Vaccines and clinical preclinical studies
Immunogenicity and safety of monovalent and bivalent SARS-CoV-2 variant adapted RBD-based protein booster vaccines in adults previously immunized with different vaccine platforms: A phase II/III, randomized clinical trial.
Perez Marc G, Coria LM, Ceballos A, Rodriguez JM, Lombardo ME, Bruno L, Páez Córdoba F, Fascetto Cassero CG, Salvatori M, Rios Medrano M, Fulgenzi F, Alzogaray MF, Mykietiuk A, Uriarte IL, Itcovici N, Smith Casabella T, Corral G, Bruno M, Roldán O, Núñez SA, Cahn F, Yerino GA, Bianchi A, Braem V, Christmann A, Corradetti S, Darraidou MC, Di Nunzio L, Estrada T, López Castelo R, Marchionatti C, Pitocco L, Trias Uriarte V, Wood C, Zadoff R, Bues F, Garrido RM, Montomoli E, Manenti A; Laboratorio Pablo Cassará group for ARVAC; Demaría A, Prado L, Pueblas Castro C, Saposnik L, Geffner J, Montes de Oca F, Vega JC, Fló J, Bonvehí P, Cassará J, Pasquevich KA, Cassataro J. Vaccine. 2025. Epub 2025 Apr 3. PMID: 40179522.
Development of bivalent RBD adapted COVID-19 vaccines for broad sarbecovirus immunity.
Bruno LA, Pueblas Castro C, Demaría A, Prado L, Fascetto Cassero CG, Saposnik LM, Páez Córdoba F, Rodriguez JM, Piccini G, Antonelli R, Lapini G, Temperton N, Del Priore SA, Hernando Insua AC, Kaufmann IG, Vega JC, Flo JM, Pasquevich KA, Coria LM, Cassataro J. NPJ Vaccines. 2025 May 29;10(1):108. doi: 10.1038/s41541-025-01156-3. PMID: 40442110. PMCID: PMC12122808.
Efficacy of mucosal vaccination using a protozoan parasite as a vehicle for antigen delivery: IgG and neutralizing response after rectal administration of LeCoVax-2, a candidate vaccine against COVID-19.
Epis S, Varotto-Boccazzi I, Manenti A, Rubolini D, Gabrieli P, Cattaneo GM, Gourlay L, Dapporto F, Monti M, Razzano I, Leonardi M, Iannacone M, Recordati C, Bertola L, Fiorina P, Marvasi L, Montomoli E, Zuccotti G, Bandi C. Pharmacol Res. 2022 Dec;186:106546. doi: 10.1016/j.phrs.2022.106546. Epub 2022 Nov 4. PMID: 36336215.
Adequate immune responses to vaccines after chemotherapy for leukaemia diagnosed in childhood.
Óskarsson Ý, Thors V, Vias RD, Lúðvíksson BR, Brynjólfsson SF, Gianchecchi E, Razzano I, Montomoli E, Gísli Jónsson Ó, Haraldsson Á. Acta Paediatr. 2023 Dec 23. doi: 10.1111/apa.17070. Online ahead of print. PMID: 38140806.
The burden of influenza and the role of influenza vaccination in adults aged 50-64 years: A summary of available evidence.
Marchi S, Fallani E, Salvatore M, Montomoli E, Trombetta CM. Hum Vaccin Immunother. 2023 Aug;19(2):2257048. doi: 10.1080/21645515.2023.2257048. Epub 2023 Oct 1. PMID: 37778401.
GRT-R910: a self-amplifying mRNA SARS-CoV-2 vaccine boosts immunity for ≥6 months in previously-vaccinated older adults.
Palmer CD, Scallan CD, Kraemer Tardif LD, Kachura MA, Rappaport AR, Koralek DO, Uriel A, Gitlin L, Klein J, Davis MJ, Venkatraman H, Hart MG, Jaroslavsky JR, Kounlavouth S, Marrali M, Nganje CN, Bae K, Yan T, Leodones K, Egorova M, Hong SJ, Kuan J, Grappi S, Garbes P, Jooss K, Ustianowski A. Nat Commun. 2023 Jun 6;14(1):3274. doi: 10.1038/s41467-023-39053-9. PMID: 37280238.
A first-in-human trial on the safety and immunogenicity of COVID-eVax, a cellular response-skewed DNA vaccine against COVID-19.
Aurisicchio L, Brambilla N, Cazzaniga ME, Bonfanti P, Milleri S, Ascierto PA, Capici S, Vitalini C, Girolami F, Giacovelli G, Caselli G, Visintin M, Fanti F, Ghirri M, Conforti A, Compagnone M, Lione L, Salvatori E, Pinto E, Muzi A, Marra E, Palombo F, Roscilli G, Manenti A, Montomoli E, Cadossi M, Rovati LC. Mol Ther. 2023 Mar 1;31(3):788-800. doi: 10.1016/j.ymthe.2022.12.017. Epub 2022 Dec 27. PMID: 36575794.
Rectal Administration of Leishmania Cells Elicits a Specific, Th1-Associated IgG2a Response in Mice: New Perspectives for Mucosal Vaccination against Leishmaniasis, after the Repurposing of a Study on an Anti-Viral Vaccine Candidate.
Varotto-Boccazzi I, Epis S, Cattaneo GM, Guerrini N, Manenti A, Rubolini D, Gabrieli P, Otranto D, Zuccotti G, Montomoli E, Bandi C. Trop Med Infect Dis. 2023 Aug 9;8(8):406. doi: 10.3390/tropicalmed8080406. PMID: 37624344.
Brand-specific estimates of influenza vaccine effectiveness for the 2021-2022 season in Europe: results from the DRIVE multi-stakeholder study platform.
Stuurman AL, Carmona A, Biccler J, Descamps A, Levi M, Baum U, Mira-Iglesias A, Bellino S, Hoang U, de Lusignan S, Bonaiuti R, Lina B, Rizzo C, Nohynek H, Díez-Domingo J; DRIVE Study Contributors. Front Public Health. 2023 Jul 20;11:1195409. doi: 10.3389/fpubh.2023.1195409. eCollection 2023. PMID: 37546295.
Memory-like innate response to booster vaccination with MF-59 adjuvanted influenza vaccine in children.
Kazmin D, Clutterbuck EA, Napolitani G, Wilkins AL, Tarlton A, Thompson AJ, Montomoli E, Lapini G, Bihari S, White R, Jones C, Snape MD, Galal U, Yu LM, Rappuoli R, Del Giudice G, Pollard AJ, Pulendran B. NPJ Vaccines. 2023 Jul 13;8(1):100. doi: 10.1038/s41541-023-00702-1. PMID: 37443176.
Leishmania tarentolae: a vaccine platform to target dendritic cells and a surrogate pathogen for next generation vaccine research in leishmaniases and viral infections.
Bandi C, Mendoza-Roldan JA, Otranto D, Alvaro A, Louzada-Flores VN, Pajoro M, Varotto-Boccazzi I, Brilli M, Manenti A, Montomoli E, Zuccotti G, Epis S. Parasit Vectors. 2023 Jan 26;16(1):35. doi: 10.1186/s13071-023-05651-1. PMID: 36703216.
Intranasal administration of a virus-like particles-based vaccine induces neutralizing antibodies against SARS-CoV-2 and variants of concern.
Rothen DA, Krenger PS, Nonic A, Balke I, Vogt AS, Chang X, Manenti A, Vedovi F, Resevica G, Walton SM, Zeltins A, Montomoli E, Vogel M, Bachmann MF, Mohsen MO. Allergy. 2022 Aug;77(8):2446-2458. doi: 10.1111/all.15311. Epub 2022 Apr 15. PMID: 35403221.
Leishmania tarentolae as an Antigen Delivery Platform: Dendritic Cell Maturation after Infection with a Clone Engineered to Express the SARS-CoV-2 Spike Protein.
Varotto-Boccazzi I, Garziano M, Cattaneo GM, Bisaglia B, Gabrieli P, Biasin M, Manenti A, Rubolini D, Clerici M, Montomoli E, Zuccotti GV, Trabattoni D, Epis S, Bandi C. Vaccines (Basel). 2022 May 19;10(5):803. doi: 10.3390/vaccines10050803. PMID: 35632559.
Efficacy and safety of a quadrivalent influenza vaccine in children aged 6-35 months: A global, multiseasonal, controlled, randomized Phase III study.
Esposito S, Nauta J, Lapini G, Montomoli E, van de Witte S. Vaccine. 2022 Mar 18:S0264-410X(22)00263-8. doi: 10.1016/j.vaccine.2022.02.088. PMID: 35315323.
Epidemic Preparedness-Leishmania tarentolae as an Easy-to-Handle Tool to Produce Antigens for Viral Diagnosis: Application to COVID-19.
Varotto-Boccazzi I, Manenti A, Dapporto F, Gourlay LJ, Bisaglia B, Gabrieli P, Forneris F, Faravelli S, Bollati V, Rubolini D, Zuccotti G, Montomoli E, Epis S, Bandi C. Front Microbiol. 2021 Dec 13;12:736530. doi: 10.3389/fmicb.2021.736530. eCollection 2021. PMID: 34966362.
Estimation of Reduction in Influenza Vaccine Effectiveness Due to Egg-Adaptation Changes-Systematic Literature Review and Expert Consensus.
Ortiz de Lejarazu-Leonardo R, Montomoli E, Wojcik R, Christopher S, Mosnier A, Pariani E, Trilla Garcia A, Fickenscher H, Gärtner BC, Jandhyala R, Zambon M, Moore C. Vaccines (Basel). 2021 Oct 29;9(11):1255. doi: 10.3390/vaccines9111255. PMID: 34835186.
Progress on Seasonal and Pandemic Influenza Vaccines.
Trombetta CM, Montomoli E. Vaccines (Basel). 2021 Sep 24;9(10):1068. doi: 10.3390/vaccines9101068. PMID: 34696176.
Immunogenicity and safety of quadrivalent versus trivalent inactivated subunit influenza vaccine in children and adolescents: A phase III randomized study.
Vesikari T, Nauta J, Lapini G, Montomoli E, van de Witte S. Int J Infect Dis. 2020 Mar;92:29-37. doi: 10.1016/j.ijid.2019.12.010. Epub 2019 Dec 12. PMID: 31838217.
A Phase 2/3 double blinded, randomized, placebo-controlled study in healthy adult participants in Vietnam to examine the safety and immunogenicity of an inactivated whole virion, alum adjuvanted, A(H5N1) influenza vaccine (IVACFLU-A/H5N1).
Duong TN, Thiem VD, Anh DD, Cuong NP, Thang TC, Huong VM, Chien VC, Phuong NTL, Montomoli E, Holt R, Scorza FB, Flores J, Tewari T. Vaccine. 2020 Feb 5;38(6):1541-1550. doi: 10.1016/j.vaccine.2019.11.059. Epub 2019 Dec 4. PMID: 31812464.
Safety and immunogenicity of UB-612 heterologous booster in adults primed with mRNA, adenovirus, or inactivated COVID-19 vaccines: a randomized, active-controlled, Phase 3 trial.
Rumyantsev A, Wang L, Wang S, Kemp T, Wriggins A, Burks A, Fisher D, Brokke K, Fix A, Hensley S, Lewis M, Zhu R, Wang K, Shasha C, Piccini G, Manenti A, Montomoli E, DeAntonio R, Saez-Llorens X, Chan M, Alberto E, Lallaine Borra MD, Jaen AM, Heppner G, Palm U, Monath TP. EClinicalMedicine. 2025 Jul 21;86:103349. doi: 10.1016/j.eclinm.2025.103349. PMID: 40727012. PMCID: PMC12301762.
