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2013 ; 32
(1
): 4-10
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Priorities for CMV vaccine development
#MMPMID24129123
Krause PR
; Bialek SR
; Boppana SB
; Griffiths PD
; Laughlin CA
; Ljungman P
; Mocarski ES
; Pass RF
; Read JS
; Schleiss MR
; Plotkin SA
Vaccine
2013[Dec]; 32
(1
): 4-10
PMID24129123
show ga
A multidisciplinary meeting addressed priorities related to development of
vaccines against cytomegalovirus (CMV), the cause of congenital CMV (cCMV)
disease and of serious disease in the immunocompromised. Participants discussed
optimal uses of a CMV vaccine, aspects of clinical study design, and the value of
additional research. A universal childhood CMV vaccine could potentially rapidly
reduce cCMV disease, as infected children are sources of viral transmission to
seronegative and seropositive mothers. A vaccine administered to adolescents or
adult women could also reduce cCMV disease by making them immune prior to
pregnancy. Clinical trials of CMV vaccines in women should evaluate protection
against cCMV infection, an essential precursor of cCMV disease, which is a more
practical and acceptable endpoint for assessing vaccine effects on maternal-fetal
transmission. Clinical trials of vaccines to evaluate prevention of CMV disease
in stem cell transplant recipients could use CMV viremia at a level triggering
pre-emptive antiviral therapy as an endpoint, because widespread use of
pre-emptive and prophylactic antivirals has rendered CMV-induced disease too rare
to be a practical endpoint for clinical trials. In solid organ transplant
patients, CMV-associated disease is sufficiently common for use as a primary
endpoint. Additional research to advance CMV vaccine development should include
identifying factors that predict fetal loss due to CMV, determining age-specific
incidence and transmission rates, defining the mechanism and relative
contributions of maternal reactivation and re-infection to cCMV disease,
developing assays that can distinguish between reactivation and re-infection in
seropositive vaccinees, further defining predictors of sequelae from cCMV
infection, and identifying clinically relevant immune response parameters to CMV
(including developing validated assays that could assess CMV antibody avidity)
that could lead to the establishment of immune correlates of protection.
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