Mark R. Schleiss, MD
Disclosures: Consulting Fee-Moderna Vaccines - 11/01/2021
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NAME: Schleiss, Mark R.

eRA COMMONS USER NAME (credential, e.g., agency login): MARK_SCHLEISS

POSITION TITLE: Professor and American Legion and Auxiliary Endowed Chair, Division of Pediatric Infectious Diseases, University of Minnesota Medical School, Minneapolis, MN

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)



(if applicable)


Completion Date





Stanford University, Stanford CA





English Literature

Medical Microbiology


Oregon Health Sciences University, Portland, Oregon





Oregon Health Sciences University, Portland, Oregon





University of Washington, Seattle, Washington



Pediatric Infectious Diseases


Fred Hutchinson Cancer Res. Ctr., Seattle, Washington



Molecular Virology


  1. Personal Statement


I have a long-standing research program focused on the study of vaccines. As a PI, I have been continuously funded since the early 1990s to study CMV biology and disease. I also lead a CDC-funded program in universal screening for cCMV in Minnesota. These data were published earlier this year, in JAMA: Pediatrics (doi: 10.1001/jama.2010.1024). I will bring this experience to my collaboration with the Emerging Infections Course faculty and the entire team in the CME group.

  1. Dollard SC, Schleiss MR. Screening newborns for congenital cytomegalovirus infection. JAMA. 2010;304(4):407-8.
  2. Schleiss MR. Congenital cytomegalovirus infection: molecular mechanisms mediating viral pathogenesis. Infect Disord Drug Targets. 2011;11(5):449-65. doi: 10.2174/187152611797636721. PMID: 21827434.
  3. Dollard SC, Dreon M, Hernandez-Alvarado N, Amin MM, Wong P, Lanzieri TM, Osterholm EA, Sidebottom A, Rosendahl S, McCann MT, Schleiss MR. Sensitivity of dried blood spot testing for detection of congenital cytomegalovirus infection. JAMA Pediatr. 2021;175(3):e205441. doi: 10.1001/jamapediatrics.2020.5441.
  4. Roark HK, Jenks JA, Permar SR, Schleiss MR. Animal models of congenital cytomegalovirus transmission: implications for vaccine development. J Infect Dis. 2020;221:S60-S73. doi: 10.1093/infdis/jiz484.

B.   Positions and Honors



19911992              General Pediatrician, Group Health Cooperative of Puget Sound, Seattle, Washington

19921999              Assistant Professor of Pediatrics, University of Cincinnati, Division of Infectious Diseases, and member, Developmental Biology Training Program, Cincinnati Children’s Hospital Medical Center and Research Foundation, Cincinnati, Ohio

20022004              Associate Professor of Pediatrics (Tenured), University of Cincinnati, Divisions of Infectious Diseases and Molecular and Developmental Biology, Cincinnati Children’s Hospital Medical Center and Research Foundation, Cincinnati, Ohio

2004present              Professor of Pediatrics, Division Director, and American Legion Chair of Pediatrics, Division of Infectious Diseases, Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN

2004present              Member, Institute of Molecular Virology, University of Minnesota, Minneapolis, MN


Clinical Information:

Active medical license in Minnesota (MD47452)

Board certified in Pediatrics

Board certified in Pediatric Infectious Diseases

Other Experience and Professional Memberships:

1997                            Society for Pediatric Research, elected to Membership

2000–2002                            Editor, Healthy Kids Magazine (American Academy of Pediatrics Publication)

2000–2003                            Society for Pediatric Research Council Member, peer elected

2001              American Pediatric Society (APS), elected to Membership

2000–2006                            National Institutes of Health, EDC-3 Study Section

2004–2009                            Secretary-Treasurer, Society for Pediatric Research (SPR), peer-elected

2009–current                            National Institutes of Health, Member, Immunity and Host Defense Study Section

2011–current                            Member, Federation of Pediatric Organizations Physician-Scientist Task Force

2012                            Member, Minnesota Department of Health Newborn Screening Task Force


1979                            Associate Member, Sigma Xi Research Honor Society, Stanford, California

1995                            Distinguished Service Award, Association for Retarded Citizens (ARC)

1999                            Mead-Johnson Teaching Award, Cincinnati Children’s Hospital, Cincinnati, Ohio

2010–2015                            Immunity and Host Defense (IHD) Study Section, Standing Member

2018                            Department of Pediatrics, Julie Ross Memorial Research Award in CMV

2015–2019                            IHD Study Section, ad hoc reviewer

2013–2021                            “Best Doctors in Minneapolis-St. Paul”, peer-elected

2021                            Recipient of CMV Research Advocacy Award, National CMV Foundation


C.  Contributions to Science

1. Research in the Biology and Epidemiology of Congenital Human CMV (HCMV) Infection

As a pediatric infectious diseases clinician, my laboratory has, in parallel with animal studies in the GPCMV model, conducted clinical research in diverse areas such as comparative genomics and genome evolution of HCMV. I will complete enrollment of 30,000 infants in the next three years. The primary goal of this program is to compare the diagnostic sensitivity of dried blood spots with saliva-based screening. This translational perspective will be valuable with respect to the work proposed in CPIC proposal with Dr. Nestrasil.


a.              Renzette N, Pokalyuk C, Gibson L, Bhattacharjee B, Schleiss MR, Hamprecht K, Yamamoto AY, Mussi-Pinhata MM, Britt WJ, Jensen JD, Kowalik TF. 2015. Limits and patterns of cytomegalovirus genomic diversity in humans. Proc Natl Acad Sci USA. 112(30):E4120-8. PMID: 26150505; PMCID: PMC4522815.

b.              Rapid intrahost evolution of human cytomegalovirus is shaped by demography and positive selection. Renzette N, Gibson L, Bhattacharjee B, Fisher D, Schleiss MR, Jensen JD, Kowalik TF. 2013. PLoS Genet. 9(9):e1003735. PMID: 24086142; PMCID: PMC3784496.

c.              Schleiss MR. Cytomegalovirus in the neonate: immune correlates of infection and protection. 2013. Clin Dev Immunol. 2013:501801. PMID: 24023565; PMCID: PMC3760263.

d.               Dollard SC, Dreon M, Hernandez-Alvarado N, Amin MM, Wong P, Lanzieri TM, Osterholm EA, Sidebottom A, Rosendahl S, McCann MT, Schleiss MR. Sensitivity of dried blood spot testing for detection of congenital cytomegalovirus infection. JAMA Pediatr. 2021;175(3):e205441. doi: 10.1001/jamapediatrics.2020.5441.


2. Use of the GPCMV as a Model for Testing Subunit Vaccines for Prevention of Congenital Infection

My laboratory has been highly productive in the study of vaccination against congenital CMV infection, using the GPCMV model. I have defined the role of cloned, recombinant gene products in subunit vaccines against congenital GPCMV infection. I have evaluated and compared several strategies and combinations of subunit immunogens, including gB and the GPCMV homolog of pp65 (GP83). This work is highly relevant to this proposal, since it demonstrates familiarity with this model. I have recently published, for the first time, a study demonstrating synergistic protection against congenital infection when gB and pp65 are combined in a vectored vaccine. However, even upon optimized conditions, subunit approaches studied to date do not induce sterilizing immunity against congenital transmission, necessitating elucidation of correlates of protection.

a.               Schleiss MR, Berka U, Watson E, Aistleithner M, Kiefmann B, Mangeat B, Swanson EC, Gillis PA, Hernandez-Alvarado N, Fernández-Alarcón C, Zabeli JC, Pinschewer DD, Lilja A, Schwendinger M, Guirakhoo F, Monath TP, Orlinger K. 2016. Additive protection against congenital cmv conferred by combined gB/pp65 vaccination using a lymphocytic choriomeningitis virus (LCMV) vector. Clin Vaccine Immunol. pii: CVI.00300-16.             

b.              Bierle CJ, Anderholm KM, Wang JB, McVoy MA, Schleiss MR. 2016. Targeted mutagenesis of guinea pig cytomegalovirus using CRISPR/Cas9-mediated gene editing. J. Virol. 90(15):6989-98. PMID: 27226370; PMCID: PMC4944286.

c.              Gillis PA, Hernandez-Alvarado N, Gnanandarajah JS, Wussow F, Diamond DJ, Schleiss MR. 2014. Development of a novel, guinea pig-specific IFN-γ ELISPOT assay and characterization of guinea pig cytomegalovirus GP83-specific cellular immune responses following immunization with a modified vaccinia virus Ankara (MVA)-vectored GP83 vaccine. Vaccine. 32:3963-70. PMID: 24856783; PMCID: PMC4279957.

d.              Swanson EC, Gillis P, Hernandez-Alvarado N, Fernández-Alarcón C, Schmit M, Zabeli JC, Wussow F, Diamond DJ, Schleiss MR. 2015. Comparison of monovalent glycoprotein B with bivalent gB/pp65 (GP83) vaccine for congenital cytomegalovirus infection in a guinea pig model: Inclusion of GP83 reduces gB antibody response but both vaccine approaches provide equivalent protection against pup mortality. Vaccine. 33(32):4013-8. PMID: 26079615; PMCID: PMC4772145.

3. Viral Immune Modulation and Live, Attenuated CMV Vaccine Design in the Guinea Pig Model

In a series of studies I have developed molecular and immunological tools to expand the utility of the GPCMV model. I determined the complete sequence of the GPCMV genome and constructed the first fully authentic GPCMV infectious BAC clone. BAC genetics was used to construct a mutant virus lacking genes encoding three MHC class I homologs that are predicted to function as NK cell evasins. The mutant was highly attenuated but retained immunogenicity when used as a live attenuated vaccine. Recent efforts have focused on the GP145 gene product, which functions to antagonize the PKR intracellular defense mechanism.

  1. Crumpler MM, Choi KY, McVoy MA, Schleiss MR. 2009. A live guinea pig cytomegalovirus vaccine deleted of three putative immune evasion genes is highly attenuated but remains immunogenic in a vaccine/challenge model of congenital cytomegalovirus infection. Vaccine 27:4209-4218. PMCID: PMID: 19389443; PMC3539795.
  2. Olejniczak MJ, Choi KY, McVoy MA, Cui X, Schleiss MR. 2011. Intravaginal cytomegalovirus (CMV) challenge elicits maternal viremia and results in congenital transmission in a guinea pig model. Virol J 8:89. PMID: 21371319; PMCID: PMC3062623.
  3. Schleiss MR, Bierle CJ, Swanson EC, McVoy MA, Wang JB, Al-Mahdi Z, Geballe AP. 2015. Vaccination with a live attenuated cytomegalovirus devoid of a protein kinase R inhibitory gene results in reduced maternal viremia and improved pregnancy outcome in a guinea pig congenital infection model. J Virol. 89(19):9727-38. PMID: 26178990; PMCID: PMC4577886.
  4. McVoy MA, Wang JB, Dittmer DP, Bierle C, Swanson EC, Fernández-Alarcón C, Hernandez-Alvarado N, Zabeli JC, Schleiss MR. 2016. Repair of a mutation disrupting the guinea pig cytomegalovirus pentameric complex acquired during fibroblast passage restores pathogenesis in immune suppressed guinea pigs and in the context of congenital infection. J Virol. 90(17):7715-27. PMID: 27307567; PMCID: PMC4988165.

4. Comparative Genomics and Analyses of a Newly Discovered Strain of Guinea Pig Cytomegalovirus

My laboratory was the first to identify specific gene sequences of guinea pig cytomegalovirus (GPCMV), define the orientation of the viral genome, and purify specific GPCMV protein products. I have also recently identified a second strain of GPCMV, only the second strain of this virus to be isolated since the original description of what is currently designated as the ATCC strain ~50 years ago. These advances in the model allow for ready generation of recombinant viruses as well as the modeling of re-infection with heterologous strains of GPCMV.

a.              Gnanandarajah JS, Gillis PA, Hernandez-Alvarado N, Higgins L, Markowski TW, Sung H, Lumley S, Schleiss MR. Identification by mass spectrometry and immune response analysis of guinea pig cytomegalovirus (GPCMV) pentameric complex proteins GP129, 131 and 133. 2014. Viruses. 6:727-51. PMID: 24531333; PMCID: PMC3939480.

b.              Schleiss MR, McAllister S, Armién AG, Hernandez-Alvarado N, Fernández-Alarcón C, Zabeli JC, Ramaraj T, Crow JA, McVoy MA. 2014. Molecular and biological characterization of a new isolate of guinea pig cytomegalovirus. Viruses. 6:448-75. PMID: 24473341; PMCID: PMC3939465.

c.              Yang D, Tamburro K, Dittmer D, Cui X, McVoy MA, Hernandez-Alvarado N, Schleiss MR. 2013. Complete genome sequence of pathogenic guinea pig cytomegalovirus from salivary gland homogenates of infected animals. Genome Announc. 1:e0005413. PMID: 23516193; PMCID: PMC3622957.

d.              Analysis of the nucleotide sequence of the guinea pig cytomegalovirus (GPCMV) genome. 2008. Schleiss MR, McGregor A, Choi KY, Date SV, Cui X, McVoy MA. Virol J. 5:139. PMID: 19014498 PMCID: PMC2614972.

Complete List of Published Work in MyBibliography: 

A complete list of publications can be found at this link (>150 publications, H-index of 48, with >6600 citations):

D. Research Support


Active Research Support:

R01 HD079918 Schleiss (PI)                                                        08/06/2015 - 05/31/2021


“Optimized Vaccines against Congenital CMV Infection”

Major Goals: The major goals of this award are to develop a CMV vaccine based on the pentameric complex proteins of CMV, and to study re-infection with heterologous strains of CMV during pregnancy.

Role: Principal Investigator


March of Dimes Birth Defects Foundation                      07/01/2017 - 06/30/2022


Longitudinal Assessment of Asymptomatic Congenital CMV Infection in Minnesota Infants Identified by Universal Screening

Major Goals: To perform epidemiologic studies on infants with clinically asymptomatic congenital CMV infection identified in the context of a universal newborn screening program.

Role: Principal Investigator


Project Number: CDC 446110                                        04/21/2019 – 12/31/2021

Diagnosing Congenital CMV Infection in Newborns as a Model for Universal Newborn Screening and Early Intervention

Source: Minnesota Department of Health (CDC Prime)

Major Goals: Establish a universal congenital CMV screening program in Minnesota. This grant also compares the analytic sensitivity of dried blood spots and saliva-based screening for cCMV, and establishes an infrastructure for follow-up of infants with cCMV infection.

Role: Principal Investigator


UMN Clinical and Translational Science Institute           03/30/2018 - 02/28/2023

Blazar, Bruce (PI)

NIH NCATS: National Center for Advancing Translational Sciences"


Major Goals: To create a clinical and translational research infrastructure at the University of Minnesota. Efforts focused on collaborative research between the UMN and Children’s Hospitals of Minnesota

Role: Co-Investigator


R01 HD098866-01A1 Schleiss (Contact PI)                                09/01/2019 - 05/31/2024


Optimizing Immunity and Maternal Host Defense Against Congenital Cytomegalovirus Infection

Major Goals:  The major goals of this award are to test the hypotheses that a rationally designed, PC-intact, but disabled infectious single cycle (DISC) vaccine will provide superior protective immunity, including against re-infection, compared to subunit gB and tonatural immunity.


Role: Principal Investigator (Contact PI)


R01 CA2284780, NIH/NCI                                              04/01/2018 - 03/31/2021


Congenital Cytomegalovirus Infection, KIR Genotypes, and Acute Lymphoblastic Leukemia

Major Goals: To investigate the relationship between congenital CMV infection and childhood leukemia (ALL) by testing newborn blood spots for evidence of CMV DNA.

Role: Co-Investigator