Prof David Goldblatt @ Meningitis & Septicaemia in Children & Adults 2017
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The document discusses optimizing pneumococcal conjugate vaccine (PCV) schedules. It provides an overview of PCV introduction and schedule changes in the UK from 1990-2015. Results are presented from a randomized controlled trial comparing immunogenicity of a 2+1 versus 1+1 PCV schedule in UK infants. The global landscape of PCV introduction is reviewed, noting opportunities to optimize schedules. Ongoing studies in multiple countries are exploring alternate PCV schedules to potentially simplify regimens while maintaining protection.
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Prof David Goldblatt @ Meningitis & Septicaemia in Children & Adults 2017
- 1. 11/23/17 1 Optimising Pneumococcal Conjugate Schedules Professor David Goldblatt UCL Great Ormond Street Institute of Child Health and Great Ormond Street Hospital for Children NHS Foundation Trust § Vaccine Schedule Refinement in the UK 1990-2015 § PCV introduction and disease control § Possible approaches to optimising PCV use § Results of a PCV 2+1 vs 1+1 Randomised Control Trial § Global PCV considerations
- 2. 11/23/17 2 1990 2000 2010 2015 202099 06 13 Men C 3+0 Men C 2+1 Men C 1+1 + adol Men C 0+1 Men ACWY adol Men B 2+1 Hib 3+0 Hib 3+1 Hib Booster campaign Licensed 3+1 PCV7 2+1 PCV13 2+1 Licensed 3+1 HPV 3 dose HPV 2 dose 08 14 UK Vaccine Introduction and Schedule Changes YEAR 2000 2006/7 2010/11 2013/14 UK (2+1) USA (3+1) PCV7 IPD < 2y 99% reduction1 PCV7 Carriage Near Elimination2 PCV7 IPD all ages 86% reduced1 13-7 69%2 PCV13-7 IPD <2 89% Reduction1 PCV7 IPD < 5y 97%3 PCV7 Carriage Mass. Children near elimination4 PCV13-7 IPD < 5 93%5 1 Waight et al 2015, 2 van Hoek et al 2014, 3 Feikin et al 2013, 4 Wroe et al 2012, 5 Moore et al 2015, 6 Yildrim et al 2017 PCV13-7 Carr Mass. Children Very Low6 Impact of PCV Introduction
- 3. 11/23/17 3 Invasive pneumococcal disease incidence rate per 100,000 popn by age grouping, E&W 1996-2005 0 10 20 30 40 50 60 70 80 <2m 2-5m 6-11 m 1 year 2-4 years 5-9 years 10-14 years 15-44 years 45-64 years 65-74 years 75-79 years 80+ years Age range Rateper100,000 population 1996/97 1997/98 1998/99 1999/00 2000/01 2001/02 2002/03 2003/04 2004/05 Data courtesy of the Health Protection Agency Optimising the use of Pneumococcal Conjugate Vaccines PCV7 Type IPD 0.32/100,00035.78/100,000 17.73/100,000 0.55/100,000 • Australian paper 2017 3+0 2+1
- 4. 11/23/17 4 Invasive pneumococcal disease incidence rate per 100,000 popn by age grouping, E&W 1996-2005 0 10 20 30 40 50 60 70 80 <2m 2-5m 6-11 m 1 year 2-4 years 5-9 years 10-14 years 15-44 years 45-64 years 65-74 years 75-79 years 80+ years Age range Rateper100,000 population 1996/97 1997/98 1998/99 1999/00 2000/01 2001/02 2002/03 2003/04 2004/05 Data courtesy of the Health Protection Agency Optimising the use of Pneumococcal Conjugate Vaccines PCV7 Type IPD 0.32/100,000 35.78/100,000 17.73/100,000 0.55/100,000 Risks of removing this dose? Whitney et al. Lancet 2006;368:1495-502
- 5. 11/23/17 5 Andrews NJ et al. Lancet Infect Dis 2014;14:839-46 1dose 2.5<13m VE 38% (95% CI -218 – 89) Miller et al Vaccine 2011 Potential benefits of reducing the PCV schedule to 1+1 • Simplified and more acceptable infant schedule • Possible reduced frequency of adverse events • Creates space in the schedule for new vaccines in the future • Cost Savings, resources saved can be used on other vaccine related interventions (eg improve coverage)
- 7. 11/23/17 7 Group V1 2m V2 3m V3 4m V4 5m V5 12m V6 13m V7 18m 1 (n=100) 2+1 DTaP/IPV/ Hib Men B PCV13 Rota DTaP/IPV/ Hib Rota DTaP/IPV/ Hib Men B PCV13 Rota MenC/Hib Men B PCV13 MMR 2 (n=100) 1+1 DTaP/IPV/ Hib Men B Rota DTaP/IPV/ Hib PCV13 Rota DTaP/IPV/ Hib Men B Rota Samples Blood A NP Swab A Blood B NP Swab B 213 106 97 103 91 107 102 100 86 2+1 1+1 CONSORT: IgG GMCs post primary and vaccination Goldblatt et al Lancet ID, 2017
- 9. 11/23/17 9 Lancet Infectious Disease Online 22rd November 2017 Presentation title - edit in Header and Footer Minutes of the 4th October 2017 Meeting published Today Minutes of the 4th October 2017: Decision to move to a 1+1 PCV schedule (3 m and 12m) based on date from PHE on current England and Wales IPD Epidemiology, Vaccine Type carriage prevalence and modelling as well as the recent 1+1 trial
- 10. 11/23/17 10 19 GLOBAL PCV INTRODUCTION STATUS - 2016 Gavi Global National Introductions (as of Dec 2016) 57 (78%) 139 (72%) Surviving Infants have access to PCV 41M (51%) 69M (52%) Surviving Infants immunized with PCV 29M (35%) 53M (37%) Top 10 PCV countries with most unimmunized/underimmunized infants Nigeria, Pakistan, Bangladesh, DRC, Uganda, Ethiopia, Angola, Nepal, Kenya, Afghanistan Philippines, Venezuela, Poland, South Africa, U.S., Dominican Republic, Brazil, Spain, Mexico, Argentina (130) IVAC VIEW-Hub and Gavi © Bill & Melinda Gates Foundation | GSK $540 million Pfizer Inc. $555 million $485 million to overall $1.5 billion AMC
- 11. 11/23/17 11 PCV IS LARGEST SINGLE “SPEND” FOR GAVI 2000-2020 20% of $20.8 billion UK: $2.462 billion Bhutan Honduras Mongolia Sri Lanka Ukraine Angola Armenia Azerbaijan Bolivia Congo Rep. Cuba Georgia Guyana Indonesia. Kiribati. Moldova Nicaragua PNG. Timor Leste Uzbekistan Vietnam Ghana Nigeria Solomon Islands $1045 $1580 Mean GNI Per capita over previous 3 years Contribution $0.20/dose Contribution 15% pa increase Inc to 100% Over 5 yrs $3.05/dose
- 12. 11/23/17 12 BMGF SPONSORED ALTERNATE PCV DOSING STUDIES South Africa (PI: Shabir Madhi) • Individual randomization • PCV10 and PCV13 • 2+1 vs. 1+1 (6 or 14 wks +9mo) • Endpoints: immunogenicity, NPC • Results: 2Q2019 United Kingdom • Individual randomization • PCV13 • 2+1 vs. 1+1 (2mo + 12 mo) • Endpoints: immunogenicity, NPC • Results: Nov 2017 India (PI: Ashish Bavdekar) • Individual randomization • PCV10 and PCV13 • 3+0 and 2+1 vs. 1+1 (6 +9mo) • Endpoints: Immunogenicity, NPC • Results: May 2019 Vietnam (PI: Kim Mulholland) • Individual randomization • PCV10 and PCV13 • 3+1, 3+0, 2+1,1+1, 0+1 • Endpoints: Immunogenicity, NPC • Results: 4Q2019 Vietnam (PI: Lay-Myint Yoshida) • Cluster randomized • PCV10: 3+0, 2+1,1+1, 0+1 • Endpoints: NPC, pneumonia • Results: 1Q2021 © Bill & Melinda Gates Foundation | 23 Gambia (PI: Grant Mackensie) • Cluster randomized • PCV13 • 3+0 vs. 1+1 (6wks +9 mo) • Endpoints: NPC • Results: 2022 Eligibility criteria for transitioning to a 1+1 • Mature PCV programme • High Coverage • Demonstrable Control of Vaccine Type Disease NOT for PCV introduction UK Experience will be crucial for the Global Effort High Quality ongoing Surveillance Essential in the UK High Risk Groups may need Direct protection In future a 0+1 could be considered
- 13. 11/23/17 13 Summary • Immunogenicity of a 1+1 schedule is equivalent to or superior to a 2+1 schedule for 9 of the 13 serotypes in PCV13 • In settings where vaccine type IPD is currently at very low levels and coverage of the booster is high, priming with a single dose of PCV13 may have little effect on rates of pneumococcal infection • The JCVIs decision to move to a 1+1 PCV schedule in the UK gives us an opportunity to evaluate the efficacy of a 1+1 schedule in a HIC • Ongoing studies in LMICs of a 1+1 schedule will help us understand whether this approach is universally acceptable. ACKNOWLEDGEMENTS • Liz Miller • Nick Andrews • Jo Southern • Mary Ramsay • Shamez Ladhani • University of Oxford: Trial Sponsorship • Matthew Snape and the OVG for recruitment to the 1+1 trial Funding NIHR Policy Research Programme [Grant number 039/0031] National Vaccine Evaluation Consortium Bill and Melinda Gates Foundation [OPP1126431]: