Vaccines and antisera 667

14.4 Vaccines and antisera 667

14 Immunologic

al prod

ucts and

vac cines

14.4 Vaccines and antisera BNF 57

Hepatitis A vaccine

deltoid region is the preferred site of injection. The subcutaneous route may be used for patients with bleeding disorders

Hepatitis A vaccine is prepared from formaldehyde-

contains influenza virus haemagglutinin inactivated hepatitis A virus grown in human diploid

Important Epaxal

grown in the allantoic cavity of chick embryos, therefore contra-

cells. indicated in those hypersensitive to eggs or chicken protein. Immunisation is recommended for:

Havrix Monodose c (GSK) A .

laboratory staff who work directly with the virus; Injection , suspension of formaldehyde-inactivated hepatitis A virus (HM 175 grown in human diploid

. staff and residents of homes for those with severe cells) 1440 ELISA units/mL adsorbed onto aluminium learning difficulties;

hydroxide, net price 1-mL prefilled syringe = £22.14, .

workers at risk of exposure to untreated sewage; 0.5-mL (720 ELISA units) prefilled syringe (Havrix individuals who work with primates;

Junior Monodose . c ) = £16.77 Excipients . include neomycin patients with haemophilia treated with plasma-

Dose by intramuscular injection (see note below), ADULT and derived clotting factors;

CHILD over 16 years, 1 mL as a single dose; booster dose, 1 mL 6– .

patients with severe liver disease; 12 months after initial dose; CHILD 1–15 years 0.5 mL; booster dose, 0.5 mL 6–12 months after initial dose .

travellers to high-risk areas (see p. 684); Note Booster dose may be delayed by up to 3 years if not given .

individuals who are at risk due to their sexual after recommended interval following primary dose with Havrix behaviour;

Monodose . The deltoid region is the preferred site of injection. The subcutaneous route may be used for patients with bleeding

. parenteral drug abusers.

disorders

Immunisation should be considered for : Vaqta c Paediatric (Sanofi Pasteur) A .

patients with chronic liver disease including chronic Injection , suspension of formaldehyde-inactivated hepatitis B or chronic hepatitis C;

hepatitis A virus (grown in human diploid cells) .

50 antigen units/mL adsorbed onto aluminium confirmed cases of hepatitis A, within 7 days of

hydroxyphosphate sulphate, net price 0.5-mL prefilled onset of disease in the primary case.

prevention of secondary cases in close contacts of

syringe = £15.65 Excipients include neomycin

A booster dose is usually given 6–12 months after the Dose by intramuscular injection (see note below) CHILD 1–17 initial dose. A second booster dose can be given 20

years, 0.5 mL as a single dose; booster dose 0.5 mL 6–18 months years after the previous booster dose to those who

after initial dose; under 1 year, not recommended continue to be at risk. Specialist advice should be sought

Note The deltoid region is the preferred site of injection. The on re-immunisation of immunocompromised indivi-

subcutaneous route may be used for patients with bleeding dis-

cines orders (but immune response may be reduced)

duals.

vac

With hepatitis B vaccine Ambirix c (GSK) TA

and HEPATITIS A VACCINE

Injection , suspension of inactivated hepatitis A virus Indications immunisation against hepatitis A infection

(grown in human diploid cells) 720 ELISA units/mL Cautions

adsorbed onto aluminium hydroxide, and recombi-

oducts see section 14.1

nant (DNA) hepatitis B surface antigen (grown in yeast pr Contra-indications see section 14.1

cells) 20 micrograms/mL adsorbed onto aluminium al Side-effects see section 14.1; for combination vac-

phosphate, net price 1-mL prefilled syringe = £31.18 cines, see also Typhoid vaccine, p. 679

Excipients include neomycin and traces of thiomersal

Dose Dose CHILD 1–15 years, by intramuscular injection (see note . below); primary course, 2 doses of 1 mL, the second 6–12 months See under preparations

unologic after initial dose

Note Primary course should be completed with Ambirix (single Single component

Imm component vaccines given at appropriate intervals may be used

Avaxim c (Sanofi Pasteur) A for booster dose); the deltoid region is the preferred site of Injection , suspension of formaldehyde-inactivated

injection in older children; anterolateral thigh is the preferred site

14 in infants; not to be injected into the buttock (vaccine efficacy

hepatitis A virus (GBM grown in human diploid cells) reduced); subcutaneous route used for patients with bleeding 320 antigen units/mL adsorbed onto aluminium

disorders (but immune response may be reduced) hydroxide, net price 0.5-mL prefilled syringe = £19.19

is not recommended for post-exposure Excipients include neomycin

Important Ambirix

prophylaxis following percutaneous (needle-stick), ocular, or Dose by intramuscular injection (see note below), ADULT and

mucous membrane exposure to hepatitis B virus CHILD over 16 years, 0.5 mL as a single dose; booster dose 0.5 mL

Twinrix 6–12 months after initial dose c (GSK) A Note Booster dose may be delayed by up to 3 years if not given

Injection , inactivated hepatitis A virus (grown in after recommended interval following primary dose with

human diploid cells) 720 ELISA units adsorbed onto Avaxim . The deltoid region is the preferred site of injection. The

aluminium hydroxide and recombinant (DNA) hepat- subcutaneous route may be used for patients with bleeding disorders; not to be injected into the buttock (vaccine efficacy

itis B surface antigen (grown in yeast cells) 20 micr- reduced)

ograms/mL adsorbed onto aluminium phosphate, net price 1-mL prefilled syringe (Twinrix c Adult ) = £27.76, Epaxal c (MASTA) A 0.5-mL prefilled syringe (Twinrix c Paediatric ) = £20.79 Injection , suspension of formaldehyde-inactivated

Excipients include neomycin and traces of thiomersal

hepatitis A virus (RG-SB grown in human diploid cells) Dose by intramuscular injection (see note below); ADULT and at least 48 units/mL, net price 0.5-mL prefilled

CHILD over 16 years, primary course of 3 doses of 1 mL, the second 1 month and the third 6 months after the first dose; syringe = £23.81 CHILD 1–15 years, 3 doses of 0.5 mL Dose by intramuscular injection (see note below), ADULT and

Accelerated schedule (e.g. for travellers departing within 1 CHILD over 1 year, 0.5 mL as a single dose; booster dose 0.5 mL 6–

month), ADULT , second dose 7 days after first dose, third dose after 12 months after initial dose (1–6 months if splenectomised)

further 14 days and a fourth dose 12 months after the first dose Note Booster dose may be delayed by up to 4 years in adults if not

Note Primary course should be completed with Twinrix (single given after recommended interval following primary dose. The

component vaccines given at appropriate intervals may be

BNF 57

14.4 Vaccines and antisera 669

used for booster dose); the deltoid region is the preferred site of injection in adults and older children; anterolateral thigh is

individuals with haemophilia, those receiving reg- preferred site in infants; not to be injected into the buttock

ular blood transfusions or blood products, and (vaccine efficacy reduced); subcutaneous route used for patients

carers responsible for the administration of such with bleeding disorders (but immune response may be reduced).

products;

Important Twinrix not recommended for post-exposure prophy- laxis following percutaneous (needle-stick), ocular or mucous

patients with chronic renal failure including those membrane exposure to hepatitis B virus.

on haemodialysis. Haemodialysis patients should be monitored for antibodies annually and re-immu- nised if necessary. Home carers (of dialysis patients)

With typhoid vaccine Hepatyrix c

should be vaccinated;

Injection individuals with chronic liver disease; , suspension of inactivated hepatitis A virus

(GSK) A .

(grown in human diploid cells) 1440 ELISA units/mL

healthcare personnel (including trainees) who have adsorbed onto aluminium hydroxide, combined with

direct contact with blood or blood-stained body typhoid vaccine containing 25 micrograms/mL viru-

fluids or with patients’ tissues; lence polysaccharide antigen of Salmonella typhi, net

laboratory staff who handle material that may con- price 1-mL prefilled syringe = £32.08 Excipients

tain the virus;

include neomycin Dose by intramuscular injection (see note below), ADULT and

other occupational risk groups such as morticians CHILD over 15 years, 1 mL as a single dose; booster doses, see

and embalmers;

under single component hepatitis A vaccine (above) and under polysaccharide typhoid vaccine, p. 679

staff and patients of day-care or residential accom- Note The deltoid region is the preferred site of injection. The

modation for those with severe learning difficulties; subcutaneous route may be used for patients with bleeding dis-

orders; not to be injected into the buttock (vaccine efficacy

staff and inmates of custodial institutions; reduced)

those travelling to areas of high or intermediate prevalence who are at increased risk or who plan ViATIM c (Sanofi Pasteur) A to remain there for lengthy periods (see p. 684);

Injection , suspension of inactivated hepatitis A virus (grown in human diploid cells) 160 antigen units/mL

families adopting children from countries with a adsorbed onto aluminium hydroxide, combined with

high or intermediate prevalence of hepatitis B; typhoid vaccine containing 25 micrograms/mL viru-

foster carers and their families. lence polysaccharide antigen of Salmonella typhi, net

Different immunisation schedules for hepatitis B price 1-mL prefilled syringe = £30.22 Excipients include neomycin

vaccine are recommended for specific circumstances Dose by intramuscular injection (see note below), ADULT and

(see under individual preparations). Generally, three or CHILD over 16 years, 1 mL as a single dose; booster doses, see

four doses are required for primary immunisation; an under single component hepatitis A vaccine (above) and under

‘accelerated schedule’ is recommended for pre-expo- polysaccharide typhoid vaccine, p. 679

sure prophylaxis in high-risk groups where rapid protec- Note The deltoid region is the preferred site of injection. The subcutaneous route may be used for patients with bleeding dis-

tion is required, and for post-exposure prophylaxis (see orders; not to be injected into the buttock (vaccine efficacy

below).

reduced) Immunisation may take up to 6 months to confer adequate protection; the duration of immunity is not known precisely, but a single booster 5 years after the primary course may be sufficient to maintain immunity

Hepatitis B vaccine

for those who continue to be at risk. Hepatitis B vaccine contains inactivated hepatitis B

Immunisation does not eliminate the need for common- virus surface antigen (HBsAg) adsorbed on aluminium

sense precautions for avoiding the risk of infection from hydroxide adjuvant. It is made biosynthetically using

known carriers by the routes of infection which have recombinant DNA technology. The vaccine is used in

been clearly established, consult Guidance for Clinical

individuals at high risk of contracting hepatitis B. Health Care Workers: Protection against Infection with Blood-borne Viruses (available at www.dh.gov.uk ). Acci-

Immunologic

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

dental inoculation of hepatitis B virus-infected blood .

parenteral drug misusers, their sexual partners, and into a wound, incision, needle-prick, or abrasion may household contacts; other drug misusers who are

lead to infection, whereas it is unlikely that indirect likely to ’progress’ to injecting;

exposure to a carrier will do so. .

individuals who change sexual partners frequently; Following significant exposure to hepatitis B, an accel- erated schedule, with the second dose given 1 month,

al

. close family contacts of a case or carrier; and the third dose 2 months after the first dose, is

prod

. babies whose mothers have had acute hepatitis B recommended. For those at continued risk, a fourth during pregnancy or are positive for hepatitis B

ucts

dose should be given 12 months after the first dose.

surface antigen (regardless of e-antigen markers); More detailed guidance is given in the memorandum hepatitis B vaccination is started immediately on

Immunisation against Infectious Disease .

and

delivery and hepatitis B immunoglobulin (see p. 682) given at the same time (but preferably at a different

Specific hepatitis B immunoglobulin (‘HBIG’) is avail-

vac

site). Babies whose mothers are positive for hepat- able for use with the vaccine in those accidentally inoculated and in neonates at special risk of infection

cines

itis B surface antigen and for e-antigen antibody should receive the vaccine only (but babies weigh-

(section 14.5).

ing 1.5 kg or less should also receive the immuno-

A combined hepatitis A and hepatitis B vaccine is also globulin regardless of the mother’s e-antigen anti-

available.

body status);

14.4 Vaccines and antisera BNF 57

(5-microgram) prefilled syringe = £9.50, 1-mL (10- Indications

HEPATITIS B VACCINE

microgram) prefilled syringe = £12.95; 40 micr- immunisation against hepatitis B infection

ograms/mL, 1-mL (40-microgram) vial = £29.30 Cautions see section 14.1

Dose by intramuscular injection (see note below), ADULT and Contra-indications see section 14.1

CHILD over 16 years, 3 doses of 10 micrograms, the second 1 Side-effects

month and the third 6 months after the first dose; see section 14.1 CHILD under 16 years, 3 doses of 5 micrograms Dose

Accelerated schedule (all ages), second dose 1 month after first . See under preparations

dose, third dose 2 months after first dose with fourth dose at 12 months

Single component Booster doses may be required in immunocompromised patients

c Engerix B with low antibody concentration (GSK) A NEONATE born to hepatitis B surface antigen-positive mother (see Injection , suspension of hepatitis B surface antigen

also notes above), 5 micrograms, first dose at birth with hepatitis B (prepared from yeast cells by recombinant DNA

immunoglobulin injection (separate site), the second 1 month, the technique) 20 micrograms/mL adsorbed onto alu-

third 2 months and the fourth 12 months after the first dose minium hydroxide, net price 0.5-mL (paediatric) vial =

Chronic haemodialysis patients, by intramuscular injection (see £9.16, 0.5-mL (paediatric) prefilled syringe = £9.67, 1- note below) 3 doses of 40 micrograms, the second 1 month and mL vial = £12.34, 1-mL prefilled syringe = £12.99 the third 6 months after the first dose; booster doses may be

required in those with low antibody concentration Excipients include traces of thiomersal

Note Deltoid muscle is preferred site of injection in adults and Dose by intramuscular injection (see note below), ADULT and

older children; anterolateral thigh is preferred site in neonates and CHILD over 16 years, 3 doses of 20 micrograms, the second 1

infants; not to be injected into the buttock (vaccine efficacy month and the third 6 months after the first dose; NEONATE

reduced)

(except if born to hepatitis B surface antigen positive mother, see below) and CHILD

1 month–16 years, 3 doses of 10 micrograms Accelerated schedule (all ages), second dose 1 month after first

With hepatitis A vaccine dose, third dose 2 months after first dose and fourth dose 12

months after first dose; exceptionally (e.g. for travellers departing See Hepatitis A Vaccine

within 1 month), ADULT over 18 years, second dose 7 days after first dose, third dose 21 days after first dose, and fourth dose 12 months after first dose Alternative schedule for CHILD 11–15 years, 2 doses of 20 micr-

Human papilloma virus vaccines

Human papilloma virus vaccine is available as a compliance with second dose uncertain)

ograms, the second dose 6 months after the first dose (this schedule not suitable if high risk of infection between doses or if

bivalent vaccine (Cervarix c ) or a quadrivalent vaccine NEONATE born to hepatitis B surface antigen-positive mother (see

(Gardasil c ). Cervarix c is licensed for use in females for

cines

also notes above), 4 doses of 10 micrograms, first dose at birth the prevention of cervical cancer and other pre- with hepatitis B immunoglobulin injection (separate site) the

vac cancerous lesions caused by human papilloma virus second 1 month, the third 2 months and the fourth 12 months after

the first dose types 16 and 18. Gardasil c is licensed for use in females

and

Renal insufficiency (including haemodialysis patients), by intra- for the prevention of cervical cancer, genital warts and muscular injection (see note below), ADULT and CHILD over 16

pre-cancerous lesions caused by human papilloma virus years, 4 doses of 40 micrograms, the second 1 month, the third 2

types 6, 11, 16, and 18. The two vaccines are not months and the fourth 6 months after the first dose; immunisation schedule and booster doses may need to be adjusted in those with

oducts interchangeable and one vaccine product should be

pr used for an entire course. However, the Department of

al Health (November 2008) states that for individuals with

low antibody concentration; NEONATE (except if born to hepatitis

B surface antigen positive mother, see above) and CHILD

1 month–

16 years 3 doses of 10 micrograms, second dose 1 month and third previous incomplete vaccination with Gardasil c , who dose 6 months after first dose or accelerated schedule, 4 doses of 10 micrograms, second dose 1 month, third dose 2 months and

are eligible for HPV vaccination under the national programme, Cervarix fourth dose 12 months after first dose; immunisation schedule and c can be used to complete the

unologic

booster doses may need to be adjusted in those with low antibody vaccination course if necessary; the individual must be concentration

informed that Cervarix c does not protect against genital

Imm

Note Deltoid muscle is preferred site of injection in adults and

warts.

older children; anterolateral thigh is preferred site in neonates, infants and young children; not to be injected into the buttock

Human papilloma virus vaccine will be most effective if

14 (vaccine efficacy reduced)

given before sexual activity starts. The first dose is given Fendrix c (GSK) A to females aged 12 to 13 years, the second and third

Injection , suspension of hepatitis B surface antigen doses are given 1–2 and 6 months after the first dose (prepared from yeast cells by recombinant DNA

(see Immunisation schedule, section 14.1); all 3 doses technique) 40 micrograms/mL adsorbed onto alu-

should be given within a 12-month period. If the course minium phosphate, net price 0.5-mL prefilled syringe

is interrupted, it should be resumed but not repeated, = £38.10

allowing the appropriate interval between the remaining

Excipients include traces of thiomersal

doses. Where there are significant challenges in sche- Dose ADULT and CHILD over 15 years with renal insufficiency

duling vaccinations, or a high likelihood that the third (including pre-haemodialysis and haemodialysis patients), by

dose will not be given, the third dose of Cervarix c can be intramuscular injection (see note below) 4 doses of 20 micr-

given 3 months after the second dose. Where appro- ograms, the second 1 month, the third 2 months and the fourth 6 months after the first dose; immunisation schedule and booster

priate, immunisation with human papilloma virus doses may need to be adjusted in those with low antibody

vaccine should be offered to females coming into the concentration

UK as they may not have been offered protection in Note Deltoid muscle is preferred site of injection; not to be

their country of origin. The duration of protection has injected into the buttock (vaccine efficacy reduced)

not been established, but current studies suggest that HBvaxPRO c (Sanofi Pasteur) A protection is maintained for at least 6 years after

Injection , suspension of hepatitis B surface antigen completion of the primary course. (prepared from yeast cells by recombinant DNA

As the vaccines do not protect against all strains of technique) 10 micrograms/mL adsorbed onto alu-

human papilloma virus, routine cervical screening minium hydroxyphosphate sulphate, net price 0.5-mL

should continue.

BNF 57

14.4 Vaccines and antisera 671