech that includes: consulting or advisory. Daniel Teschner reports a relationship with Gilead that includes: consulting or advisory. Daniel Teschner reports a relationship with iQone that includes: consulting or advisory. Daniel Teschner reports a relationship with MSD that includes: consulting or advisory. Daniel Teschner reports a relationship with Octapharma that includes: consulting or advisory. Daniel Teschner reports a relationship with Pfizer that includes: consulting or advisory. Daniel Teschner reports a relationship with Shire that includes: consulting or advisory. Daniel Teschner reports a relationship with Takeda that includes: consulting or advisory. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2024 The Author(s).)
Databáze:	MEDLINE
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