HPV VACCINE

BY
DR HINDUMATHI
HOD & PROFFESOR OF OBG
 HUMAN PAPILLOMA VIRUS
• Small non enveloped single double stranded
DNA (52-55mm)
• Encapsulated with protein capsid made up of
72 pentameric capsomeres
• Wide infection from ranging from benign
warts to malignant cancers including cervical ,
anal and oropharyngeal cancers
• Human papilloma virus is the most common sexually
transmitted infection (STI)

• Most sexually active men & women being exposed to

the virus at some point during their lifetime

• Increased risk of HPV at younger age

• Highest prevalence occurs amongst adolescent &

young adults between age 15-25 years
• HPV is widely prevalent and ubiquitous. The
average lifetime probability of acquiringthis
infection varies from 85% for women to 91% for
men.
• Human papilloma virus (HPV), is a common virus
that is transmitted primarily sexually through skin-
to-skin or skin-to-mucosa contact. Persistent
infection can lead to cervical, vulval , vaginal, anal,
penile and oropharyngeal cancers, as well as genital
warts
 HPV GENOME
• Early region (E1-E7): viral replication
transcription and immune evasion
• Late region (L1-L2) :Assembly and formation of
viral capsid
• Upstream Regulatory Protein (URR): Non
coding segment for Transcription and
Replication
• E6 &E7 play a central role in development of
cancers
 LIFE CYCLE OF HPV
• HPV targets cutaneous and mucosal squamous
epithelium composed of basal layer of
undifferentiated cells. HPV can only establish in
actively dividing cells. The virus relies on host cell
for its genome replication. HPV itself does not
encode for any enzymes or polymerases. E6, E7 are
critical for growth, persistence and transformation
of host genome, persistence of high-risk HPV being
the major risk factor for the development of ano -
genital cancer
 Classification – HPV types

– HPV types are classified on basis of potential to cause cancer

– At least 30 HPV types target genital mucosa classified as High risk (Oncogenic) and low
risk types
Low-risk
High-risk types types

H L
I 16,18, 31, 33, 45, 6, 11 & others O
G 52, & 58 (42,43,44) W
H
Cause high/low R
R grade cervical I
I lesions & cancers S
Genital warts
S of K
K • Cervix
• Anal
• Vaginal
• Vulvar
• Penile
• Oropharyngeal
 Classification
HPV Type

Low risk types Lesions Regio

……………………………………………………………………………

……………………………………………………………………………

……………………………………………………………………………
ype 6,11 & others (42,43,44)

Genital
Warts

High risk types

pes 16, 18, 31, 33, 35, 39,

45, 51, 52, 56, 58, 59 Cancer
HPV & Cervical cancer
 HPV & Cervical cancer deaths in
- ICO/IARC HPV InformationIndia
Centre 2022
Women at Annual no.
risk for of
cervical cervical
cancer >=15 cancer
Annual no.
yrs of 77,348
Deaths

51.15 cervical
cancer
Deaths
Crore cases
1,23,907 Annually
Deaths
Contributes 17% of Globe Annually Contributes 23% of Globe

Contributes 21% of Globe

 RISK FACTORS OF CERVICAL CANCERS
• 1) INFECTION - HPV (16, 18, 31, 33), HIV,
CHLAMYDIA
• 2) EARLY FIRST COITUS
• 3) STD
• 4) EARLY 1ST PREGNANCY
• 5) TOO MANY & TOO FREQUENT BIRTHS6) LOW
SOCIOECONOMIC STATUS7) MULTIPLE
PARTNERS8) IMMUNOSUPRESSION9) OCP
USERS10) SMOKING
• 6) LOW SOCIOECONOMIC STATUS
• 7) MULTIPLE PARTNERS
• 8) IMMUNOSUPRESSION
• 9) OCP USERS
• 10) SMOKING
 GLOBAL STARTERGY TO ELIMINATE
CERVICAL CANCER
• World Health Organization (WHO) calls for 'A World
Free of Cervical Cancer”. The Global Strategy for the
Elimination of Cervical Cancer, spearheaded by the
WHO presents a comprehensive framework to
eradicate cervical cancer as a public health issue. The
strategy emphasizes the need for widespread HPV
vaccination, aiming to immunize 90% of girls aged 9-
14years by 2030. It also targets screening 70% of
women aged 35-45 years with high-performance tests
and ensuring that 90% of women with invasive
cervical7cancer receive effective treatment
 SCREENING
• 1. PAP Test
• 2. Colposcopy
• 3.HPV - DNA detection(PCR, Southern Blot
Assay, Hybrid Capture)
 DIAGNOSTIC MODALITIES
• Exfoliative Cytology
• HPV - DNA Testing@ Visual Inspection with
Acetic Acid
• Colposcopy
• Cervicography
• Endo cevical Curettage & Biopsy with /
without colposcopy)
• Diagnostic Conisation
HPV VACCINE
• HPV vaccination stands at the forefront of
modern preventive medicine and is one of the
most important discoveries of modern medicine
and offers significant protection against genital
and oropharyngeal cancer and genital warts. The
introduction of vaccines against the most
oncogenic HPV types has revolutionized the
landscape of public health, providing a powerful
tool to reduce the burden of these diseases
• Prophylactic HPV vaccines are composed of
virus-like particles that stimulate theimmune
system to produce antibodies against the
virus. Preventing infection andsubsequent
development of HPV-related cancers. The
vaccines are most effectivewhen administered
before exposure to the virus, and this is why
they arerecommended for preteens and young
adults before they become sexually active
 THE ROLE OF HPV VACCINE
• Prophylactic HPV vaccines are composed of
virus-like particles that stimulate theimmune
system to produce antibodies against the
virus. Preventing infection andsubsequent
development of HPV-related cancers. The
vaccines are most effectivewhen administered
before exposure to the virus, and this is why
they arerecommended for preteens and young
adults before they become sexually active
 VACCINES MARKETED IN INDIA
• Bivalent (CERVARIX by GSK) licensed for
females aged 10-45 years.
• Quadrivalent ( Gardasil by MSD) licensed for
females aged 9-45 years.
• Nonavalent ( Gardasil 9 by MSD) licensed for
females and males aged 9-45years
• Quadrivalent ( Cervavac by SIIL) licensed for
females and males aged 9-26 years
 VACCINE SAFETY
• * Among males and females of all ages receiving HPV
vaccine, injection site reactions included pain (35-88%),
redness (5-40%), and swelling (4-35%).
• Adverse events following HPV vaccination are generally
mild and of short duration®
• Mild systemic adverse events included headache,
dizziness, myalgia, arthralgia, and gastrointestinal
symptoms (nausea, vomiting, and abdominalpain).
• HPV vaccines are safe and well tolerated and can be used
in persons who areimmunocompromised or human
immunodeficiency virus (HIV) infection
 STORAGE
• All HPV vaccines are stored at 2-8° C, not
frozen but protected from light. They should
be administered immediately after removal
from the refrigerator
 DOSAGE
• The vaccine is available as 0.5ml dose. It
should be given intramuscularly inthe deltoid
region. The individual should be seated during
vaccination andobserved in a separate room
for 15 minutes after vaccination
PRIMARY AND SECODARY TARGET GROUPS

• To prevent cervical cancer, the World Health

Organization (WHO)recommends vaccinating girls
aged 9–14 years before they become sexually active.
• Vaccinating over 80% of girls in this age group also
helps protect boys from HPV infection.
• Vaccinating other groups, such as older girls, boys,
men, or men who have sex with men (MSM), is
recommended only if it is possible and affordable, and
does not take resources away from vaccinating the
primary target group, which is girls aged 9-14 years
 BENEFITS AND IMPACT
• By reducing the prevalence of HPV infections
in communties, vaccintion contributes to herd
immunity, indirectly protecting those who may
not been vaccinated.·
• This collective immunity is crucial in
controlling the spread of HPV and reducing
the incidence of associated cancers over time.
• In countries with high vaccintion coverage,
significant declines have been observed in HPV
infections due to vaccine-contained types, genital
warts, precancerous lesions and cancer,
demonstrating the real-world impact of vaccination
programs.

Cervical cancer rates have been declining in

populations where HPV vaccination is widespread,
offering hope for future generations.
 CO ADMINISTRATION AND
INTERCHANGEBILITY
• As per licensing indications, specific HPV vaccine
may be administered concomitantly with other
routine vaccines containing diphtheria (d),
tetanus(T), and acellular pertussis (pa), with no
clinically relevant interference with antibody
response to any of the components of either
• However, if the vaccine used for the prior dose(s)
is unknown or unavailable, any HPV vaccine may
be administered to complete the recommended
 SPECIAL SITUATIONS
• HPV vaccine can be safely co-administered with other age-
appropriatevaccines
• It is not recommended for use in pregnancy. If the patient
conceives after the first dose, it is advisable to give further
doses after pregnancy
• If inadvertent vaccination occurs during pregnancy, there is
no need for the medical termination of pregnancy
• Lactating women can receive HPV vaccine.
• Sexual assault survivors should be given age-appropriate
HPV vaccination,with the first dose at the time of initial
examination
• Women with abnormal Pap/positive HPV test/previous
HPV lesions: Can be vaccinated if they desire; however,
they should be counselled that it is not a therapeutic
vaccine and will not treat existing pathology and that
there is reduced efficacy in older women.
• HPV vaccination is a primary prevention intervention
and does not eliminate the need for screening, since
the existing vaccines do not protect against all high-risk
HPV. Screening for cervical cancer should be done as
per the guidelines
• Women/girls with immuno compromised or
immuno suppressed state should be
administered a 3-dose schedule, or a
minimum of 2 doses
 WHO global strategy to
eliminate cervical cancer

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Source: https://www.who.int/publications/i/item/9789240014107
36
HPV VACCINE LICENSED IN
INDIA
 HPV Vaccines
Gardasil Licensed in India
Cervarix Gardasil 9 CERVAVAC
Manufacturer MSD GSK MSD SIIPL
Type Prophylactic vaccine consisting of virus-like particles containing L1 capsid proteins
Nonavalent vaccine
Quadrivalent vaccine Bivalent vaccine: Quadrivalent vaccine
HPV types 6 ,11,
Antigens HPV types 6,11 ,16 and HPV types 16 and HPV types 6 ,11 ,16
16,18,31,33,45,52
18 18 and 18
and 58
Antigen
Expression Yeast Baculovirus Yeast Yeast
system
ASO4: aluminium Alum:Aluminium
Alum:Aluminium hydroxide, 3- hydroxyphosphate Aluminum Hydroxide
Adjuvant hydroxyphosphate deacylated sulfate
sulfate monophosphoryl lipid
A
Licensed in India only Licensed in India for Licensed in India for Licensed in India for
Gender
for Females Females Female and male Female and male

Girls : 9-14 yrs - 2 Dose Girls : 9-14 yrs - 2 Girls & Women : 9- Girls/Boys : 9-14 yrs
(at 0 and 6M) Dose (at 0 and 26 yrs - 3 Dose ( at - 2 Dose (at 0 and
Vaccination Women : 15 yrs and between 5 to 13M) 0, 2 and 6M) 6M)
Schedule older – Women : 15-45 yrs– Boys - 9-14 yrs - 3 Women/Men : 15-26
3 Dose (at 0, 2 and 6 3 Dose (at 0, 1 and 6 Dose ( at 0, 2 and yrs – 3 Dose (at 0, 2
M) M) 6M) and 6 M)
38
 CATCH UP VACCINATION
• Vaccine is also recommended for girls &
women 13-26 years of age who did notreceive
it when they were younger Additional
(booster) doses are notrecommended HPV
vaccine may be given at the sametime as
other vaccines