# Presentation: 514437

## Hepatitis B and Hepatitis B Vaccine

**Epidemiology and Prevention of Vaccine-Preventable Diseases**
**National Immunization Program**
**Centers for Disease Control and Prevention**

**Revised January 2007**

## NOTICEContent and order of the slides in this file may differ from those presented on the  broadcast and webcast

## Hepatitis B Virus

**Small DNA virus**
**Humans are only known host**
**Several subtypes that do not affect virulence or infectivity**
**May retain infectivity for more than 7 days at room temperature**

## Hepatitis B Virus

**HBsAg**

**HBcAg**

**HBeAg**

**Notes:**
Although HBV has numerous antigens, only the presence of HBsAg indicates active infection.  Antibody to HBsAg, from either disease or vaccine, indicates immunity.

## Hepatitis B Virus Infection

**More than 350 million chronically infected worldwide**
**Established cause of chronic hepatitis and cirrhosis**
**Cause of up to 80% of hepatocellular carcinomas**
**600,000 deaths worldwide in 2002**

## Hepatitis B Clinical Features

**Incubation period 60-150 days (average 90 days)**
**Nonspecific prodrome of malaise, fever, headache, myalgia**
**Illness not specific for hepatitis B**
**At least 50% of infections asymptomatic**

## Hepatitis B Complications

**Fulminant hepatitis**
**Hospitalization**
**Cirrhosis**
**Hepatocellular carcinoma**
**Death**

## Risk of Chronic HBV Carriage by Age of Infection

## Hepatitis B Epidemiology

**Reservoir****	****	****	****Human**
**Transmission****	****	****Bloodborne           ****	****	****	****	****	****	****Asymptomatic cases****	****	****	****	****	****transmit **** **
**Communicability****	****1-2 months before****	****	****	****	****	****and after onset of****	****	****	****	****	****symptoms****	**

## Hepatitis B—United States, 1978-2006*

**Year**

***2006 provisional total**

**Notes:**
The reduction of reported cases in the late 1990s is not likely due to vaccine.  An estimated 100k infections continue to occur annually, primarily in young adults.

## Hepatitis–United States, 2005

**Highest incidence among adults 25 to 45 years of age**
**79% associated with high risk sexual activity or injection drug use**
**5% associated with other known exposures (e.g., household and occupational exposures)**
**16% deny a specific risk factor for infection   **

## Hepatitis B Vaccine

**Composition****	****Recombinant HBsAg**** **
**Efficacy****	****	****95% (Range, 80%-100%)**** **
**Duration of****Immunity****	****	**_**>**_**15 years**** **
**Schedule****	****	****3 Doses**

## Hepatitis B Vaccine Formulations

**Recombivax HB (Merck)**** - 5 mcg/0.5 mL (pediatric)**** - 10 mcg/1 mL (adult)**** - 40 mcg/1 mL (dialysis)**** **
**Engerix-B (GSK)**** - 10 mcg/0.5 mL (pediatric)**** - 20 mcg/1 mL (adult)**

## Recommended Dose of Hepatitis B Vaccine

**Infants and children**
**<11 years of age**
**Adolescents 11-19 years**
**Adults **_**>**_**20 years**

- Recombivax HB
_**Dose (mcg)**_
**0.5 mL (5)**
**0.5 mL (5)**
**1.0 mL (10)**

- Engerix-B
_**Dose (mcg)**_
**0.5 mL (10)**
**0.5 mL (10)**
**1.0 mL (20)**

## Hepatitis B VaccineLong-term Efficacy

**Immunologic memory established following vaccination**
**Exposure to HBV results in anamnestic anti-HBs response**
**Chronic infection rarely documented among vaccine responders**

## Hepatitis B Vaccine

**Routine booster doses are **_**NOT**_** routinely recommended for any group**

## Hepatitis B Vaccine Indications

**Infants beginning at birth**
**Adolescents through 18 years of age **
**Adults at increased risk of HBV infection **

## 
Dose+

Primary 1
Primary 2
Primary 3  

_**Dose+**_
**Primary 1**
**Primary 2**
**Primary 3  **

_**Usual Age**_
**    **
**	****Birth   **
**	****1- 2 months**
**	****6-18 months***

**Minimum**
_**Interval**_
**- - -**
**  ****4 weeks**
**  ****8 weeks****

- Hepatitis B Vaccine
- Routine Infant Schedule

***  infants who mothers are HBsAg+ or whose HBsAg status is**
**   ****unknown should receive the third dose at 6 months of age**
**** at least 16 weeks after the first dose**
**+an additional dose at 4 months is acceptable if the clinician prefers to use a combination vaccine that contains hepatitis B vaccine**

## Third Dose of Hepatitis B Vaccine

**Minimum of 8 weeks after second dose, **_**and**_
**At least 16 weeks after first dose, **_**and**_
**For infants, at least 24 weeks of age**

## Preterm Infants

**Preterm infants <2,000 grams have a decreased response to vaccine administered before 1 month of age **
**Delay first dose until chronologic age 1 month if mother **_**documented**_** to be HBsAg negative**
**Postexposure management must be started immediately if the mother is HBsAg positive, or if the mother’s HBsAg status is not known **

## COMVAX

**Hepatitis B-Hib combination**
**Use when either antigen is indicated**
**Cannot administer to infants younger than 6 weeks of age**
**May be used in infants whose mothers are HBsAg positive or status is unknown**

## Pediarix

**DTaP– IPV – Hep B combination**
**Approved for 3 doses at 2, 4 and 6 months**
**Minimum age for first dose is 6 weeks**
**May be used in infants whose mothers are HBsAg positive or status is unknown**

**Notes:**
In December 2002, the US Food and Drug Administration approved a new combination vaccine- Pediarix- which is manufactured by Glaxo Smith Kline. This vaccine contains DTaP, inactivated polio and hepatitis B vaccines. The DTaP component is Infanrix, and the hepatitis B component is Engerix-B, which were previously licensed in the U.S.

Pediarix is approved for the first three doses of the DTAP and IPV series, which are usually given at about 2, 4, and 6 months of age. However, Pediarix is approved for use through 6 years of age. 

The minimum age for the first dose of Pediarix is 6 weeks. So it can’t be used for the birth dose of the hepatitis B series. 

## Pediarix

**May be used interchangeably with other pertussis-containing vaccines if necessary**
**Can be given at 2, 4, and 6 months to infants who received a birth dose of hepatitis B vaccine (total of 4 doses)**
**May be used in infants whose mothers are HBsAg positive or status unknown **

**Notes:**
Interchangeable

Can be used after a birth dose of heaptitis B – total of 4 doses O.K.

Pediarix may be used in infants born to women who are hepatitis B surface antigen positive or whose hepatitis B status is unknown. 

Like COMVAX, Pediarix is not approved for this use. But at it’s February 2003 meeting, ACIP voted to allow the use of Pediarix to complete the hepatitis B series in these infants. But remember that the minimum age for Pediarix is 6 weeks, so it must NOT be used for the birth or one month dose of the hepatitis B series.

Another important fact to remember about Pediarix is that the minimum intervals between doses are dictated by the single antigen with the longest minimum intervals. Therefore, Pediarix minimum intervals are determined by the hepatitis B component. 

As for hepatitis B vaccine, the minimum interval between the first two doses of Pediarix is 4 weeks. The third dose must be administered at least 8 weeks after the second dose, and should follow the first dose by at least 16 weeks. The third dose should not be given before 6 months of age to be counted as a valid third dose of hepatitis B vaccine. 

## Twinrix

**Combination hepatitis B (adult dose) and hepatitis A vaccine (pediatric dose)**
**3-dose series at 0, 1, 6-12 months**
**Approved for persons 18 years of age and older**
**Can be used interchangeably with monovalent hepatitis B and hepatitis A vaccine**

## Dose

Primary 1
Primary 2
Primary 3  

**Primary 1**
**Primary 2**
**Primary 3  **

** ****Minimum**
_**Interval**_
**- - -   **
** ****	****4 weeks**
** ****	****8 weeks***

**   ****Usual**
**  **_**Interval**_
**      ****---**
**1 month**
**5 months**

**Hepatitis B Vaccine**
**Adolescent and Adult Schedule**

***third dose must be separated from**
** ****first dose by at least 16 weeks**

## Alternative Adolescent Vaccination Schedule

**Two 1.0 mL (10 mcg) doses of Recombivax HB separated by ****4-6 months**
**Approved only for adolescents  11 through 15 years of age**
**Only applies to Merck hepatitis B vaccine**

## Postvaccination Serologic Testing

**Not routinely recommended following vaccination of infants, children, adolescents, or most adults**
**Recommended for:**
**hemodialysis patients**
**immunocompromised persons**
**Sex partners of persons with chronic HBV infection**
**certain healthcare personnel **

## Postvaccination Serologic Testing

**	****Healthcare personnel ****who have contact with patients or blood and are at ongoing risk for injuries with sharp instruments or needles should be tested for antibody after vaccination **

## Management of Nonresponse to Hepatitis B Vaccine

**Complete a second series of three doses**
**Should be given on the usual schedule of 0, 1 and 6 months**
**Retest 1-2 months after completing the second series**

## Hepatitis B VaccineAdverse Reactions

**Pain at injection site**
**Mild systemic complaints****(fatigue, headache)**
**Temperature ****≤****99.9****°****F ****(37.7****°****C)**
**Severe systemic reactions**

_**Adults**_
**13%-29%**
**11%-17%**
**1%**
**rare**

**Infants and **_**Children**_
**3%-9%**
**0%-20%**
**0.4%-6%**
**rare**

## Hepatitis B VaccineContraindications and Precautions

**Severe allergic reaction to a vaccine component or following a prior dose**
**Moderate or severe acute illness**** **

## Prevention of Perinatal Hepatitis B Virus Infection

**Begin treatment within 12 hours of birth**
**Hepatitis B vaccine (first dose) and HBIG at different sites**
**Complete vaccination series at 6 months of age**
**Test for anti-HBs and HBsAg at 9 to 18 months of age**

## National Immunization ProgramContact Information

**Telephone****	****	****800.CDC.INFO**** **
**Email****	****	****	****nipinfo@cdc.gov**** **
**Website****	****	****www.cdc.gov/nip**