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ACIP CMV Vaccine Workgroup
Initial Considerations for CMV Vaccine Policy
Tatiana M. Lanzieri, MD, MPH
ACIP CMV WG Co -Lead
April 15th, 2025
Measles, Rubella and CMV Epidemiology TeamViral Vaccine Preventable Diseases BranchDivision of Viral DiseasesNational Center for Immunization & Respiratory Diseases
The burden of congenital CMV is substantial but awareness is low
Need to assess vaccine acceptability and feasibility of implementation
Primary maternal infections have a higher risk of vertical transmission, are
estimated to cause most cCMV infections in the U.S., and result in more severe
cCMV disease if occurring in the first trimester of pregnancy
Vaccination before pregnancy, and long -lasting protection throughout childbearing years
would be needed
CMV seroprevalence increases with age, but certain groups of the population already have
high seroprevalence by adolescenceCMV as a public health problem
CMV gBand pentamer complex ( gH, gL, UL128, UL130, UL131)
-3 doses: 0, 2, 6 months after the first dose
Phase 3 trial (ongoing)
-Randomization: 1:1 vaccine:placebo ,
within each serostatus group, and
stratified by age group
-Follow -up: 24 months after the 3rddose,
with an extension to 48 months for a
subset of the cohortModerna mRNA -1647 CMV vaccine
Study Details | A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA -1647 Cytomegalovirus (CMV) Vaccine in Healt hy Participants 16 to 40 Years of Age |
ClinicalTrials.gov7,500 non -pregnant
females
(16-40 years)
5,500
CMV IgG seronegative
(Vaccine efficacy)2,000
CMV IgG seropositive
(Safety and reactogenicity)
–Vaccine efficacy against primary infection in CMV -seronegative (vaccine vs. placebo recipients)
from 28 days up to 24 -48 months after the 3rd dose
›Primary infection: seroconversion from negative to positive for IgG against CMV antigens
not included in vaccine
–Safety and reactogenicity in all participants
–Immunogenicity at day 1 and months 3, 7, 12
–Immune persistence at months 18, 24, and 30
›gB and pentamer antigen -specific neutralizing antibody titers and binding antibody
concentrations in CMV -seronegative vaccine vs. placebo recipients
–
–Symptomatic primary infection, urinary CMV excretion (CMV -seropositive)
–Moderna mRNA -1647 CMV vaccine – clinical trial endpoints
Study Details | A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA -1647 Cytomegalovirus (CMV) Vaccine in Healt hy Participants 16 to 40 Years of Age | ClinicalTrials.govSecondaryPrimary
Exploratory
No safety concerns
Immunogenicity – need to better understand differences in neutralizing
antibody levels against epithelial cell and fibroblast entry; antibody -dependent
cellular cytotoxicity and phagocytosis (ADCC & ADPC)
Long -term protection – some data showing antibody persistence through at
least 3 years following dose 1WG interpretation of data from Moderna’s mRNA -1647
vaccine phase 1 and phase 2 trials
Moderna’s planned vaccine indication is for non- pregnant females 16 -40 years; 3- dose series
(6 months)
Efficacy will be assessed only for primary infection among initially CMV -seronegative subjects
Data on duration of immunity will be limited; need to ensure protection before pregnancy and
throughout childbearing age years
Efficacy against vertical transmission, cCMV infection or disease?
Better understanding of correlates of protection against vertical transmission is needed
Benefit to CMV -seropositive individuals yet unknown while serological testing prior to
vaccination would pose implementation challenges
Groups considered for vaccine recommendations might change as data from future clinical trials (e.g. adolescents, transplant patients) become availableWG considerations on Moderna’s mRNA -1647 vaccine
phase 3 trial
Next steps
Public
Health
ProblemBenefits
and
HarmsValues FeasibilityResource
UseEquity AcceptabilityEvidence to Recommendation ( EtR) Domains
An effective CMV vaccine could reduce cCMV disease burden
Over 16,000 children born with cCMV infection in the U.S. every year; nearly 3,000 with cCMV disease
mRNA -1647 CMV vaccine candidate
Shown to be safe and immunogenic in phase 1 and 2 studies
Efficacy data on prevention of primary CMV infection in CMV -seronegative women 16 -40 years of age from
ongoing phase 3 trial expected next year
Need to ensure protection against CMV infection before pregnancy to reduce vertical transmission
Low awareness and potential need for serological screening might pose implementation
challenges
The CMV ACIP WG will meet regularly to review data and develop CMV vaccine policy
options Conclusions
ACIP Members
•Denise Jamieson (WG chair)
•Bonnie Maldonado
Liaisons
•David Kimberlin (AAP)
•Liat Greenwood Chernoff (ACNM)
•Naima Joseph (ACOG)
•Tabitha Hanson (AIM)
•Leisha Nolen (CSTE)
•Ajit Limaye (IDSA)
•Caleb Lyu (NACCHO)
•Maria Carrillo -Marquez (PIDS)Acknowledgments - ACIP CMV WG Members
Ex Officio Members
•Douglas Pratt (FDA)
•Britt Rizek (HRSA)
•Matthew Clark (IHS)
Consultants
•Andrea Ciaranello (Harvard Medical School)
•Rana Chakraborty (University of Miami)
•Sonja Rasmussen (Johns Hopkins University)
•Martina Badell (SMFM)
CDC Staff - DVD
•Tatiana Lanzieri (WG co -lead)
•David Sugerman (WG co -lead)
CDC Staff - DVD
•Tom Clark (ACIP advisor)
•Sara Oliver (ACIP advisor)
•Dan Filardo
•Jessica Leung
•Chelsea Lutz
•Lois Park
•Kelley Raines
•Ashrita Rau
•Brian WakemanAcknowledgments - ACIP CMV WG CDC Participants
CDC Staff - non-DVD
•Amimah Asif (ISD)
•Karen Pazol (ISD)
•Christine Olson (ISO)
•Elizabeth Quincer (ISO)
•Kate Woodworth (DBDID)
•Alison Fountain (DBDID)
•Naomi Tepper (DRH)
ACIP Staff
•Melinda Wharton
•Jessica MacNeil
•Leslie Lee
•Stephanie Thomas
For more information, contact CDC 1 -800- CDC-INFO (232- 4636) TTY: 1- 888- 232- 6348
www.cdc.gov
The findings and conclusions in this report are those of the authors and do not
necessarily represent the official position of the Centers for Disease Control and Prevention.