Brendan B. McGinnis Congenital CMV Foundation main page

Public Awareness and Vaccine Research Support. Working Together to Eradicate Congenital CMV Disease.
Member of the External Partner Group, in conjunction with the National Center on Birth Defects and Developmental
Disabilities (NCBDDD) and the Centers for Disease Control and Prevention (CDC)

Brendan B. McGinnis Congenital CMV Foundation |

The Brendan B. McGinnis Congenital CMV Foundation is a non-profit 501 (c) (3) dedicated to
raising public awareness about congenital CMV, to raise donations to support research for a vaccine
for CMV, and to affect change in the medical community so that physicians will begin to test women
for CMV prior to pregnancy. Ultimately, our mission is to save babies yet to be born from suffering
the often devastating consequences of congenital CMV by eradicating this common but potentially
life-altering virus.

The process of vaccine evaluation

Development of a vaccine to prevent congenital CMV has been slow but recent progress has

rekindled

government, academic, and industry interest in this problem. Before a vaccine can be

licensed it must

complete three phases of evaluation in humans: phase I, safety testing and

immunogenicity; phase II,

small scale preliminary efficacy; phase III, large scale efficacy/safety.

Candidate vaccines under evaluation

Thus far two experimental vaccines have completed phase II trials.

The live “Towne” vaccine did not protect mothers from becoming infected when given at a

relatively

low dose. A phase II trial using this vaccine at a higher more immunogenic dose was

prematurely

discontinued by NIH’s National Institute of Allergy and Infectious Diseases. A phase I

trial of a

modified version of the Towne vaccine (“Towne/Toledo chimeras”) will begin September

2010.

The second vaccine, the “gB/MF59” vaccine, contains a single component of the virus,

glycoprotein B,

mixed with a novel adjuvant, MF59. In a phase II trial this vaccine reduced the

incidence

of infection by half. While not ideal, this is the first sign of success for any CMV vaccine.

Several other vaccine candidates are approaching or are in phase I trials, and phase II trials are

being

planned. These trials, however, are both expensive and time consuming. The odds of a

typical

subject acquiring CMV are 1-2 per hundred per year, so even a small phase II trial can

involve

immunizing hundreds of subjects and following them for signs of CMV acquisition for 2-3

years.

Hence, it may be 10 years or more before a candidate vaccine successfully completes

phase III testing with sufficient efficacy and safety to justify licensure.

Who would be vaccinated?

The population that would receive a CMV vaccine is not certain. Initial vaccination efforts may

focus on

preadolescent girls or women contemplating pregnancy, particularly if immunity induced

by the vaccine

is short-lived. However, universal childhood vaccination, perhaps with booster

immunizations at later

ages, remains a possibility. The latter would have the potential to virtually

eradicate CMV from the

general population, as has been achieved for many other viruses. This

would benefit other patient

populations (transplant and AIDs patients), as well as those who opt

not to receive the vaccine,

or those who, for some reason, do not adequately respond to the

vaccine.

The costs of vaccine development

Vaccine development builds upon basic science understanding of how the human immune system

controls or prevents viral infection and what parts of the virus may best serve as “targets” for

immune

responses, and hence might work well in a vaccine. Over the past 50 years the number

of research

dollars invested in understanding CMV biology and immunity probably totals several

hundred million.

Based on this basic knowledge, candidate vaccines are designed and tested in

animals.

Each of these studies, and there have been many, cost a few million dollars.

Before a vaccine candidate can progress to phase I trials the vaccine itself must be manufactured

by a

facility certified to produce pharmaceuticals safe for use in human subjects. Even for a

relatively

simple vaccine this can cost half a million dollars per candidate vaccine.

Next the vaccine must undergo extensive safety/toxicological testing in animals, again,

at a cost of

several hundred thousand dollars.

Phase I trials can sometimes be done with a relatively small number of subjects and may cost

under

$1M. The cost of phase II trials varies depending on design; however, the recent gB/MF59

phase II trial

involved 464 subjects, took 10 years, and cost $7.5M. Only a vaccine that shows

considerable

promise in a phase II trial is likely to go on to phase III. A phase III efficacy trial will

likely run $10-20M,

but if the FDA requires a 40,000 subject safety trial, it could cost up to $100M.

The economic burden of CMV

Although formidable, the costs of vaccine development are dwarfed by the economic burden of

caring

for children affected by congenital CMV infections, estimated at $1B annually for the U.S.

alone.

This is only for health care costs and does not attempt to place a value on the

suffering that could be prevented by an effective vaccine.

Please see our "What We Do" page to learn more about

our support for CMV Vaccine

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