[MCOH-EH] Correspondence to MCOEH re incomplete Hepatitis B vaccination with positive titers -contra recent CDC comments

[Grubbs, Scott]

My apologies- in my note of April 30, I somehow did not attach the excerpts, or they won't show in this system.   I added them to this email.  Hopefully that will make much more sense!

Scott





I include excerpts of two CDC documents regarding this subject, which indicate the presence of protective immunity *after less than three vaccinations.*  Please note the term "long term immunity" in the correction (first document).  The second document (abstracted from the link in the correction) indicates the percentage of vacinees who have "protective antibody response" after 1, 2 or 3 vaccinations.



Obviously, if the positive titer in an individual who only had two vaccinations was obtained 10 years ago, the concern (regarding long term protection) would justify repeating the vaccination; however, if it is obtained at the time of HBV exposure and shows protective immunity, then it doesn't make sense to give Immune globulin other than for medicolegal reasons; perhaps to the employee's harm. Obtaining a current titer while giving a third vaccine (and immune globulin if a negative current  HBsAb titer) would make sense and provide more certainty of long term immunity for future exposures.



Again, only my opinion, but I think it is based on solid evidence.



The 2013 reference below evidently does not take into account the information above, which is also from the CDC.



Odd, the reference below indicates "HCP exposed to a source patient who is HBsAg-positive or has unknown HBsAg status do not need to take special precautions to prevent secondary transmission during the follow-up period; however, they should refrain from donating blood, plasma, organs, tissue, or semen (1). The exposed HCP does not need to modify sexual practices or refrain from becoming pregnant (1). If an exposed HCP is breast feeding, she does not need to discontinue (1). No modifications to an exposed HCP's patient-care responsibilities are necessary to prevent transmission to patients based solely on exposure to a source patient who is HBsAg-positive or has unknown HBsAg status."  Does unprotected sex not = semen donation?



Don't like to contradict official guidance, but it is  self-contradictory.



Scott Grubbs, MD

WorkWell Occupational Health

Greenville, SC





MMWR Weekly October 26, 2007/ 56(42);1114

Erratum: Vol. 55, No. RR-16

In the MMWR Recommendations and Reports, "A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP), Part II: Immunization of Adults,"   (https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5516a1.htm ) (an error occurred. In Appendix A, page 28, second column, line 10, the sentence should read, "However, long-term protection has been demonstrated only for persons who have completed a licensed vaccination series and have ever had an anti-HBs concentration of >10 mIU/mL; persons with an anti-HBs-positive result but who did not complete a vaccine schedule might not have long-term protection from HBV infection."



......................................................................................................

A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States
Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: Immunization of Adults
MMWR December 8 2006

Adult Vaccination Schedules and Results of Vaccination
Preexposure Vaccination

Vaccination of Adults
Primary vaccination consists of >3 intramuscular doses of hepatitis B vaccine (Table 2<https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5516a1.htm#tab2>). The 3-dose vaccine series administered intramuscularly at 0, 1, and 6 months produces a protective antibody response in approximately 30%--55% of healthy adults aged <40 years after the first dose, 75% after the second dose, and >90% after the third dose (124,125). After age 40 years, the proportion of persons who have a protective antibody response after a 3-dose vaccination regimen declines below 90%, and by age 60 years, protective levels of antibody develop in only 75% of vaccinated persons (126). In addition to age, other host factors (e.g., smoking, obesity, genetic factors, and immune suppression) contribute to decreased vaccine response (127--130). Alternative vaccination schedules (e.g., 0, 1, and 4 months or 0, 2, and 4 months) have been demonstrated to elicit dose-specific and final rates of seroprotection similar to those obtained on a 0-, 1-, 6-month schedule (131).
...

Nonstandard Vaccine Schedules

No apparent effect on immunogenicity has been documented when minimum spacing of doses (i.e., 4 weeks between doses 1 and 2, 8 weeks between doses 2 and 3, and 16 weeks between doses 1 and 3) is not achieved precisely. Increasing the interval between the first 2 doses has little effect on immunogenicity or final antibody concentration (132--134). The third dose confers the maximum level of seroprotection but acts primarily as a booster and appears to provide optimal long-term protection (135). Longer intervals between the last 2 doses result in higher final antibody levels but might increase the risk for acquisition of HBV infection among persons who have a delayed response to vaccination. No differences in immunogenicity are observed when vaccines from different manufacturers are used to complete the vaccine series.

References:

124.Andre FE. Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine. Am J Med 1989;87(Suppl 3A):S14--20.

125.Zajac BA, West DJ, McAleer WJ, Scolnick EM. Overview of clinical studies with hepatitis B vaccine made by recombinant DNA. J Infect 1986;13(Suppl A):39--45.
126.Averhoff F, Mahoney F, Coleman P, Schatz G, Hurwitz E, Margolis H. Immunogenicity of hepatitis B vaccines: implications for persons at occupational risk for hepatitis B virus infection. Am J Prev Med 1998;15:1--8.
127.Shaw FE Jr, Guess HA, Roets JM, et al. Effect of anatomic injection site, age and smoking on the immune response to hepatitis B vaccination. Vaccine 1989;7:425--30.
128.Weber DJ, Rutala WA, Samsa GP, Santimaw JE, Lemon SM. Obesity as a predictor of poor antibody response to hepatitis B plasma vaccine. JAMA 1985;254:3187--9.
129.Wood RC, MacDonald KL, White KE, Hedberg CW, Hanson M, Osterholm MT. Risk factors for lack of detectable antibody following hepatitis B vaccination of Minnesota health care workers. JAMA 1993;270:2935--9.
130.Alper CA, Kruskall MS, Marcus-Bagley D, et al. Genetic prediction of nonresponse to hepatitis B vaccine. N Engl J Med 1989;321:708--12.
131.Lemon SM, Thomas DL. Vaccines to prevent viral hepatitis. N Engl J Med 1997;336:196--204.
132.Hadler SC, de Monzon MA, Lugo DR, Perez M. Effect of timing of hepatitis B vaccine doses on response to vaccine in Yucpa Indians. Vaccine 1989;7:106--10.
133.Halsey NA, Moulton LH, O'Donovan JC, et al. Hepatitis B vaccine administered to children and adolescents at yearly intervals. Pediatrics 1999;103(6 Pt 1):1243--7.
134.Wistrom J, Ahlm C, Lundberg S, Settergren B, Tarnvik A. Booster vaccination with recombinant hepatitis B vaccine four years after priming with one single dose. Vaccine 1999;17:2162--5.
135.Jilg W, Schmidt M, Deinhardt F. Vaccination against hepatitis B: comparison of three different vaccination schedules. J Infect Dis 1989;160:766--9.
136.Clemens R, Sanger R, Kruppenbacher J, et al. Booster immunization of low- and non-responders after a standard three dose hepatitis B vaccine schedule---results of a post-marketing surveillance. Vaccine 1997;15:349--52.





-----Original Message-----

From: MCOH-EH [mailto:mcoh-eh-bounces at mylist.net] On Behalf Of Harriman, Kathleen (CDPH-CID-DCDC-IMM)

Sent: Tuesday, November 14, 2017 3:01 PM

To: mcoh-eh at mylist.net<mailto:mcoh-eh at mylist.net>

Subject: #ExtMail# [MCOH-EH] MCOH-EH Digest, Vol 252, BBP exposures



The CDC Guidance for Evaluating Health-Care Personnel for Hepatitis B Virus Protection and for Administering Postexposure Management, Recommendations and Reports, December 20, 2013 / 62(RR10);1-19 (https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6210a1.htm) states that anti-HBs greater than or equal to 10 mIU/mL should only be used as a correlate of protection for HCP with documentation of a complete HepB vaccine series.  HCP who lack documentation of a dose or doses of HepB vaccine should be considered unvaccinated for those dose(s) for which documentation is lacking.  Please refer to Table 2 in the above referenced MMWR for the post-exposure management protocol, including for unvaccinated or incompletely vaccinated HCP.



Kathleen Harriman

Immunization Branch

California Department of Public Health

kathleen.harriman at cdph.ca.gov<mailto:kathleen.harriman at cdph.ca.gov>





Date: Tue, 14 Nov 2017 18:18:46 +0000

From: "Grubbs, Scott" <Scott_Grubbs at bshsi.org<mailto:Scott_Grubbs at bshsi.org>>

To: MCOH/EH <mcoh-eh at mylist.net<mailto:mcoh-eh at mylist.net>>

Subject: Re: [MCOH-EH] BBP exposures



While the person does need to complete the series for long term immunity assurance, for the exposure of the moment, it would seem reasonable to think that they have the right antibodies to deal with it.  However, I am not an ID doc, so that is just my opinion.

Scott Grubbs, MD

WorkWell Occupational Health

Greenville, SC



From: MCOH-EH [mailto:mcoh-eh-bounces at mylist.net] On Behalf Of Tim Crump

Sent: Monday, November 13, 2017 12:43 PM

To: MCOH/EH

Subject: Re: [MCOH-EH] BBP exposures



I would be interested in knowing how people are testing workers who have not completed the Hepatitis B immunization series.  Our staff who sustain a needle stick or other BBFE afterhours are seen in the ED, where they do not necessarily know their immunization status.  They test everyone w/ HepB sAb.  My understanding of CDC recommendations is that workers who have not completed the series should be tested w/ HepB core Ab, and that surface antibody is uninterpretable if the immu series is not complete.  So my question is, can the HepB surface antibody be used as a marker of immunity to Hep B at that moment, or is it misleading and should be put aside when the immu series is incomplete, potentially making a worker a candidate for HBIG?  Thanks for any insight, Tim



Tim Crump, MSN, FNP

Family Nurse Practitioner

Multnomah Pavilion 1 SE, Suite 1110

Occupational Health

Healthcare Human Resources



Oregon Health & Science University

3181 SW Sam Jackson Park Rd

Mail code: UHN 89

Portland, OR 97239-3098

Department Phone: 503-494-5271

Office Phone: 503-346-1152

Fax: 503-494-4457

Email: crumpt at ohsu.edu<mailto:crumpt at ohsu.edu<mailto:crumpt at ohsu.edu%3cmailto:crumpt at ohsu.edu>>




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