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Malaysian Society of Infectious Diseases & Chemotherapy

Guidelines for Adult Immunisation

Content

Message from Editor

Editorial Panel

Quick Guide

Contraindications and Special Considerations

Temporary Deferral of Immunisation

Route and Site of Administration

Post Vaccination

Anaphylaxis

Storage and Disposal of Vaccines

Vaccine Combinations

Multiple Vaccinations

Adverse Event Following Immunisation (AEFI)

Cholera

Diphtheria

Tetanus

Pertussis

Haemophilus influenzae

Hepatitis A

Hepatitis B

Human Papillomavirus (HPV)

Influenza

Japanese Encephalitis (JE)

Measles

Mumps

Rubella

Meningococcal Disease

Pneumococcal Disease

Poliomyelitis

Rabies

Typhoid

Varicella

Yellow Fever

Zoster

Passive Immunisation

Avian Influenza

Chikungunya

Clostridioides difficile

COVID-19

Dengue

Ebola

Enterovirus 71

Human Immunodeficiency Virus (HIV)

Malaria

Zika

Adults Who Missed Childhood Immunisation

Elderly and Patients With Chronic Ilnesses

Healthcare workers

Human Immunodeficiency Virus (HIV)

Immunocompromised Patients

Miscellaneous Groups

Travelers

Vets & Animal Handlers

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Available Vaccines

Tetanus

In this chapter:

Introduction

Tetanus is caused by Clostridium tetani which produces a potent toxin that has two components, i.e., tetanospasmin (alpha-neurotoxin) and tetanolysin (alpha-haemolysin). The organisms usually gain entry through open wounds and lacerations or via penetrating injuries. Neonatal tetanus is due to infection of the baby’s umbilical stump. Tetanus is not transmitted from person to person.

Tetanospasmin is mainly responsible for the features of tetanus which manifests as rigidity and painful spasms of skeletal muscles. The muscle stiffness usually involves the jaw (lockjaw) and neck and then becomes generalised. The disease is often fatal and death results from respiratory failure, hypotension or cardiac arrhythmia.

The case-fatality ratio for tetanus is highest in infants and the elderly and is approximately 10%-20% even in modern health care facilities. The risk for both tetanus disease and mortality was higher among persons aged ≥65 years than in persons aged <65 years. Tetanus occurs almost exclusively among persons who are unvaccinated or inadequately vaccinated or in those whose vaccination histories are unknown.

Due to widespread immunisation, tetanus is now a rare disease in Malaysia. In 2018, the incidence rate of neonatal tetanus and other tetanus was 0.08 and 0.09 per 100,000 population respectively.

As tetanus is associated with apparently minor or trivial injury, especially in the elderly, active immunisation is thus important for its prevention.

Vaccines

 
  • This is a toxoid-derived vaccine that is adsorbed onto an adjuvant (aluminium salt, usually aluminium phosphate) to increase its immunogenicity. Tetanus toxoid is available as a combination with diphtheria toxoid (DT, Td), or with both diphtheria toxoid and pertussis (DTaP/Tdap). 
  • DT is given to children younger than 7 years of age while Tdap is used in adolescents and adults.

  • Other combinations available include DTaP-HepB-Hib-IPV and DTaP-Hib-IPV which are mainly used in childhood immunisation.

Note:

Upper-case letters in the above abbreviations denote full-strength doses of diphtheria (D) and tetanus (T) toxoids and pertussis (P) vaccine. Lower-case “d” and “p” denote reduced doses of diphtheria and pertussis used in the adolescent/adult formulations. The “a” in DTaP and Tdap stands for “acellular”, meaning that the pertussis component contains only a part of the pertussis organism.

Vaccines Available in Malaysia

 

A. Tetanus® toxoid

  1. TT Vaccine® (Adsorbed tetanus vaccine)
    Propharm (M) Sdn Bhd/PT Bio Farma, Indonesia

  2. Tetanus Toxoid Vaccine® (Adsorbed tetanus vaccine)
    SM Pharmaceuticals Sdn Bhd/Serum Institute of India, India

B. Combination vaccines

  1. Adacel® (Tdap; tetanus-diphtheria-acellular pertussis)
    Sanofi Aventis (M) Sdn Bhd /Sanofi Pasteur Limited, Canada

  2. Adacel® Polio (Tdap -IPV; tetanus-diphtheria-acellular pertussis inactivated polio)
    Sanofi Aventis (M) Sdn Bhd/Sanofi Pasteur, France

  3. Boostrix® (Tdap; tetanus-diphtheria-acellular pertussis)
    GlaxoSmithKline Pharmaceutical Sdn Bhd/GlaxoSmithKline Biologicals S.A., Belgium

  4. Boostrix-Polio® (Tdap-IPV; diphtheria-tetanus-acellular pertussis-inactivated polio)
    GlaxoSmithKline Pharmaceutical Sdn Bhd/GlaxoSmithKline Biologicals S.A., Belgium

  5. Infanrix Hexa® (DTaP; diphtheria-tetanus-acellular pertussis-inactivated polio-Hib-Hep B)
    GlaxoSmithKline Pharmaceutical Sdn Bhd/GlaxoSmithKline Biologicals S.A., Belgium

  6. Infanrix-IPV+Hib® (DTaP; diphtheria-tetanus-acellular pertussis-inactivated polio-Hib)
    GlaxoSmithKline Pharmaceutical Sdn Bhd / GlaxoSmithKline Biologicals S.A., Belgium
  7. Infanrix-IPV (DTaP; diphtheria-tetanus-acellular pertussis-inactivated polio)
    GlaxoSmithKline Pharmaceutical Sdn Bhd / GlaxoSmithKline Biologicals S.A., Belgium

  8. Adsorbed DT® ( DT; diphtheria- tetanus)
    Propharm (M) Sdn Bhd/ FT Bio Farma, Indonesia

  9. DTP® (DTP; tetanus-diphtheria-acellular pertussis)
    Propharm (M) Sdn Bhd/ FT Bio Farma, Indonesia

  10. Pentaxim® (DTaP; diphtheria-tetanus-acellular pertussis-inactivated polio/Hib)
    Sanofi-Aventis (M) Sdn Bhd/ Sanofi Pasteur, France

  11. Hexaxim® (DTaP; diphtheria-tetanus-acellular pertussis-inactivated polio-Hib-Hep B)
    Sanofi-Aventis (M) Sdn Bhd/ Sanofi Pasteur, France

  12. SII Diphtheria and Tetanus Vaccine Adsorbed® (Paediatric) -10 and 20 doses) (DT; diphtheria-tetanus)
    SM Pharmaceuticals Sdn Bhd/ Serum Institute of India

  13. SII Diphtheria, Tetanus and Pertussis Vaccine Adsorbed® – (10 and 20 doses) (DTaP; diphtheria-tetanus-acellular pertussis)
    SM Pharmaceuticals Sdn Bhd/ Serum Institute of India

C. Tetanus Immune Globulin (TIG)   

  1. Sero-Tet® (Human tetanus immune globulin)
    Propharm (M) Sdn Bhd /Green Cross Corporation, South Korea

  2. Igantet® (Human antitetanus Ig) 
    Grifols (M) Sdn Bhd /Instituto Grifols S.A., Spain

Mode of Administration

 

The dose of all tetanus-containing vaccines is 0.5mL, to be given by intramuscular (IM) injection.

Co-administration with Other Vaccines

Several vaccines can be given together as long as there are no contraindications for individual agents. There are no contraindications to simultaneous administration of live attenuated vaccines with inactivated or toxoid vaccines. Do not mix tetanus toxoid with other vaccines in the same syringe, unless approved for mixing by manufacturer.

Contraindications and Adverse Effects

 

The only absolute contraindication to tetanus containing vaccines is anaphylaxis reaction after the previous dose, or to any component of the vaccine.

Common adverse effects include pain, tenderness, localised erythema and discomfort at the injection site. Uncommon general adverse effects following Td vaccination include headache, lethargy, malaise, myalgia and fever. Anaphylaxis, urticaria and peripheral neuropathy occur very rarely.

The adverse reactions to a single dose of Tdap are similar in adults and adolescents, whether administered shortly (18 months) or at a longer interval after a previous dose of a vaccine containing tetanus/diphtheria toxoids. Thus, frequent administration of tetanus toxoid does not increase the risk of developing injection site reaction as had been perceived previously.

To date, the most frequently reported adverse events for tetanus toxoid vaccines received by National Adverse Drug Reactions Monitoring Centre, NPCB include local site reactions such as injection site pain and swelling, fever and rash.

Target Groups in Malaysia

 
  • All adults (parents, siblings, grandparents, child-care providers and healthcare personnel) who have or anticipate having close contact with an infant aged <12 months should receive a single dose of Tdap to protect against pertussis if they have not received Tdap previously.
  • Adults who have never been vaccinated should be given the complete 3-dose primary series which comprises a 1st dose of Tdap followed by 2 doses of Td. Adults whose vaccination status is unknown should also be given the complete 3-dose primary series.
  • All adults who have not completed the primary series of diphtheria and tetanus toxoids should complete the primary series, one of which should include the Tdap.

  • All adults who have not had a booster dose in 10 years or more should receive a booster dose of Tdap vaccine. Thereafter, a booster dose should be administered every 10 years.

  • All pregnant women at each pregnancy, irrespective of the patient’s prior history of receiving Tdap. Optimal timing is in the 3rd trimester, between 27 and 36 weeks gestation, to maximise the maternal antibody response and passive antibody transfer to the infant.

  • Pregnant women with unknown or incomplete tetanus vaccination should receive 3 vaccinations containing tetanus and reduced diphtheria toxoids.

  • Patients who have recovered from tetanus should complete the full immunisation schedule as the disease does not confer immunity.

  • Patients with tetanus prone wounds. These wounds are other than clean, minor cuts. The types of wounds that are more likely to favour the growth of C. tetani are compound fractures, bite wounds, wounds containing foreign bodies (wood splinters or rose thorns), wounds with extensive tissue damage and wounds obviously contaminated with soil. Post exposure prophylaxis and wound management is given below.

Post-exposure Prophylaxis and Treatment

 

For wound management, the need for active immunisation, with or without passive immunisation, depends on the condition of the wound and the patient’s vaccination history (refer to Table 3.1).

Implications for Healthcare Workers (HCWs)

 

A dose of Tdap is recommended to be given as soon as feasible to all healthcare workers who have not received Tdap previously. Td boosters are advocated every 10 years thereafter.

Evidence for Effectiveness

 

Tetanus vaccination stimulates the production of antitoxin and protects against the toxin produced by Clostridium tetani in contaminated wounds; however, it does not prevent the growth of the organism.

Complete immunisation (3 primary doses and 2 booster doses) induces protective levels of antitoxin throughout childhood and into adulthood. However, by middle age, about 50% of vaccinated persons will have waned immunity. A single dose of tetanus toxoid produces a rapid anamnestic response in such persons.

Table 3.1 Guide to Tetanus Prophylaxis in Wound Management

table 3.1

*The recommended dose for TIG is 250IU, given by IM injection, as soon as practicable after the injury. If more than 24 hours have elapsed, 500IU should be given. Because of its viscosity, TIG should be given to adults using a 21 gauge needle. For children, it can be given slowly using a 23 gauge needle.

† All wounds other than minor clean wounds should be considered ‘tetanus-prone’.

# Individuals with humoral immune deficiency (including HIV-infected persons who have immunodeficiency) should be given TIG if they have received a tetanus-prone injury, regardless of the time since their last dose of tetanus-containing vaccine.

§ Persons who have no documented history of a primary vaccination course (3 doses) with a tetanus toxoid-containing vaccine should receive all missing doses and must receive TIG

Recommendations for Vaccination for Pertussis, Tetanus, and Diphtheria

 

  • Primary vaccination in adults: Three doses of vaccine are required with an interval of 4-6 weeks between the 1st and 2nd doses, and 6-12 months between the 2nd and 3rd doses. Tdap can be used for the 1st dose with Td vaccine for the subsequent doses.
  • Booster vaccination: Persons aged ≥19 years who previously have not received a dose of Tdap should receive a single dose of Tdap. To ensure continued protection against tetanus and diphtheria, booster doses of Td should be administered every 10 years throughout life.
  • Do NOT administer DTaP to adolescents and adults as the higher doses of the diphtheria and pertussis components may result in greater adverse effects.

References

  1. Centers for Disease Control and Prevention (CDC). (2018). Recommendations of Advisory Committee on Immunization Practices. Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States. MMWR, 67(2), 1-44 https://www.cdc.gov/mmwr/volumes/67/rr/rr6702a1.htm
  2. Centers for Disease Control and Prevention (CDC). (2008). Recommendations for Postexposure Interventions to Prevent Infection with Hepatitis B Virus, Hepatitis C Virus, or Human Immunodeficiency Virus, and Tetanus in Persons Wounded During Bombings and Other Mass-Casualty Events in United States. MMWR, 57(RR06), 1-19 https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5706a1.htm
  3. Centers for Disease Control and Prevention (CDC). (2011).  Advisory Committee on Immunisation Practices (ACIP). Immunisation of Health-Care Personnel. MMWR, 2011,  60(RR07), 1-45. https://www.cdc.gov/mmwr/pdf/rr/rr6007.pdf
  4. Centers for Disease Control and Prevention (CDC). (2012). Advisory Committee on Immunisation Practices (ACIP). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) in pregnant women. MMWR,  62(07), 131-135.  https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6207a4.htm
  5. Halperin, S. A., Sweet, L., Baxendale, D., et al. (2006). How soon after a prior tetanus-diphtheria vaccination can one give adult formulation tetanus-diphtheria-acellular pertussis vaccine? Pediatr Infect Dis J, 25, 195-200
  6. Malaysian National Centre of Adverse Drug Reactions database. https://npra.gov.my/
  7. Marlovits, S., Stocker, R., Efstratiou,  A., et al. (2000). Effect on diphtheria immunity of combined tetanus and diphtheria booster vaccination in adults. Eur J Clin Microbiol Infect Dis 19, 506-13
  8. McQuillan, G. M., Kruszon-Moran, D., Deforest, A., Chu, S. Y, Wharton, M. Serologic immunity to diphtheria and tetanus in the United States. Ann Intern Med, 136, 660-6
  9. Ministry of Health of Malaysia (MOH). (2019). Health facts: Incidence rate and mortality rate of communicable diseases. https://www.moh.gov.my/index.php/pages/view/58
  10. Ministry of Health Malaysia. (2019). National Pharmaceutical Regulatory Agency (NPRA). Senarai Produk Vaksin Berdaftar Dengan Pihak Berkuasa Kawalan Dadah.
  11. Rushdy,  A. A., White, J. M.,  Ramsay M. E., Crowcroft , N. S. Tetanus in England and Wales, 1984– 2000. Epidemiol Infect, 130, 71-7
  12. Talbot, E. A., Brown, K. H., Kirkland, K. B.,  et al. (2010). The safety of immunising with tetanus-diphtheria-acellular pertussis vaccine (Tdap) less than 2 years following previous tetanus vaccination: Experience during a mass vaccination campaign of healthcare personnel during a respiratory illness outbreak. Vaccine, 28, 8001-7