Safety, Immunogenicity, and Efficacy of Cytomegalovirus Vaccines: A Systematic Review of Randomized Controlled Trials
<b>Background/Objectives:</b> Cytomegalovirus (CMV) is widespread and mostly causes asymptomatic infections in immunocompetent hosts, but it may lead to severe and life-threatening diseases in immunocompromised individuals, such as transplant patients and congenitally infected children,...
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2025-01-01
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| author | Manuela Chiavarini Anita Genga Giorgia Maria Ricciotti Marcello Mario D’Errico Pamela Barbadoro |
| author_facet | Manuela Chiavarini Anita Genga Giorgia Maria Ricciotti Marcello Mario D’Errico Pamela Barbadoro |
| author_sort | Manuela Chiavarini |
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| description | <b>Background/Objectives:</b> Cytomegalovirus (CMV) is widespread and mostly causes asymptomatic infections in immunocompetent hosts, but it may lead to severe and life-threatening diseases in immunocompromised individuals, such as transplant patients and congenitally infected children, representing a significant public health concern. Although there are no licensed CMV vaccines, the development of a CMV vaccine is considered a high priority due to its potential to reduce the burden associated with CMV-related complications, and several approaches are under investigation. The objective of this systematic review was to synthesize the evidence on various CMV vaccines currently under clinical development. <b>Methods</b>: According to the PRISMA guidelines (PROSPERO ID: CRD42024516601), a comprehensive literature search was conducted to identify all the randomized controlled trials that have evaluated the safety, immunogenicity, and efficacy of vaccine candidates compared to a placebo. A total of 26 studies were identified: 11 on transplant patients and 15 on healthy individuals. <b>Results</b>: Several vaccine candidates have shown encouraging results in terms of safety and specific immune responses, notably adjuvanted gB vaccines and DNA vaccines targeting gB and pp65. The results were divided into RCTs on healthy individuals and those on transplant recipients, because the CMV-specific immune response to a vaccine is complex and varies depending not only on the type of vaccine, but also on the immunological status of the individual. <b>Conclusions</b>: Challenges remain in achieving broad efficacy across diverse populations, particularly for immunocompromised patients. Thus, the present work seeks to support future decisions and guide further research in the development of an effective and widely available CMV vaccine. |
| format | Article |
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| institution | Kabale University |
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| language | English |
| publishDate | 2025-01-01 |
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| series | Vaccines |
| spelling | doaj-art-484871f138674ce2a0ba07fc6eaff7be2025-01-24T13:51:53ZengMDPI AGVaccines2076-393X2025-01-011318510.3390/vaccines13010085Safety, Immunogenicity, and Efficacy of Cytomegalovirus Vaccines: A Systematic Review of Randomized Controlled TrialsManuela Chiavarini0Anita Genga1Giorgia Maria Ricciotti2Marcello Mario D’Errico3Pamela Barbadoro4Department of Health Sciences, University of Florence, Viale GB Morgagni 48, 50134 Florence, ItalyDepartment of Biomedical Sciences and Public Health, Section of Hygiene, Preventive Medicine and Public Health, Polytechnic University of the Marche Region, 60126 Ancona, ItalyDepartment of Biomedical Sciences and Public Health, Section of Hygiene, Preventive Medicine and Public Health, Polytechnic University of the Marche Region, 60126 Ancona, ItalyDepartment of Biomedical Sciences and Public Health, Section of Hygiene, Preventive Medicine and Public Health, Polytechnic University of the Marche Region, 60126 Ancona, ItalyDepartment of Biomedical Sciences and Public Health, Section of Hygiene, Preventive Medicine and Public Health, Polytechnic University of the Marche Region, 60126 Ancona, Italy<b>Background/Objectives:</b> Cytomegalovirus (CMV) is widespread and mostly causes asymptomatic infections in immunocompetent hosts, but it may lead to severe and life-threatening diseases in immunocompromised individuals, such as transplant patients and congenitally infected children, representing a significant public health concern. Although there are no licensed CMV vaccines, the development of a CMV vaccine is considered a high priority due to its potential to reduce the burden associated with CMV-related complications, and several approaches are under investigation. The objective of this systematic review was to synthesize the evidence on various CMV vaccines currently under clinical development. <b>Methods</b>: According to the PRISMA guidelines (PROSPERO ID: CRD42024516601), a comprehensive literature search was conducted to identify all the randomized controlled trials that have evaluated the safety, immunogenicity, and efficacy of vaccine candidates compared to a placebo. A total of 26 studies were identified: 11 on transplant patients and 15 on healthy individuals. <b>Results</b>: Several vaccine candidates have shown encouraging results in terms of safety and specific immune responses, notably adjuvanted gB vaccines and DNA vaccines targeting gB and pp65. The results were divided into RCTs on healthy individuals and those on transplant recipients, because the CMV-specific immune response to a vaccine is complex and varies depending not only on the type of vaccine, but also on the immunological status of the individual. <b>Conclusions</b>: Challenges remain in achieving broad efficacy across diverse populations, particularly for immunocompromised patients. Thus, the present work seeks to support future decisions and guide further research in the development of an effective and widely available CMV vaccine.https://www.mdpi.com/2076-393X/13/1/85systematic reviewcytomegalovirusvaccinecongenital infectionlatencyglycoproteins |
| spellingShingle | Manuela Chiavarini Anita Genga Giorgia Maria Ricciotti Marcello Mario D’Errico Pamela Barbadoro Safety, Immunogenicity, and Efficacy of Cytomegalovirus Vaccines: A Systematic Review of Randomized Controlled Trials Vaccines systematic review cytomegalovirus vaccine congenital infection latency glycoproteins |
| title | Safety, Immunogenicity, and Efficacy of Cytomegalovirus Vaccines: A Systematic Review of Randomized Controlled Trials |
| title_full | Safety, Immunogenicity, and Efficacy of Cytomegalovirus Vaccines: A Systematic Review of Randomized Controlled Trials |
| title_fullStr | Safety, Immunogenicity, and Efficacy of Cytomegalovirus Vaccines: A Systematic Review of Randomized Controlled Trials |
| title_full_unstemmed | Safety, Immunogenicity, and Efficacy of Cytomegalovirus Vaccines: A Systematic Review of Randomized Controlled Trials |
| title_short | Safety, Immunogenicity, and Efficacy of Cytomegalovirus Vaccines: A Systematic Review of Randomized Controlled Trials |
| title_sort | safety immunogenicity and efficacy of cytomegalovirus vaccines a systematic review of randomized controlled trials |
| topic | systematic review cytomegalovirus vaccine congenital infection latency glycoproteins |
| url | https://www.mdpi.com/2076-393X/13/1/85 |
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