Further available immunization option to prevent pneumococcal disease

Ivo Vojtek; Bernard Hoet

doi:10.12688/f1000research.5990.1

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Correspondence

Further available immunization option to prevent pneumococcal disease

[version 1; peer review: 2 approved]

Ivo Vojtek¹, Bernard Hoet¹

PUBLISHED 07 Jan 2015

Author details Author details

¹ GSK Vaccines, Wavre, 1300, Belgium

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Abstract

In their recent review, Charles Feldman and Ronald Anderson provide an overview of various clinical aspects of pneumococcal infections. We would like to complete this report by providing some additional information on a widely-used immunization option, which was not originally mentioned in the article. The protein D pneumococcal conjugate vaccine (PHiD-CV) has been pre-approved by WHO and its impact is supported by real-life data from the regions of its use.

Keywords

PHiD-CV, efficacy, post-marketing surveillance

Corresponding author: Ivo Vojtek

Competing interests: IV and BH are employed by GSK group of companies. BH owns stock in GSK group of companies.

Grant information: GlaxoSmithKline Biologicals SA funded all costs associated with the development of this manuscript.

Copyright: © 2015 Vojtek I and Hoet B. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Data associated with the article are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).

How to cite: Vojtek I and Hoet B. Further available immunization option to prevent pneumococcal disease [version 1; peer review: 2 approved]. F1000Research 2015, 4:3 (https://doi.org/10.12688/f1000research.5990.1) First published: 07 Jan 2015, 4:3 (https://doi.org/10.12688/f1000research.5990.1) Latest published: 07 Jan 2015, 4:3 (https://doi.org/10.12688/f1000research.5990.1)

Correspondence

We write in response to the report by Charles Feldman and Ronald Anderson about the recent advances in the understanding of Streptococcus pneumoniae infections¹.

While this article provided an informative and complete review of the current burden of the disease, pathogenesis and therapeutic options, we have noted a significant omission in the chapter dealing with available immunization strategies, which did not mention the WHO prequalified Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV; GSK Vaccines, Belgium). This vaccine is currently licensed in more than 125 countries with more than 200 million doses distributed as of August 2014 and is used in vaccination programmes in more than 40 countries or regions.

We feel it is important that health care professionals are made aware of the available evidence supporting the use of this vaccine in order that they are able to make an informed choice about the best care for their patients, and therefore we provide additional information to supplement the review article. It is the only modern pneumococcal conjugate vaccine with impact on invasive pneumococcal disease, pneumonia and acute otitis media that has been proven in two pivotal randomized controlled efficacy trials performed in Finland and Latin America^2–4. Thanks to its world-wide use, there is also a plethora of post-marketing and epidemiology data spanning five continents, recently reviewed by Plosker⁸, that proves its impact on the pneumococcal disease and makes it a worth-while alternative to the pneumococcal conjugate vaccine PCV13 which the health care community should be made aware of^5–7. We have summarized the main effectiveness and impact data in Table 1.

Table 1. Summary of the main effectiveness and impact data of PHiD-CV.

IPD: Invasive Pneumococcal disease; VE: vaccine efficacy; RR: relative rate reduction.

Randomized Clinical Trials
Region	Indication
Region	Invasive Pneumococal Disease	Acute Otitis Media	Consolidated pneumonia
Finland	Vaccine serotype - 3+1 VE=100% (95%CI : 83, 100)² Vaccine serotype - 2+1 VE=92% (95% CI: 58, 100)²	X	X
Finland	Any Serotype - 3+1/2+1 VE=93% (95% CI: 75, 99)²	X	VE=44% (95% CI: 24, 59)⁴
Latin America	Vaccine serotype - 3+1 VE=100% (95% CI: 77, 100)³ Any Serotype - 3+1 VE=67% (95% CI: 22, 86)³	Vaccine serotype VE=70% (95% CI: 30, 87)³ Clinical Diagnosed VE=19% (95% CI: 4, 31)³	VE=26% (95% CI: 8, 40)³
Impact and surveillance data on Invasive Pneumococcal Disease
Quebec (case- controlled study)	Vaccine-type (+6A) VE=99% (95% CI: 79, 100)⁵ 19A IPD VE=67% (95% CI: 8, 88)⁵ All IPD VE=75% (95% CI: 53, 79)⁵
Brazil (case- controlled study)	Vaccine type VE=84% (95% CI: 66, 92)⁶ 19A VE=82% (95% CI: 11, 96)⁶
Finland (time series analysis)	Vaccine type RR=92% (95% CI: 85, 96)⁷ 19A RR=77% (95% CI: 41, 93)⁷ All IPD RR=80% (95% CI: 72, 86)⁷

Author contributions

IV wrote the abstract and the main body of the article. BH supervised the process. Both authors critically edited the correspondence and agreed to the final content.

Competing interests

IV and BH are employed by GSK group of companies. BH owns stock in GSK group of companies.

Grant information

GlaxoSmithKline Biologicals SA funded all costs associated with the development of this manuscript.

Acknowledgments

The authors would like to thank Bram Blomme (XPE Pharma and Science c/o GSK) for editorial support.

References

1. Feldman C, Anderson R: Recent advances in our understanding of Streptococcus pneumoniae infection. F1000Prime Rep. 2014; 6: 82. PubMed Abstract | Publisher Full Text | Free Full Text
2. Palmu AA, Jokinen J, Borys D, et al.: Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet. 2013; 381(9862): 214–22. PubMed Abstract | Publisher Full Text
3. Tregnani MW, Saez-Llorens X, Lopez P, et al.: Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial. PLoS Med. 2014; 11(6): e1001657. PubMed Abstract | Publisher Full Text | Free Full Text
4. Palmu AA, Kilpi TM, Rinta-Kokko H, et al.: Impact of 10-Valent Pneumococcal Conjugate Vaccine (PCV10) against Hospital-Diagnosed Pneumonia among Vaccine-Eligible Children in Finland. Presented at: 54th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 5–9, 2014, Washington DC. Reference Source
5. Deceuninck G, De Wals P: Effectiveness of Three Pneumococcal Conjugate Vaccines (PCVs) to Prevent Invasive Pneumococcal Disease (IPD) in Quebec, Canada. Presented at: 9^th International Symposium on Pneumococci and Pneumococcal Diseases; March 9–13, 2014, Hyderabad, India. Reference Source
6. Domingues CM, Verani JR, Montenegro Renoiner EI, et al.: Effectiveness of ten-valent pneumococcal conjugate vaccine against invasive pneumococcal disease in Brazil: a matched case-control study. Lancet Respir Med. 2014; 2(6): 464–71. PubMed Abstract | Publisher Full Text
7. Jokinen J, Rinta-Kokko H, Siira L, et al.: Impact of 10-valent pneumococcal conjugate vaccine (PCV10) on invasive pneumococcal disease (IPD) among vaccine-eligible children in Finland. Presented at: 8th World Congress of the World Society for Pediatric Infectious Diseases (WSPID), November 19–22, 2013, Capetown.
8. Plosker GL: 10-Valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine: a review in infants and children. Paediatr Drugs. 2014; 16(5): 425–44. PubMed Abstract | Publisher Full Text

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Version 1

VERSION 1 PUBLISHED 07 Jan 2015

Author details Author details

¹ GSK Vaccines, Wavre, 1300, Belgium

Competing interests

IV and BH are employed by GSK group of companies. BH owns stock in GSK group of companies.

Grant information

GlaxoSmithKline Biologicals SA funded all costs associated with the development of this manuscript.

Article Versions (1)

version 1

Published: 07 Jan 2015, 4:3

https://doi.org/10.12688/f1000research.5990.1

Copyright

© 2015 Vojtek I and Hoet B. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Data associated with the article are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).

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Vojtek I and Hoet B. Further available immunization option to prevent pneumococcal disease [version 1; peer review: 2 approved]. F1000Research 2015, 4:3 (https://doi.org/10.12688/f1000research.5990.1)

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Reviewer Report 23 Mar 2015

Marco Safadi, Department of Pediatrics, Santa Casa University, São Paulo, Brazil

Approved

https://doi.org/10.5256/f1000research.6408.r7587

The correspondence article “Further available immunization option to prevent pneumococcal disease” from Vojtek & Hoet provides relevant information regarding one of the currently available pneumococcal conjugate vaccines. This information was missing in the review article (Recent advances in our understanding ... Continue reading

The correspondence article “Further available immunization option to prevent pneumococcal disease” from Vojtek & Hoet provides relevant information regarding one of the currently available pneumococcal conjugate vaccines. This information was missing in the review article (Recent advances in our understanding of Streptococcus pneumoniae infection ) written by Feldman & Anderson.

The correspondence article is well written and should be considered for indexing.

I have only minor comments:

In the second paragraph, when mentioning that the PHiD-CV vaccine is currently licensed in more than 125 countries, the authors should make clear that the vaccine is licensed for active immunization against invasive disease, pneumonia, and acute otitis media (AOM) caused by S. pneumoniae in infants and young children up to 5 years of age.
In the third paragraph, when mentioning that the PHiD-CV vaccine is a worth-while alternative to the pneumococcal conjugate vaccine PCV13, the authors should add: … in children younger than 5 years of age.
In Table 1, when showing the different study results observed with the PHiD-CV vaccine, the authors should specify which results are vaccine efficacy data and which are vaccine effectiveness data.

Competing Interests: No competing interests were disclosed.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Reviewer Report 20 Jan 2015

Paola Marchisio, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy

Approved

https://doi.org/10.5256/f1000research.6408.r7220

I read with great interest the letter of Vojtek and Hoet. Well done and necessary. I have some remarks and suggestions:

In the abstract the term “pre-approved” is not clear to all the readers. The exact date of approval would be useful

I read with great interest the letter of Vojtek and Hoet. Well done and necessary. I have some remarks and suggestions:

In the abstract the term “pre-approved” is not clear to all the readers. The exact date of approval would be useful because it could inform the readers that PHiD-CV has a long and great history.
Page 2: “prequalified” is not clear (see above)
Page 2 , second column, third line. I would add “evidence based” before “informed choice” in order to stress the big amount of available rigorous data.
Page 2, 11th line: I would say “proves its beneficial impact…”
It should be underlined that PHiD-CV is approved for use in children younger than 5 years of age (that could be one the reason why it was not quoted in the paper of Feldam which focuses mostly on adult/elderly patients)
In the table I would add “schedule” before “3+1” or “2+1” . In the current version one may read “minus 3 plus 1” and may misunderstand.

Competing Interests: No competing interests were disclosed.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Paola Marchisio, University of Milan, Milan, Italy
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23 Mar 2015 | for Version 1

Marco Safadi, Department of Pediatrics, Santa Casa University, São Paulo, Brazil

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Approved

The correspondence article “Further available immunization option to prevent pneumococcal disease” from Vojtek & Hoet provides relevant information regarding one of the currently available pneumococcal conjugate vaccines. This information was missing in the review article (Recent advances in our understanding of Streptococcus pneumoniae infection ) written by Feldman & Anderson.

The correspondence article is well written and should be considered for indexing.

I have only minor comments:

In the second paragraph, when mentioning that the PHiD-CV vaccine is currently licensed in more than 125 countries, the authors should make clear that the vaccine is licensed for active immunization against invasive disease, pneumonia, and acute otitis media (AOM) caused by S. pneumoniae in infants and young children up to 5 years of age.
In the third paragraph, when mentioning that the PHiD-CV vaccine is a worth-while alternative to the pneumococcal conjugate vaccine PCV13, the authors should add: … in children younger than 5 years of age.
In Table 1, when showing the different study results observed with the PHiD-CV vaccine, the authors should specify which results are vaccine efficacy data and which are vaccine effectiveness data.

Competing Interests

No competing interests were disclosed.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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20 Jan 2015 | for Version 1

Paola Marchisio, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy

19 Views Cite this report Responses(0)

Approved

I read with great interest the letter of Vojtek and Hoet. Well done and necessary. I have some remarks and suggestions:

In the abstract the term “pre-approved” is not clear to all the readers. The exact date of approval would be useful because it could inform the readers that PHiD-CV has a long and great history.
Page 2: “prequalified” is not clear (see above)
Page 2 , second column, third line. I would add “evidence based” before “informed choice” in order to stress the big amount of available rigorous data.
Page 2, 11th line: I would say “proves its beneficial impact…”
It should be underlined that PHiD-CV is approved for use in children younger than 5 years of age (that could be one the reason why it was not quoted in the paper of Feldam which focuses mostly on adult/elderly patients)
In the table I would add “schedule” before “3+1” or “2+1” . In the current version one may read “minus 3 plus 1” and may misunderstand.

Competing Interests

No competing interests were disclosed.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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[1] 1. Feldman C, Anderson R: Recent advances in our understanding of Streptococcus pneumoniae infection. F1000Prime Rep. 2014; 6: 82. PubMed Abstract | Publisher Full Text | Free Full Text

[2] 2. Palmu AA, Jokinen J, Borys D, et al.: Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet. 2013; 381(9862): 214–22. PubMed Abstract | Publisher Full Text

[3] 3. Tregnani MW, Saez-Llorens X, Lopez P, et al.: Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial. PLoS Med. 2014; 11(6): e1001657. PubMed Abstract | Publisher Full Text | Free Full Text

[4] 4. Palmu AA, Kilpi TM, Rinta-Kokko H, et al.: Impact of 10-Valent Pneumococcal Conjugate Vaccine (PCV10) against Hospital-Diagnosed Pneumonia among Vaccine-Eligible Children in Finland. Presented at: 54th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 5–9, 2014, Washington DC. Reference Source

[5] 5. Deceuninck G, De Wals P: Effectiveness of Three Pneumococcal Conjugate Vaccines (PCVs) to Prevent Invasive Pneumococcal Disease (IPD) in Quebec, Canada. Presented at: 9^th International Symposium on Pneumococci and Pneumococcal Diseases; March 9–13, 2014, Hyderabad, India. Reference Source

[6] 6. Domingues CM, Verani JR, Montenegro Renoiner EI, et al.: Effectiveness of ten-valent pneumococcal conjugate vaccine against invasive pneumococcal disease in Brazil: a matched case-control study. Lancet Respir Med. 2014; 2(6): 464–71. PubMed Abstract | Publisher Full Text

[7] 7. Jokinen J, Rinta-Kokko H, Siira L, et al.: Impact of 10-valent pneumococcal conjugate vaccine (PCV10) on invasive pneumococcal disease (IPD) among vaccine-eligible children in Finland. Presented at: 8th World Congress of the World Society for Pediatric Infectious Diseases (WSPID), November 19–22, 2013, Capetown.

[8] 8. Plosker GL: 10-Valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine: a review in infants and children. Paediatr Drugs. 2014; 16(5): 425–44. PubMed Abstract | Publisher Full Text

Further available immunization option to prevent pneumococcal disease

Abstract

Keywords

Correspondence

Table 1. Summary of the main effectiveness and impact data of PHiD-CV.

Author contributions

Competing interests

Grant information

Acknowledgments

References

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