Vaccine Update Practical Point

Vaccine Update Practical Point

Chonnamet Techasaensiri, MD

Division of Infectious Diseases

Department of Pediatrics

Faculty of Medicine Ramathibodi Hospital

Type of Vaccines

• Live attenuated vaccines: MMR, varicella, JE, OPV, rotavirus

• Toxoid vaccines: d/D, T

• Component vaccines eg. polysaccharide or polypeptide: Hib, PCV, PPSV

• Inactivated (killed) vaccines: rabies, JE, wP, influenza

• Surface Ag (recombinant) vaccines: HBV

Age Vaccines

BirthBCG

HBV1

2 mos DTP-HB-Hib1, OPV1, Rota

4 mos DTP-HB-Hib2, OPV2, IPV, Rota

6 mos DTP-HB-Hib3, OPV3, Rota

9 mos MMR1

1 ½ yrs DTP4, OPV4, JE1, MMR2

2 ½ yrs JE2

4 yrs DTP5, OPV5

11 yrs HPV

12 yrs (gr 6) dT

Rota

HPV

Live JE

2020

2013

2014

Expanded Program on Immunization and Pilot Project: Ministry of Public Health, Thailand

IPV, bOPV2015-2016

Hib2019

General Recommendation for Immunization

• Facilities for immediate allergic reaction, observation 15-20 mins after immunization for syncope and allergic reaction

• Multiple vaccines should be given on separate sites, at least 1 inch apart

• 28-day minimum interval for >2 live injectable vaccines if not given at the same visit (except OPV, rotavirus vaccine)

CDC. MMWR 2011;60(2):1-61.


• Minor illness is not a contraindication for immunization

• Lapsed immunization• Continue vaccination to complete series

• No need for re-immunization

• Vaccine doses should not be administered at intervals less than minimum intervals or at an age younger than the minimum age suboptimal immune response

CDC. MMWR 2011;60(2):1-61.


• Vaccine administered <4 d before the minimum interval or age are considered valid except for rabies vaccine

• Vaccine administered >5 days earlier than the minimum interval or age• Should not be counted as valid doses

• Should be repeated as age appropriate

CDC. MMWR 2011;60(2):1-61.

Catch-Up Schedule

Live Vaccine During Corticosteroid Treatment

Corticosteroid Therapy Live virus vaccination

Topical, aerosol• With evidence of immune

suppression

YesNo

Physiologic maintenance Yes

Low or moderate dose Yes

High dose*• <14 days

• >14 days

Yes after cessation of steroid treatmentYes at >1 mo after cessation

Immunocompromised host No

* High dose: >2 mg/kg/day prednisolone or its equivalent, or >20 mg/day if BW >10 kg

Post-exposure Vaccination

• Varicella: <120 hours “may prevent or modify”

• Measles: <72 hours “may prevent or modify”

• Tetanus: with/without TIG

• Rabies: with/without RIG

• Hepatitis B: with/without HBIG

• Hepatitis A: up to 2 weeks

BCG

• Live-attenuated M. bovis

• BCG vaccination schedule depends on epidemiology data in each country

• Meta-analyses indicate a consistent BCG-induced protective efficacy in young non-HIV-infected children• 73% (67-79%) against TB meningitis

• 77% (58-87%) against miliary disease

• Protective effect of BCG against pulmonary disease in childhood is variable

BCG Disease

• BCG abscess

• Osteitis

• Osteomyelitis

• Regional lymphadenitis

• Disseminated disease

Potential factors affecting the rate of adverse reactions include the BCG dose, vaccine strain, host (age, immune) and method of vaccine administration.

Diphtheria – Tetanus - Pertussis

• Whole cell is effective, however

• Reactogenic

• Rate of serious adverse effects

Anaphylaxis 1:100,000 doses

Seizure in 48 hours 1:1750 doses

HHE 3.5-291:100,000 doses

Prolong crying > 3 hours 1:100 doses

T > 40.5oC in 48 hours 0.3:100 doses

• Not recommend in > 6 year-old

• DTwP induced immunity decline 50% in 6-12 years, after childhood vaccine most adults are susceptible

• DTaP as efficaceous but less reactogenic

DTwP

• Diphtheria outbreak in Southern and Northeast Thailand in 2012

• In Thailand pertussis is still present esp. in adolescents and adults, but hard to make diagnosis

• Tetanus have been rare in Thailand

• TT should have been replaced by dT (10-25% of Thai adolescents and adults are susceptible to diphtheria)

• DTwP-HB has been used widely in EPI

• Still found problems of adverse events following immunization (AEFI) >> rationale for widely use of DTaP

Diphtheria – Tetanus - Pertussis

Vaccine Age Recommended

DTwP 2 mos – 6 yrs

DTaP 2 mos – 6 yrs

DT 2 mos – 6 yrs

Tdap >7 yrs

dT >7 yrs

Use of Tdap and Tdap-IPV: Thailand

• Tdap or Tdap-IPV can be used as the booster dose at 4-6 years of age

• Tdap or TdaP should be offered to all adolescent and adults every 10 years

• Administer one dose of Tdap vaccine to pregnant women during each pregnancy (preferred during 27–36 weeks’ gestation), regardless of number of years since prior Td or Tdap vaccination.

• Tdap can be administered regardless of interval since the most recent tetanus or diphtheria-toxoid containing vaccine

Polio Vaccine

OPV IPV

Cost Low High

Route of administration Oral SC or IM

Intestinal immunity Yes No

Control outbreak after the 1st dose Yes No

Immunocompromised host Contraindicated Safe

Vaccine-associated paralytic poliomyelitis (VAPP)

Possible No

Interfere with enteroviral infection Yes No

Polio vaccine

1. Oral polio vaccine (OPV)

• Monovalent oral polio vaccines

mOPV1 or mOPV3

• Bivalent oral polio vaccine

type 1 and 3

• Trivalent oral polio vaccine or Sabin vaccinetype 1, 2 and 3

2. Inactivated polio vaccine (IPV)

type 1, 2 and 3

Oral polio vaccine or Sabin vaccine

Disadvantages

• Approx. 1 in every 2.7 million first doses of the vaccine can cause paralysis (VAPP).

• Virus in the vaccine may genetically change and start to circulate among a population. These viruses are known as circulating vaccine-derived polioviruses (cVDPV).

http://www.polioeradication.org/Polioandprevention/Thevaccines/Oralpoliovaccine(OPV).aspx#sthash.1BTkBIsC.dpuf-

MMR Vaccines in Thailand

Name (Company) Measles Rubella Mumps

MMR (Masu) Edmonston-Zagreb

Wistar RA 27/3M strain

L-Zagreb

Priorix (GSK) Schwarz Wistar RA 27/3M strain

Modified JerylLynn

MMR II (MSD) Ender’s Wistar RA 27/3M strain

Jeryl Lynn

MMR Efficacy

• Seroconversion after MMR vaccination• Measles: 95% after 1 dose, >99% after 2 doses

• Rubella >95%, confer long-term immunity, probably lifelong

• Mumps• Jeryl-Lynn 61.6-80.7%

• Urabe 54.4-73.1%

• Rubini 55.3%

Ong G, et al. J Infect. 2005;51(4):294-8.Bonnet MC, et al. Vaccine. 2006;24:7037-45.Richard JL, et al. Eur J Epidemiol. 2003;18(6):569-77.

Mumps Vaccines: Adverse events

Strain Aseptic meningitis Parotitis

Jeryl Lynn 0/1,800,000 - 1/950,000 0.5%

L-Zagreb 1/55,000 - 1/3,300 3.1%

Urabe 1/69,000 – 1/400 1.3%

A Review for the Global Advisory Committee on Vaccine Safety. W.H.O. June, 2003

MMR: Contraindications

• Previous anaphylactic reaction to MMR or its components

• Pregnancy or possibility of pregnancy within 4 wks

• Severe immunodeficiency

Patient with egg allergy can receive MMR vaccine

MMRV vaccines: risk of febrile convulsions

ProQuad™

1 additional case in 2,300 doses

(One additional case of febrile convulsion 7–10 days post-vaccination for every 2,300

doses of MMRV administered, in comparison with

MMR + V at separate injection sites1)

Priorix-Tetra™

1 additional case in 5,882 or 2,747 subjects

(An additional case of febrile convulsion per 5,882 or 2,747 subjects post-vaccination

with MMRV compared with matched controls who received MMR, or

simultaneous MMR + V vaccinations2)

Second dose

of MMRV

Children

4–6 years

No such link found to date3

First dose

of MMRV

Children

12–23 months1

or

9–30 months2

1Klein et al. Pediatrics 2010; 126: e1–8; 2GlaxoSmithKline. Priorix-Tetra™ European SmPC 2013; 3Klein et al. Pediatrics 2012; 129: 809–14

HBV Vaccine

• Thai MOPH recommends DPT-HBV at 2, 4, 6 months of age

• Maternal positive HBsAg: Infant should receive HBV at 1 month of age• Total HBV vaccine = 5 doses

• The second dose should be administered at age 1 to 2 months• Monovalent HepB vaccine should be used for doses administered before age 6 weeks

• Administration of a total of 4 doses of HepB vaccine is permissible when a combination vaccine containing HepB is administered after the birth dose1

1. MMWR Morb Mortal Wkly Rep. Feb 10, 2012.

HBV Vaccine

• Infants who did not receive a birth dose should receive 3 doses of a HepB-

containing vaccine starting as soon as feasible

• The minimum interval between dose 1 and dose 2 is 4 weeks, and between dose

2 and 3 is 8 weeks. The final (third or fourth) dose in the HepB vaccine series

should be administered no earlier than age 24 weeks and at least 16 weeks after

the first dose

MMWR Morb Mortal Wkly Rep. Feb 10, 2012.

Testing for Anti-HBs 1-2 Months After Vaccination

• Routine: not indicated

• Recommended for

• Infants: HBsAg +mothers

• Hemodialysis patients

• HIV-infected persons

• People at occupational risk of exposure from needlestickinjuries

• Immunocompromised patients at risk of exposure to HBV

Repeat a series of vaccination in non-responders

Shortened interval for postvaccinationserology in infants born to HBsAg-positive

mothers

• In agreement with updated recommendations from the CDC, we now obtain postvaccination serology at age 9-12 months (or 1-2 months after the final dose) rather than at age 9-18 months as previously recommended.

• The shortened interval permits earlier revaccination of susceptible infants and may avoid unnecessary revaccination of infants who responded appropriately but whose antibody levels declined with time.

Schillie S, et al. Morb Mortal Wkly Rep. 2015; 64:1118.

Management of HBV Non-Responders

• 4% of vaccinated newborns do not reach a protective antibody level (10 mIU/mL), and 0.4% is a true non-responder even after a 4th dose1

• Recipients who do not respond after 1o series

• Reimmunize with 3 additional doses

• Check anti-HBsAb 1-2 months later, if remains negative unlikely to respond to additional doses

Silvestri AD. Genes Immun 2001;2(7):367-72.

Japanese Encephalitis Vaccines

Characteristics CD-JEVAX® IMOJEV® JEVAC®

Live/inactivated Live-attenuated Live-attenuated Inactivated

Vaccine strain SA14-14-2 SA14-14-2 Beijing P-3

Cell growth PHK Vero cells Vero cells

Dosing primary Single dose Single dose 2 doses D0,D28

Booster schedule Booster after 3-12

months

Booster after 12 to

24 months*

Booster after 1 year

* Adults: no need for a booster dose up to 5 yearsPediatrics (>9 months): a booster dose should be given in order to confer long term protection

Hib Vaccine

• Thailand has a much lower disease burden than the western countries (Thai 3.8/100,000 pop <5 yrs, US 40 before Hibvaccine, US after vaccine 0.11/100,000 pop <5 yrs)

• In Thailand, invasive Hib diseases found almost all in younger than 2 years of age

• In 2019, Hib vaccine was introduced in Thai EPI

• The booster dose may not need, but can give as combine vaccine

Rotavirus

VP7 (G serotype)VP4 (P serotype)

Gene VP7 VP4

Serotype

Number of

serotypes

Most common

serotypes

Emerging

G

15

G1, G2, G3, G4

G9

P

28

P4, P8

P6

Divided into 7 groups, A* (vast majority)-G

Santos N, et al. Rev Med Virol 2005; 15:29-56.

Gray J, et al. J Pediatr Gastroenteol Nutr. 2008;46:S24-31.

Rotavirus

Prevalence of Rotavirus Genotype in Thailand between 1998-2009

Prevalence and phylogenetic analysis of rotavirus genotypes in Thailand between 2007 and 2009. Kamonwan Khananurak , Viboonsak Vutithanachot b, Nipat Simakachorn , Apiradee Theamboonlers , Voranush Chongsrisawat a, Yong Poovorawan. Infection, Genetics and Evolution 10 (2010) 537–545

WHO-prequalified Rotavirus Vaccines

HRV BHRV 5 BHRV 1 BHRV 5 (Serum)

Human rotavirus vaccine (GSK)

Bovine Human reassortment

(Merck)

Bovine Human vaccine (Bharat)

Bovine Human reassortment

(Serum Institute of India)

Strains G1P[8] G1-G4, P[8]Bovine Human

G9P[11], 116E strainG1-G4, G9

Storage 2-8◦C 2-8◦CFrozen at -20◦C ± 5◦CLiquid formulation

37◦C for two years. (Lyophilized buffer)

Dose 2 dose 3 dose 3 dose 3 dose

Efficacy Developing

Country

61% (South Africa)

59% (Vietnam,

Bangladesh)

56% (India)

67% (Niger)

Licensure2007

(WHO)2008

(WHO)2014 (India)2018(WHO)

2018 (WHO)

HRV ; Human Rotavirus Vaccine GSKBHRV 5 ; Bovine Human Rotavirus Vaccine MSDBHRV 1 : Bovine Human Rotavirus Vsccine Bharat Bioteach

Data should not be directly compared between different vaccines as different study methods may have been used

Deen J. Human Vaccine & Immunotherapeutics 2018;14: 495-499

Modified from Parashar et al, Emerg Infect Dis 1998 4(4) 561–570

VP6

G1P8

G3P8

G4P8

G9P8

G2P4

G8P4

G12P6

Group A rotavirus

share the same VP6

Incidence of Intussusception after RV Implementation

• Australia (HRV, RV5) 1 : 18,000

• US (HRV, RV5) 1-5 : 100,000

• Mexico (HRV) 1 : 51,000

• Brazil (HRV) 1 : 68,000

Carlin JB et al. Clin Infect Dis 2013;57:1427–34; Glass R. New Engl J Med 2014;370;6:568–570; Wkly Epidemiol Rec

2013;88:49–64; Murphy et al. New Engl J Med 2001; 344: 564–72

Rosillon D, et al. Pediatr Infect Dis J. 2015;34:763-8

Risk of Intussusceptions during 7 Days after First Dose of RV1 and RV5

Rosillon D, et al. Pediatr Infect Dis J. 2015;34:763-8

Risk of Intussusceptions during 7 Days after Second Dose of RV1 and RV5

Influenza Vaccine

• Trivalent inactivated influenza vaccine• Split virion: FluarixTM, VaxigripTM

• Subunit vaccine: Agrippal S1TM, InfluvacTM, InflexalTM

• Quadrivalent inactivated influenza vaccine• Split virion: FluquadriTM, Fluarix tetraTM, Vaxigrip tetraTM

• Cell based: SKYCellfluTM

Type 2020-2021 Northern 2021 Southern 2021-2022 Northern

A/H1N1A/Guangdong-

Maonan/SWL1536/2019A/Victoria/2570/2019 A/Victoria/2570/2019

A/H3N2 A/Hong Kong/2671/A2019 A/Hong Kong/2671/2019 A/Cambodia/e0826360/2020

B/Victoria B/Washington/02/2019 B/Washington/02/2019 B/Washington/02/2019

B/Yamagata B/Phuket/3073/2013 B/Phuket/3073/2013 B/Phuket/3073/2013

https://www.who.int/influenza/vaccines/virus/recommendations/2021-22_north/en/

Recommended composition of influenza virus egg-based vaccines

Type 2020-2021 Northern 2021 Southern 2021-2022 Northern

A/H1N1 A/Hawaii/70/2019 A/Wisonsin/588/2019 A/Wisonsin/588/2019

A/H3N2 A/Hong Kong/2671/A2019 A/Hong Kong/2671/2019 A/Cambodia/e0826360/2020

B/Victoria B/Washington/02/2019 B/Washington/02/2019 B/Washington/02/2019

B/Yamagata B/Phuket/3073/2013 B/Phuket/3073/2013 B/Phuket/3073/2013

https://www.who.int/influenza/vaccines/virus/recommendations/2021-22_north/en/

Recommended composition of influenza virus cell- or recombinant-based vaccines

Influenza Vaccine: Recommendation

• Persons at high risk for influenza complications• Aged 6 mos – 4 yrs, >65 yrs

• Person with medical conditions, immunosuppression, conditions that compromise respiratory function

• Residents of chronic-care facilities

• Receiving long term aspirin therapy

• Pregnant women

• Obesity

• Health care personnel

• House hold contacts of high risk persons

Influenza Vaccine

• Influenza vaccine can be successfully administered to egg allergic individuals

• There is no evidence that egg ovalbumin is the antigen responsible for adverse reactions to TIV in egg allergic individuals

• Most manufacturers use the lowest ovalbumin content

Greenhawt MJ, Li JT. AAAAI. October 2010.

Only anaphylaxis type of egg hypersensitivity that vaccine should be held

Product VarilrixTM VarivaxTM Varicella GCCTM

Vaccine OKA/ GSK OKA/ Merck MAV/06 strain

Indication >12 months of age

Schedule 2 doses1-12 yrs: First dose at 12-15 months

Second dose at 2.5-6 years>13 yrs: 4 wks apart

Formulation Licensed 19844

Refrigerator Form Since 1994

Licensed 19955

Refrigerator Form since 2000

Refrigerator Form

Minimum Expire Date of PFU

2,000 PFU 1,350 PFU 1,400 PFU

Thermostability(post reconstitution)

90 min at 25◦C8 hrs at 2-8◦C

30 minutes post reconstitution

30 minutes post reconstitution

1. VarilrixTM Prescribing Information 2.VarilvaxTM Prescribing Information 3.Varicella GCC TM Prescribing Information 4. Kreth HW, Lee BW, Kosuwon P, Salazar J, BarzagaNG, Bock HL, et al. Sixteen Years of Global Experience with the First Refrigerator-Stable Varicella Vaccine (VarilrixTM). BioDrugs 2008;22:387-402. 5. Marin M, Guris D, Chaves SS, Schmid S, Seward JF, MBBS CDC. Prevention of Varicella Recommendation of the Advisory Committee on Immunization Practice (ACIP), MMWR 2007;56:1-376. VarilvaxTM Summary of Product Characteristics 2014 46

Random effects model of 1-dose varicella VE for prevention of all varicella, by vaccine

Marin M, et al. Pediatrics. 2016;137(3):e20153741.


Random effects model of 1-dose varicella VE for prevention of combined moderate and severe varicella, by vaccine


Lee YH. J Korean Med Sci 2016; 31: 1897-1901

In Korea, more than half of all vaccinees were immunized with vaccine A, derived from an MAV/06 strain of varicella isolated from a 33-month-old Korean boy in 1989

Hepatitis A Vaccines

Characteristics HavrixTM AvaximTM VaqtaTM HealiveTM Mevac-ATM

Live/inactivated Inactivated Inactivated Inactivated Inactivated Live-

attenuated

Vaccine strain HM175 GBM CR326 TZ84 H2

Dose in

children

0.5 ml

(1-18 yrs)

0.5 ml

(1-15 yrs)

0.5 ml

(1-17 yrs)

0.5 ml

(1-16 yrs)

0.5 ml

Dose in adults 1 ml

(>19 yrs)

1 ml

(>16 yrs)

1 ml

(>18 yrs)

1 ml

(>16 yrs)

0.5 ml

Dosing

schedule

2 doses D0,

M6-12

2 doses D0,

M6-12

2 doses D0,

M6-12

2 doses D0,

M6-12

Single dose

Comparison of Anti-HAV IgG Positivity From 1971 to 2014

Sa-nguanmoo P, et al. PLoS One. 2016;11(3):e0151304.

SynflorixTM

Protein Carriers: Protein D†Diphtheria toxoid

‡Tetanus toxoid

4 6B 9V 14 18C‡ 19F† 23F 1 5 7F

Prevnar*Protein Carrier:

CRM197

4 6B 9V 14 18C 19F 23F

Prevnar13TMProtein Carrier:

CRM197

4 6B 9V 14 18C 19F 23F 1 5 7F 3 6A 19A

Pneumovax 23TM

2 9N 11A 15B 2033F

4 6B 9V14

15

3

8 10A 12F 17F 22F 18C 19F 23F 7F 19A

PCV 15ProteinCarrier: CRM197

4 6B 9V 14 18C 19F 23F 1 5 7F 3 6A 19A 22F 33F

Pneumococcal conjugate vaccines

Pneumococcal polysaccharide vaccine

Klugman K, et al. Vaccine 2011;295:C43-48.

Pneumococcal Conjugate (PCV) and Polysaccharide (PPSV) Vaccines

Property Conjugate Polysaccharide

T-cell dependent immune response

(response by children <2 yo)

Yes No

Immune memory Yes No

Lack of hyporesponsiveness Yes No

Booster effect Yes No

Persistence of protection Yes No

Herd immunity Yes No

Reduction of nasopharyngeal carriage of bacteria

yes NoPichichero M. Consultant for Pediatricians 2005;June:263-7.

Comparison of Polysaccharide & Conjugate Vaccines

CDC. MMWR 2013;62 (25):521-4.

** Including chronic obstructive pulmonary disease, emphysema, and asthma

Indications for PCV13 and PPSV23 Administration and Revaccination for Children 6–18 years

Human Papilloma Virus

• Double strand DNA virus

• > 100 types identified

• 30-40 anogenital

• Oncogenic types• 16, 18: 70% of cervical cancer

• Non-oncogenic types• 6, 11 for genital warts

Quadrivalent and Bivalent HPV Vaccines

Quadrivalent (Gardasil, MSD) Bivalent (Cervarix, GSK)

VLPs HPV-6, HPV-11, HPV-16, HPV-18 HPV-16, HPV-18

Manufacturing Sacharomyces cerevisiae (bread yeast) expressing L1 Trichoplusia ni (Hi-5) insect cell line infected with L1 recombinant baculovirus

Composition 20/40/40/20 µg VLP 20/20 µg VLP

Schedule 0, 2 and 6 monthsOptional: 0, 6 months in age <15 yrs

0, 1 and 6 months Optional: 0, 6 months in age <15 yrs

Adjuvant Alum: 225 µg aluminum hydroxysulfate ASO4: 500 µg aluminum hydroxide, 50 µg deacylated monophosphoryl lipid A

HPV Vaccines

Petrosky E, et al. MMWR Morb Mortal Wkly Rep. 2015;64:300-4.

9v-HPV: Efficacy

Petrosky E, et al. MMWR Morb Mortal Wkly Rep. 2015;64:300-4.

TETRAVALENT DENGUE VACCINE * CONSTRUCT

• There are 4 genetic constructs, 1 for each serotype

• The envelope (E) and precursor membrane (prM) genes from each serotype were combined with the genes encoding the capsid and nonstructural proteins from the yellow fever (YFV 17D) vaccine strain

• The 4 recombinant, live, attenuated dengue viruses are combined into a single vaccine which is freeze-dried and contains no adjuvant or preservatives

*Vaccine referred to in the literature as Chimeric Yellow Fever 17D-Tetravalent Dengue Vaccine (CYD-TDV).

Guirakhoo, 2001, J Virol.Guirakhoo, 2000, J Virol.Guy, 2011, Vaccine.

Reduction in

symptomatic dengue

65.6%(95% CI: 60.7–69.9)

Reduction in

hospitalized dengue

80.8%(95% CI: 70.1–87.7)

CONSISTENT EFFICACY PROFILE OF CYD 14 & CYD 15 STUDIES IN SUBJECTS 9–16 YEARS OF AGE DURING ACTIVE PHASE

1.Hadinegoro, 2015, N Engl J Med.

Key Efficacy Results25-month active phase* Pooled efficacy analyses‡1

*Data come from the 2 pivotal, phase III, large-scale efficacy trials CYD14 and CYD15, which were designed to fully assess efficacy; postdose 1; 1Full Analysis Set

for Efficacy (FASE): all subjects who received at least one injection. †dengue hemorrhagic fever, World Health Organization 1997 criteria. CI=confidence interval;

DENV=dengue virus.

Reduction in

severe dengue †

93.2% (95% CI: 77.3–98.0)

For each serotype:

DENV-1: 58.4% (95% CI: 47.7–66.9)

DENV-2: 47.1% (95% CI: 31.3–59.2)

DENV-3: 73.6% (95% CI: 64.4–80.4)

DENV-4: 83.2% (95% CI: 76.2–88.2)

By dengue serostatus:

Seropositive: 81.9% (95% CI: 67.2–90.0)

Seronegative: 52.5% (95% CI: 5.9–76.1)

ค ำแนะน ำเพื่อเป็นแนวทำงในเวชปฏิบตัิกำรใชว้คัซีนไขเ้ลือดออก (Denvaxia)โดยสมำคมโรคติดเชือ้ในเด็กแห่งประเทศไทยและสมำคมโรคตดิเชือ้แห่งประเทศไทย วนัท่ี 26 ธนัวำคม 2560

ค ำแนะน ำเพื่อเป็นแนวทำงในเวชปฏิบติักำรใชว้คัซีนไขเ้ลือดออก (Denvaxia)

• ในผูท่ี้เคยติดเชือ้มำก่อน (seropositive) 1,000 คน เมื่อฉีดวคัซีนจะปอ้งกนักำรนอนโรงพยำบำลจำกไขเ้ลือดออกได ้15 คนและปอ้งกนัไขเ้ลือดออกรุนแรง (ซึง่หมำยรวมถงึ DHF grade I, II, III, IV, และ severe dengue อ่ืนๆ) ได ้4 คน ในเวลำ 5 ปี

• ในผูท่ี้ไม่เคยติดเชือ้มำก่อน (seronegative) 1,000 คน เมื่อฉีดวคัซีนจะท ำใหมี้โอกำสเพิ่มกำรนอนโรงพยำบำลจำกไขเ้ลือดออก 5 คนและเพิ่มกำรเป็นไขเ้ลือดออกรุนแรง (ซึง่หมำยรวมถึง DHF grade I, II, III, IV, และ severe dengue อ่ืนๆ) 2 คน ในเวลำ 5 ปี

ค ำแนะน ำเพื่อเป็นแนวทำงในเวชปฏิบตัิกำรใช้วคัซีนไขเ้ลือดออก (Denvaxia)

สำมำรถประมำณควำมเสี่ยงของกำรจะเกิดไขเ้ลือดออกรุนแรง (severe dengue) ในเวลำ 5 ปี ไดด้งันี ้• ผูท่ี้ seropositive และไดร้บัวคัซีน โอกำสเกิด นอ้ยกวำ่ 1 ตอ่ 1,000 คนท่ีฉีดวคัซีน• ผูท่ี้ seropositive และไม่ไดร้บัวคัซีน โอกำสเกิด เท่ำกบั 4.8 ตอ่ 1,000 คนท่ีไม่ไดฉี้ดวคัซีน• ผูท่ี้ seronegative และไดร้บัวคัซีน โอกำสเกิด เท่ำกบั 4 ตอ่ 1,000 คนท่ีฉีดวคัซีน• ผูท่ี้ seronegative และไมไ่ดร้บัวคัซีน โอกำสเกิดเท่ำกบั 1.7 ตอ่ 1,000 คนท่ีไม่ไดฉี้ดวคัซีน

Guideline for Rabies Exposure Prophylaxis

65

2018 20182018


Pre Exposure Prophylaxis (PREP)IM 1-1Day 0-7

IM 1-1Day 0-7

IM 1-1Day 0-7

ID 2-2Day 0-7/21

ID 2-2Day 0-7

ID 2-2Day 0-7

**For special risk personIM 1-1-1ID 1-1-1Day 0-7-21/28

**For special risk personIM 1-1-1Day 0-7-21/28

66

2018 20182018

Source:แนวทางการดูแลรกัษาผูส้มัผสัโรคพษิสนุัขบา้, สถานเสาวภา สภากาชาดไทย พ.ศ.2561 และค าถามทีพ่บบอ่ย, แนวทางเวชปฏบิตัโิรคพษิสนุัขบา้ และค าถามทีพ่บบอ่ย พมิพค์รัง้ที ่6, 2561, ส านักโรคตดิต่อทัว่ไป กรมควบคมุโรค กระทรวงสาธารณสขุ, WHO Expert Consultation on Rabies, 2018, WHO TRS 1012

Categories of exposure and post exposure prophylaxis

WHO Categor

y

Type of contract with a suspect or confirmed rabid animal Recommendedtreatment

I

Touching or feeding animals,

licks on intact skin, contact of intact skin with secretions or excretions of a rabid animal or human

Touching or feeding animals, licks on intact skin, contact of

intact skin with secretions or excretions of a rabid animal or human

Touching or feeding animals,

licks on intact skin

No treatment

II

Nibbling of uncovered skin Minor sickness or

abrasions without bleeding

Eats raw products from rabid animal

Nibbling of uncovered skin Minor sickness or abrasions

without bleeding

Nibbling of uncovered skin Minor scratches or

abrasions without bleeding

Vaccine should be injected as soon as

possible

III

Single or multiple transdermal bites or scratches, Lick on broken skin.

Contamination of mucous membrane with saline

Exposure to bat

Single or multiple transdermal bites or scratches, Lick on broken skin.

Contamination of mucous membrane with saline (i.e. licks, eats raw products from rabid animal)

Exposure to bat

Single or multiple transdermal bites or scratches

Contamination of mucous membrane with saliva from licks

Licks in broken skin Exposure to bat

Vaccine and RIG should be

administered as soon as possible

แนวทางการดูแลรกัษาผูส้มัผสัโรคพษิสนุัขบา้, สถานเสาวภา สภากาชาดไทย พ.ศ.2561 และค าถามทีพ่บบอ่ย, แนวทางเวชปฏบิตัโิรคพษิสนุัขบา้ และค าถามทีพ่บบอ่ย พมิพค์รัง้ที ่6, 2561, ส านักโรคตดิต่อทัว่ไป กรมควบคมุโรค กระทรวงสาธารณสุข, WHO Expert Consultation on Rabies, 2018, WHO TRS 1012


Post Exposure Prophylaxis (PEP)IM 1-1-1-1-1 (Essen)Day 0-3-7-14-28

IM 1-1-1-1-1 (Essen)Day 0-3-7-14-30

IM 1-1-1-1Day 0-3-7-14to28

X XIM 2-1-1Day 0-7-21/28

ID 2-2-2-0-2 (Modified TRC-ID)Day 0-3-7-(14)-28

ID 2-2-2-0-2 (Modified TRC-ID)Day 0-3-7-(14)-30

ID 2-2-2-0-0Day 0-3-7-(14)-(28)

68

2018 20182018

Source:แนวทางการดูแลรกัษาผูส้มัผสัโรคพษิสนุัขบา้, สถานเสาวภา สภากาชาดไทย พ.ศ.2561 และค าถามทีพ่บบอ่ย, แนวทางเวชปฏบิตัโิรคพษิสนุัขบา้ และค าถามทีพ่บบอ่ย พมิพค์รัง้ที ่6, 2561, ส านักโรคตดิต่อทัว่ไป กรมควบคมุโรค กระทรวงสาธารณสขุ, WHO Expert Consultation on Rabies, 2018, WHO TRS 1012


Short post exposure prophylaxis regimen for previous vaccinate person / Booster regimen

Within 6 months of completion PEP/PREPIM 1ID 1Day 0

Within 6 months of completion PEP/PREPIM 1ID 1Day 0

Within 3 months of completion PEP/PREPNo PEP is recommend

Over 6 months of completion PEP/PREPIM 1-1ID 1-1Day 0-3

ID 4Day 0



ID 4Day 0

69

2018 20182018

แนวทางการดูแลรกัษาผูส้มัผสัโรคพษิสนุัขบา้, สถานเสาวภา สภากาชาดไทย พ.ศ.2561 และค าถามทีพ่บบอ่ย, แนวทางเวชปฏบิตัโิรคพษิสนุัขบา้ และค าถามทีพ่บบอ่ย พมิพค์รัง้ที ่6, 2561, ส านักโรคตดิต่อทัว่ไป กรมควบคมุโรค กระทรวงสาธารณสุข, WHO Expert Consultation on Rabies, 2018, WHO TRS 1012

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