CSL partners with NIH for CMV trial in pregnant women

It’s not as well known, but cytomegalovirus (CMV) is the most common infectious cause of congenital malformation in developed countries. In Australia alone, 465 babies are born each year with congenital CMV disease, which is greater than the number born with Down syndrome.

Now a new partnership between the US National Institutes of Health (NIH) and CSL is aiming at testing whether CMV immunoglobulin (antibodies against CMV collected from human plasma) might be an effective preventative of transmission of CMV from mother to baby.

The trial will be run by the NIH across 14 Maternal Foetel Medicine Units across the US, screening approximately 160,000 pregnant women to settle on 800 subjects who will participate in a placebo controlled double blind trial.

Infants born to those in the study will be monitored for two years to determine the efficacy of the immunoglobulin.

The entire trial is expected to cost between $30m and $50m, with CSL donating $2.5 million worth of immunoglobulin manufactured at its Swiss plant for the study.

The primary focus of the trial is to determine whether CMV immunoglobulin lowers the rate of congenital CMV infection among the offspring of women who have been diagnosed with a primary CMV infection during pregnancy, meaning they haven’t had CMV before during their lifetime.

It also seeks to determine whether CMV immunoglobulin prevents of lessens the severity of the effects of CMV infection in the baby as at age two, and whether the CMV immunoglobulin affects neurodevelopmental level at that age.

Finally, it is also seeking whether the virus load measures in the maternal blood predicts adverse neonatal outcomes or response to the CMV immunoglobulin.

The trial begins this month, with primary analysis expected in 2016.

The immunoglobulin is already used as a treatment for individuals undergoing surgery, so has already been approved for use in other indications besides pregnant mothers and their offspring.

The effects of congenital CMV include deafness, blindness, cerebral palsy, mental and physical disabilities, seizures and death.

CMV is a common virus spread amongst young children, and this is the typical vector for mothers to acquire a primary infection during pregnancy and then pass the infection on to subsequent offspring.

CMV can be controlled through hygiene, such as through hand washing and avoiding contact with young children, but even with these measures it is difficult to guard against infection.

There are other treatments for CMV under investigation, including a vaccine, although these are some years away from being marketed.

CSL (ASX:CSL) has been trading level at $32.39 in Thursday’s trading.