How to Handle an Adverse Reactions due to Rabies Vaccine...

How to Handle

an Adverse Reactions due to

Rabies Vaccine and

Rabies Immunoglobulin

Suda Punrin, MD

Outline

• What is adverse reactions ?

• Adverse reactions from rabies vaccine and RIG

• Management

Adverse reactions (AEs)

Definition

• One that is noxious, is unintended, and occurs at doses normally used in man

Classify

• Type A

• Type B

International drug monitoring. Report of a WHO meeting. World Health Organ Tech Rep Ser 1972;498:1-25

White KD. et. al. J Allergy Clin Immunol 2015;136:219-34

Access from www.topicalsteroidaddiction.weebly.com , August 23, 2016

Vaccine adverse reactions

Local reactions

- Pain

- Swelling

- Erythema

Systemic reactions

- Fever

- Headache

- Myalgia

- Lymphadenopathy

Allergic reactions

- Immediate/

IgE-mediated/

anaphylaxis

- Non-immediate/

Delayed

hypersensitivity

Moylett E. and Hanson C. J Allergy Clin Immunol 2004;114:1010-20

Disease attributable events

Often falsely labeled as allergic

สรุปรายงานอาการไม่พึงประสงค์จากการใช้ยา ประจ าปี 2557

ศูนย์เฝ้าระวังความปลอดภัยด้านผลิตภัณฑ์สุขภาพ ส านักงานคณะกรรมการอาหารและยา

≥ 9 Definite ใช่แน่

5-8 Probable ใช่

1-4 Possible อาจจะใช่

≤ 0 Doubtful น่าสงสัย

ศูนย์เฝ้าระวังความปลอดภัยด้านผลิตภัณฑ์สุขภาพ ส านักงานคณะกรรมการอาหารและยา 2557

Symptoms Certain Probable Possible Unlikely

Anaphylaxis 1 23 7 -

Angioedema 8 36 16 -

Urticaria 21 175 104 -

Rash 58 286 186 -

Symptoms Certain Probable Possible Unlikely

Anaphylaxis 5 49 10 -

Angioedema 2 23 10 -

Urticaria 8 134 67 -

Rash 24 267 98 -

Local reactions 4 73 21 -

Serum sickness - 11 4 -

Rabies vaccine

Rabies immunoglobulin

U.S., Vaccine Adverse Event Reporting System (VAERS)

• Human Diploid Cell Rabies Vaccine (HDCV, Imovax ®)

1990 – 2015: 1,611 reports

• Purified Chick Embryo Cell (PCEC, RabAvert®)

1997 – 2005: 336 reports

Dobardzic A, et. al. Vaccine 2007;25:4244-51 Moro PL, et. al. PLoS Negl Trop Dis 2016;10:e0004846


• Most common adverse events (AEs) included pyrexia, headache, myalgia and nausea

• 5.8 – 7 % were serious AEs * (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness)


*Some appeared to be unrelated to vaccination


• Allergic reactions were mostly urticaria, rash and angioedema


Dobardzic A, et. al. Vaccine 2007;25:4244-51

*No pattern among 13 neurological AEs suggesting a plausible relationship to vaccination

Fulbright J. et. al. J Pediatr Hematol Oncol 2015;37:e427–8

Immune-mediated thrombocytopenia

Kaliner C. et. al. JAMA 1965;193:109-12 Access picture from www.fda.gov , August 23, 2016

Suwansrinon K, et. al. Trans R Soc Trop Med Hyg 2007;101:206-8

QSMI 1987 – 2005 ; 72,132 patients

60 % received purified ERIG : 40 % received HRIG

Adverse events ERIG HRIG

No. (%) 786 (1.8%) 26 (0.09%)

Local reactions 352 13

Serum sickness-like symptoms

312 2

Other systemic symptoms*

122 11

*Fever, headache, malaise § One case of anaphylaxis after ERIG administration

A. Neumayr, J. Blum IDCases 3 2016:1–2

Local reaction

Serum sickness

Access from www.studyblue.com , access August 23, 2016

Symptomatic treatment

Serum – sickness like reactions

How to manage ?

Vaccine adverse reactions

Local reactions

- Pain

- Swelling

- Erythema *record site of

vaccination

Systemic reactions

- Fever

- Headache

- Myalgia

- Lymphadenopathy

Allergic reactions

- Immediate/

IgE-mediated/

anaphylaxis

- Non-immediate/

Delayed

hypersensitivity

Moylett E. and Hanson C. J Allergy Clin Immunol 2004;114:1010-20

Disease attributable events

Often falsely labeled as allergic *record Lot.no. of vaccine

Immediate reaction Non – immediate reaction

Maculopapular rash

Angioedema

Urticaria

Corticosteroids should not be given !

Allergy ?

History Physical examination Timelines Casuality assessment: - Naranjo’s algorithm In vivo/ In vitro test

Allergy

What components ?

Virus or bacteria particle

Culture media: egg, milk

Additives: preservatives, adjuvants,

stabilizers, antibiotics

Contamination: latex

Fritsche P.,Helbling A.,Ballmer-Weber BK. Swiss Med Wkly 2010;140:238 – 46

Prevent further reactions and avoid unnecessary vaccine restriction

วัคซีน ส่วนประกอบของวัคซีน

PCECV (RABIPUR®)

เชื้อไวรัสโรคพิษสุนัขบ้าชนิดเชื้อตาย TRIS-hydroxymethyl, aminomethane, sodium chloride, EDTA

potassium-L-glutamate, saccharose, polygeline (เจลาติน)

PVRV (VERORAB®)

เชื้อไวรัสโรคพิษสุนัขบ้าชนิดเชื้อตาย มอลโตส sodium chloride และ ฮิวแมน แอลบูมิน

CPRV (TRCS SPEEDA®)

เชื้อไวรัสโรคพิษสุนัขบ้าชนิดเชื้อตาย เด๊กซแ์ทรน ฮิวแมน แอลบูมิน

ท่ีมา: เอกสารก ากับยา

Niclou M. et. al. Austin J Allergy 2014;1:3

21-year old German soldier: PrEP before a military mission in Afghanistan

10 min after 1st dose of PCEC: dizziness, sweats, pruritus, N/V,

hypotension and tachycardia

Dx: psychovegetative reaction

5 min after 2nd dose of PCEC: same symptoms with urticaria

A polygelin-free rabies vaccine was given for 3rd dose

without symptoms

แพ้ไข่ จะฉีดวัคซีนป้องกันโรคพิษสุนัขบ้า ได้หรือไม่ ?

Kelso J. et al. J Allergy Clin Immunol 2012;130:25–43

Vaccines Contains

HDCV (Imovax®) Human serum albumin, Beta-propiolactone, MRC-5 cellular protein, neomycin, phenol red (phenolsulfonphthalein), vitamins

PCEC (RabAvert®) Amphotericin B, Beta-propiolactone, bovine albumin or serum, potassium glutamate, chlortetracycline, EDTA, neomycin, chicken protein, egg albumin (ovalbumin)

Purified chick embryo cell rabies vaccine

Egg-containing vaccines Vaccine Egg protein content Approach in egg-

allergic patients

Measles & Mumps Picograms - nanograms

Administer in usual manner *

Rabies (PCEC) Picograms - nanograms

Administer in usual manner *

Influenza Micrograms To be discussed

Yellow fever Micrograms

Skin test prior giving

Caubet JC., et al. Pediatr Allergy Immunol 2014: 25: 394–403

* If nature of allergy is not severe reactions, e.g. anaphylaxis

If investigation could not be done…

U.S. ACIP recommendation (1)

• Once initiated, rabies prophylaxis should not be discontinued because of local or mild systemic AEs

• Usually, such reactions can be successfully managed with symptomatic treatment

Manning SE, et al. MMWR Recomm Rep 2008;57:1-28

U.S. ACIP recommendation (2)

• When a person with hypersensitivity to rabies vaccine must be revaccinated, empiric intervention such as pretreatment with antihistamines might be considered.

• Epinephrine should be readily available

• Person should be carefully observed after vaccination

Manning SE, et al. MMWR Recomm Rep 2008;57:1-28

Optional management in case of mild AEs

• Switch to other brand of rabies vaccine

วัคซีน ส่วนประกอบของวัคซีน

PCECV (RABIPUR®)

เชื้อไวรัสโรคพิษสุนัขบ้าชนิดเชื้อตาย TRIS-hydroxymethyl, aminomethane, sodium chloride, EDTA

potassium-L-glutamate, saccharose, polygeline (เจลาติน)

PVRV (VERORAB®)

เชื้อไวรัสโรคพิษสุนัขบ้าชนิดเชื้อตาย มอลโตส sodium chloride และ ฮิวแมน แอลบูมิน

CPRV (TRCS SPEEDA®) เชื้อไวรัสโรคพิษสุนัขบ้าชนิดเชื้อตาย เด๊กซแ์ทรน ฮิวแมน แอลบูมิน

Gupta M, et. al. J Allergy Clin Immunol Pract 2015;3:281-2

Graded challenge in immediate reactions

Other managements

• Observe responsible cat or dogs for 10 days

• Check rabies neutralizing antibody

Summary

• Local/mild reactions are common and do not contraindicate future doses

• Risk for acquiring rabies must be carefully considered before deciding to discontinue vaccination

• Allergy to rabies biologics are rare and should be further evaluated

Thank you for your attention

Thank you for your attention

How to Handle an Adverse Reactions due to Rabies Vaccine...

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