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Aging and disease    2019, Vol. 10 Issue (2) : 404-418     DOI: 10.14336/AD.2018.0512
Review Article |
Efficacy and Safety of the Pneumococcal Conjugate-13 Valent Vaccine in Adults
Fawziah Marra*, Nirma Khatri Vadlamudi
Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, Canada
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Abstract  

Invasive pneumococcal disease and pneumococcal pneumonia cause substantial morbidity and mortality in the elderly. This review focuses on the immunogenicity, safety, efficacy and effectiveness data on the use of the 13-valent conjugate pneumococcal vaccine (PCV13) in adults. A MEDLINE literature search was performed from January 1946 to December 2017. Additional references were identified from a review of literature citations. All English-language randomized trials, observational studies and meta-analyses assessing the immunogenicity, efficacy, effectiveness and safety of PCV13 in adults were evaluated. Six randomized controlled studies evaluated immunogenicity and safety of PCV13 in adults and showed that the conjugated vaccine elicited a greater immune response to the majority of the 13 serotypes compared to the 23-valent polysaccharide pneumococcal vaccine (PPV23). Administering PCV13 prior to PPV23 elicits greater immune responses and multiple doses of PCV13 demonstrated modest advantage. PCV13 titers declined after a year but remained above baseline. A randomized clinical trial (CAPiTA) showed that PCV13 was effective in preventing community-acquired pneumonia (CAP) and vaccine-type invasive pneumococcal disease, but not any cause pneumonia. Safety data shows PCV13 elicits minor local reactions, such as pain at the injection site. Major side effects that were commonly reported included muscle fatigue and headache. Both local and systemic adverse events were comparable to PPV23. While PCV13 has a well-established immunogenicity and safety profile in adults, there is sparse data on sequential or multiple dosing, efficacy and effectiveness in adults. As there are few countries who have adopted PCV13 for routine adult immunization, there is a need to evaluate the effectiveness of PCV13 in a real-world setting.

Keywords Immunization      S. pneumonia or pneumococcus      Streptococcus pneumoniae      pneumococcal conjugate vaccines      PCV13      older adults      effectiveness      efficacy     
Corresponding Authors: Marra Fawziah   
About author:

These authors contributed equally to this study.

Issue Date: 12 March 2018
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Fawziah Marra
Nirma Khatri Vadlamudi
Cite this article:   
Fawziah Marra,Nirma Khatri Vadlamudi. Efficacy and Safety of the Pneumococcal Conjugate-13 Valent Vaccine in Adults[J]. Aging and disease, 2019, 10(2): 404-418.
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http://www.aginganddisease.org/EN/10.14336/AD.2018.0512     OR     http://www.aginganddisease.org/EN/Y2019/V10/I2/404
Study NameDesignPPV23 NaïveAge groupDuration of follow upPCV13 (N)1PPV23 (N)1PLB (N)Immunogenicity2
Jackson 2013a [26]R, DBY50-64 years4 yearsBaseline for 60-64 yrs: N=417 (411)
At 1 year for 50-59 yrs: N=406
Baseline for 60-64 yrs: N=414 (407)-In 60-64 yrs: PCV13 arm had a statistically significantly higher OPA titers in 9/13 serotypes (1,4,6A,6B,7F,9V,18C,19A,23F) compared to PPV23.
In 50-59 yrs: PCV13 arm had a statistically significantly higher OPA titers in 9/13 serotypes (1,4,5,6A,6B,7F,9V,14,19A) compared to G2.
Jackson 2013b [27]R, DBN≥70 years1 year431448-PCV13 arm had a statistically significantly higher OPA titers in 11/13 serotypes (1,4,5,6A,6B,7F,9V,18C,19A,19F,23F) compared to PPV23.
Greenberg 2014 [29]R, DBY60-64 years1 year482238-PCV13 arm had a statistically significantly higher OPA titers in 11/13 serotypes (1,4,5,6A,6B,7F,9V,18C,19A,19F,23F) compared to PPV23.
Juergens 2014 [30]RN≥65 years2 yearsBaseline for PCV13 with AlPO4: N=309 (307)
Baseline for PCV13 without AlPO4: N=305 (302)
Baseline: 301 (300)PCV13 (with AlPO4) arm had a statistically significantly higher OPA titers and IgG GMCs in 11/13 serotypes (1,3,4,5,6A,6B,9V,18C, 19A,19F,23F) compared to PPV23.
PCV13 (without AlPO4): had a statistically significantly higher IgG GMCs in 1/13 serotypes (7F) compared to PCV13 (with ALPO4).
Shiramoto 2015 [31]R, DBY≥65 years4 months382382-PCV13 arm had a statistically significantly higher OPA titers in 13/13 serotypes.
van Deursen 2017 [32]R, DBY≥65 years2 years1006-1005PCV13 arm had a statistically significantly higher OPA titers in 13/13 serotypes. At 12 months, PCV13 arm had a statistically significantly reached GMFR (OPA titers) in 9/13 serotypes (4,6A,6B, 7F, 14, 18C, 19A,19F, 23F). At 24 months, PCV13 arm had a statistically significantly reached GMFR (OPA titers) in 6/13 serotypes (4,6A,6B, 18C, 19A, 23F).
Table 1  Studies evaluating immunogenicity of 13-valent conjugate pneumococcal vaccine (PCV13) in adults.
Study NameAge groupSequential Dosing IntervalPCV13/PCV13 (N)1PCV13/PPV23 (N)1PCV13PPV23 PCV13 (N)1PPV23/PCV13 (N)1Immunogenicity
Jackson 2013b [27]≥70 years1 yearAt 1 yr:
N=391 (372)
--At 1 yr:
N=404 (373)
1. PCV13/PCV13 had statistically significantly higher OPA titers in 3/13 serotypes (6A, 6B, 23F) compared to PCV13 alone.
2. PCV13/PCV13 had statistically significantly higher OPA titers in 10/13 serotypes (1,4,5,6A,6B,9V,18C,19A,19F,23F) compared to PPV23 alone.
3. PCV13/PCV13 had statistically significantly higher OPA titers in 12/13 serotypes (1,3,4,5,6A, 6B,7F,9V,19A, 19F, 23F) compared to sequential dose of PPV23/PCV13.
4. PPV23/PCV13 OPA titers did not differ statistically compared to PCV13 alone.
Jackson 2013c [28]50-64 years4 yearsFor 60-64 yrs: N=108
For 50-59 yrs: N=214 (211)
For 60-64 yrs: N=108For 60-64-year age group:
1. PCV13/PPV23 had statistically significantly higher OPA titers in 10/13 serotypes (1,3,5,6A,6B,7F,18C,19A,23F) compared to PPV23 alone.
2. PCV13/PPV23 had statistically significantly higher OPA titers in 8 serotypes (1,3,5,9V,18C,19A,19F) compared to PCV13 alone.
3. PCV13/PCV13 had statistically significantly higher OPA titers in 7/13 serotypes (1,4,6A,6B,7F,9V,18C,19A,23F) compared to PCV13 alone.
For 50-59-year-old age group:
1. PCV13/PCV13 had statistically significantly higher OPA titers in 6/13 (1,4,6A,6B,7F,9V,18C,19A,23F) compared to PCV13 alone.
2. PCV13/PCV13 had statistically significantly higher OPA titers in 5/13 serotypes (4,6A,7F,9V,19A) compared to PCV13/PCV13 in 60-64-year age group.
Greenberg 2014 [29]60-64 years1 year160 (133)267 (237)-223 (199)1. PCV13/PPV23 had a statistically significantly higher OPA titers in 7/13 serotypes (3,5,6A, 6B,7F,19F,23F) compared to PPV23 alone.
2. PCV13/PPV23 had a statistically significantly higher OPA titers in 11/13 serotypes (1,3,4,5,6B,7F,9V, 18C,19A,19F,23F) compared to PPV23/PCV13.
3. PCV13/PCV13 had a statistically significantly higher OPA titers in 6/13 serotypes (1,3,6A, 6B,7F,9V) compared to PPV23/PCV13.
4. PCV13/PCV13 had a statistically significantly higher OPA titers in 1/13 serotypes (23F) compared to PCV13 alone.
5. PCV13/PPV23 had a statistically significantly higher OPA titers in 1/13 serotypes (3) compared to PCV13 alone.
6. PPV23/PCV13 OPA titers did not differ statistically compared to PCV13 alone.
Juergens 2014 [30]≥65 years1 yearAt 1 yr:
N=136
At 1 yr:
N=131
At 2 yr:
N=104
-1. PCV13/PPV23 had a statistically significantly higher OPA titers in 8/13 serotypes (1,3,5,6A, 6B,9V,19F,23F) compared to PPV23 alone.
2. PCV13/PPV23/PCV13 had a statistically significantly higher OPA titers in 3/13 serotypes (6A, 6B,23F) compared to PCV13/PPV23.
3. PCV13/PCV13 had a statistically significantly higher OPA titers in 1/13 serotypes (23F) compared to PCV13 alone.
4. PCV13/PPV23/PCV13 OPA titers did not differ statistically compared to PCV13 alone.
Table 2  Studies evaluating immunogenicity of 13-valent conjugate pneumococcal vaccine (PCV13) in adults in sequential dosing.
Comorbidities TypeUSA [21,50]Canada [22,79]United Kingdom [51]Germany [52]Australia [24]New Zealand [23]
No underlying comorbidities1PCV13 given at ≥65 years; PPV23 after at least 12 monthsPCV13 given at ≥65 years; PPV23 after at least 8 weeks---PCV13 given at age ≥65 years; PPV23 after at least 8 weeks
Immunocompromising condition2 or anatomical/functional asplenia3PCV13 given at 19-64 years; PPV23 after ≥8 weeks; again after ≥5 years; then at age ≥65 yearsPCV13 given at 19-64 years; PPV23 after ≥8 weeks; again after ≥5 years; then at age ≥65 yearsPCV13 given at 19-64 years; PPV23 after ≥8 weeks; then at age ≥65 yearsPCV13 given at 19-59 years; PPV23 after 6-12 months; again after ≥6 years; then at age ≥60 yearsPCV13 given at 19-64 years; PPV23 after ≥8 weeks; again after ≥5 yearsPCV13 given at ≥18 years; PPV23 after ≥8 weeks; again after ≥5 years; then at age ≥65 years
Cerebrospinal fluid leak or cochlear implantPCV13 given at 19-64 years; PPV23 after ≥8 weeks4-PCV13 given at 19-64 years; PPV23 after ≥8 weeks; again after ≥5 yearsPCV13 given at 19-59 years; PPV23 after 6-12 months; again after ≥6 years-PCV13 given at ≥18 years; PPV23 after ≥8 weeks; again after ≥5 years; then at age ≥65 years
Hematopoietic stem cell transplant (HSCT)-3 doses of PCV13 starting 3-9 months after transplant (at least 4 weeks apart); PPV23 given 12-18 months after transplant (6-12 months after last PCV13 dose); PPV23 booster 1 year after last dosePCV13 given 9-12 months after transplant; PPV23 given 12-18 months after transplant (6-12 months after last PCV13 dose)-3 doses of PCV13 starting 6 months after transplant (at least 8 weeks apart); PPV23 given 12 months from last PCV13 dose; No more than 3 PPV23 lifetime dosesPCV13 given after transplant; PPV23 given after at least 8 weeks from PCV13; then re-vaccination after 5 years; last dose at age ≥65 years
Chronic illness or lifestyle risk factors5PCV13 at age ≥ 65 years, then PPSV23 after at least 12 months----PCV13 given at ≥18 years; PPV23 after ≥8 weeks; again after ≥5 years; then at age ≥65 years
Table 3  Guidelines for use of the 13-valent conjugate pneumococcal vaccine (PCV13) in adults.
Figure 1.  Current Pneumococcal Vaccination Guidelines

Abbreviations: PCV13 - 13 valent conjugate pneumococcal vaccine; PPV23 - 23 valent pneumococcal polysaccharide vaccine.

1This recommendation is for pneumococcal naïve persons

2Defined as congenital or acquired immunodeficiency, HIV infection, chronic renal failure, nephrotic syndrome, leukaemia, lymphoma, Hodgkin disease, generalized malignancy, multiple myeloma, solid organ transplant and iatrogenic immunosuppression

3Defined as sickle cell disease and other haemoglobinopathies, congenital or acquired asplenia, splenic dysfunction and splenectomy

4Revaccination with PPV23 not required at 5-year mark

5Defined as chronic heart, lung disease, liver disease or diabetes

6Defined as smoker, homeless or persons with alcoholism or illicit drug use

7ACIP (US) and NACI (Canada) recommends those with prior PPV23 vaccination are recommended to wait a year before obtaining PCV13.

8Germany’s recommended age is 19-59 years

9NZ MoH recommends PCV13 at age ≥18 years and 19-64 respectively

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