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5 Tetanus

Keyupdate

I an injury is considered to be tetanus prone and there is any doubt aboutthe adequacy o previous tetanus immunisation, the individual must have

tetanus-specifc immunoglobulin (TIG) and the recommended primary courseo three doses o a tetanus toxoid-containing vaccine (Td or Tdap the latteris not unded). See Prevention o tetanus ollowing injury, in section 5.5.

Oer a booster dose o Td or someone travelling overseas and it has beenmore than 10 years since the last dose (see section 4.5).

When Tdap is to be given to adolescents or adults to protect inants or othervulnerable individuals rom pertussis, a minimum interval between previousdoses o Td or Tdap does not apply. Available data suggest that there is no

increase in adverse events when tetanus and diphtheria toxoid-containingvaccines are given two years apart compared to when they are given ten ormore years apart.1,2

5.1 Introduction

Tetanus is caused by the action o tetanus toxin released by Clostridiumtetani, a spore-orming gram-positive bacillus. Tetanus has long been knownas the scourge o parturient women, newborn babies and wounded soldiers.

In the 18th century one out o every six inants born at the Rotunda Hospitalin Dublin died rom neonatal tetanus. Hippocrates described tetanus, butthe cause was not recognised until 1884 and the toxin not purifed until1890. The toxoid (chemically inactivated toxin) was frst prepared in 1924.

5.2 Theillness

Tetanus is a clinical diagnosis, and is characterised by muscular rigidityand very painul contraction spasms. When severe it is associated with

a characteristic acial grimace (risus sardonicus) and arching o the back(opisthotonus). The patient suering rom tetanus remains alert unless theybecome severely hypoxic. A toxin produced by Clostridium tetani(a gram-positive, spore-orming, motile, anaerobic bacillus) causes the disease. Thetoxin reaches the central nervous system via the axons and irreversibly bindsto nerve terminals at the neuromuscular junction, blocking the release oinhibitory neurotransmitters and leading to the tetanic muscle spasms.

The incubation period is between 3 and 21 days, commonly about 10

days, but it has been reported to vary rom one day to several months. Thebacteria need an anaerobic environment in which to grow, and this is otenound in damaged and necrotic tissue. Initial symptoms include weakness,stiness or cramps, and difculty chewing or swallowing ood.

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Reflex muscle spasms usually occur within one to our days o the initialsymptoms, the interval being called the onset period. The shorter theincubation and onset periods, the more severe the disease. Even withmodern intensive care tetanus mortality is about 10 percent overall, andmuch higher in older people.

Neonatal tetanus, rom inection o the umbilical stump, is the commonestorm o the disease in non-developed countries.

5.3 Epidemiology

The most common source o environmental exposure to C. tetanispores andbacilli is the soil. However soil is not the only reservoir o the organism.Animals, both herbivores and omnivores, can carry C. tetanibacilli andspores in their intestines and the organism is readily disseminated in their

aeces. Once introduced into the relatively anaerobic conditions ound inwound tissue, they germinate and produce toxin.

Tetanus spores or bacilli can easily be introduced into a wound at thetime o injury, even when the injury is quite trivial. Contaminated wounds,especially wounds with devitalised tissue and deep-puncture trauma, areat greatest risk. The incidence o tetanus reflects the eectiveness o thelocal immunisation programme, with low incidence in regions with highimmunisation coverage.

A person with tetanus is not inectious to others, and vaccination providesindividual protection only, with no herd immunity.

NewZealandepidemiology

Almost all the recent cases o tetanus in New Zealand, in both adults andchildren, occurred in individuals without a documented history o a primaryimmunisation course o a tetanus-containing vaccine. From 2000 to 2010,there were 34 hospitalisations due to tetanus (fve were aged 4049 years

and 23 were aged 60 years and older). Since 1997 a total o 28 tetanuscases have been reported, however not all cases o tetanus are notifed, asillustrated in the hospitalisation data shown in Figure 5.1. O the reportedcases, three cases were children, two aged 14 years and one aged 59years. None o the children were vaccinated. Seven cases o tetanus werenotifed in 2010, a signifcant increase rom the one case reported in 2009,and the highest number o cases since 1992. The age distribution o thesecases were: one case aged 14 years (unvaccinated), one case aged 4049years (last vaccinated in 1995), one case aged 6069 years (vaccination

status unknown) and our cases aged 70 years and older (two not vaccinatedand two o unknown vaccination status). One aged 70 years and older diedrom the disease.

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Tetanus

Figure5.1Tetanushospitalisations19702010,tetanusnotications19802010andtetanusdeaths20012010

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5

10

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20

25

30

Year

Tetanus discharges Tetanus notifications Deaths due to tetanusNumber

1970

1971

1972

1973

1974

1975

1976

1977

1978

1979

1980

1981

1982

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

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2003

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2006

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2010

Source: Ministry o Health

The 200507 National Serosurvey o Vaccine Preventable Diseases oundthat 85 percent o 610-year-olds, 94 percent o 1115-year-olds,95 percent o 1624-year-olds, 95 percent o 2544-year-olds and 89 percentoN 45-year-olds had presumed protective levels o tetanus antibody.3

HistoryoftheNewZealandImmunisationSchedule

The history o tetanus vaccine use prior to the introduction o diphtheria,tetanus and whole-cell pertussis (DTwP) vaccine prior to 1960 is notwell recorded, but tetanus vaccine was widely used in World War II andsubsequently by the armed orces.

In New Zealand, universal inant immunisation with tetanus toxoid began in1960 with the use o three doses o triple vaccine. Anyone born beore 1960is less likely to have received a primary series, unless they were in the armedorces. Older women appear to be at particular risk. The frst scheduled

vaccine used or inants (rom 1960) was the DTwP vaccine, with three dosesat monthly intervals at three, our and fve months o age, and a diphtheriatetanus (DT) booster beore school entry (at fve years o age). A DT boosterat age 18 months was added in 1964, primarily to enhance protectionagainst tetanus. There was a change to a more immunogenic adsorbedvaccine in 1971 and the dose given at age our months was dropped.

In 1980 the dose o DT given at age fve years was replaced by themonovalent tetanus toxoid (TT) given at age 15 years, as part o a move

rom 10-yearly to 20-yearly boosters or tetanus. It was considered thatmore requent boosters were unnecessary and the cause o signifcant localreactions. There was a return to a three-dose primary series o DTwP (by theaddition o a six weeks o age vaccination) in 1984 because two doses had

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been inadequate to control pertussis. In 1996 the booster o adult tetanusdiphtheria vaccine (Td), which had been changed rom TT in 1994 (seebelow), and previously given at age 15 years, was changed to age 11 years.

In 2002 the primary schedule or tetanus, given in combination vaccinesat age six weeks, three months and fve months ollowed by a dose at 15

months, was changed when a urther dose was introduced at age our yearsbeore school entry. The Td given at age 11 years continued.

Since 2006 the primary schedule or tetanus has been given in combinationvaccines at age six weeks, three months, fve months (DTaP-IPV-HepB/Hib),our years (DTaP-IPV) and 11 years (Tdap).

The adult tetanus diphtheria vaccine (Td) replaced the tetanus toxoid(TT) vaccine in 1994, and 10-yearly boosters were recommended. Thechange was recommended to maintain the adult populations immunity

to diphtheria, in response to outbreaks overseas aecting adults and theabsence o natural boosting because the disease had become rare. From2002 adult boosters have been recommended at ages 45 and 65 years(instead o 10-yearly) as a pragmatic attempt to increase coverage in theadult population.

5.4 Vaccines

Tetanus immunisation protects by stimulating the production o antitoxin,

providing immunity against the eects o the toxin. It does not preventC. tetanigrowing in a contaminated wound. The tetanus vaccine isprepared rom cell-ree toxin treated with ormaldehyde to produce atoxoid. The toxoid is adsorbed onto an aluminium salt adjuvant to improveimmunogenicity.

Tetanus vaccine as a single antigen is no longer available in New Zealand. Itis only available in combination with other vaccines.

The tetanus toxoid-containing vaccines unded as part o the Schedule are: DTaP-IPV-HepB/Hib, Inanrix-hexa (GSK), diphtheria, tetanus, acellular

pertussis, inactivated polio, hepatitis B and Haemophilus infuenzaetype b vaccine

DTaP-IPV, Inanrix-IPV (GSK), diphtheria, tetanus, acellular pertussisand inactivated polio vaccine

Tdap, Boostrix (GSK), a smaller adult dose o diphtheria and pertussis

vaccine together with tetanus vaccine Td, ADT Booster (CSL), a smaller adult dose o diphtheria vaccine

together with tetanus vaccine.

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Tetanus

See sections 3.4 and 4.4 or more detailed vaccine inormation.

Efcacyandeffectiveness

The tetanus vaccine was 100 percent eective when given to pregnantwomen to protect against neonatal tetanus in a randomised controlled

trial (RCT). Tetanus in adults is too rare or vaccine efcacy to be tested ina clinical trial. However, the eectiveness o tetanus vaccine was clearlydemonstrated in World War II, when only 12 cases o tetanus occurredamong the 2.7 million wounded US army personnel (0.44 per 100,000),compared to 70 cases out o 520,000 wounded in World War I (13.4 per100,000). O the 12 cases, only our had completed primary immunisation.Immunised cases have less severe disease and a lower case atality.

In most studies 100 percent o inants have protective levels o tetanus

antibody ater three doses o vaccine given at intervals o our weeks orlonger. The duration o antibody persistence depends on the initial antibodylevel. Calculations o tetanus antibody decay have shown that a three-doseprimary schedule in inancy will provide protection or at least fve years, anda booster at fve years will provide protection or at least another 21 years.4

Dosageandadministration

The dose o DTaP-IPV-HepB/Hib (Inanrix-hexa), DTaP-IPV (Inanrix-IPV), Tdap(Boostrix) and Td (ADT Booster) is 0.5 mL administered by intramuscularinjection (see section 2.4).

DTaP-IPV-HepB/Hib (Inanrix-hexa) must be reconstituted by adding theentire contents o the supplied container o the DTaP-IPV-HepB vaccine tothe vial containing the Hib pellet. Ater adding the vaccine to the pellet,the mixture should be shaken until the pellet is completely dissolved.

The adult Td vaccine, which has a reduced dose o diphtheria toxoid, is usedin individuals aged seven years and older (see also section 4.5).

5.5 Recommendedimmunisationschedule

Usualchildhoodschedule

A primary course o tetanus vaccine is given as DTaP-IPV-HepB/Hib (Inanrix-hexa) at ages six weeks, three months and fve months, ollowed by a dose

o DTaP-IPV (Inanrix-IPV) at age our years beore school entry. A booster isgiven at age 11 years (school Year 7), which includes a pertussis componentgiven as the vaccine Tdap (Boostrix).

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I a course o immunisation is interrupted or any reason, it may be resumedwithout repeating prior doses (see Appendix 2).

Adultsandchildrenfromsevenyearsofage

For adults and children who present with a tetanus-prone wound, boosters

are recommended in accordance with the guidelines in the ollowingsections and Table 5.1.

For previously unimmunised adults and children aged seven years and older,a primary immunisation course consists o three doses o 0.5 mL o Td atintervals o not less than our weeks. This is shorter than the manuacturersrecommended schedule o zero, one and six months but is likely to increasecompliance. A booster dose is recommended 10 years later. Alternatively,three doses o Tdap (not unded) may be given, plus a Tdap booster (not

unded) in 10 years (see section 4.5).For children given a primary course as inants and a booster at age ouryears, a urther booster o tetanus toxoid-containing vaccine is given at age11 years as Tdap vaccine.

Adults are recommended to have their tetanus immunisation statusassessed at age 45 and 65 years, and either given a booster dose o tetanustoxoid-containing vaccine i more than 10 years has elapsed since theprevious dose, or a primary course i there is any doubt about the adequacy

o previous tetanus immunisation (uncertain or no history o a prior primarycourse).

Protection against tetanus is expected to last at least 20 years ollowing abooster dose ater the primary series. The recommendation or a boosterdose at age 45 and 65 years is intended to ensure ongoing protection, andto acilitate delivery by recommending the booster at a time when routinepreventive care or adults may be taking place.

People born beore 1960 are less likely to have had a primary series otetanus vaccine. General practitioner visits at or around age 45 and 65years should be used to check on the immunisation history. I there isno reliable history o the patient having received a primary series, thevaccine at that episode should be considered the frst o a primary series.The next two injections should be given at our-week intervals, or at ourweeks and six months. A booster dose is recommended in 10 years time.

Oer a booster dose o Td or someone travelling overseas and it has been

more than 10 years since the last dose (see section 4.5).

Prior clinical tetanus does not usually coner immunity, and immunisation isrequired. In 1995 a 40-year-old man developed tetanus or a second time

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Tetanus

because he ailed to complete the recommended course o immunisationater the frst episode o tetanus.5

DoseintervalsbetweenTdandTdap

It is recommended that or students who have recently received a tetanus

diphtheria (Td) vaccine booster (eg, at the time o an injury), the age 11(school Year 7) Tdap immunisation should be delayed until two years aterthe dose o Td and oered beore the student reaches the age o 16 years.Students who would normally receive the Year 7 event at school should bereerred to their general practitioner or ollow-up and recall.

Available data suggest that there is no increase in adverse events whentetanus and diphtheria toxoid-containing vaccines are given two yearsapart compared to when they are given ten or more years apart.1,2 However,

when Tdap is to be given to adolescents or adults to protect inants or othervulnerable individuals rom pertussis, a minimum interval between dosesdoes not apply.

Preventionoftetanusfollowinginjury

Following injury it is essential that all wounds receive adequate surgicaltoilet and removal o devitalised tissue. Further treatment depends on thecircumstances o each case.

I the injury is considered to be tetanus-prone and there is there is any doubtabout the adequacy o previous tetanus immunisation, the individual musthave tetanus-specifc immunoglobulin (TIG) and the recommended primarycourse o three doses o a tetanus toxoid-containing vaccine (Td or Tdap the latter is not unded).

The defnition o a tetanus-prone injury is not straightorward, becausetetanus can occur ater apparently trivial injury, such as rom a rose thorn, orwith no history o injury. However, there are certain types o wounds likely to

avour the growth o tetanus organisms. These include: compound ractures

bite wounds

deep, penetrating wounds

wounds containing oreign bodies (especially wood splinters)

wounds complicated by pyogenic inections

wounds with extensive tissue damage (eg, crush injuries, avulsions,contusions or burns)

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any superfcial wound obviously contaminated with soil, dust or horsemanure (especially i topical disinection is delayed more than 4 hours)

reimplantation o an avulsed tooth minimal washing and cleaning o thetooth is conducted to increase the likelihood o successul reimplantation.

Generalmeasuresforthetreatmentoftetanus-pronewounds

Wounds or injuries should be classifed as tetanus-prone or non-tetanus-prone as ollows (see Table 5.1):

non-tetanus-prone wounds clean, minor wounds that are less than sixhours old, non-penetrating and with negligible tissue damage

tetanus-prone wounds all wounds that may be contaminated and/orinected, and are penetrating, more than six hours old and with tissue

damage.

Immunised individuals respond rapidly to a booster injection o tetanustoxoid-containing vaccine, even ater a prolonged interval. Tetanus toxoid-containing vaccine and TIG should be given at the same time, but intodierent limbs and using separate syringes.

Table5.1 Guidetotetanusprophylaxisinwoundmanagement

Historyoftetanusvaccination

Timesincelastdose

TypeofwoundTdorTdapasappropriatea,b

TIGd

N 3 doses < 5 years Tetanus-prone wounds No No

N 3 doses 510 years Clean minor wounds No No

N 3 doses 510 years Tetanus-prone wounds Booster dose No

N 3 doses > 10 years Tetanus-prone wounds Booster dose No

< 3 doses oruncertain

Clean minor wounds Complete course

3 dosescNo

< 3 doses oruncertain

Tetanus-prone wounds Complete course

3 dosescYes

a I a previously unimmunised child is aged less than 7 years, consider using DTaP-IPV-HepB/

Hib, Inanrix-hexa.

b Tdap is not currently unded or primary courses or booster doses or individuals age 16 years

and older.c Three doses at not less than our weekly intervals.

d TIG = Tetanus immunoglobulin. The recommended TIG dose is 250 IU given by IM injection as

soon as practicable ater injury. I more than 24 hours has elapsed, 500 IU is recommended.

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Tetanus

Tetanus immunoglobulin (TIG) availability and storage

TIG is issued in ampoules, each containing 250 IU. (Ampoules o 2000 IUare used or treatment and not or prophylaxis.) These should be protectedrom light and stored in a rerigerator at +2 to +8C. They must never berozen. TIG is given intramuscularly.

TIG dose

The recommended dose to prevent tetanus is 250 IU o TIG or recentinjuries, but this should be increased to 500 IU i more than 24 hours haselapsed since injury, or i there is a risk o heavy contamination or ollowingburns.

There is no need to test the patients sensitivity beore administeringTIG, but caution is necessary i the patient is known to suer completeimmunoglobulin A (IgA) defciency. In this situation, specialist help should

be sought (see section 1.7).

Patients with impaired immunity who suer a tetanus-prone wound mayhave ailed to respond to prior vaccination and may thereore require TIG.

5.6 Expectedresponsesandadverseeventsfollowingimmunisation(AEFI)

Expectedresponses

Local reactions such as pain, redness and swelling around the injection sitehave been reported in 095 percent o recipients. Local reactions generallyincrease with the number o doses given. The local reactions are usuallyminor and only last a day or so. In a small percentage o vaccine recipientsthe reactions will be severe enough to limit movement o the arm and maylast or about a week.

High levels o antibody beore immunisation (usually rom an excessivenumber o immunisations) are associated with more severe local reactions.

Note that the reaction may be due to some o the other vaccine components(eg, aluminium).

See chapter 6 or inormation on reactions ollowing the ourth and fth doseo a diphtheria, tetanus, pertussis antigen-containing vaccine.

Sterile abscesses and persistent nodules at the injection site may developi the injection is not given deeply enough into the muscle. The deeper theinjection, the less the risk o reaction.6

The change rom TT to Td was associated with the reporting o more local aswell as other reactions. Generalised reactions ater Td are uncommon, butmay include headache, lethargy, malaise, myalgia and pyrexia.

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Adverseeventsfollowingimmunisation

Anaphylaxis was reported at a rate o 1.6 per million doses o Td in the USrom 1991 to 1995. There have been no reports o anaphylaxis ater Td wasintroduced in New Zealand. The 1994 US Institute o Medicine7 review oadverse events rom tetanus vaccine concluded that the evidence supported

a link with brachial plexus neuropathy at a rate o 0.5 to 1 per 100,000doses within our weeks o immunisation. No evidence has been ound or aconnection between receiving tetanus vaccine and Guillain-Barr syndrome.A large population based study ound no link with Guillain-Barr in anestimated 730,000 children who were o eligible age to receive DTwP in apopulation o 2.2 million children aged less than 15 years, nor in adults whoreceived tetanus toxoid-containing vaccines.8

Adverse events should be reported to CARM, PO Box 913, Dunedin, using the

prepaid postcard HP3442, or via online reporting at http://otago.ac.nz/carm(see AEFI reporting process in section 2.5).

When reporting local reactions, state the size o the redness and/or swelling,as well as the number o previous doses o vaccine.

5.7 Contraindications

See section 1.8 or general contraindications or all vaccines.

Although there is the general contraindication to administering a vaccinewhen a patient has a ebrile illness, protection against the risk o tetanusis paramount i the wound is thought to be tetanus-prone. Immunisationshould not be postponed because the patient has a minor inection.

Immunisation with Td (or tetanus toxoid-containing vaccine) should notbe repeated in individuals who have had previous severe hypersensitivityreactions. Most cases o hypersensitivity have been reported in individualswho have had an excessive number o booster injections outside theguidelines noted above (see also sections 4.7 and 6.7).

5.8 Controlmeasures

All cases o tetanus must be notifed immediately on suspicion to thelocal medical ofcer o health, who should be provided with as accurateimmunisation history as possible.

See the discussion on preventing tetanus ollowing injury within section 5.5.

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References1. Halperin SA, Sweet L, Baxendale D, et al. 2006. How soon ater a prior tetanus-diphtheria

vaccination can one give adult ormulation tetanus-diphtheria-acellular pertussis vaccine?

Pediatric Inectious Disease Journal 25(3): 195200.

2. Talbot EA, Brown KH, Kirkland KB, et al. 2010. The saety o immunizing with tetanus-

diphtheria-acellular pertussis vaccine (Tdap) less than 2 years ollowing previous tetanus

vaccination: experience during a mass vaccination campaign o health care personnel during

a respiratory illness outbreak. Vaccine 28(50): 80017.

3. Weir R, Jennings L, Young S, et al. 2009. National Serosurvey o Vaccine Preventable

Diseases. Wellington: Ministry o Health.

4. Simonsen O, Bentzon MW, Kjeldsen K, et al. 1987. Evaluation o vaccination requirements to

secure continuous antitoxin immunity to tetanus. Vaccine 5: 11522.

5. Smith J. 1995. Tetanus inection may not coner immunity. New Zealand Public Health Report

6: 53.

6. Mark A, Carlsson RM, Granstrom M. 1999. Subcutaneous versus intramuscular injection orbooster DT vaccination o adolescents. Vaccine 17: 206772.

7. Vaccine Saety Committee, Institute o Medicine. 1994. Diphtheria and tetanus toxoids.

In: Stratton KR , Howe CJ, Johnston RB (eds).Adverse Events Associated with Childhood

Vaccines: Evidence bearing on causality. Washington, DC: National Academies Press:

67117.

8. Tuttle J, Chen RT, Rantala H, et al. 1997. The risk o Guillain-Barr syndrome ater tetanus-

toxoid-containing vaccines in adults and children in the United States.American Journal o

Public Health 87: 204548.

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