University

of Texas Southwestern Medical Center maternal-fetal specialists

have confirmed a potential new protocol to protect pregnant women

who are at risk for hepatitis B, a health problem that affects 2

billion people worldwide.

“font-size: 9.0pt; font-family: Verdana; mso-bidi-font-family:”>An

accelerated hepatitis B vaccination schedule for high-risk pregnant

women was found effective and well-tolerated. The findings appear

in the journal Obstetrics & Gynecology.

“font-size: 9.0pt; font-family: Verdana; mso-bidi-font-family:”>While

the normal three-shot regimen of hepatitis B vaccine for adults –

given over a six-month period – has long been recommended for

pregnant women, that schedule often proved unmanageable in the

course of a pregnancy.

“font-size: 9.0pt; font-family: Verdana; mso-bidi-font-family:”>“It’s

difficult to get all three doses in pregnancy, and people tend to

get lost to follow-up, especially high-risk populations,” said Dr.

Jeanne Sheffield, associate professor of obstetrics and gynecology

at UT Southwestern and lead author of the study.

“font-size: 9.0pt; font-family: Verdana; mso-bidi-font-family:”>The

research team stepped up the process for pregnant women and used

the normal three-shot dosage given to adults over a 12-week period.

That regimen is the shortest recommended schedule in non-pregnant

adults that still offers protective long-term immunity.

“font-size: 9.0pt; font-family: Verdana; mso-bidi-font-family:”>“Now

that we’ve shown it’s efficacious in pregnancy, people are

interested,” said Dr. Sheffield, who also heads the maternal-fetal

medicine fellowship program. “We’ve already received a number of

requests for our specific protocol from physicians who see

high-risk patients and are interested in starting a vaccination

program.”

“font-size: 9.0pt; font-family: Verdana; mso-bidi-font-family:”>In

the U.S., nearly 1.5 million people live with chronic hepatitis B

infection, and it is the underlying cause of 3,000 deaths per year.

The American College of Obstetricians and Gynecologists recommended

in 1993 and in 2007 that pregnant women at risk for hepatitis B

should receive vaccination.

“font-size: 9.0pt; font-family: Verdana; mso-bidi-font-family:”>Dr.

Sheffield said, however, that health care providers seldom offer

the hepatitis B vaccine series to reproductive-aged women because

of lack of physician and patient education, patients’ fear of

vaccination and its purported side effects, and the overall

reluctance to vaccinate pregnant women.

“font-size: 9.0pt; font-family: Verdana; mso-bidi-font-family:”>Even

though the Centers for Disease Control and Prevention reports

pregnancy is not a contraindication to hepatitis B vaccine, limited

data were available on its use in pregnancy.

“font-size: 9.0pt; font-family: Verdana; mso-bidi-font-family:”>In

the current study, conducted at Parkland Memorial Hospital,

researchers enrolled high-risk women with a current diagnosis of a

sexually transmitted disease, injection drug use or both, over a

six-year period. Of 200 women enrolled, 168 received all three

doses of the vaccine.

“font-size: 9.0pt; font-family: Verdana; mso-bidi-font-family:”>Researchers

found that race, maternal age, tobacco and alcohol use, and

gestational age at first vaccination did not affect the development

of antibodies against hepatitis B – using the accelerated schedule.

Obesity did have a negative influence, however.

“font-size: 9.0pt; font-family: Verdana; mso-bidi-font-family:”>The

accelerated schedule in pregnancy had seroconversion rates (90

percent) that were comparable to the standard schedule in healthy

adults. The study also showed no increase in preterm delivery rates

or neonatal intensive care admissions.

“font-size: 9.0pt; font-family: Verdana; mso-bidi-font-family:”>“The

vaccine was well-tolerated in our pregnant women, and no serious

adverse events were reported,” Dr. Sheffield said. “Initial

concerns about the ability of a pregnant woman to mount an

effective immune response to a vaccine are largely unfounded. It’s

doable.”

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