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Hospitals weigh ID route for HBV nonresponders
CDC recommends two series of IM for HCWs
Is intradermal (ID) vaccination the answer for those who don’t respond to two full series of hepatitis B vaccine?
Based on recent studies, some hospitals are considering the practice, although the Centers for Disease Control and Prevention (CDC) maintains its recommendation to use only the intramuscular (IM) route. As many as 75% of those who didn’t respond to the first three-shot series of IM injections will respond to a second series, says Eric Mast, MD, MPH, medical epidemiologist with the prevention branch of CDC’s Division of Viral Hepatitis.
Those few health care workers who still do not show an adequate antibody response would receive immune globulin in the case of an exposure, he says.
"The Advisory Committee on Immunization Practices has reviewed the immunogenicity data [of the ID vaccine], and that’s their recommendation," he says. "I don’t anticipate it being revisited in the near future. There hasn’t been a real demand to revisit it."
CDC’s recommendation: "At this time, low-dose intradermal vaccination of adults should be performed only under research protocol with written informed consent." 1
Yet some hospitals are considering the ID use based on recent studies showing high response rates.
In an Australian study, 18 health care workers who did not respond to IM hepatitis B vaccine received the ID vaccine every other week for up to four doses.
Seventeen of them (94%) developed protective antibodies. 2
A similar 1995 study of Connecticut health care workers found that 88% of previous nonresponders achieved immunity with up to four doses of high-dose intradermal vaccine. 3
"It seems to me that the data are pretty compelling," says Mark Russi, MD, MPH, associate professor of medicine and public health at the Yale University School of Medicine and director of occupational health at Yale-New Haven (CT) Hospital, which has not yet decided to use the ID route. "I think most of us would like to [add] it into our practice if there were an official go-ahead," he says.
Yet some studies have also shown an ID antibody response that is effective but lower than with the IM route. 4
"Seroconversion rates have been inconsistent," Mast says. "Some studies have found relatively high, others have found lower conversion rates. There’s little information about the long-term protection. All the long-term protection data are data with the intramuscular route of administering."
The carefully controlled environment of a clinical study also may overstate the benefits, says Mast. "What you see in study situations may be different from what is seen in actual programmatic practice," he says.
Goal is to provide maximum protection
Yet in clinical practice, employee health professionals would like another tool to protect health care workers from hepatitis B, which has a higher seroconversion rate from bloodborne pathogen exposures that HIV or hepatitis C.
Pat Dalton, RN, COHN-S, occupational health administrator at Pitt County Memorial Hospital in Greenville, NC, brought the issue to the hospital’s infection control committee.
The occupational health and infection control physicians ultimately decided to try the ID route for those who didn’t respond to two full IM series. Although there are some published reports of skin discoloration at the ID injection site, Dalton says no hospital employees have had any adverse effects.
"If our ultimate goal is to assure that as many people as possible develop antibodies and we’ve already given them two full series and they have not developed antibodies, what’s the downside of giving them ID doses?" Dalton asks.
The hospital will track the vaccinations, noting factors that may affect the response to the vaccine. With the IM vaccine, lower conversion rates have been linked to smoking and obesity in some studies.
At Vanderbilt Occupational Health Clinic in Nashville, TN, medical director Melanie Swift, MD, is following the medical literature on ID hepatitis B with interest. "There’s certainly a lot of talk about it," she says, noting that changes in practice often evolve as the medical community evaluates new data.
But Swift also notes that the number of true nonresponders is very low. Some health care workers who say they are nonresponders did not complete the full second series, she says.
"Most people who think they’re a nonresponder were told that, because at the time they got vaccinated, they had completed what was recommended, [which was less than the three-dose second series]," she says.
"Now we found that you really need to apply more stringent criteria before you call someone a nonresponder," Swift adds.
1. Centers for Disease Control and Prevention. Hepatitis B virus: A comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991; 40(RR-13):1-19.
2. Playford EG, Hogan PG, Bansal AS, et al. Intradermal recombinant hepatitis B vaccine for health care workers who fail to respond to intramuscular vaccine. Infect Control Hosp Epidemiol 2002; 23:87-90.
3. Levitz RE, Cooper BW, Regan HC. Immunization with high-dose intradermal recombinant hepatitis B vaccine in health care workers who failed to respond to intramuscular vaccination. Infect Control Hosp Epidemiol 1995; 16:88-91.
4. Tant M, Gerkin R, Englender SJ, et al. Epidemiologic notes and reports: Inadequate immune response among public safety workers receiving intradermal vaccination against hepatitis B — United States, 1990-1991. MMWR 1991; 40:569-572.