ObjectiveTo investigate the association of plasma cartilage acidic protein 1 (CRTAC1), a novel biochemical marker of osteoarthritis (OA), and total joint replacement (TJR) in postmenopausal women.MethodsThe association of plasma CRTAC1 with the incidence of TJR was investigated in a prospective cohort including 478 postmenopausal women. A total of 38 women underwent a TJR for OA during a median follow-up of 18 years. Every one of the TJR cases were age- and BMI (kg/m2)-matched with 2 controls with no TJR from the same cohort. Plasma CRTAC1 was measured before TJR. The association between CRTAC1 and TJR incidence was investigated by conditional logistic regression.ResultsIncreased CRTAC1 was associated with a higher risk of TJR with an odds ratio (OR) of 1.80 (95% CI 1.11-2.92) for 1 SD increase, which remained significant after adjusting for Western Ontario and McMaster Universities Osteoarthritis Index, knee OA baseline severity (Kellgren-Lawrence grade), hip OA, and hip bone mineral density. Urinary crosslinked C-telopeptide of type II collagen (CTX-II) was also associated with a higher risk of TJR with an adjusted OR of 1.83 (95% CI 1.11-3.00). When CRTAC1 and CTX-II were included in the same model, both markers were significantly associated with TJR with similar ORs.ConclusionCRTAC1 is a new risk indicator of TJR for OA in postmenopausal women. Combined with knee and hip OA and CTX-II, it may help to identify subjects at risk for TJR.

01 Feb 2024·International Journal of Infectious Diseases

Long-term efficacy of the peptide-based COVID-19 T cell activator CoVac-1 in healthy adults

Article

Author: Jaeger, Simon U ; Tegeler, Christian M ; Oezbek, Melek Tutku ; Schroeder, Sarah M ; Heitmann, Jonas S ; Denk, Monika ; Fischer, Imma ; Bitzer, Michael ; Michel, Tanja M ; Marconato, Maddalena ; Schindler, Michael ; Salih, Helmut R ; Richter, Marion ; Meisner, Christoph ; Ruetalo, Natalia ; Rammensee, Hans-Georg ; Maringer, Yacine ; Schneiderhan-Marra, Nicole ; Walz, Juliane S ; Tandler, Claudia ; Wiesmüller, Karl-Heinz

OBJECTIVEST cell immunity is key for the control of viral infections including SARS-CoV-2, in particular with regard to immune memory and protection against arising genetic variants.METHODSWe recently evaluated a peptide-based SARS-CoV-2 T cell activator termed CoVac-1 in a first-in-human trial in healthy adults. Here, we report on long-term safety and efficacy data of CoVac-1 until month 12.RESULTSCoVac-1 is well tolerated without long-term immune-related side effects and induces long-lasting anti-viral T cell responses in 100% of study participants, with potent expandability of clusters of differentiation (CD4⁺) and CD8⁺ T cells targeting multiple different CoVac-1 T cell epitopes. T cell responses were associated with stronger injection site reaction. Beyond induction of T cell immunity, 89% of subjects developed CoVac-1-specific immunoglobulin G antibodies which associated with the intensity of the T cell response, indicating that CoVac-1-specific CD4⁺ T cells support the induction of B-cell responses. Vaccination with approved COVID-19 vaccines boosted CoVac-1-specific T cell responses. Overall, a low SARS-CoV-2 infection rate (8.3%) was observed.CONCLUSIONTogether, a single application of CoVac-1 elicits long-lived and broad SARS-CoV-2-specific T cell immunity, which further supports the current evaluation of our T cell activator in patients with congenital or acquired B-cell defects.

01 Nov 2023·Vaccine

Immunogenicity and reactogenicity of a first booster with BNT162b2 or full-dose mRNA-1273: A randomised VACCELERATE trial in adults ≥75 years (EU-COVAT-1)

Article

Author: Mallon, Patrick ; Carcas, Antonio J ; Stemler, Jannik ; Cüppers, Arnd ; Posch, Martin ; Gaillard, Colette ; Hotterbeekx, An ; Heringer, Sarah ; Lammens, Christine ; Zarrouk, Marouan ; Cornely, Oliver A ; Tischmann, Lea ; Malhotra-Kumar, Surbhi ; König, Franz ; Neuhann, Julia M ; Negi, Riya ; Bethe, Ullrich ; Goossens, Herman ; Frías-Iniesta, Jesús ; Kumar-Singh, Samir ; Koehler, Philipp ; Yeghiazaryan, Lusine ; Akova, Murat ; Saini, Gurvin ; Leon, Alejandro Garcia ; Loens, Katherine ; Salmanton-García, Jon ; Grothe, Jan

BACKGROUNDVaccination remains crucial for protection against severe SARS-CoV-2 infection, especially for people of advanced age, however, optimal dosing regimens are as yet lacking.METHODSEU-COVAT-1-AGED Part A is a randomised controlled, adaptive, multicentre phase II trial evaluating safety and immunogenicity of a 3rd vaccination (1st booster) in individuals ≥75 years. Fifty-three participants were randomised to full-doses of either mRNA-1273 (Spikevax®, 100 µg) or BNT162b2 (Comirnaty®, 30 µg). The primary endpoint was the rate of 2-fold circulating antibody titre increase 14 days post-vaccination measured by quantitative electrochemiluminescence (ECL) immunoassay, targeting RBD region of Wuhan wild-type SARS-CoV-2. Secondary endpoints included the changes in neutralising capacity against wild-type and 25 variants of concern at 14 days and up to 12 months. Safety was assessed by monitoring of solicited adverse events (AEs) for seven days after on-study vaccination. Unsolicited AEs were collected until the end of follow-up at 12 months, SAEs were pursued for a further 30 days.RESULTSBetween 08th of November 2021 and 04th of January 2022, 53 participants ≥75 years received a COVID-19 vaccine as 1st booster. Fifty subjects (BNT162b2 n = 25/mRNA-1273 n = 25) were included in the analyses for immunogenicity at day 14. The primary endpoint of a 2-fold anti-RBD IgG titre increase 14 days after vaccination was reached for all subjects. A 3rd vaccination of full-dose mRNA-1273 provided higher anti-RBD IgG titres (Geometric mean titre) D14 mRNA-127310711 IU/mL (95 %-CI: 8003;14336) vs. BNT162b2: 7090 IU/mL (95 %-CI: 5688;8837). We detected a pattern showing higher neutralising capacity of full-dose mRNA-1273 against wild-type as well as for 23 out of 25 tested variants.INTERPRETATIONThird doses of either BNT162b2 or mRNA-1273 provide substantial circulating antibody increase 14 days after vaccination. Full-dose mRNA-1273 provides higher antibody levels with an overall similar safety profile for people ≥75 years.FUNDINGThis trial was funded by the European Commission (Framework Program HORIZON 2020).

100 Deals associated with CoVac-1

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	DE	Universitaetsklinikum Tuebingen	18 Jan 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2011	Not Applicable	Prostatic Cancer	-	ICA-1	jqvzipcqoq(rbyyxsiyme) = kmuyievurm osrlxqzgyh (lquzoubmcv )	-	15 Apr 2011

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