Biology Reference
In-Depth Information
HCMV Vaccines in Clinical Trials
A number of HCMV vaccines have been evaluated in clinical trials. These vaccine
candidates are summarized in Table 1. A variety of strategies have been employed,
but generally HCMV vaccines can be conceptually subdivided into the categories
of live, attenuated vaccines, and subunit vaccines that target individual proteins
(see the chapter by W. Gibson, this volume). Progress in study of these vaccines is
considered the next section.
Table 1
HCMV vaccines that have undergone evaluation in clinical trials
Live, attenuated vaccines
AD169 vaccine
Elicited HCMV-specific antibody responses
in seronegative vaccine recipients
Significant injection-site and systemic reactogenicity
No ongoing studies active
Towne (±rhIL12)
Elicits humoral and cellular immune responses
Favorable safety profile; no evidence for latency
or viral shedding in recipients
Lack of efficacy for HCMV infection; reduced HCMV
disease in renal transplant recipients
Augmentation of immunogenicity by inclusion
of recombinant IL-12 in phase 1 studies
Towne/Toledo chimera vaccines
Favorable safety profile; no evidence for latency or viral
shedding in recipients
Attenuated compared to Toledo strain of HCMV
No efficacy data available
Subunit vaccines
Glycoprotein B/MF59 adjuvant
Favorable safety profile
(CHO cell expression)
High-titer neutralizing antibody and strong
cell-mediated immune responses
Efficacy studies ongoing in young women, adolescents,
renal transplant patients
Glycoprotein B/canarypox vector
Favorable safety profile
Suboptimal immunogenicity
Prime-boost effect when administered in combination
with Towne vaccine
pp65 (U83)/canarypox vector
Favorable safety profile
Strong antibody and cell-mediated immune responses
No efficacy data available
gB/pp65/IE1 trivalent DNA vaccine
DNA vaccine with poloxamer adjuvant
gB/pp65 bivalent DNA vaccine
Phase I studies completed
Phase 2 study ongoing with bivalent gB/pp65 vaccine
in HSC transplant recipients
gB/pp65/IE1 alphavirus replicon
Based on replication-deficient alphavirus technology
trivalent vaccine
Generation of virus-like replicon particles (VRPs)
Phase I clinical trial recently initiated
