Recommendations for Using Pneumococcal Vaccines among Adults

Transcription

1 Recommendations for Using Pneumococcal Vaccines among Adults AI Collaborative Webinar July 2017 Tamara Pilishvili Respiratory Diseases Branch, CDC National Center for Immunization & Respiratory Diseases Division of Bacterial Diseases

2 ACIP Recommendations through 2012: Pneumococcal Polysaccharide Vaccine (PPSV23) All adults 65 yrs and older Adults years old with the following conditions Advisory Committee on Immunization Practices, MMWR

3 Age-specific incidence of invasive pneumococcal disease, U.S., 1998 Incidence (cases per 100,000) < Age (years) 3

4 Conjugate Vaccines Benefit the Unvaccinated: Rates of IPD Caused by PCV7 Serotypes, A d u lts 1 8y e a rso ld PCV7 introduction 2009 vs. baseline 65+: -97%(-96,-98) 50-64: -92% (-89,-94) 18-49: -96 (-94,-97) Moore, IDSA, 2009

5 Burden of pneumococcal disease among adults 65 years of age Adults 65 years at increased risk for pneumococcal disease and serious illness from the major clinical syndromes associated with it Case-fatality rate for pneumococcal bacteremia is ~15% overall, but as high as 60% among adults 65 years ~18,000 fatal cases of pneumococcal disease am ong adults 65 years each year in the U nited St at es 6

6 13-valent Pneumococcal Conjugate Vaccine (PCV13) for Adults Licensed for use among adults >50 years old on 12/30/11 FDA approved under the Accelerated Approval Pathway Based on non-inferior immunogenicity compared to PPSV23 Indications Prevention of pneumococcal disease (including pneumonia and invasive disease) in adults 50 years of age and older Prevention of disease caused by Streptococcus pneumoniaeserotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Post-approval condition of licensure: Randomized controlled trial of PCV13 against pneumococcal pneumonia among adults >65 years old in the Netherlands (CAPiTA) 8

7 ACIP Recommendations in Recommended a dose of PCV13 in sequence with PPSV23 for Adults with immunocompromising conditions, functional or anatomic asplenia, CSF leaks or cochlear implants (2012) All adults >65 years of age (2014) 9

8 Why did ACIP recommend PCV13 for immunocompromised adults?

9 Incidence of IPD in adults aged years with selected underlying conditions, United States, fold increased risk Cases per 100,000 persons fold increased risk HEALTHY CVD DIABETES PULMONARY KIDNEY LIVER ALCOHOL HIV/AIDS HEMATOLGICAL CANCER Kyaw, JID 2005;192:377-86

10 Trends in IPD rates among adults yrs old with & without HIV-infection, before and after PCV7 introduction, Adults with HIV infection Adults without HIV infection 6-8/ 100K 64 / 100K Cohen, AIDS 2010;24(14):

11 PCV efficacy against Invasive Pneumococcal Disease (IPD) Double-blind, randomized, placebo-controlled Efficacy trial among HIV-Infected Adults in Malawi (N=496) 2 doses of PCV7 given 4 weeks apart Endpoint Vaccine Efficacy (95% CI) PCV7-serotype IPD 74% (30%, 90%) French N, et.al. N Engl J Med 2010;362:

12 Immunogenicity of PCVs in immunocompromised adults PCV does elicit an immune response in HIV+ and cancer patients 1,2,3,4,5,6 Response following a single dose of PCV is as good or better than PPV23 (both in vaccine naive or previously vaccinated) 1,2,3 Studies with sequential vaccination show similar or improved immune response if PCV given first 1,2,3 Revaccination with PCV show similar immunogenicity compared to the first dose 4 1. Feikin Diag Lab Immunology 2004, 2. Lesprit AIDS 2007, 3. Penaranda AIDS Miro JID, Chan JID, Crum JID, 2010

13 In adults with immunocompromising conditions, should we use PCV13, PPSV23 or Both? Proportion of IPD by vaccine serotype, 2010 Immunocompromised 29% 50% 21% 21% of disease due to serotypes in PPSV23 not covered by PCV13 Opportunity for broader serotype protection through use of BOTH vaccines PCV13 PPV23/NonPCV13 Other CDC, ABCs, unpublished, 2011

14 Conclusions for high-risk adults Extremely high burden of disease among immunocompromised adults Indirect effects of PCV13 use in children unlikely to eliminate PCV13 serotypes from immunocompromised adults Benefits of PCV13 use in this group outweigh the harms PCV13 alone may not provide adequate coverage of serotypes causing disease Combined regimen of PCV13 and PPSV23 likely better than either vaccine alone ACIP Decision: Benefits likely outweigh harms and both PCV13 and PPSV23 should be recommended for adults with immunocomromising conditions

15 Recommendation for PCV13 and PPSV23 for high risk adults Vaccine naïve adults: PCV13 dose is recommended to be given before PPSV23, whenever possible PPSV23 should be given at least 8 weeks after a dose of PCV13 Recommendations for 2 nd dose of PPSV and a dose at age 65 years or older remain unchanged PPSV23-immunized adults A dose of PCV13 is recommended to be given to adults with immunocompromising conditions who received 1 or more doses of PPSV23 1 or more years after the last PPSV23 dose Tot al number and interval between PPSV23 doses unchanged from current recommendations 15

16 Prevention of pneumococcal disease among adults 19 years w ith functional or anatomic asplenia or immunocompromising conditions PCV13 + PPSV23 + PPSV23 (@< 65 years) (@< 65 years) (@<65 years) * 8 weeks 5 years + PPSV23 (@ 65 years) 21

17 Prevention of pneumococcal disease among adults 19 years w ith cochlear implants or CSF leaks PCV13 + PPSV23 + (@< 65 years) (@< 65 years) PPSV23 (@ 65 years) 8 weeks 5 years 22

18 Prevention of pneumococcal disease am ong adults 19 years w ith high risk conditions Current guidelines Use of PCV13 and PPSV23 for Adults with Immunocompromising Conditions: Recommendations of the Advisory Committee on Immunization Practices (ACIP) remain unchanged ml/mm6140a4.htm 20

19 Why did ACIP recommend PCV13 for adults >=65 years old?

20 New Evidence Supporting PCV13 use among adults, CAPiTA results Study/population CAPITA ~85,000 Adults 65+ Netherlands Endpoint Vaccine Efficacy (95% CI) PCV13-serotype IPD 75% (41%, 91%) PCV13-serotype non-bacteremic pneumonia 45% (14%, 65%) CAPITA, ACIP June

21 Summary of evidence supporting PCV13 use among adults >65 years of age Prevents IPD and non-bacteremic pneumonia 1 75% reduction in vaccine type IPD 45% reduction in vaccine type non-bacteremic pneumonia Immune response non-inferior or improved (for some serotypes) for PCV13 (or PCV7) vs. PPSV23 2,3 Safety demonstrated in clinical trials 1 CAPITA, June 2014 ACIP 2 Phase III trials, Pfizer, ACIP 2011, DeRoux et al. CID 2008, Goldblatt et al

22 Summary of evidence supporting PCV13 use among adults >65 years of age Vaccine preventable disease burden remaining among adults >65 years Estimated 2,600 PCV13 type IPD cases in Over 50,000 PCV13-type inpatient CAP 2 In the short-term, PCV13 likely provides adequate coverage of disease causing serot ypes 20-25% IPD due to PCV13 types 1 ~10% of all CAP due to PCV13 types 2 1 Active Bacterial Core Surveillance, Estimat e based on studies using serotype-specific urine antigen test, Pfizer 12

23 PCV13 now recommended in series w ith P P S V 2 3 fo r a ll a d u lts 6 5 y e a rs 13

24 A d u lts 65 years of age with no previous pneumococcal vaccine (PCV13 or PPSV23) or unknown vaccination history Recommendation Administer a dose of PCV13 first, followed by a dose of PPSV23 Guidance on intervals for sequential use A dose of PPSV23 should be given at least 1year* following a dose of PCV13. The two vaccines should not be co-administered. If a dose of PPSV23 was inadvertently given earlier than the recommended interval, the dose need not be repeated. *June 2015 ACIP vote 14

25 PCV13-naïve adults 65 years of age previously vaccinated with PPSV23 Recommendation Administer a dose of PCV13 Guidance on intervals for sequential use Administer PCV13 at least 1 year after the receipt of the most recent PPSV23 dose For those for whom an additional dose of PPSV23 is indicated, administer it at least 1 year* after PCV13 and at least 5 years after the most recent dose of PPSV23 *June 2015 ACIP vote 17

26 PCV13-naïve adults 65 years of age previously vaccinated with PPSV23 PPSV23 + PCV13 (@ 65 years) >1 year >5 years PPSV23 + PCV13 + PPSV23 (@< 65 years) (@ 65 years) (@ 65 years) * 1 year >1 year 18

27 September 19, 2014 / 63(37); ; October 12, 2012, Vol 61, #40; June 28, 2013 / 62(25); ; December 10, 2010 / 59(RR11);1-18 June 28, 2013 / 62(25); Intervals Between the Two Pneumococcal Vaccines Incorporating June 2015 Changes Age groups 19 years Underlying conditions PCV13 PPSV23 PPSV23 PCV13 High-risk immunocompetent (CSF leak, cochlear implants) Functional or anatomic asplenia Immunocompromised 8 weeks 1 year 65 years NA 1 year 1 year

28 Indications for PCV13 and PPSV23 Advisory Committee on Immunization Practices, MMWR 2012

29 Prevention of pneumococcal disease among adults 19 years w ith chronic medical conditions PPSV23 + (@< 65 years) PCV13 (@ 65 years) PPSV23 (@ 65 years) >1 year 5 years 23

30 PATIENT SCENARIOS 24

31 A 65 year old female patient with no underlying medical conditions and no previous pneumococcal vaccinations Administer vaccines as follows: 1 dose of PCV13 now 1 dose of PPSV23 1 year after administering PCV13 Rationale: Patient scenario #1 She is 65 years old and has no history of pneumococcal vaccination, so she is recommended both pneumococcal vaccines 31

32 A 67 year old male patient with no underlying medical conditions who received a dose of PPSV23 at age 65 years Administer vaccines as follows: 1 dose of PCV13 now Rationale: He is 65 years old Patient scenario #2 It has been 1 year since PPSV23 Only 1 dose of PPSV23 is recommended for adults 65 years 32

33 A 66 year old male patient with cochlear implants who received a dose of PPSV23 at age 55 years Administer vaccines as follows: 1 dose of PCV13 now 1 dose of PPSV23 1 year after administering PCV13 Rationale: He is 65 years old Patient scenario #3 At least 1 year has passed since he received PPSV23 It s been 5 years since his previous PPSV23 dose 33

34 A 66 year old female patient infection with HIV who received a dose of PPSV23 at ages 52, 57, and 65 years and a dose of PCV13 at 64 years Do not administer any vaccines Rationale: Patient scenario #4 Only 1 dose of PCV13 is recommended in an adult s lifetime Only 1 dose of PPSV23 is recommended for adults 65 years 34

35 Standards for Adult Immunization Practices Assess the immunization status of all your patients Strongly recommend vaccines that patients need Administer needed vaccines or refer patients to a vaccinating provider Document vaccines received by your patients 35

36 CDC Resources Clinician: Adult immunization information/schedule Patient: Education materials on adult immunization Implementation of Standards Pneumococcal disease and vaccine resources 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. National Center for Immunization & Respiratory Diseases Division of Bacterial Diseases