Prof. DR. Hinky Hindra Irawan Satari, dr., Sp.A(K), M.Trop.Paed.

Riwayat Pendidikan Formal

• Dokter Umum, FK UNPAD, 1981
• Dokter Spesialis Anak, FKUI, 1992
• Master of Tropical Pediatrics, School of Tropical Medicine, Liverpool University, UK 1995
• Konsultan Penyakit Infeksi dan Pediatri Tropis, Kolegium IDAI, 2002
• Doktor dalam Bidang Ilmu Kedokteran, FKUI, 2012

Jabatan & Organisasi

– Guru Besar Dep IKA FKUI-RSCM, 2018
– Ketua, Komnas PP-KIPI, KemKes RI 2015 – sekarang
– Ketua, Pokjanas Pencegahan Pengendalian Infeksi (PPI), KemKes RI 2017-sekarang
– Ketua, Perkumpulan Pengendalian Infeksi (INASIC): 2017-sekarang
– Ketua, Komite Ahli Tim Eliminasi Campak-Rubela, KemKes RI, 2016 - sekarang
– Anggota ITAGI: 2009-sekarang
– Anggota, Tim Pakar Satgas Penanganan COVID-19, BPNB, 2020 - sekarang
– Anggota Tim Advokasi Imunisasi, IDI: 2021-sekarang
– Anggota, Komite Ahli Tim Eradikasi Polio, KemKes RI, 2015-sekarang
– Anggota, Komite Pencegahan dan Pengendalian Resistensi Antimikroba, Kemkes RI, 2015 – sekarang
– Standing Committee, International Society of Tropical Pediatrics, 2015 – sekarang
– Anggota, Verification Committee on Measles and Rubella Elimination, WHO-SEARO, 2015-sekarang
Surveilans dan keamanan vaksin HPV di Indonesia

Prof. DR. dr. Hindra Irawan Satari , Sp.A(K), MTropPaed

Ketua Komnas KIPI
 HPV Vaccination in Indonesia

Bali Sejak 2015

(Mandiri/APBN)
 PERCENTAGE HPV IMMUNIZATION COVERAGE IN
(BIAS/SCHOOL IMMUNIZATION MONTH)
ELEMENTARY SCHOOL GRADE 5 AND 6

GRADE 5 92.01%
(2016) (66.094)

GRADE 5 94,3%
(2017) (80.553)

GRADE 6 99,98%
(2017) (48.044)
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 Details of HPV Pilot Program Coverage Rate 2017
in Indonesia
DISTRICT/CITY TARGET COVERAGE
5th Grade 6th Grade 5th Grade 6th Grade
(n) (%) (n) (%)
Seribu Island 192 199 224 116.7% 197 99.0%

South Jakarta 9,376 8,220 7,991 85.2% 7,619 92.7%

East Jakarta 10,163 9,141 10,507 103.4% 9,937 108.7%

Central Jakarta 6,829 5,891 7,082 103.7% 6,984 118.6%

West Jakarta 15,650 14,168 14,454 92.4% 13,240 93.5%

North Jakarta 12,392 10,436 10,636 85.8% 10,067 96.5%

54602 48055 50894 93.2% 48.044 99.98%

Kulon Progo 2949 2948 100.0%

Gunung Kidul 4717 4701 99.7%

7666 7649 99.8%

Kota Surabaya 23145 22010 95.1%

23145 22010 95.1%

85413 48055 80553 94.3% 48044 99.98%

 Methodology
vStudy Design è Cohort prospective study
vDescriptive Study à No hypotheses tested
vN è 500
vBatch No. è 24473;32864;36314
vImmunization Schedule (Dose) è at least 1 dose
of QHPV Vaccine given at inclusion criteria
vTarget Participant è Elementary School Grade
6th, in 5 region of DKI Jakarta
 Objective
Primary
To assess serious systemic reaction occured within 30
minutes after QHPV Vaccine immunization

Secondary
1. To assess systemic reaction occured after QHPV vaccine
Immunization
2. To assess local reaction occured after QHPV vaccine
Immunization
3. To observe Serious Adverse Event Following
Immunization after QHPV vaccine Immunization
 Study Flow Chart
Number of Visit First Visit Second Visit Third Visit
(K1) (K2) (K3)
Interval Visit (Day) Baseline K1+3H K1+28H
Signed Inform Consent X
Inclusion & Exclusion Criteria X
Anamnesis Clinical/medical History X
Physical Examination X X X
Vaccination Dose X
Observation of immediate reaction (in 30
X
minutes)
Observation of Local and systemic reaction X X X
Kartu Harian Anak Sekolah (KHAS/Daily
KHAS-1
Cards) distribution
Kartu Harian Anak Sekolah (Daily Cards) KHAS-1
retrieval
Anamnesis of Medical Treatment/ X
X X
medication taken
Serious AE Observations
Indicator Observation
 Logistic
KHAS/ DAILY CARD

LOCAL REACTION
MEASUREMENT BAND
Protocol to recording symptoms
 Study Timeline

EC Sosialication Data
Logistic Analyst
Observation
Nov
2016 Apr- Agst- Okt-
- Feb Mei Sep Nov Jan Mar
2017 2017 2017 2017 2018 2018 Submission
to Asia
Pacific
Journal of
Feb- Juni- Okt Des Feb
Cancer
Mar Juli 2017 2017 2018 Prevention
2017 2017

Proposal Material Monitoring

Meeting Preparation PMS evaluation Final
Province Implementati Report
Level with on
KOMNAS
 Parameter n (%)
Age (years)
10 1 (0.2)
11 194 (38.8)
12 281 (56.2)
13 23 (4.6)
14 1 (0.2)
Regionwise distribution
North Jakarta 100 (20)
South Jakarta 100 (20)
Demographic Central Jakarta 100 (20)
West Jakarta 100 (20)
of East Jakarta 100 (20)
Participants Medical/Clinical History before HPV Vaccination
Asthma 1 (0.2)
Flu & Cough 2 (0.4)
Lump on back neck 1 (0.2)
Lump on right neck 1 (0.2)
Fever 1 (0.2)
Dyspepsia 9 (1.8)
Bronchitis 1 (0.2)
Nasal Congestion 1 (0.2)
No Symptom 483 (96.6)
Total participants 500 (100)
 Systemic Reaction: Fever
Subjects distribution by fever level and time of observation

There were no incidences of moderate or severe fever during the study period. Mild
fever was reported in 1.6% participants (n=8), with the highest peak noted on the
5thday after immunization. The fever subsided after the 6th day.
Local Reaction : Pain & Redness
 Local Reaction: Pain & Redness
• Majority of the participants (59.6%; n=298) experienced some
degree of pain during the study period. Severe pain was
reported within the first 30 minutes by 12% (n=62) of the
participants and it resolved by the 3rd day.
• Mild and moderate pain subsided after day 12 and 14,
respectively.
• Redness at the site of injection (regardless of severity) was
experienced by 23.6% (n=118) of the participants with the
redness being of mild severity in majority of these cases.
• The redness was noted within 30 minutes after the injection,
gradually decreased, and resolved after 12 days following
immunization.
 Local Reaction: Swelling

Swelling at the site of injection (regardless of severity level) was noted in 17.2%
(n=86) of the participants and was of mild severity in majority of the cases. The
swelling occurred within 30 minutes after the injection, gradually decreased, and
completely subsided after 10 days following immunization
Mean duration of adverse event in day for systemic
and local reaction regardless of severity
Others Systemic & Local Reaction
Others Local n %
Reaction
None 491 98.2%
Myalgia 9 1.8%
Total 500 100%

Others Systemic n %
Reaction
None 496 99.2%
Asthenia 1 0.2%
Myalgia 2 0.4%
Arthralgia 1 0.2%
Total 500 100%
One hundred and ninety eight females aged 12-
15 y observer-blinded randomized trial to assess
the immunogenicity and reactogenicity of the
tetravalent HPV vaccine Gardasil® (group 2), in
comparison to the bivalent HPV vaccine,
Cervarix® (group 1), which was routinely offered
in the national vaccination schedule at the time.
For the majority of local and general reactions,
recipients of both vaccines reported comparable
frequencies.
Local and systemic events were rarely of high
severity, except for tenderness at the injection
site which reached a severe level after at least
one of the doses in 24% of the Cervarix® group
and 7% of the Gardasil® group (p = 0.001
comparing groups). For most reactions, no dose
response was recorded, except for swelling with
higher reporting at dose 3 (17.7%) than dose 1
(3.1%) for Cervarix®. SAE reporting was low (n =
3) and considered unrelated to either vaccine.
This paper supports the body of evidence that
Gardasil® has an acceptable safety profile when
compared with Cervarix® and other vaccines
given in the national program.
 Summary
• There were no SAEs reported in the current
study following immunization with the QHPV
vaccine. Among systemic reactions, mild fever
was noted in 1.6% of the participants.
• The overall pain prevalence in the current study
was found to be 59.6%. This was higher
compared to another post licensure study
(53%)1, but lower compared with a phase III HPV
clinical trial (81.3%).2
• Nevertheless, the mean duration of pain in the
current study was about 2 days, which seems to
be an acceptable duration.
1. Slade BA, Leidel L, Vellozzi C et al. Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine. JAMA. 2009;302(7):750-757.
2. MSD Data on File. Pooled Data from Protocols 007,011,012,013,015,016 & 018 for elevated temperature days 1 to 5 following any vaccination visit.
 Summary
• Among other local reactions, the prevalence
of swelling (17.2%) was lower compared with
another post licensure study (22%)1 and with
Phase III HPV Clinical Trial (24.2%)2
• The prevalence of redness was also lower
compared to the post licensure study (24% vs.
28%) 1 and almost similar to that noted in the
phase III HPV clinical trial (23%).2
1. Slade BA, Leidel L, Vellozzi C et al. Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine. JAMA. 2009;302(7):750-757.
2. MSD Data on File. Pooled Data from Protocols 007,011,012,013,015,016 & 018 for elevated temperature days 1 to 5 following any vaccination visit.
 Summary
• The implementation of 2nd dose of QHPV vaccine among
girls studying in sixth grade of elementary school was
associated with a good and tolerable safety profile.
• The QHPV immunization program is an effective strategy
for optimizing HPV vaccine coverage in public programs
and its inclusion in the Indonesia NIP seems beneficial.
• The outcome of the current study as well as the
extensive post-approval safety surveillance data should
be considered to reinforce and implement the national
recommendation for HPV immunization among
preadolescents and adolescents in Indonesia.
Poster presented at Published on Asian Pacific Journal
AOGIN/IPVC 2018 Cancer Prev. 2019 Mar 26:20(3)
Thank you