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Pneumococcal vaccine for preventing Streptococcus pneumoniae infection in HIV-infected individuals (Protocol) Sadlier C, Bennett K, Matthews A, Mockler D, Wilson F, Bergin C

Sadlier C, Bennett K, Matthews A, Mockler D, Wilson F, Bergin C. Pneumococcal vaccine for preventing #Streptococcus pneumoniae infection in HIV-infected individuals. Cochrane Database of Systematic Reviews 2016, Issue 1. Art. No.: CD002236. DOI: 10.1002/14651858.CD002236.pub2.

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Pneumococcal vaccine for preventing Streptococcus pneumoniae infection in HIV-infected individuals (Protocol) Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS HEADER . . . . . . . . . . ABSTRACT . . . . . . . . . BACKGROUND . . . . . . . OBJECTIVES . . . . . . . . METHODS . . . . . . . . . REFERENCES . . . . . . . . APPENDICES . . . . . . . . WHAT’S NEW . . . . . . . . HISTORY . . . . . . . . . . CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST . SOURCES OF SUPPORT . . . .

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[Intervention Protocol]

Pneumococcal vaccine for preventing Streptococcus pneumoniae infection in HIV-infected individuals Corinna Sadlier1 , Kathleen Bennett2 , Anne Matthews3 , David Mockler4 , Fiona Wilson5 , Colm Bergin1 1 Department of Genitourinary Medicine and Infectious Diseases (GUIDE), St James’s Hospital, Dublin, Ireland. 2 Department of Pharmacology and Therapeutics, School of Medicine, Trinity College Dublin, Dublin, Ireland. 3 School of Nursing and Human Sciences, Dublin City University, Dublin, Ireland. 4 John Stearne Library, Trinity Centre for Health Sciences, St. James Hospital, Dublin 8, Ireland. 5 School of Medicine, Discipline of Physiotherapy, Trinity College Dublin, Dublin, Ireland

Contact address: Corinna Sadlier, Department of Genitourinary Medicine and Infectious Diseases (GUIDE), St James’s Hospital, Dublin, Ireland. [email protected]. Editorial group: Cochrane Infectious Diseases Group. Publication status and date: Edited (no change to conclusions), published in Issue 1, 2016. Citation: Sadlier C, Bennett K, Matthews A, Mockler D, Wilson F, Bergin C. Pneumococcal vaccine for preventing Streptococcus pneumoniae infection in HIV-infected individuals. Cochrane Database of Systematic Reviews 2016, Issue 1. Art. No.: CD002236. DOI: 10.1002/14651858.CD002236.pub2. Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT This is the protocol for a review and there is no abstract. The objectives are as follows: To determine the efficacy and safety of pneumococcal vaccine (PPV23 or PCV, or both, of any valency, alone or in combination) in HIV-positive individuals.

BACKGROUND

Description of the condition Streptococcus pneumoniae (S. pneumoniae) is a leading cause of community-acquired pneumonia and invasive bacterial infections worldwide. Over 90 pneumococcal serotypes have been identified, with 10 serotypes accounting for most pneumococcal infections (Hausdorff 2000a; Hausdorff 2000b). Invasive pneumococcal disease (IPD) occurs when S. pneumoniae bacteria infect a normally sterile site (a site where bacteria are not usually isolated) such as the cerebrospinal fluid (causing meningitis) or the bloodstream (causing bacteraemia), and causes an overall mortality of approximately 20% (Rello 2010).

People living with human immunodeficiency virus (HIV) are disproportionately affected by S. pneumoniae infection. The risk of IPD is 30 to 100 times greater in HIV-positive individuals compared to HIV-negative age-matched controls (Redd 1990; Janoff 1992; Yin 2012), and 25% will have a recurrent episode of IPD within a 12-month period (French 2000; McEllistrem 2002). Advanced immunosuppression in people who are untreated for HIV infection is characterized by impaired B cell immunity, which is probably the most important risk factor for IPD. However, drug use and cirrhosis are also more common in people living with HIV than in the general population and these factors also increase the risk of IPD (French 2004; Harboe 2014). Although some studies have reported a decrease in IPD incidence following the widespread introduction of highly active antiretroviral therapy (HAART) (Nuorti 2000; Feikin 2004; Grau 2005), this finding


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has not been consistent (Jordano 2004; Barry 2006; Nunes 2011).

Description of the intervention Two pneumococcal vaccine types are currently available to protect against pneumococcal disease: polysaccharide pneumococcal vaccines (PPVs) and conjugate pneumococcal vaccines (PCVs). The first PPV was licensed in 1977, and contained capsular material from 14 pneumococcal serotypes (PPV14). PPV14 was replaced in 1983 by PPV23, which provides extended serotype coverage against the 23 pneumococcal serotypes causing approximately 85% to 90% of cases of pneumococcal disease in the USA (Butler 1993; Butler 1995). In the most recent Cochrane Review of PPV23, which included 18 trials with over 60,000 participants, there was strong evidence that PPV23 reduced IPD in the general population. However, the evidence was less clear regarding protection against communityacquired pneumonia, or against IPD in adults with chronic illness, such as asthma or COPD (Moberley 2013). Several studies have shown that the magnitude and durability of immunological response to PPV23 vaccination is inferior in HIV-positive individuals compared with healthy controls, and failure of PPV23 is well described in this patient group (Janoff 1998; Kroon 1999; Rodriguez 2003). Conjugate vaccines covalently couple polysaccharide antigens to a carrier protein to stimulate a greater immune response (Avery 1929). The seven-valent conjugate vaccine was designed to provide protection against the serotypes responsible for approximately 80% of infections in the USA (O’Brien 2003), and was shown to be highly effective in both immunocompetent and immunocompromised populations including children and adults (Black 2000; French 2010). A nine-valent conjugate vaccine was developed for use in sub-Saharan Africa with the addition of two major serotypes prevalent in the region. This vaccine was effective in children in South Africa (Mbelle 1999; Huebner 2002; Huebner 2004), but never went into production or entered routine use. The 13-valent conjugated pneumococcal vaccine superceded other conjugate vaccines and entered routine use in 2010. PCV13 extends coverage of PCV7 by including antigens to six additional serotypes of pneumococcus, including the 19A serotype, which increased in frequency in the USA following the introduction of PCV7 immunization in children (Rosen 2011; Tomczyk 2014). PCV13 protects against approximately 80% of pneumococcal serotypes causing pneumococcal disease in children (Harboe 2014).

Why it is important to do this review This Cochrane review is of great importance as the efficacy of pneumococcal vaccination in HIV-positive individuals, the degree of protection and the safety afforded remain debated (Pederson

2011). The long-standing recommendation for pneumococcal vaccine in HIV-positive individuals remains, given the increased burden of pneumococcal-associated infection and complications in this population. Current recommendations are PCV13 followed by PPV23 after eight weeks for prevention of pneumococcal disease in pneumococcal vaccine naive HIV-positive adults, and PCV13 vaccine at least one year after PPV23 for those people previously vaccinated with PPV23 (CDC 2012).

OBJECTIVES To determine the efficacy and safety of pneumococcal vaccine (PPV23 or PCV, or both, of any valency, alone or in combination) in HIV-positive individuals.

METHODS

Criteria for considering studies for this review

Types of studies Randomized controlled trials (RCTs) and non-RCTs comparing pneumococcal vaccine with no intervention or control vaccines. Types of participants Adults and children who are infected with HIV. Types of interventions

Intervention

Any pneumococcal vaccine (PPV23 or PCV, or both, of any valency, alone or in combination). Control

Placebo, no intervention, or an alternative pneumococcal vaccine or vaccine schedule. Types of outcome measures

Primary outcomes

• IPD • All-cause pneumonia • All-cause mortality


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Secondary outcomes

• Vaccine type IPD • Vaccine type pneumonia • Adverse effects of vaccine

Search methods for identification of studies

Electronic searches We will attempt to identify all relevant RCTs, regardless of language or publication status. We will use search the strategy detailed in Appendix 1 to search the following databases from 1 January 1980: CENTRAL (Cochrane Central Register of Controlled Trials), MEDLINE, EMBASE, PubMed and CINAHL. In MEDLINE (Pubmed), we will combine subject-specific terms with sensitivity-maximising version of the Cochrane Highly Sensitive Search Strategy for identifying randomized trials (Lefebvre 2011). For ongoing or unpublished studies, we will search conference abstract archives on the following websites: Conference on Retroviruses and Opportunistic Infections (CROI), the International AIDS Conference (IAC), the International AIDS Society Conference on HIV Pathogenesis Treatment and Prevention (IAS), Infectious Diseases Society of America (IDSA), International Conference on Antimocrobial Agents and Chemotherapy (ICAAC) and European Conference of Microbiology and Infectious Diseases (ESCMID) for abstracts presented at conferences. In addition, we will search the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), Current Controlled Trials and ClinicalTrials.gov to identify ongoing trials and recently published studies.

Searching other resources We will contact individual researchers, experts working in the field and authors of major trials to address whether any relevant manuscripts are in preparation or in press. We will also search the reference list of all included RCTs for additional trials relevant to this Cochrane review.

Data collection and analysis

Selection of studies Two review authors (CS and CB) will independently screen the abstracts of all studies identified by electronic or bibliographic searches to identify publications relevant to this Cochrane review. We will obtain full-text articles for all citations we deem potentially eligible. Two review authors will independently apply the inclusion

and exclusion criteria to all full-text articles using a standardized eligibility form. We will resolve any disagreements by consensus and will refer to a third review author (FW or AM) if required. We will not blind the review authors to trial author, institution or journal throughout the screening process.

Data extraction and management Two review authors (CS and CB) will independently extract data from included trials using a standardized data extraction form. We will extract details of the trial methods (including method of randomization, blinding, routine monitoring and timing of data collection), participants (including age, gender, ethnicity, baseline CD4+ T cell count and viral load, and use of antiretroviral therapy), interventions (including vaccine type and schedule of vaccination) and setting (country, rural or urban, and year of conduct). For dichotomous outcomes, we will record the number of participants experiencing the event and the total number of participants in each treatment group. We will resolve any disagreement by consensus or third party adjudication. We will contact trial authors to clarify any omitted data or trial characteristics.

Assessment of risk of bias in included studies We will follow the guidance of the Cochrane Handbook of Systematic Reviews of Interventions (Higgins 2011) and use the ’Risk of Bias’ assessment tool to assess the risk of bias of included RCTs. Two review authors (CS and AM) will assess the risk of bias of included RCTs across six domains: sequence generation; allocation concealment; blinding (of participants, personnel and outcome assessors); incomplete outcome data; selective outcome reporting; and other sources of bias. For sequence generation and allocation concealment, we will report the methods used. For blinding, we will describe who was blinded and the blinding method. For incomplete outcome data, we will report the percentage and proportion of participants lost to follow-up. For selective outcome reporting, we will report any discrepancies between the methods used and the results in terms of the outcomes measured or the outcomes reported. For other biases, we will describe any other trial features that could have affected the trial result (for example, if the trial was stopped early). We will categorise our risk of bias judgements as either ’low’, ’high’ or ’unclear’. Where the risk of bias is unclear, we will attempt to contact the trial authors for clarification and will resolve any differences of opinion through discussion. In addition to the above criteria, we will assess non-RCTs (including case control and cohort studies) for control of important baseline confounding factors. We will included the following confounders in this assessment: age, gender, CD4 T cell count, antiretroviral therapy, other chronic illness and influenza vaccination status. We will assess trials on the proportion of confounding fac-


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tors, whether trial authors considered confounders and whether confounders were balanced between groups at baseline.

60%, may represent moderate heterogeneity; 50% to 90%, may represent substantial heterogeneity; and 75% to 100%, may represent considerable (very substantial) heterogeneity.

Measures of treatment effect We will summarize dichotomous data using the risk ratio (RR) and present all outcomes with 95% confidence intervals (CIs).

Unit of analysis issues If trials have multiple comparison groups, we will analyse data as individual pair-wise comparisons. When conducting meta-analysis, we will ensure that participants in the control group are counted only once by dividing the events and participants evenly between the intervention groups. We will perform analyses of all outcomes at the individual level. Where we include both cluster-RCTs and individually RCTs in a meta-analysis, we will use the generic inverse variance method to input cluster-adjusted effect estimates and standard error (SE) values. Where trial authors have not adjusted their results for the effect of clustering, we will perform an approximate adjustment using an estimate of the design effect obtained from similar trials. Where no appropriate design effects are available, we will perform a sensitivity analysis imputing different design effects to assess the robustness of the result to the possible effects of clustering.

Dealing with missing data Where data are incomplete or missing, we will contact trial authors to request additional information where possible. If standard deviations are missing from continuous data, we will use other statistics (CIs, SEs, T values, P values and F values) that allow for their calculation.

Assessment of heterogeneity We will assess statistical heterogeneity by visual inspection of the forest plots for overlapping CIs, applying the Chi-square test with a 10% level of statistical significance and using the I² statistic. We will base our interpretation of the I² statistic on the guidance from the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011): 0% to 40%, might not be important; 30% to

Assessment of reporting biases We will assess the possibility of publication bias by examining funnel plots for asymmetry. We will attempt to minimise the potential for publication bias by our comprehensive search strategy, which includes evaluating published and unpublished literature. Data synthesis We will conduct meta-analyses, if appropriate, using Review Manager (RevMan) (RevMan 2014). In the first instance we will use a fixed-effect model, but we will use the random-effects model if we detect moderate statistical heterogeneity. If there is substantial heterogeneity we will consider not pooling results, and where we feel it is inappropriate we will summarize data narratively and in tables. Quality of evidence We will assess the quality of the body of evidence for each outcome using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach (Guyatt 2008), which defines the quality of evidence for each outcome as “the extent to which one can be confident that an estimate of effect or association is close to the quantity of specific interest” (Higgins 2011). Using the GRADEpro software, we will generate GRADE ’Summary of findings’ tables for the main comparisons (GRADEpro GDT 2015). Subgroup analysis and investigation of heterogeneity We will investigate potential sources of heterogeneity through a series of analyses and will subgroup the included trials by: geographical region, participant age, baseline CD4+ cell count, baseline viral load and HIV risk group. Sensitivity analysis We will perform a series of sensitivity analyses to investigate the robustness of the results to the individual ’Risk of bias’ domains.


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REFERENCES

Additional references Avery 1929 Avery OT, Goebel WF. Chemo-immunological studies on conjugated carbohydrate-proteins. II. Immunological specificity of synthetic sugar-protein antigens. Journal of Experimental Medicine 1929;50(4):533–50. Barry 2006 Barry PM, Zetola N, Keruly JC, Moore RD, Gebo KA, Lucas GM. Invasive pneumococcal disease in a cohort of HIV-infected adults: incidence and risk factors, 19902003. AIDS 2006;20(3):437–44. Black 2000 Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen JR, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group. Pediatric Infectious Disease Journal 2000;19(3):187–95. Butler 1993 Butler JC, Breiman RF, Campbell JF, Lipman HB, Broome CV, Facklam RR. Pneumococcal polysaccharide vaccine efficacy. An evaluation of current recommendations. JAMA 1993;270(15):1826–31. Butler 1995 Butler JC, Breiman RF, Lipman HB, Hofmann J, Facklam RR. Serotype distribution of Streptococcus pneumoniae infections among preschool children in the United States, 1978-1994: implications for development of a conjugate vaccine. Journal of Infectious Diseases 1995;171(4):885–9. CDC 2012 Centers for Disease Control and Prevention. Use of 13valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report 2012;61 (40):816–9. Feikin 2004 Feikin DR, Feldman C, Schuchat A, Janoff EN. Global strategies to prevent bacterial pneumonia in adults with HIV disease. The Lancet Infectious Diseases 2004;4(7): 445–55. French 2000 French N, Nakiyingi J, Carpenter LM, Lugada E, Watera C, Moi K, et al. 23-valent pneumococcal polysaccharide vaccine in HIV-1-infected Ugandan adults: double-blind, randomised and placebo controlled trial. The Lancet 2000; 355(9221):2106–11. French 2004 French N, Moore M, Haikala R, Kaäyhty H, Gilks CF. A case-control study to investigate serological correlates of clinical failure of 23-valent pneumococcal polysaccharide vaccine in HIV-1-infected Ugandan adults. The Journal of Infectious Diseases 2004;190(4):707–12.

French 2010 French N, Gordon SB, Mwalukomo T, White SA, Mwafulirwa G, Longwe H, et al. A trial of a 7-valent pneumococcal conjugate vaccine in HIV-infected adults. New England Journal of Medicine 2010;362(9):812–22. GRADEpro GDT 2015 [Computer program] McMaster University (developed by Evidence Prime, Inc.). GRADEpro GDT: GRADEpro Guideline Development Tool. Available from www.gradepro.org. McMaster University (developed by Evidence Prime, Inc.), 2015. Grau 2005 Grau I, Pallares R, Tubau F, Schulze MH, Llopis F, Podzamczer D, et al. Epidemiologic changes in bacteremic pneumococcal disease in patients with human immunodeficiency virus in the era of highly active antiretroviral therapy. Archives of Internal Medicine 2005; 165(13):1533–40. Guyatt 2008 Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336(7650):924–6. Harboe 2014 Harboe ZB, Larsen MV, Ladelund S, Kronborg G, Konradsen HB, Gerstoft J, et al. Incidence and risk factors for invasive pneumococcal disease in HIV-infected and nonHIV-infected individuals before and after the introduction of combination antiretroviral therapy: persistent high risk among HIV-infected injecting drug users. Clinical Infectious Diseases 2014;59(8):1168–76. Hausdorff 2000a Hausdorff WP, Bryant J, Paradiso PR, Siber GR. Which pneumococcal serogroups cause the most invasive disease: implications for conjugate vaccine formulation and use, part I. Clinical Infectious Diseases 2000;30(1):100–21. Hausdorff 2000b Hausdorff WP, Bryant J, Kloek C, Paradiso PR, Siber GR. The contribution of specific pneumococcal serogroups to different disease manifestations: implications for conjugate vaccine formulation and use, part II. Clin Infectious Diseases 2000;30(1):122–40. Higgins 2011 Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org. Huebner 2002 Huebner RE, Mbelle N, Forrest B, Madore DV, Klugman KP. Immunogenicity after one, two or three doses and impact on the antibody response to coadministered antigens of a nonavalent pneumococcal conjugate vaccine in infants of Soweto, South Africa. Pediatric Infectious Disease Journal 2002;21(11):1004–7.


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Huebner 2004 Huebner RE, Mbelle N, Forrest B, Madore DV, Klugman KP. Long-term antibody levels and booster responses in South African children immunized with nonavalent pneumococcal conjugate vaccine. Vaccine 2004;22(21-22): 2696–700. Janoff 1992 Janoff EN, Breiman RF, Daley CL, Hopewell PC. Pneumococcal disease during HIV infection. Epidemiologic, clinical, and immunologic perspectives. Annals of Internal Medicine 1992;117(4):314–24. Janoff 1998 Janoff EN, Douglas JM Jr, Gabriel M, Blaser MJ, Davidson AJ, Cohn DL, et al. Class-specific antibody response to pneumococcal capsular polysaccharides in men infected with human immunodeficiency virus type 1. Journal of Infectious Diseases 1988;158(5):983–90.

infected adults in the era of an antiretroviral treatment program. PLoS One 2011;6(11):e27929. Nuorti 2000 Nuorti JP, Butler JC, Gelling L, Kool JL, Reingold AL, Vugia DJ. Epidemiologic relation between HIV and invasive pneumococcal disease in San Francisco County, California. Annals of Internal Medicine 2000;132(3):182–90. O’Brien 2003 O’Brien KL, Dagan R. The potential indirect effect of conjugate pneumococcal vaccines. Vaccine 2003;21(17-8): 1815–25. Pederson 2011 Pedersen RH, Lohse N, Østergaard L, Søgaard OS. The effectiveness of pneumococcal polysaccharide vaccination in HIV-infected adults: a systematic review. HIV Medicine 2011;12(6):323–33.

Jordano 2004 Jordano Q, Falcó V, Almirante B, Planes AM, del Valle O, Ribera E, et al. Invasive pneumococcal disease in patients infected with HIV: still a threat in the era of highly active antiretroviral therapy. Clinical Infectious Diseases 2004;38 (11):1623–8.

Redd 1990 Redd SC, Rutherford GW 3rd, Sande MA, Lifson AR, Hadley WK, Facklam RR, et al. The role of human immunodeficiency virus infection in pneumococcal bacteremia in San Francisco residents. The Journal of Infectious Diseases 1990;162(5):1012–7.

Kroon 1999 Kroon FP, van Dissel JT, Ravensbergen E, Nibbering PH, van Furth R. Antibodies against pneumococcal polysaccharides after vaccination in HIV-infected individuals: 5-year follow-up of antibody concentrations. Vaccine 1999;18(5-6):524–30.

Rello 2010 Rello J, Luján M, Gallego M, Vallés J, Belmonte Y, Fontanals D, et al. Why mortality is increased in healthcare-associated pneumonia; lessons from pneumococcal bacteremic pneumonia. Chest 2010;137(5):1138–44.

Lefebvre 2011 Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies [Chapter 6: Searching for studies.]. Cochrane Handbook for Systematic Reviews of. CochraneDatabase of Systematic Reviews Interventions 2011;5.1.0.

RevMan 2014 [Computer program] The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.

Mbelle 1999 Mbelle N, Huebner RE, Wasas AD, Kimura A, Chang I, Klugman KP. Immunogenicity and impact on nasopharyngeal carriage of a nonavalent pneumococcal conjugate vaccine. The Journal of Infectious Diseases 1999; 180(4):1171-6.

Rodriguez 2003 Rodriguez-Barradas MC, Alexandraki I, Nazir T, Foltzer M, Musher DM, Brown S, et al. Response to human immunodeficiency virus-infected patients receiving highly active antiretroviral therapy to vaccination with 23-valent pneumococcal polysaccharide vaccine. Clinical Infectious Diseases 2003;37(3):438–47.

McEllistrem 2002 McEllistrem MC, Mendelsohn AB, Pass MA, Elliott JA, Whitney CG, Kolano JA, et al. Recurrent invasive pneumococcal disease in individuals with human immunodeficiency virus infection. The Journal of Infectious Diseases 2002;185(9):1364-8. Moberley 2013 Moberley S, Holden J, Tatham DP, Andrews RM. Vaccines for preventing pneumococcal infection in adults. Cochrane Database of Systematic Reviews 2013, Issue 1. [DOI: 10.1002/14651858.CD000422.pub3] Nunes 2011 Nunes MC, von Gottberg A, de Gouveia L, Cohen C, Kuwanda L, Karstaedt AS, et al. Persistent high burden of invasive pneumococcal disease in South African HIV-

Rosen 2011 Rosen JB, Thomas AR, Lexau CA, Reingold A, Hadler JL, Harrison LH, et al. Geographic variation in invasive pneumococcal disease following pneumococcal conjugate vaccine introduction in the United States. Clinical Infectious Diseases 2011;53(2):137–43. Tomczyk 2014 Tomczyk S, Bennett NM, Stoecker C, Gierke R, Moore MR, Whitney CG, et al. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report 2014;63(37):822–5.


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Yin 2012 Yin Z, Rice BD, Waight P, Miller E, George R, Brown AE, et al. Invasive pneumococcal disease among HIV-positive individuals, 2000-2009. AIDS 2012;26(1):87-94.

References to other published versions of this review Louie 2000 Louie J, Rutherford G. Pneumococcal vaccine for prevention of Streptococcus pneumoniae infection in HIV infected persons. Cochrane Database of Systematic Reviews 2000, Issue 3. [DOI: 10.1002/14651858.CD002236] ∗ Indicates the major publication for the study

APPENDICES

Appendix 1. Search strategy

EMBASE 1. ’Streptococcus pneumoniae’/exp 2. ‘Streptococcus infection’/exp 3. (Streptococc* NEXT/1 (pneumon* OR infection*)):ab,ti OR ‘s. pneumoniae’:ab,ti 4. (pneumococc* NEAR/5 (pneumon* OR sepsis OR sinusit* OR meningit* OR ‘otis media’ OR infection OR disease OR bacteraemia)):ab,ti 5. (bacteraemic NEAR/1 pneumon*):ab,ti 6. #1 OR #2 OR #3 OR #4 OR #5 7. ’Pneumococcus vaccine’/exp 8. ’Streptococcus vaccine’/exp 9. ‘polysaccharide vaccine’/exp 10. ((pneumococc* OR Streptococc*) NEAR/5 (vaccin* OR conjugat* OR immuni* OR polysaccharide OR inoculat*)):ab,ti 11. (PCV OR CVP OR PPV OR PPSV):ab,ti 12. #7 OR #8 OR #9 OR #10 OR #11 13. ‘Human immunodeficiency virus’/exp 14. ‘Human immunodeficiency virus infection’/exp 15. (‘human immunedeficiency virus’ OR ‘human immune-deficiency virus’ OR ‘human mmune-deficiency virus’ OR hiv OR ‘hiv+1’ OR ‘hiv+2’ OR ‘acquired immunodeficiency syndrome’ OR ‘acquired mmune+deficiency syndrome’ OR ‘acquired immune+deficiency syndrome’ OR ‘acquired immunedeficiency syndrome’):ab,ti 16. #13 OR #14 OR #15 17. #6 AND #12 AND #16 18. ’animal’/de OR ’animal experiment’/de OR ’invertebrate’/de OR ’animal tissue’/de OR ’animal cell’/de OR ’nonhuman’/de 19. ’human’/de OR ’normal human’/de OR ’human cell’/de 20. #18 AND #19 21. #18 NOT #20 22. #17 NOT #21 PubMed 1. “streptococcus pneumoniae”[Mesh] Pneumococcal vaccine for preventing Streptococcus pneumoniae infection in HIV-infected individuals (Protocol) Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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2. “Pneumonia, Pneumococcal”[Mesh] 3. “Pneumococcal Infections”[Mesh] 4. Pneumococc*[tiab] OR Pneumonia*[tiab] 5. 1 OR 2 OR 3 OR 4 6. “Streptococcal Vaccines”[Mesh] 7. “Vaccines, Conjugate”[Mesh] 8. Pneumococcus vaccin*[tiab] OR pneumococcal conjugate vaccin*[tiab] OR Pneumococcal Vaccin*[tiab] OR streptococcus vaccin*[tiab] OR Streptococcus inocul*[tiab] OR pneumococcal immuniz*[tiab] OR pneumococcal immunis*[tiab] OR Pneumococcus immuniz*[tiab] OR pneumococcal polysaccharide vaccine*[tiab] OR PCV[tiab] OR CVP[tiab] OR PPV[tiab] OR PPSV[tiab] 9. 6 OR 7 OR 8 10. “HIV”[Mesh] 11. “HIV Infections”[Mesh] 12. human immunodeficiency virus[tiab] OR HIV[tiab] OR acquired immunodeficiency syndrome[tiab] OR acquired immunodeficiency syndrome[tiab] OR acquired immune-deficiency syndrome[tiab] OR AIDS[tiab] 13. 10 OR 11 OR 12 14. 5 AND 9 AND 13 15. “Randomized Controlled Trial” [pt] 16. “Controlled Clinical Trial” [pt] 17. randomized[tiab] OR randomised[tiab] 18. placebo[tiab] 19. “Placebos”[Mesh] 20. drug therapy[sh] 21. randomly[tiab] 22. trial[tiab] 23. groups[tiab] 24. 15 OR 16 OR 17 OR 18 OR 19 OR 20 OR 21 OR 22 OR 23 25. 14 AND 24

CINAHL 1. (MH “Streptococcal Infections+”) 2. TI (pneumococc* N5 (pneumon* OR sepsis OR sinusit* OR meningit* OR ‘otis media’ OR infection OR disease OR bacteraemia)) OR AB (pneumococc* N5 (pneumon* OR sepsis OR sinusit* OR meningit* OR ‘otis media’ OR infection OR disease OR bacteraemia)) 3. TI (bacteraemic N1 pneumon*) OR AB (bacteraemic N1 pneumon*) 4. TI (‘invasive pneumococcal disease’ OR ipd OR ‘streptococcus pneumoniae’ OR ‘s. pneumoniae’) OR AB (‘invasive pneumococcal disease’ OR ipd OR ‘streptococcus pneumoniae’ OR ‘s. pneumoniae’) 5. 1 OR 2 OR 3 OR 4 6. (MH “Pneumococcal Vaccine”) 7. TI (pneumococc* N5 (vaccin* OR conjugat* OR immuni* OR polysaccharide OR inoculat*)) OR AB (pneumococc* OR Streptococc*) N5 (vaccin* OR conjugat* OR immuni* OR polysaccharide OR OR inoculat*)) 8. TI ( PCV OR CVP OR PPV OR PPSV ) OR AB ( PCV OR CVP OR PPV OR PPSV ) 9. 6 OR 7 OR 8 10. (MH “Human Immunodeficiency Virus+”) OR (MH “HIV-Infected Patients+”) OR (MH “HIV Infections+”) 11. TI ( ‘human immunodeficiency virus’ OR HIV OR ‘acquired immunodeficiency syndrome’ OR ‘acquired immuno-deficiency syndrome’ OR ‘acquired immune-deficiency syndrome’ OR AIDS) OR AB ( ‘human immunodeficiency virus’ OR HIV OR ‘acquired immunodeficiency syndrome’ OR ‘acquired immuno-deficiency syndrome’ OR ‘acquired immune-deficiency syndrome’ OR AIDS) 12. 10 OR 11 13. 5 AND 9 AND 12 14. PT clinical trial 15. (MH “Clinical Trials+”) 16. TI clinical trial* OR AB clinical trial* 17. TI ( single blind* or double blind* ) OR AB ( single blind* or double blind* ) 18. TI random* OR AB random* Pneumococcal vaccine for preventing Streptococcus pneumoniae infection in HIV-infected individuals (Protocol) Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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19. 14 OR 15 OR 16 OR 17 OR 18 20. 13 AND 19 The Cochrane Library (includes CENTRAL trial registry) 1. [mh “streptococcus pneumoniae”] 2. [mh “Pneumonia, Pneumococcal”] 3. [mh “Pneumococcal Infections”] 4. (pneumococc* near/5 (pneumon* or sepsis or sinusit* or meningit* or ‘otis media’ or infection or disease OR bacteraemia)):ti,ab,kw 5. (‘invasive pneumococcal disease’ OR ipd OR ‘streptococcus pneumoniae’ OR ‘s. pneumoniae’):ti,ab,kw 6. #1 OR #2 OR #3 OR #4 OR #5 7. [mh “Streptococcal Vaccines”] 8. [mh “Vaccines, Conjugate”] 9. ((pneumococc* OR Streptococc*) near/5 (vaccin* OR conjugat* OR immuni* OR polysaccharide OR inoculat*)):ti,ab,kw 10. (PCV OR CVP OR PPV OR PPSV):ti,ab,kw 11. #7 OR #8 OR #9 OR #10 12. [mh “HIV”] 13. [mh “HIV Infections”] 14. (human immunodeficiency virus OR HIV OR acquired immunodeficiency syndrome OR acquired immuno-deficiency syndrome OR acquired immune-deficiency syndrome OR AIDS):ti,ab,kw 15. #12 OR #13 OR #14 16. #6 AND #11 AND #15 Trial Registries

WHO ICTRP (http://www.who.int/ictrp/en/)

clinicaltrials.gov

www.clinicaltrialsregister.eu

(hiv OR aids) AND (“Pneumococcus vaccine” OR “Streptococcus vaccine” )

WHAT’S NEW

Date

Event

Description

21 December 2015

Amended

The protocol has been completely amended with new methods and new author team

21 December 2015

New citation required and minor changes

The protocol has been updated to take into consideration new methods and a new author team


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HISTORY Protocol first published: Issue 3, 2000

Date

Event

Description

25 November 2013

Amended

We linked Additional references to the protocol text.

24 November 2013

Amended

We amended the Background section.

18 November 2013

Amended

We added new authors to the review team; C Bergin

18 November 2013

Amended

We updated the Background and Additional references sections.

11 November 2013

Amended

We amended the protocol draft.

CONTRIBUTIONS OF AUTHORS CS and CB developed this protocol. DM designed the search strategy. KB provided input regarding the statistical methods. FW and AM reviewed and provided input into the protocol.

DECLARATIONS OF INTEREST CS has been awarded a Health Research Board (HRB) of Ireland grant to complete this Cochrane review. The HRB is a non-profit government organization whose primary remit is the promotion and dissemination of health research. This is the only funding provided to assist this Cochrane review. CS and CB have undertaken research examining the immunogenicity of pneumococcal vaccine in HIV-positive individuals. They have collaborated with Pfizer on the analysis of study samples. KB has no known conflicts of interest. AM has no known conflicts of interest. DM has no known conflicts of interest. FW has no known conflicts of interest.


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SOURCES OF SUPPORT Internal sources • Trinity College Dublin, Dublin, Ireland.

External sources • Cochrane Fellowship, Health Research Board, Ireland.


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