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GRADE: 15-valent pneumococcal conjugate vaccine (PCV15) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23) for adults aged 19–64 years with underlying medical conditions or other risk factorsGrading of Recommendations, Assessment, Development, and Evaluation										Related Pages
					Introduction
On October 21, 2021, the ACIP recommended use of 20-valent pneumococcal conjugate vaccine (PCV20 [Prevnar 20, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.]) alone or 15-valent pneumococcal conjugate vaccine (PCV15 [Vaxneuvance, Merck Sharp & Dohme Corp.]) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23) [Pneumovax23, Merck Sharp & Dohme Corp Inc.]) for all adults aged ≥65 years, and for adults aged 19–64 years with certain underlying medical conditions or other risk factors*, who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown. A systematic review and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach was employed to guide ACIP’s deliberations regarding use of these vaccines.
**Introduction Footnote**
*Alcoholism, chronic heart/liver/lung disease, chronic renal failure, cigarette smoking, cochlear implant, congenital or acquired asplenia, CSF leak, diabetes mellitus, generalized malignancy, HIV, Hodgkin disease, immunodeficiency, iatrogenic immunosuppression, leukemia, lymphoma, multiple myeloma, nephrotic syndrome, solid organ transplants, or sickle cell disease or other hemoglobinopathies.
Methods
A systematic literature search was completed to review all available evidence on the immunogenicity and safety of PCV15 and PCV20 among age groups for which the vaccines were approved.  Since only immunogenicity and safety data were available for PCV15 or PCV20, the search included PCV13 and PPSV23 efficacy or effectiveness studies to help interpret PCV15 and PCV20 immunogenicity study findings. Literature search for evidence on both PCV15 and PCV20 was done simultaneously given the similarities in the policy questions and given that use of both PCV15 and PCV20 were considered by the ACIP simultaneously. GRADE assessment was performed for PCV15 and PCV20 studies only. As a basis for the GRADE analysis, the policy question consisting of the population, intervention, comparison, and outcomes of interest was defined (Table 1).Table 1. Policy Question and PICO
Table 1: Policy question and definition of the Population, Intervention, Comparison, and Outcome for GRADE analysis
Policy question:
**Should PCV15 in series with PPSV23 be recommended to US adults aged 19-64 years with immunocompromising or chronic medical conditions?**Population
US adults aged 19-64 years with immunocompromising or chronic medical conditionsIntervention
One dose of PCV15 followed by PPSV23Comparison
1. PCV13 followed by PPSV23 (immunocompromised adults aged **19-64 years**)*
2. PPSV23 (immunocompetent adults with chronic medical conditions aged **19-64 years**)†Outcomes
Vaccine-type invasive pneumococcal disease, vaccine-type non-bacteremic pneumococcal pneumonia, and vaccine-type pneumococcal mortality
Serious adverse events following immunization**Table 1. Footnote**
*Immunocompromised adults include adults with immunocompromising condition (chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, human immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease, or other hemoglobinopathies), CSF leak, or cochlear implant; immunocompetent adults are those without these conditions.
†Chronic medical conditions include chronic heart/lung/liver disease, diabetes mellitus, alcoholism, and cigarette smoking.Table 2: Outcomes and Rankings
Table 2: Outcomes and Rankings
Outcome
Importance*
Included in evidence profileVaccine-type invasive pneumococcal disease
Critical
YesVaccine-type non-bacteremic pneumococcal pneumonia
Critical
YesVaccine-type pneumococcal mortality
Critical
YesSerious adverse events following immunization
Critical
Yes
**Table 2. Footnote**
*Three options: 1. Critical; 2.  Important but not critical; 3. Not important for decision making
We leveraged a systematic review presented to the World Health Organization Strategic Advisory Group of Experts (SAGE) meeting in October 2020, which included literature up to March 2019 (1). To identify literature published during April 2019 to February 2021, we searched Pubmed, Medline, Embase, CINAHL, Scopus, Epistemonikos and Cochrane library databases. The search terms are included in **appendix I**. Search results were supplemented by an updated Pubmed search using “V114*”, “PCV15”, “PCV20”. Unpublished data were provided by the vaccine manufacturers.
Studies were included if they presented primary data on PCV15 use in series with PPSV23 in adults with underlying medical conditions or other risk factors†. Of the 2,499 titles screened for WHO SAGE and 923 titles screened for the updated review in 2021, 2 unpublished PCV15 studies were included in the GRADE analysis (2, 3). Characteristics of these studies are presented in appendix II. Beneficial and harmful outcomes for the GRADE assessment were selected by the ACIP Pneumococcal Vaccines Work Group calls and via an email survey in which the Work Group members were asked to rank the relative importance of each outcome. Vaccine-type invasive pneumococcal disease, vaccine-type non-bacteremic pneumococcal pneumonia, vaccine-type pneumococcal mortality, and serious adverse events (SAEs) following immunization were deemed to be critical outcomes (Table 2).
**Methods Footnote**
*V114 is the name used for Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate
†Alcoholism, chronic heart/liver/lung disease, chronic renal failure, cigarette smoking, cochlear implant, congenital or acquired asplenia, CSF leak, diabetes mellitus, generalized malignancy, HIV, Hodgkin disease, immunodeficiency, iatrogenic immunosuppression, leukemia, lymphoma, multiple myeloma, nephrotic syndrome, solid organ transplants, or sickle cell disease or other hemoglobinopathiesTable 3a. Summary of Studies Reporting Immunogenicity
Table 3a. Summary of Studies Reporting Immunogenicity
Study
Age or other characteristic of importance
N intervention
N comparison
Comparator vaccine
GMR range* (Serotype)
GMT/GMR Interpretation†, ‡
Absolute difference in % seroresponders§ (serotype)
Seroresponders
Interpretation¶
Study limitations (Risk of Bias)V114-017
Native Americans or adults with chronic medical conditions** aged 18-49 years of age
742-844
247-283
PCV13 + PPSV23
(6-month interval between vaccines; 1-month post PPSV23)
0.88(4) to 1.42 (18C)
PCV15+PPSV23>PCV13+PPSV23 in 9/13 serotypes
PCV15+PPSV23 significantly higher in 1/13 (serotype 18C)
PCV15+PPSV23<PCV13+PPSV23 for 22F and 33F (PCV15-unique serotypes) after PPSV23
-6.7 (6A) to 6.0 (14)
PCV15+PPSV23>PCV13+PPSV23 in 5/13 serotypes (all non- significant)
PCV15+PPSV23<PCV13+PPSV23 for 22F and 33F (PCV15-unique serotypes) after PPSV23
Not seriousV114-018
Adults ≥18 years of age with HIV
102-123
105-117
PCV13 + PPSV23
(8-week interval between vaccines; 1-month post PPSV23)
0.89 (6A) to 1.52 (5)
PCV15+PPSV23>PCV13+PPSV23 in 11/13 serotypes (all non-significant)
PCV15+PPSV23>PCV13+PPSV23 for serotype 22F and PCV15+PPSV23<PCV13+PPSV23 for serotype 33F (PCV15-unique serotypes) after PPSV23
-2.0 (3) to 15.0 (19F)
PCV15+PPSV23>PCV13+PPSV23 in 10/13 serotypes
Confidence interval not reported
PCV15+PPSV23<PCV13+PPSV23 for 33F and equivalent for 22F (PCV15-unique serotypes) after PPSV23
Not serious
**Table 3a. Footnotes**
GMR=geometric mean ratio, GMT=geometric mean titers, OPA=opsonophagocytic activity, PCV13=13-valent pneumococcal conjugate vaccine, PCV15=15-valent pneumococcal conjugate vaccine, PPSV23=23-valent pneumococcal polysaccharide vaccine
*GMR (geometric mean ratio) is the ratio of pneumococcal OPA GMTs. Ratio calculated as [GMT (PCV15+PPSV23] / [GMT (comparator vaccine)]. Range is shown for the 13 serotypes shared between PCV13 and PCV15 only.
†GMR noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
‡If GMR non-inferiority was not assessed, “statistical significance” of GMTs (geometric mean titers) defined as: 95% CI of GMT point estimates did not overlap.
**§**Seroresponse: subjects with >=4-fold rise in OPA GMT titer 30 days post-vaccination compared to pre-vaccination. Range is shown for the 13 serotypes shared between PCV13 and PCV15
**¶**If seroresponse non-inferiority was not assessed, “statistical significance” defined as:  95% CI of % seroresponders did not overlap.
**Chronic heart/liver/lung disease, cigarette smoking, diabetes mellitusTable 3b. Summary of Studies Reporting Safety
Table 3b. Summary of Studies Reporting Safety
Study
Age or other characteristic of importance
N intervention
N comparison
Comparator vaccine
Absolute % difference (% SAE PCV15 – % SAE comparator)
N related to vaccine
Study limitations (Risk of Bias)V114-017
Native Americans or adults with chronic medical conditions* aged 18-49 years of age
1036
345
PCV13 + PPSV23
(1-month observation period post-PPSV23)
-0.6
0
Not seriousV114-018
Adults ≥18 years of age with HIV
150
148
PCV13 + PPSV23
(4-month observation period post PPSV23)
-2.8
0
Not serious
**Table 3b. Footnotes**
PCV13=13-valent pneumococcal conjugate vaccine, PCV15=15-valent pneumococcal conjugate vaccine, PPSV23=23-valent pneumococcal polysaccharide vaccine, SAE=serious adverse events
*Chronic heart/liver/lung disease, cigarette smoking, diabetes mellitusTable 4. GRADE Summary of Findings Table
Table 4. GRADE Summary of Findings Table
Certainty assessment
Number of patients
Results
Certainty
ImportanceNo of studies (reference)
Study design
Risk of bias
Inconsistency
Indirectness
Imprecision
Other considerations
Intervention
Comparison*
Relative effect
Absolute effectVaccine effectiveness (Vaccine-type invasive pneumococcal disease, Vaccine-type non-bacteremic pneumococcal pneumonia, Vaccine-type pneumococcal mortality)**2 (3, 4)**
Randomized studies
Not serious
Not serious
Serious†
Not serious
Not serious
844
352
PCV15+PPSV23 had higher immune responses vs. PCV13+PPSV23 for 9–11 PCV13 serotypes (GMT) or 5–10 PCV13 serotypes (% seroresponders) across both studies. Of all comparisons across studies (PCV15+PPSV23 vs. PCV13+PPSV23), only one serotype in a single study was found to be significantly higher by GMTs (serotype 18C).
2, moderate
CriticalSerious adverse events**2 (3, 4)**
Randomized studies
Not serious
Not serious
Not serious
Serious‡
Not serious
0/1186
0/493
non estimable
—
2, moderate
Critical
**Table 4. Footnote**
GMT=geometric mean titers, PCV13=13-valent pneumococcal conjugate vaccine, PCV15=15-valent pneumococcal conjugate vaccine, PPSV23=23-valent pneumococcal polysaccharide vaccine, SAE=serious adverse events
*Number of patients based on minimum number included in immunogenicity comparisons presented; some comparisons may have had more patients than this minimum.
†These are all immunogenicity studies and there are no correlates of protection.
**‡**No vaccine-related serious adverse events reported.Table 5: Summary of Evidence for Outcomes of Interest
Table 5. Summary of Evidence for Outcomes of Interest
Outcome
Importance
Included in evidence profile
CertaintyVaccine-type invasive pneumococcal disease
Critical
Yes
2, moderateVaccine-type non-bacteremic pneumococcal pneumonia
Critical
Yes
2, moderateVaccine-type pneumococcal mortality
Critical
Yes
2, moderateSerious adverse events following immunization
Critical
Yes
2, moderateSummary
The evidence type for use of PCV15 in series with PPSV23 for adults aged 19–64 years with certain underlying medical conditions or other risk factors* was determined to be 2 (moderate certainty of evidence). The ACIP reviewed the results of both GRADE analysis and the Evidence to Recommendations (EtR) framework in September 2021. In October 2021, the ACIP recommended use of PCV15 in series with PPSV23 for adults aged 19–64 years with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown.
**Summary Footnote**
*Alcoholism, chronic heart/liver/lung disease, chronic renal failure, cigarette smoking, cochlear implant, congenital or acquired asplenia, CSF leak, diabetes mellitus, generalized malignancy, HIV, Hodgkin disease, immunodeficiency, iatrogenic immunosuppression, leukemia, lymphoma, multiple myeloma, nephrotic syndrome, solid organ transplants, or sickle cell disease or other hemoglobinopathies.Appendix I. Search Strategy
Appendix I: Search Strategies
Database
Strategy
Run Date
Records**Medline
(OVID)**
1. streptococcus pneumoniae/
2. (pneumococcal or pneumococci or “streptococcus pneumonie” or “streptococcus pneumoniae” or “s pneumoniae”).tw,kf.
3. 1 or 2
4. vaccination/ or immunization/ or Vaccines, Conjugate/
5. (vaccine? or vaccination? or immunisation or immunization).tw,kf.
6. 4 or 5
7. Pneumococcal Vaccines/
8. (heptavalent or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or pcv10 or “pcv 10” or “13valent” or “13 valent” or pcv13 or “pcv 13” or ppv23 or “ppv 23” or “23 valent” or “23valent”).tw,kf.
9. 7 or 8
10. (3 and 6)
11. 10 or 9
12. comparative effectiveness research/ or treatment outcome/ or Vaccine Potency/
13. (efficacy or effectiveness or effects or “immune response” or impact or “treatment outcome”).tw,kf.
14. 12 or 13
15. adult/ or aged/ or “aged, 80 and over”/ or frail elderly/
16. (adult? or elderly or elderlies).tw,kf.
17. 15 or 16
18. 11 and 14 and 17
19. (201904* OR 201905* OR 201906* OR 201907* OR 201908* OR 201909* OR 201910* OR 201911* OR 201912* OR 2020* OR 2021*).ed,ep,yr,dp,dt.
20. 17 and 18
02/18/2021
351**Embase
(OVID)
1988-**
1. Streptococcus pneumoniae/
2. (pneumococcal or pneumococci or “streptococcus pneumonie” or “streptococcus pneumoniae” or “s pneumoniae”).tw,kw.
3. 1 or 2
4. vaccination/ or immunization/ or vaccine/
5. (vaccine? or vaccination? or immunisation or immunization).tw,kw.
6. 4 or 5
7. Pneumococcus vaccine/
8. (heptavalent or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or pcv10 or “pcv 10” or “13valent” or “13 valent” or pcv13 or “pcv 13” or ppv23 or “ppv 23” or “23 valent” or “23valent”).tw,kw.
9. 7 or 8
10. 3 and 6
11. 9 OR 10
12. comparative effectiveness/ or treatment outcome/
13. (efficacy or effectiveness or effects or “immune response” or impact or “treatment outcome”).tw,kw.
14. 12 or 13
15. aged/ or adult/ or aged hospital patient/ or frail elderly/ or institutionalized elderly/ or very elderly/
16. (adult? or elderly or elderlies).tw,kw.
17. 15 or 16
18. 11 and 14 and 17
19. (201904* OR 201905* OR 201906* OR 201907* OR 201908* OR 201909* OR 201910* OR 201911* OR 201912* OR 2020* OR 2021*).dc
20. limit 19 to (conference abstracts or embase)
02/18/2021
521
–
duplicates
=
unique items**Cochrane Library**
(
(
(pneumococcal or pneumococci or “streptococcus pneumonie” or “streptococcus pneumoniae” or “s pneumoniae”):ti,ab
AND
([mh Vaccines] OR [mh Immunization] OR (vaccine# or vaccination# or immunisation or immunization):ti,ab)
)
OR
(MH “Pneumococcal Vaccine”) OR TI (heptavalent or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or pcv10 or “pcv 10” or “13valent” or “13 valent” or pcv13 or “pcv 13” or ppv23 or “ppv 23” or “23 valent” or “23valent”) OR AB (heptavalent or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or pcv10 or “pcv 10” or “13valent” or “13 valent” or pcv13 or “pcv 13” or ppv23 or “ppv 23” or “23 valent” or “23valent”)
)
AND[mh “Treatment Outcomes”] OR (efficacy or effectiveness or effects or “immune response” or impact or “treatment outcome”):ti,abAND[mh Adult] OR [mh Aged+] OR (adult# or elderly or elderlies):ti,ab
02/18/2021
56
–
duplicates
=
unique items**CINAHL
(EbscoHost)**
(
(TI (pneumococcal or pneumococci or “streptococcus pneumonie” or “streptococcus pneumoniae” or “s pneumoniae”) OR AB (pneumococcal or pneumococci or “streptococcus pneumonie” or “streptococcus pneumoniae” or “s pneumoniae”)) AND ((MH “Vaccines”) OR (MH “Immunization”) OR TI (vaccine# or vaccination# or immunisation or immunization) OR AB (vaccine# or vaccination# or immunisation or immunization))
OR
(MH “Pneumococcal Vaccine”) OR TI (heptavalent or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or pcv10 or “pcv 10” or “13valent” or “13 valent” or pcv13 or “pcv 13” or ppv23 or “ppv 23” or “23 valent” or “23valent”) OR AB (heptavalent or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or pcv10 or “pcv 10” or “13valent” or “13 valent” or pcv13 or “pcv 13” or ppv23 or “ppv 23” or “23 valent” or “23valent”)
)
AND
(MH “Treatment Outcomes”) OR TI (efficacy or effectiveness or effects or “immune response” or impact or “treatment outcome”) OR AB (efficacy or effectiveness or effects or “immune response” or impact or “treatment outcome”)
AND
((MH “Adult”) OR (MH “Aged+”) OR TI (adult# or elderly or elderlies) OR AB (adult# or elderly or elderlies))Limiters – Published Date: 20190401-20210218; Exclude MEDLINE records
02/18/2021
43
–
duplicates
=
unique items**Scopus
(for WOS)**
**(TITLE-ABS-KEY**(“heptavalent” or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or “pcv10” or “pcv 10” or “13valent” or “13 valent” or “pcv13” or “pcv 13” or “ppv23” or “ppv 23” or “23 valent” or “23valent”) OR (**TITLE-ABS-KEY**(“vaccine$” or “vaccination$” or “immunisation” or “immunization”) AND **TITLE-ABS-KEY**(“pneumococcal” or “pneumococci” or “streptococcus pneumonie” or “streptococcus pneumoniae” or “s pneumoniae”))) AND**TITLE-ABS-KEY**(“adult$” or “elderly” or “elderlies”) **AND TITLE-ABS-KEY**(“efficacy” or “effectiveness” or “effects” or “immune response” or “impact” or “treatment outcome”)
Limit April 2019 –
02/18/2021
458
–
duplicates
=
unique items**Epistemonikos**
Search 1:
(pneumococcal OR pneumococci OR “streptococcus pneumonie” OR “streptococcus pneumoniae” OR “s pneumoniae”) AND (vaccine* OR vaccination* OR immunisation OR immunization) AND (efficacy OR effectiveness OR effects OR “immune response” OR impact OR “treatment outcome”) AND (adult* OR elderly OR elderlies)
– limited to 2019-2021Search 2:
(heptavalent OR “7 valent” OR “7valent” OR “pcv 7” OR pcv7* OR “10 valent” OR “10valent” OR pcv10 OR “pcv 10” OR “13valent” OR “13 valent” OR pcv13 OR “pcv 13” OR ppv23 OR “ppv 23” OR “23 valent” OR “23valent”) AND (efficacy OR effectiveness OR effects OR “immune response” OR impact OR “treatment outcome”) AND (adult* OR elderly OR elderlies)
– limited to 2019-2021
02/18/2021
19 + 10
–
duplicates
=
unique itemsAppendix II. Studies Included in the Review of Evidence
Appendix II. Studies Included in the Review of Evidence
Study
Study design
Country (or more detail, if needed)
Age (measure central tendency – mean/SD)
Total population
N Intervention
N comparison
Outcomes
Funding sourceV114-017
Phase III randomized controlled trial
US
Native Americans or adults with chronic medical conditions* aged 18-49 years of age (mean 35.8, SD 8.9)
1381
1035
346
Immunogenicity,
Safety
MerckV114-018
Phase III randomized controlled trial
US
Adults ≥18 years of age with HIV (mean 40.0)
298
150
148
Immunogenicity,
Safety
Merck
**Appendix II Footnote**
*Chronic heart/liver/lung disease, cigarette smoking, diabetes mellitusReferences
World Health Organization. Strategic Advisory Group of Experts on Immunization 5-7 October 2020. 2020 [cited 2021 July 28]; Available from: https://terrance.who.int/mediacentre/data/sage/SAGE_eYB_October_2020.pdf?ua=1.
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAXTM23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY). . Available from: https://ClinicalTrials.gov/show/NCT03547167.
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAXTM23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018). https://ClinicalTrials.gov/show/NCT03480802.
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAXTM23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY). https://ClinicalTrials.gov/show/NCT03547167.Top of Page
							
					
							Last Reviewed:  January 27, 2022						Source: 	National Center for Immunization and Respiratory Diseases
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