antibody testing at least 3 months after completion of

immunisation.

Advice on the management of cases, carriers, contacts and

outbreaks must be sought from health protection units. The

immunisation history of infected individuals and their

contacts should be determined; those who have been

incompletely immunised should complete their

immunisation and fully immunised individuals should

receive a reinforcing dose. See advice on antibacterial

treatment to prevent a secondary case of diphtheria in a

non-immune individual.

Useful Resources

Advice reflects that in the handbook Immunisation against

Infectious Disease (2013), which in turn reflects the guidance

of the Joint Committee on Vaccination and Immunisation

(JCVI). The advice also incorporates changes announced by

the Chief Medical Officer and Health Department Updates.

Chapters from the handbook (including updates since 2013)

are available at:

www.gov.uk/government/collections/immunisation-againstinfectious-disease-the-green-book

Haemophilus influenzae type B

conjugate vaccine

Overview

Haemophilus influenzae type b (Hib) vaccine is made

from capsular polysaccharide; it is conjugated with a protein

such as tetanus toxoid to increase immunogenicity,

especially in young children. Haemophilus influenzae type b

vaccine immunisation is given in combination with

diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis

vaccine (Infanrix hexa ®), as a component of the primary

course of childhood immunisation (see Immunisation

schedule). For infants under 1 year, the course consists of

3 doses of a vaccine containing Haemophilus influenzae type

b component with an interval of 1 month between doses. A

booster dose of Haemophilus influenzae type b vaccine

(combined with meningococcal group C conjugate vaccine)

should be given at 1 year of age, on or after the child’s first

birthday.

Children 1–10 years who have not been immunised against

Haemophilus influenzae type b need to receive only 1 dose of

Haemophilus influenzae type b vaccine (combined with

meningococcal group C conjugate vaccine). However, if a

primary course of immunisation has not been completed,

children born before August 2017 should be given 3 doses of

the combined vaccine they were started on. The risk of

infection falls sharply in older children and the vaccine is not

normally required for children over 10 years.

Haemophilus influenzae type b vaccine may be given to

those over 10 years who are considered to be at increased

risk of invasive H. influenzae type b disease (such as those

with sickle-cell disease or complement deficiency, or those

receiving treatment for malignancy).

Invasive Haemophilus influenzae type b disease

After recovery from infection, unimmunised and partially

immunised index cases under 10 years of age should

complete their age-specific course of immunisation.

Previously vaccinated cases under 10 years of age should be

given an additional dose of haemophilus influenzae type b

vaccine (combined with meningococcal group C conjugate

vaccine) if Hib antibody concentrations are low or if it is not

possible to measure antibody concentrations. Index cases of

any age with asplenia or splenic dysfunction should

complete their immunisation according to the

recommendations below; fully vaccinated cases with

asplenia or splenic dysfunction should be given an additional

dose of haemophilus influenzae type b vaccine (combined

with meningococcal group C conjugate vaccine) if they

received their previous dose over 1 year ago.

See also use of rifampicin p. 582 in the prevention of

secondary cases of Haemophilus influenzae type b disease.

Useful Resources

Advice reflects that in the handbook Immunisation against

Infectious Disease (2013), which in turn reflects the guidance

of the Joint Committee on Vaccination and Immunisation

(JCVI). The advice also incorporates changes announced by

the Chief Medical Officer and Health Department Updates.

Chapters from the handbook (including updates since 2013)

are available at:

www.gov.uk/government/collections/immunisation-againstinfectious-disease-the-green-book

Hepatitis A vaccine

Overview

Hepatitis A vaccine p. 1318 is prepared from formaldehydeinactivated hepatitis A virus grown in human diploid cells.

Immunisation is recommended for:

. laboratory staff who work directly with the virus;

. staff and residents of homes for those with severe learning

difficulties;

. workers at risk of exposure to untreated sewage;

. individuals who work with primates;

. patients with haemophilia or other conditions treated with

plasma-derived clotting factors;

. patients with severe liver disease;

. travellers to high-risk areas;

. individuals who are at risk due to their sexual behaviour;

. parenteral drug abusers.

Immunisation should be considered for:

. patients with chronic liver disease including chronic

hepatitis B or chronic hepatitis C;

. prevention of secondary cases in close contacts of

confirmed cases of hepatitis A, within 14 days of exposure

to the primary case (within 8 weeks of exposure to the

primary case where there is more than 1 contact in the

household).

A booster dose is usually given 6–12 months after the

initial dose. A second booster dose can be given 20 years

after the previous booster dose to those who continue to be

at risk. Specialist advice should be sought on reimmunisation of immunocompromised individuals.

For rapid protection against hepatitis A after exposure or

during an outbreak, in adults a single dose of a monovalent

vaccine is recommended; for children under 16 years, a

single dose of the combined vaccine Ambirix ® can also be

used.

Public Health England recommends the use of

intramuscular normal immunoglobulin p. 1290 in addition to

hepatitis A vaccine for prevention of infection in close

contacts (of confirmed cases of hepatitis A) who are 60 years

of age or over, have chronic liver disease, or HIV infection, or

who are immunosuppressed. For further guidance, see

Immunoglobulins p. 1287.

Post-exposure prophylaxis is not required for healthy

children under 1 year of age, so long as all those involved in

nappy changing are vaccinated against hepatitis A. However,

children 2–12 months of age can be given a dose of hepatitis

A vaccine if it is not possible to vaccinate their carers, or if

the child becomes a source of infection to others [unlicensed

use]; in these cases, if the child goes on to require long-term

protection against hepatitis A after the first birthday, the full

course of 2 doses should be given.

BNF 78 Vaccination 1299

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Useful Resources

Advice reflects that in the handbook Immunisation against

Infectious Disease (2013), which in turn reflects the guidance

of the Joint Committee on Vaccination and Immunisation

(JCVI). The advice also incorporates changes announced by

the Chief Medical Officer and Health Department Updates.

Chapters from the handbook (including updates since 2013)

are available at:

www.gov.uk/government/collections/immunisation-againstinfectious-disease-the-green-book

Hepatitis B vaccine

Overview

Hepatitis B vaccine p. 1319 contains inactivated hepatitis B

virus surface antigen (HBsAg) adsorbed onto an adjuvant. It

is made biosynthetically using recombinant DNA

technology.

From August 2017, vaccination against hepatitis B is

recommended as part of the routine immunisation

schedule. Primary immunisation (see Routine immunisation

schedule) requires 3 doses, administered at intervals of

1 month from the age of 2 months, to be given as part of the

combined diphtheria with tetanus, pertussis, hepatitis B,

poliomyelitis and haemophilus influenzae type b vaccine

p. 1312 (Infanrix hexa ®).

As part of the selective neonatal immunisation

programme, vaccination is recommended for neonates

whose mothers have had acute hepatitis B during pregnancy

or are positive for hepatitis B surface antigen (regardless of

e-antigen markers). Hepatitis B vaccination is started

immediately after birth with a dose of the monovalent

hepatitis B vaccine (no later than 24 hours after delivery),

followed by a second dose at 4 weeks; the routine

immunisation combination vaccine (Infanrix hexa ®) at weeks

8, 12 and 16; and a further dose of the monovalent hepatitis

B vaccine at one year of age.

Neonates born to highly infectious mothers should also

receive hepatitis B immunoglobulin p. 1290 at the same time

as the first dose of monovalent hepatitis B vaccine, but

administered at a different site—more detailed guidance is

given in the handbook Immunisation against Infectious

Disease (www.gov.uk/government/publications/hepatitis-b-thegreen-book-chapter-18).

Following significant exposure to hepatitis B (e.g.

through needle-stick injury or unprotected sex) and for preexposure prophylaxis in high-risk groups, an ’accelerated

schedule’ using the single, monovalent hepatitis B vaccine is

recommended immediately, with the second dose given

1 month after the initial dose, and the third dose given

2 months after the initial dose. For those at continued high

risk following exposure, a fourth dose should be given

12 months after the first dose. More detailed guidance is

given in the handbook Immunisation against Infectious

Disease.

Specific hepatitis B immunoglobulin can also be indicated

for use with the vaccine in those accidentally inoculated and

in neonates at special risk of infection. If hepatitis B

immunoglobulin is indicated, it should be given as soon as

possible, ideally at the same time or within 24 hours of the

first dose of vaccine, but not after seven days have elapsed

since exposure. See also Hepatitis B immunoglobulin in

Immunoglobulins p. 1287.

In the UK, groups at high-risk of hepatitis B include:

. parenteral drug misusers, their sexual partners, and

household contacts; other drug misusers who are likely to

‘progress’ to injecting;

. individuals who change sexual partners frequently;

. close family contacts of a case or individual with chronic

hepatitis B infection;

. individuals with haemophilia, those receiving regular

blood transfusions or blood products, and carers

responsible for the administration of such products;

. patients with chronic renal failure including those on

haemodialysis. Haemodialysis patients should be

monitored for antibodies annually and re-immunised if

necessary. Home carers (of dialysis patients) should be

vaccinated;

. individuals with chronic liver disease;

. healthcare personnel (including trainees) who have direct

contact with blood or blood-stained body fluids or with

patients’ tissues;

. laboratory staff who handle material that may contain the

virus;

. other occupational risk groups such as morticians and

embalmers;

. staff and patients of day-care or residential

accommodation for those with severe learning difficulties;

. staff and inmates of custodial institutions;

. those travelling to areas of high or intermediate

prevalence who are at increased risk or who plan to remain

there for lengthy periods;

. families adopting children from countries with a high or

intermediate prevalence of hepatitis B;

. foster carers and their families.

Following a primary course of immunisation, most people

do not require a reinforcing dose of a hepatitis B-containing

vaccine. A single booster dose should be offered to

healthcare workers approximately five years after primary

immunisation, to patients on renal dialysis with anti-HBs

levels below 10mlU/mL, and at the time of a subsequent

significant exposure.

Immunisation does not eliminate the need for

commonsense precautions for avoiding the risk of infection

from known carriers by the routes of infection which have

been clearly established, consult Guidance for Clinical Health

Care Workers: Protection against Infection with Blood-borne

Viruses (available at www.dh.gov.uk/

). Accidental inoculation of hepatitis B virus-infected

blood into a wound, incision, needle-prick, or abrasion may

lead to infection, whereas it is unlikely that indirect

exposure to a carrier will do so.

A combined hepatitis A and B vaccine p. 1317 is also

available.

Useful Resources

Advice reflects that in the handbook Immunisation against

Infectious Disease (2013), which in turn reflects the guidance

of the Joint Committee on Vaccination and Immunisation

(JCVI). The advice also incorporates changes announced by

the Chief Medical Officer and Health Department Updates.

Chapters from the handbook (including updates since 2013)

are available at:

www.gov.uk/government/collections/immunisation-againstinfectious-disease-the-green-book

Human papillomavirus vaccine

Overview

Human papillomavirus vaccine is available as a bivalent

vaccine (Cervarix ®) or a quadrivalent vaccine (Gardasil ®).

Since 2012, only Gardasil ® is offered as part of the national

immunisation programme. Cervarix ® is licensed for use in

females for the prevention of cervical cancer and other precancerous lesions caused by human papillomavirus types 16

and 18. Gardasil is licensed for use in females for the

prevention of cervical and anal cancers, genital warts and

pre-cancerous genital (cervical, vulvar, and vaginal) and anal

lesions caused by human papillomavirus types 6, 11, 16, and

18. The vaccines may also provide limited protection against

1300 Vaccination BNF 78

Vaccines

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disease caused by other types of human papillomavirus. The

two vaccines are not interchangeable and one vaccine

product should be used for an entire course.

Human papillomavirus vaccine will be most effective if

given before sexual activity starts. From September 2014, a

2-dose schedule is recommended, as long as the first dose is

received before the age of 15 years. The first dose is given to

females aged 11 to 14 years, and the second dose is given

6–24 months after the first dose (for the purposes of

planning the national immunisation programme, it is

appropriate to give the second dose 12 months after the

first—see Immunisation schedule). If the course is

interrupted, it should be resumed (using the same vaccine)

but not repeated, even if more than 24 months have elapsed

since the first dose or if the girl is then aged 15 years or

more.

Females receiving their first dose aged 15 years or older

require a 3-dose schedule (see Cervarix ® and Gardasil ®),

with the second and third doses given 1 and 4–6 months

after the first dose; all 3 doses should be given within a

12-month period. If the course is interrupted, it should be

resumed (using the same vaccine) but not repeated, allowing

the appropriate interval between the remaining doses.

If a 3-dose course of vaccination had been started before

September 2014 in a female aged under 15 years, then where

possible this should be completed; the interrupted course

should be resumed (using the same vaccine) but not

repeated, allowing the appropriate interval between the

remaining doses.

Under the national programme in England, females remain

eligible to receive the human papillomavirus vaccine up to

the age of 18 years if they did not receive the vaccine when

scheduled. Where appropriate, immunisation with human

papillomavirus vaccine should be offered to females coming

into the UK as they may not have been offered protection in

their country of origin. The duration of protection has not

been established, but current studies suggest that protection

is maintained for at least 6 years after completion of the

primary course.

As the vaccines do not protect against all strains of human

papillomavirus, routine cervical screening should continue.

Useful Resources

Advice reflects that in the handbook Immunisation against

Infectious Disease (2013), which in turn reflects the guidance

of the Joint Committee on Vaccination and Immunisation

(JCVI). The advice also incorporates changes announced by

the Chief Medical Officer and Health Department Updates.

Chapters from the handbook (including updates since 2013)

are available at:

www.gov.uk/government/collections/immunisation-againstinfectious-disease-the-green-book

Influenza vaccine 23-Apr-2019

Overview

While most viruses are antigenically stable, the influenza

viruses A and B (especially A) are constantly altering their

antigenic structure as indicated by changes in the

haemagglutinins (H) and neuraminidases (N) on the surface

of the viruses. It is essential that influenza vaccine p. 1322 in

use contain the H and N components of the prevalent strain

or strains as recommended each year by the World Health

Organization.

The influenza vaccines recommended for immunisation

are the adjuvanted trivalent influenza vaccine (inactivated),

high dose trivalent influenza vaccine (inactivated), cellgrown quadrivalent influenza vaccine (inactivated), standard

egg-grown quadrivalent influenza vaccine (inactivated), and

live attenuated influenza vaccine. The choice of vaccine is

dependent on the person’s age and contra-indications.

The ideal time for immunisation is between September and

early November.

Immunisation is recommended for people at high risk from

influenza, and to reduce transmission of infection. Annual

immunisation is strongly recommended for individuals aged