Outline
Non infectious
HPV VLP
Quadrivalent
2vHPV
4vHPV
(Cervarix)
(Gardasil)
L1 VLP types
16, 18
6, 11, 16, 18
Manufacturer
GlaxoSmithKline
Merck
AS04:
AAHS:
Adjuvant
Quadrivalent
9-valent
2vHPV
4vHPV
9vHPV
(Cervarix)
(Gardasil)
(Gardasil 9)
L1 VLP types
16, 18
6, 11, 16, 18
Manufacturer
GlaxoSmithKline
Merck
Merck
AS04:
AAHS:
AAHS:
Adjuvant
% of HPV positives and are based on the upper estimate attribution of multiple HPV types
http://www.cdc.gov/cancer/hpv/statistics/cases.htm
HPV
attributable
% (95% CI)
HPV 16/18
attributable
% (95% CI)
HPV 31/33/45/52/58
attributable
% (95% CI)
Cervical
91 (88-92)
66 (63-69)
15 (12-17)
Vaginal
75 (63-84)
55 (43-67)
18 (11-30)
Vulvar
69 (62-75)
49 (41-56)
14 (10-20)
Penile
63 (52-73)
48 (37-59)
9 (4-17)
Anal
Male
Female
89 (77-95)
92 (85-96)
79 (66-88)
80 (70-87)
4 (1-13)
11 (6-19)
Oropharyngeal
Male
Female
72 (68-76)
63 (55-71)
63 (59-68)
51 (43-59)
4 (3-7)
9 (6-15)
Adapted from Saraiya, presented at AIN Conference, March 1315, 2015, Atlanta, GA.
HPV
attributable
% (95% CI)
HPV 16/18
attributable
% (95% CI)
HPV 31/33/45/52/58
attributable
% (95% CI)
Cervical
91 (88-92)
66 (63-69)
15 (12-17)
Vaginal
75 (63-84)
55 (43-67)
18 (11-30)
Vulvar
69 (62-75)
49 (41-56)
14 (10-20)
Penile
63 (52-73)
48 (37-59)
9 (4-17)
Anal
Male
Female
89 (77-95)
92 (85-96)
79 (66-88)
80 (70-87)
4 (1-13)
11 (6-19)
Oropharyngeal
Male
Female
72 (68-76)
63 (55-71)
63 (59-68)
51 (43-59)
4 (3-7)
9 (6-15)
Adapted from Saraiya, presented at AIN Conference, March 1315, 2015, Atlanta, GA.
HPV
attributable
% (95% CI)
HPV 16/18
attributable
% (95% CI)
HPV 31/33/45/52/58
attributable
% (95% CI)
Cervical
91 (88-92)
66 (63-69)
15 (12-17)
Vaginal
75 (63-84)
55 (43-67)
18 (11-30)
Vulvar
69 (62-75)
49 (41-56)
14 (10-20)
Penile
63 (52-73)
48 (37-59)
9 (4-17)
Anal
Male
Female
89 (77-95)
92 (85-96)
79 (66-88)
80 (70-87)
4 (1-13)
11 (6-19)
Oropharyngeal
Male
Female
72 (68-76)
63 (55-71)
63 (59-68)
51 (43-59)
4 (3-7)
9 (6-15)
Adapted from Saraiya, presented at AIN Conference, March 1315, 2015, Atlanta, GA.
10
10000
9000
8000
7000
females
males
6000
5000
4000
3000
2000
1000
0
HPV 16/18
5 additional types
HPV-associated cancers
~33,000 per year
64% of cancers attributable to HPV 16/18
66% of cervical cancer
Other cancers: range, 48% penile -80% anal
CIN2 lesions
~50% attributable to HPV 16/18
~25% attributable to 5 additional types
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Design
~14,000 women aged 16-26 years
Randomized trial: 9vHPV or 4vHPV
Objectives
Demonstrate efficacy for HPV 31,33,45,52,58
Demonstrate non-inferior immunogenicity for
HPV 6,11,16,18
14
9vHPV
n/total
4vHPV
n/total
Vaccine efficacy
(95% CI)
1/6016
30/6017
35/5939
810/5953
15
HPV 6,11,16,18
related outcomes
9vHPV
n/total
4vHPV
n/total
1/5883
3/5898
16
GMT (mMU/mL)
10000
1000
100
10
1
6
11
16
18
31
33
Anti-HPV
45
52
58
Efficacy
~97% protection against HPV 31,33,45,52,58-related outcomes
Similar protection against HPV 6,11,16,18-related disease
Non-inferior immunogenicity
For HPV 6,11,16,18 compared with 4vHPV in 1626 and 915 year olds
For all 9 HPV vaccine types in adolescent females and males compared
to adult females and in adult males compared to adult females
Concomitant use
No impact on immunogenicity or safety administered concomitantly
with quadrivalent meningococcal conjugate vaccine (Menactra) and
tetanus, diphtheria, acellular pertussis vaccine (Adacel)
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM426457.pdf
18
Concomitant use
No difference in safety profile when co-administered with
quadrivalent meningococcal conjugate vaccine (Menactra) and
tetanus, diphtheria, acellular pertussis vaccine (Adacel)
19
RECOMMENDATIONS
Vaccines
2vHPV or 4vHPV for females
4vHPV for males
21
Licensed for
Bivalent
(Cervarix)
Quadrivalent
(Gardasil)
9-valent
(Gardasil 9)
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23
MMWR 2015;64:300-4
24
MMWR 2015;64:300-4
25
MMWR 2015;64:300-4
26
No change in recommendations
HPV vaccine not recommended for use in pregnancy
27
28
Routine
recommendation
for females
Routine
recommendation
for males
Tdap
MCV4
Percent
80
60
40
3 HPV (girls)
>1 HPV (boys)
20
3 HPV (boys)
0
2006
2007
2008
2009
2010
2011
2012
2013
Year
NIS-Teen = National Immunization Survey-Teen
MMWR 2014:63;625-33
30
Resources
ACIP website with slides, minutes and recommendations
http://www.cdc.gov/vaccines/acip/index.html
Additional resources for providers/patients/clients
http://www.cdc.gov/vaccines/vpd-vac/hpv/
www.cdc.gov/vaccines/YouAreTheKey
www.cdc.gov/hpvwww.cdc.gov/vaccines/teens
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Thank you
bse4@cdc.gov
For more information please contact Centers for Disease Control and Prevention
1600 Clifton Road NE, Atlanta, GA 30333
Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348
E-mail: cdcinfo@cdc.gov Web: http://www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention.
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