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  Clinical Practice Guidelines

CRISBERT I. CUALTEROS, M.D. (+63919)8586556
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• Vaccination

– Administration of any vaccine or toxoid for

prevention of disease

• Immunization

– The process of inducing immunity artificially

by either vaccination or administration of


Definition of Terms

• Vaccine

– A preparation of proteins, polysaccharides or nucleic

acids of pathogens that are delivered to the immune

system as single entities, as part of complex particles,

or by live-attenuated agents to induce specific

responses that inactivate, destroy or suppress the


• Toxoid

– A modified bacterial toxin that has been made

nontoxic but remains the capacity to stimulate the

formation of antitoxin

Definition of Terms

• Immune globulin

– An antibody-containing solution derived from

human blood obtained from large pools of plasma

and used primarily for the maintenance of

immunity of immunodeficient persons or for

passive immunization

• Antitoxin

– An antibody derived from the serum of humans or

animals after stimulation with specific antigens

Definition of Terms

Active immunizatioActive immunization

– Involves stimulating the immune system to produce

antibodies and cellular immune responses that protect

against the infectious agent

– Administration of all or part of a microorganism to

evoke an immunologic response mimicking that of

natural infection but that usually presents little or no

risk to the recipient

Passive immunization

– Consists of providing temporary protection through

administration of exogenously produced antibody

– Also occurs naturally through transplacental

transmission of antibodies to a fetus

Vaccine Administration

1. Oral vaccines

• BF does not interfere with successful immunization of

oral vaccines

• Vomiting within 10 mins of receiving an oral dose in an

indication for repeating the dose

2. Parenteral vaccines

• SQ or IM = anterolateral aspect of the upper thigh and

the deltoid area of the upper arm

• Upper outer aspect of buttocks should not be used

because the area has a significant layer of SQ fat and

one may also damage the sciatic nerve

Constituents of a Vaccine

1. Active immunizing agents

2. Preservatives, stabilizers and antibiotics

3. Conjugating agents

– Carrier proteins of proven immunologic potential which when

chemically combined to less immunologic polysaccharide

antigens, enhances the type and magnitude of immune

responses in patients with immature immune systems

4. Suspending fluid

5. Adjuvants

– Aluminum salt used to increased immunogenicity and to

prolong the stimulatory effect

Expanded Program on

Immunization (EPI)

Main objectives:

2. To reduce the morbidity and mortality rates

of the six EPI diseases

• Polio

• Measles

• Diphtheria

• Pertussis

• Tetanus

• Tuberculosis

3. To reduce the incidence of neonatal tetanus

Expanded Program on

Immunization (EPI)

• Implemetation is contained in PD No. 996

• Provides for compulsory basic immunization for

infants and children below eight years of age

• Presidential proclamation No. 6

• Enjoins all governmental as well as nongovernmental

agencies and organizations to

achieve the goal of immunizing every Filipino

against the 6 EPI diseases

• In 1993, expanded to include Hep B

Expanded Program on

Immunization (EPI)

• Concerned with 3 populations:

1. Infants below 1 year

2. School entrants

3. Pregnant women

EPI for Infants

Measles 9 mos* 1

HBV Birth 3 4 wks

OPV 6 wks 3 4 wks

DPT 6 wks 3 4 wks

BCG Birth 1



between doses

Minimum age # of doses

at first dose


*Measles vaccine

– may be given at 6 months of age

– In areas with >15% of measles cases and

deaths occurring before 9 months of age

– For groups at high risk of measles death

• Infants in refugee camps

• Infants admitted to hospitals

• Infants affected by disasters

• During outbreaks

Fully immunized child

• 1 BCG


at birth or anytime before reaching 12

• 3 doses of DPT and polio

weeks interval between each dose, the 1

, with at least 4st

dose being given 6 wks after birth or

thereafter, as long as the 3

before the child reaches 12 mos of age

rd dose is given

• 1 dose of measles

at the age of 9 mos

• 3 doses of hep B

between doses


with at least 4 wks interval

Minimum Intervals and Ages

• Minimum Age

– Youngest age group at risk for a disease

– If child is too young

–If beyond the minimum age


↓ immunogenicity↑ risk of

• Minimum Interval

– Recommended ages and intervals between

doses of the same antigen(s) provide the

best evidence of efficacy

General Rule

• Decreasing the interval between doses

of a multi-dose vaccine

may interfere

with antibody response and protection.

• Increasing the interval between doses

of a multi-dose vaccine


does notthe effectiveness of a vaccine.

Minimum Intervals and Ages

Vaccine doses should not be given at


intervals or


less than the minimumearlier than the minimum


• Vaccine doses administered up to 4

days before the minimum interval or age

can be counted as


– Doses administered 5 days or earlier than

the minimum interval or age should not be

counted as valid doses

the appropriate age

revaccinate at

Extended Intervals between Doses

• It is not necessary to restart the series

or add doses of any vaccine due to

extended intervals between doses

• No significant difference in final titer

Number of Doses

• Live attenuated vaccines generally

produce long-lasting immunity with a

single dose

–First dose

–Second dose


provides protectionensures

Number of Doses

• Inactivated vaccines require multiple

doses and may require periodic

boosting to maintain immunity.

– Antibody titers may decrease below

protective levels after a few years

– Additional doses are given to raise

antibodies back to protective levels

Simultaneous Administration of


General Rule:

There is no contraindication to the

simultaneous administration of any

vaccines (live and inactivated)

– Does not result in decreased antibody

responses or increased rates of adverse


– Increases the probability that a child will be

fully immunized at the appropriate age

Non-simultaneous Administration

of Different Vaccines


2 live injected* 4 weeks

All others None

*Exception: cholera and yellow fever vaccines

should be administered >3weeks

None; can be administered

simultaneously or at any interval

between doses


28 day minimum interval if not

administered simultaneously

2 inactivated


None; can be administered

simultaneously or at any interval

between doses

Inactivated and live

Recommended minimum interval

between doses

Antigen combination

2 live parenteral*

*Some live oral vaccines (oral typhoid and oral polio) can be administered

simultaneously or at any interval before or after inactivated or live parenteral


Contraindications to Immunization

• Contraindication

– Condition in a recipient that

chance of a serious adverse reaction

greatly increases the

• Precaution

– Condition in a recipient that

chance or severity of a serious adverse reaction

– May compromise the ability of the vaccine to

produce immunity

may increase the

Permanent Contraindications to


• Severe allergic reaction to a prior dose of

vaccine or to a vaccine component

– Generalized urticaria, swelling of the mouth and

throat, difficulty breathing, wheezing, hypotension,


– Allergy to vaccine antigen, animal protein,

antibiotics, preservatives, or stabilizers

• Encephalopathy within 7 days of pertussis


Permanent Precautions to further

doses of Pertussis-containing vaccine

• Temperature > 105ºF (40°C)

• Collapse or shock-like state (hypotonic

hypotensive episode)

• Persistent, inconsolable crying lasting 3

or more hours occurring within 48 hours

of a dose

• Seizure, with or without fever, occurring

within 3 days of a dose

Temporary Contraindications to

Vaccination with Live Vaccines

• Pregnancy

• Immunosuppresion

– Diseases – Congenital immunodeficiency,

leukemia or lymphoma, generalized


– Drugs – alkylating agents, antimetabolites,

radiation therapy

– Corticosteroids - >20 mg/day or >2 mkDay

Invalid Contraindications to


• Mild illness

• Antibiotic therapy

• Disease exposure or convalescence

• Pregnancy in the household

• Breastfeeding

• Premature birth

• Allergies to products not in vaccine

• Family history unrelated to immunosuppression

• Need for TB skin testing

• Need for multiple vaccines

Invalid Contraindications

• Minor illness

– Low-grade fever, upper respiratory

infection, otitis media, mild diarrhea

– Diarrhea

the dose; revaccinate after 4 weeks

may give OPV but don’t count

• Antibiotic therapy

– No effect on immune response to a


– Will not inactivate a live virus vaccine

Invalid Contraindications

• Disease exposure or convalescence

– Will not affect response to a vaccine or

increase the likelihood of an adverse event

• Pregnancy in the household

– Most vaccines, including live vaccines

(MMR, varicella) can be given to infants or

children with pregnant household contacts

Invalid Contraindications

• Breastfeeding

– Does not decrease the response to routine

childhood vaccines

• Premature birth

– Vaccines should be started on schedule based on

child’s chronologic age

– Premature infants respond adequately to vaccines

used in infancy

Invalid Contraindications

• Nonspecific allergies, allergies to

antibiotics not in vaccine, non-severe

egg allergies, and allergies to duck


• Family history of adverse event

unrelated to immunosuppression, or

family history of seizures or SIDS

Invalid Contraindications

• Need or requirement for TB skin test (PPD)

– All vaccines can be given on the same day as a

TB skin test, or any time after a PPD is applied

skin test, potentially causing a false negative

response in someone who actually has a TB


MMR vaccine may decrease the response to a TB

• MMR can be given on the same day as a PPD but if one

or more days have elapsed

giving a routine PPD

wait 4 – 6 weeks before

General Rule

There are

immunization of a sick child if the child

is well enough to go home.


no contraindications to

Hepatitis B

HB vaccine + HBIg (within 12


HB vaccine (within 12 hrs)

+ HBIg (within 7 days) if

HBsAg is (+)

HBsAg ?

If infant is HBsAg and anti-HBs (-), reimmunize with 3

doses at 2 month intervals and retest

HBsAg (+)

Maternal status

Test mother for HBsAg within

12 hrs of birth and if

unavailable, give infant HBIg

Test mother for HBsAg


Check anti-HBs and HBsAg at 9-15 mos

4 vaccines (0,1,2,6 mo3 vaccines (0,1,6 mo) )

HB Vaccine + HBIG

(within 12 hrs)

HB vaccine + HBIG

(within 12 hrs)


³2000g Infants <2000g

Hepatitis B

Infants <2000Maternal status Infants

³2000g g

HBsAg (-)

Follow-up anti-HBs and HBsAg testing not needed

May give Hep B containing combination vaccine >6 wks of


HB vac 3 doses (0,1,6 mo) HB vac 3 doses (1,2,6 mos)

HB vaccine 1 dose at 30

days of chronologic age if

medically stable, or at

hospital discharge if before

30 days of chronologic age

HB vaccine at birth

Hepatitis B

6 monthHBV3 s

HBV2 1-2 months

If mother found to be

HBsAg (+), give 0.5 ml

ASAP, not later than 1

wk after birth


HBsAg ? HBV1 Birth (within 12 hrs)

HBV3 6 months

HBV2 1-2 months

HBsAg (+) HBV1 + HBIg Birth (within 12 hrs)

Maternal Status Vaccine dose and HBIg Age

Measles/Mumps/Rubella (MMR)

• Offers

12 months of age or older (2 doses are given

to safeguard against primary vaccine failures)

• MMR is given in 2 doses:

³95% protection after a single dose at

• MMR1 at 12-15 mos of age

• MMR2 at school entry (4-6 yrs of age)

• Those who have not received the 2

school entry should receive the second dose


nd dose atbut no later than 11-12 years of age


• Give vaccine within 72 hrs of exposure

• Ig may be given within 6 days of exposure

• Indicated for household contacts of patients with

measles (<1 yr old, pregnant women,


• Not indicated for contacts who have received at least 1

dose of vaccine at 12 months of age or older unless they

are immunocompromised

• 0.25 ml/kg IM

• 0.50 ml/kg IM for immunocompromised patients

• Maximum dose is 15 ml

• Another dose has to be given if there is re-exposure and

>2wks have lapsed since IVIg was given


• Work restrictions:

Active = exclude from duty 7 days after

rash onset

Exposed = exclude for 5-21 days after


Intervals between Ig administration

and measles/MMR/Varicella









Interval, mo



Replacement for immune

def. (as IVIg)

Plasma/platelet conc

Whole blood

Packed RBCs

Blood transfusion

Indication for Ig


Immunocompromised 10



Measles prophylaxis as Ig

Rabies (as RIG) 7

HBIg 6

Hep A prophylaxis (as Ig) 5

Tetanus (as TIG)

Indication for Ig Interval, mo

Measles/Mumps/Rubella (MMR) -


• Communicable 6-10 days before onset of

parotitis and 9 days after clinical disease

• Source isolation: droplet precautions

• Exposure definition: direct contact with

respiratory secretions or saliva

• Susceptible:

– no hx of physician diagnosed mumps

– No serologic evidence of immunity


• N. meningitidis groups A, B, C, Y, W135

• Transmission: Droplet spread

Direct contact from carriers

or infected individuals

• IP: 2-10 days

• Period of communicability: until 24 hrs

after initiation of antimicrobial therapy

Disease Risk for Contacts of

Individuals with Meningococcal


High risk: chemoprophylaxis recommended (close contact)

• Household contact: especially young children

• Child care or nursery school contact during 7 days before onset of illness

• Direct exposure to index patient’s secretions through kissing or sharing of

toothbrushes/utensils during 7 days before onset of illness

• Mouth-to-mouth resuscitation, unprotected contact during endotracheal

intubation during 7 days before onset of illness

• Frequently slept or ate in same dwelling as index patient during 7 days

before onset of illness

Low risk: chomoprophylaxis not recommended

• Casual contact: no hx of direct exposure to index patient’s oral secretions

• Indirect contact: only contact is with a high risk contact, no direct contact

with the index patient

• Health care professionals without direct exposure to patient’s oral


Antimicrobial regimens for


Single dos

³ 18 yrs 500 mg, po e



18 yrs* 500 mg, po Single dose


> 15 yrs 250 mg, IM Single dose



15 yrs 125 mg, IM Single dose

> 1 mo 10 mg/kg/dose, po BID (max 600 mg)



1 mo 5 mg/kg/dose, po BID 2 days

Age Dose Duration


1.0 Purified chick embryo cell vaccine (PCECV) 1 ml/vial 0.2 ml ml

Purified duck embryo vaccine (PDEV) 1 ml/vial 0.2 ml 1.0 ml

Purified vero cell rabies vaccine (PVRV) 0.5ml/vial 0.1 ml 0.5 ml

Vaccine Prep ID dose IM dose

Rabies: Pre-exposure prophylaxis

• For those at high risk of exposure to rabies

such as

vets, animal handlers, field workers, HCW

personnel in rabies diagnostic lab,

• 1 dose on day 0, 7 and 21 or 28:

1. 0.1 ml ID PVRV, PCECV, PDEV

2. 0.5 ml IM PVRV

3. 1.0 ml IM PDEV OR PCECV

• 1 booster dose q 2-3 years depending on



• Category 1

• Sharing of food/drink with patient/casual contact

• No prophylaxis required but may give pre-exposure


• Category 2

• Licking of broken skin, superficial bites without bleeding

• Give vaccine

• Category 3

• Bites with bleed

• Splashing or splattering of fluids into eyes/mouth

• Scalpel nicks/needle stick injuries

• Mouth to mouth resuscitation, licking of intact mucosa

such as eyes, lips, vulva

• Give vaccine and RIG

Rabies: Post-exposure


Days 0, 3, 7 = 2 doses

Days 30 and 90 = 1 dose

PVRV 0.1 ml

PDEV 0.2 ml

PCECV 0.2 ml

2 site ID regimen ID


Day 0 = 8 doses

Day 7 = 4 doses

Day 30 and 90 = 1 dose

PVRV 0.1 ml

PDEV 0.2 ml

PCECV 0.2 ml

8 site ID regimen ID


Day 0 = 2 doses

Day 7 = 1 dose

Day 21 = 1 dose

PVRV 0.5 ml

PDEV 1.0 ml

PCECV 1.0 ml

Zagreb (2-1-1) IM

– induces early Ab response

– for those who want to

complete the course earlier

– for those if RIG can’t be


Days 0, 3, 7, 14, 28

(1 dose/day)

PVRV 0.5 ml

PDEV 1.0 ml

PCECV 1.0 ml

Essen (1-1-1-1-1) IM

– for IC’ed pxs

Regimen Route Type and dose Schedule

Rabies: Post-exposure


• Booster doses:

• IM: PVRV 0.5 ml or PDEV/PCECV 1.0 ml

• ID: PVRV 0.1 ml or PDEV/PCECV 0.2 ml

• < 6 mos = no booster dose

• 6 mos -1yr = 1 dose (day 0)

• >1 yr - 3 yrs = 2 doses (days 0 and 3)

• > 3 yrs = full course of active vaccine

Rabies: Post-exposure


• Passive immunization

– Human RIG (HRIG)

• Dose: 20 iu/kg

• Available in 300 iu/2 ml vial

– Equine RIG (ERIG)

• Dose: 40 iu/kg

• Available in 1000 iu/5 ml vial)


• Susceptible individuals:

– Infectious 10-21 days following exposure

– No previous history of infection

• Work restrictions:

– Restrict from patient contact 10-21 days


• Give VZIg within 96 hrs after exposure

• Given IM

• Minimal dose = 1 vial (1.25 ml or 125 u)

• Usual dose = 1 vial/10 kg

• Maximum dose = 625 u (5 vials)

• For immunocompromised patients, infants and pregnant


• Duration of protection is unknown, but another dose

should be given if >3 weeks have lapsed since Ig was


• Live attenuated vaccine for >12 months old

• 1 dose for those <12 years old

• 2 doses, 1 month apart for those >12 years of age

Adult/HCW Immunization

Routine Adult Immunization

3 doses (0,1, 6 monthsHepatitis B )

Influenza Every year

Pneumococcal Single dose (booster q 5 yrs)

MMR 2 doses (0,1 month)

<13 yrs = 1 dose

>13 yrs = 2 doses at 0, 1 month


3 doses (0,1, 6-12 months)

Booster q 10 years

Tetanus- diphtheria toxoid

Vaccine Schedule

Additional Vaccines for HCW

Primary – 3 injections on days

0, 7 and 21 or 28

Booster q 2 years

Rabies (IM/ID)


human diploid cell vaccine


purified vero cell vaccine


purified duck embryo vaccine



purified chick embryo

1 capsule each on days 0,2,

and 4 (1 hr ac meals)

Single dose

Booster 2 2-3 years


live-attenuated Ty21a

oral enteric-coated capsule,

polysaccharide Ty2

Intramuscular-VI capsular

SchedulVaccine e

When we know what we know, then

children grow up to be like us:

Safe and Protected







Definition of Terms



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