This site is intended only for healthcare professionals resident in India

Search

Menu

Close

Sign InLog Out
Our medicinesTherapy areasExplore ContentExplore contentMaterialsVideosLet's connectLet's ConnectPfizer medical information

Menu

Close

About

Burden of Disease

Burden of Disease

Description of the DiseaseGlobal EpidemiologyIndian EpidemiologyPneumococcal Disease and InfluenzaChallenges

Risk Factors
 

Risk Factors

Secondary Infections
​​​​​​​

Secondary Infections

Mechanism of Action
​​​​​​​

Mechanism of Action

Prevention of Pneumococcal Disease
 

Polysaccharide VaccineConjugate VaccineDifference

Need for Pneumococcal Vaccination

In ElderlyIn India

Cost-effectiveness of PCV13
 

NeedIndian StudiesGlobal Studies

Legacy of Prevenar
 

ManufacturingCRM197Activation and ConjugationPneumococcal Disease and InfluenzaDistributionVideos

Safety
 

Safety

Conclusion
 

Conclusion
Dosing

Dosing
 

Adults ≥18 Years of AgeAdults ≥50 Years of AgeCOVID VaccinationFlu Vaccination
Efficacy

Prevenar 13® Clinical Experience
 

IntroductionClinical Trials

Efficacy of Prevenar 13®
 

IntroductionStudyObjectiveMethodologyCriteriaResultsConclusion

Effectiveness of Prevenar 13® 
 

IntroductionObjectiveMethodologyAnalysisResultsLimitationsLearningsConclusion

Indian Clinical Trials
 

IntroductionStudy DesignResultsLimitationsConclusion
Recommendations for Use

Recommendations for Use
 

ACIP 2019NCCN 2020RSSDI 2020IMA GuidelinesIAOH Guidelines for Working AdultsClinical Practice Guidelines 2019 (ICS/NCCP)The Geriatric Society of India, 2015Indian Society of Nephrology
FAQs

PCV13 in Pulmonology
 

RoleComplicationsClinical DataRecommendations

PCV13 in Nephrology
 

RoleClinical DataRecommendations

PCV13 in Oncology
 

RoleClinical DataRecommendations

PCV13 in Rheumatology
 

RoleComplicationsDataRecommendationsConsensus

PCV13 in Diabetes
 

RoleComplicationsDataRecommendations

PCV13 in HIV Infection
 

RoleBurdenPulmonary InfectionDataEfficacyRecommendations

PCV13 in Cardiology
 

RoleBurdenComplicationsDataRecommendations
Resources

Resources

Summary of Prescribing InformationDownloadable ResourcesEvents and WebinarsLatest Articles

Data

Immunogenicity and Safety Data of PCV13 in HIV-infected Adults

  

A randomised clinical trial was performed to compare the immunologic response towards a combined immunisation strategy involving the use of PCV13 with PPSV23 (prime-boost vaccine group), as compared with PPSV23 alone, in HIV-infected adults. The prime-boost vaccine group achieved a ≥4-fold increase in GMT at Week 8 and a ≥2-fold increase in IgG GMC at 8 weeks. This study revealed that combining PCV13 with PPSV23 results in a higher magnitude of immune response in HIV-infected individuals at 8 weeks as compared with PPSV23 alone.1

  

A study investigated the immunogenicity induced by combined PCV13 and PPSV23 vaccines in HIV-infected adults. It was observed that the use of PPSV23 12 months after PCV13 improves PCV13 immunogenicity and PPSV23 has a decreasing effect on PCV13-associated immunological memory. These findings are in line with different guidelines that recommend the use of PCV13, instead of PPSV23 in HIV-positive individuals.2

  

In an open-label study, 329 HIV-infected adults previously vaccinated with PPSV23 were assessed for safety and immune response to 3 doses of PCV13. PCV13 appeared well-tolerated and immunogenic in HIV-infected adults with CD4 counts ≥200 cells/mm.3,4 A Phase 3, open-label, single-arm study evaluated the immunogenicity and safety of 3 PCV13 doses followed by 1 dose of PPSV23 at 1 month in vaccine-naive individuals. Among 301 individuals enrolled and vaccinated, 279 individuals completed the study. The study revealed that the PCV13 regimen elicited significant immune responses to all serotypes and was well-tolerated in these HIV-infected individuals. However, subsequent PPSV23 or PCV13 administration resulted in only modest increases in the antibody titres.5

  

A randomised clinical trial conducted in Brazil with 331 HIV-infected patients evaluated the safety and efficacy of PCVs in these patients, alone and combined. In this study, both PCV7 and PPSV23 were found to be immunogenic and well-tolerated in these patients, and the immunogenicity of PCV7 was higher than PPSV23. No benefits were observed in combining the 2 vaccines.6

Song et al compared the immunogenicity of PCV13 in HIV-infected patients with CD4 T-cell count <350 cells/μL, as compared with those with a higher CD4 T-cell count. Although PCV13 was well- tolerated in all HIV-infected patients irrespective of their immune status, it showed significantly lower immunogenicity among patients with CD4 T-cell count <350 cells/μL, as compared with those HIV-infected patients with a higher CD4 T-cell count. The findings of this study indicate that it would be important to assess the optimum timing of vaccination in HIV-infected patients for achieving sufficiently protective immunity. However, current guidelines recommend PCV13 use in HIV-infected patients irrespective of CD4 T-cell count.7 

  

Another recent study explored the virological and immunological outcomes of HIV-1–positive patients after immunisation with PCV13. In this retrospective study conducted in individuals aged ≥50 years, it was observed that in first 6 months after PCV13 vaccination amongst patients on stable virological suppression, confirmed virological failures and viral blips were rarely found. These findings indicated that the PCV13 is well tolerated in HIV-1–positive patients with respect to immunological and virological outcomes.8

  

A prospective pilot study compared the long-term immunological response with PCV13 versus PPSV23 among HIV-infected adults. It was observed that both vaccines achieved a serologic response that was durable over the long term. However, after 5 years of vaccination, minor differences were observed between the immunogenicity of the 2 vaccines, whereby PCV13 was found to be better than PPSV23.9

  

A study assessed the antibody responses of PCV13 and/or PPSV23 in elderly HIV-infected adults, aged between 50 and 65 years. As compared with the recommended regimen of PCV13/PPSV23, PPSV23 alone demonstrated a clear immunological advantage in older HIV-infected individuals, and as compared with HIV-PCV13/PPSV23 controls, antibody responses to PCV13/PPSV23 were lower.10 A previous study by the group had reported that upon revaccination with PPSV23 in this group of older adults, PCV13 does not enhance cellular responses.11

  


HIV, human immunodeficiency virus; CD4, cluster of differentiation 4; GMC, geometric mean concentration;
GMT, geometric mean titre; PCV7, 7-valent pneumococcal conjugate vaccine; PCV13, 13-valent pneumococcal conjugate vaccine; PPSV23, 23-valent pneumococcal polysaccharide vaccine.


References:

Sadlier C, O’Dea S, Bennett K, et al. Immunological efficacy of pneumococcal vaccine strategies in HIV-infected adults: a randomized clinical trial. Sci Rep. 2016;6:32076.

Farmaki PF, Chini MC, Mangafas NM, et al. Immunogenicity and immunological memory induced by the 13-valent pneumococcal conjugate followed by the 23-valent polysaccharide vaccine in HIV-infected adults. J Infect Dis. 2018;218(1):26-34.

Glesby MJ, Brinson CC, Greenberg RN, et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in HIV-positive adults with prior 23-valent pneumococcal polysaccharide vaccination. Presented at: 20th conference on retroviruses and opportunistic infections (CROI); March 3-6, 2013; Atlanta, GA, USA.

CDC. Pneumococcal disease. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-preventable Diseases. 13th ed. CDC; 2015. Accessed May 17, 2022. https://www.cdc.gov/vaccines/pubs/pinkbook/front-matter.html

Bhorat AE, Madhi SA, Laudat F, et al. Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination. AIDS. 2015;29(11):1345-1354.

 Ho YL, Brandão AP, de Cunto Brandileone MC, et al. Immunogenicity and safety of pneumococcal conjugate polysaccharide and free polysaccharide vaccines alone or combined in HIV-infected adults in Brazil. Vaccine. 2013;31(37):4047-4053.

Song JY, Cheong HJ, Noh JY, et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in HIV-infected adults in the era of highly active antiretroviral therapy: analysis stratified by CD4 T-cell count. Hum Vaccin Immunother. 2020;16(1):169-175.

Dell’Acqua R, Galli L, Poli A, et al. Viro-immunological outcomes after 13-valent pneumococcal vaccination in HIV-1-infected individuals on stable virological suppression. AIDS. 2019;33(13):1987-1994.

Belmonti S, Rossetti B, Modica S, et al. Long-term serological response to 13-valent pneumococcal conjugate vaccine versus 23-valent polysaccharide vaccine in HIV-infected adults. Infect Dis Ther. 2019;8(3):453-462.

Ohtola JA, Saul-McBeth JL, Iyer AS, et al. Quantitative and functional antibody responses to the 13-valent conjugate and/or 23-valent purified polysaccharide vaccine in aging HIV-infected adults. J AIDS Clin Res. 2016;7(3):556.

Ohtola JA, Khaskhely NM, Saul-Mcbeth JL, et al. Alterations in serotype-specific B cell responses to the 13-valent pneumococcal conjugate vaccine in aging HIV-infected adults. Vaccine. 2016;34(4):451-457.

   

Please click the Prescribing Information link to view the safety and adverse events information of Prevenar 13®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.

   

PP-PRV-IND-0268 July 2022

PCV13 in HIV Infection

Dosing

Help protect your adult patients against pneumococcal pneumonia with single-dose administration

Learn more


Efficacy

Efficacy proven by the CAPiTA study

Learn more


Recommendations for Use

The ACIP recommends routine use of PCV13 among adults

Learn more

PfizerPro AccountPfizerPro Account

To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.

Sign in or RegisterSign inRegisterAccountSign Out
 
These pages are not intended for patients or for members of the general public. The web pages contain promotional content. For the use only of Registered Medical Practitioners or a Hospital or a Laboratory. Full prescribing information available on request. For more details on, Who is a Registered Medical Practitioner, please visit "https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf", Page No. 39, Rule 2 part (ee), last accessed on 26th April2021.
​​​​​​​
Address: The Capital,  A Wing, 1802, 18th Floor, Plot No. C-70, ‘G’ Block, Bandra Kurla Complex, Bandra East, Mumbai – 400051, India.
 
PP-PRV-IND-0268

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.

Heading

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.

ButtonButton

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Hac habitasse platea dictumst quisque sagittis purus sit amet volutpat. Lectus magna fringilla urna porttitor rhoncus. Venenatis urna cursus eget nunc scelerisque viverra. Id donec ultrices tincidunt arcu non sodales.

Sagittis aliquam malesuada bibendum arcu vitae elementum curabitur. Pellentesque elit ullamcorper dignissim cras tincidunt. Orci ac auctor augue mauris augue neque. Dui vivamus arcu felis bibendum ut tristique et egestas quis. Sed vulputate mi sit amet mauris commodo.

Nunc eget lorem dolor sed viverra ipsum. Sed ullamcorper morbi tincidunt ornare.

 
Copyright © 2022 Pfizer Limited, India. All rights reserved. Applicable for Pfizer Products, Product Microsites and Therapy Areas section of the website:
  • All content published herein is intended and strictly only for informational, educational, academic and/or research purposes and shall not be utilized to diagnose or treat a health problem or disease without referring to the full prescribing information for list of approved indications as contained in the product package insert
  • ​​​​​​​While due care and caution has been taken to ensure that the content herein is free from mistakes or omissions, Pfizer makes no claims, promises or guarantees about the accuracy, completeness or adequacy of the information herein
 
For the use of Registered Medical Practitioners only*

These pages are not intended for patients or for members of the general public. The web pages contain promotional content.


If you select 'No', you will be redirected to Pfizer.co.in

For more details on, Who is a Registered Medical Practitioner*, please visit https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf , Page No. 39, Rule 2 part (ee), last accessed on 13th September 2019.
​​​​​​​Address: The Capital, A Wing, 1802, 18th Floor, Plot No. C-70, 'G' Block, Bandra Kurla Complex, Bandra East, Mumbai - 400051.


PP-UNP-IND-0012 14 July 2022
Yes No
You are now leaving PfizerPro website

​​​​​You are now leaving Pfizer Pro website and will be redirected to another website. Note that you will be governed by the Terms & Conditions and Privacy Policy of the external website. Would you like to continue?
​PP-UNP-IND-0012 14 July 2022