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1 Immunisation update Brian Eley Paediatric Infectious Diseases Unit Red Cross War Memorial Children s Hospital Department of Paediatrics and Child Health University of Cape Town

2 Immunisation schedules, 2012 Age EPI Private (1) Private (2) Age Private (3) At birth OPV (0) BCG OPV (0) BCG OPV (0) BCG At birth OPV (0) BCG 6 weeks OPV (1) PCV(1) HBV (1) DTaP-IPV/Hib (1) RV (1) PCV(1) HBV (1) DTaP-IPV/Hib (1) RV (1) PCV(1) DTaP-IPV/Hib /HBV (1) RV (1) 2 months PCV(1) DTaP-IPV/Hib /HBV (1) RV (1) 10 weeks HBV (2) DTaP-IPV/Hib (2) PVC (2) HBV (2) DTaP-IPV/Hib (2) PVC (2) DTaP-IPV/Hib /HBV (2) 3 or 4 months PVC (2) DTaP-IPV/Hib /HBV (2) RV (2) 14 weeks RV (2) PCV(2) 9 months PCV (3) Measles (1) months 18 months DTaP-IPV/Hib (4) Measles (2) RV (2) PCV(3) HBV (3) HBV (3) DTaP-IPV/Hib (3) DTaP-IPV/Hib (3) Measles Varicella (1) PCV (4) MMR (1) Hep A (repeat 6 months later) DTaP-IPV/Hib (4) 5-6 years Varricella (2) MMR (2) TdaP-IPV or DTaP RV (2) PCV(3) DTaP-IPV/Hib /HBV (3) Measles Varicella (1) PCV (4) MMR (1) Hep A (repeat 6 months later) DTaP-IPV/Hib or DTaP-IPV/Hib/HBV (4) Varricella (2) MMR (2) 4 or 6 months PCV(3) DTaP-IPV/Hib /HBV (3) 9 months Measles Varicella (1) months PCV (4) MMR (1) Hep A (repeat 6 months later) 18 months DTaP-IPV/Hib or DTaP- IPV/Hib/HBV (4) 5-6 years Varricella (2) MMR (2) 6 years Td (1) TdaP-IPV or DTaP 6 years TdaP-IPV or DTaP 9 or 10 years HPV quad from 9 yrs HPV bival from 10 yrs HPV quad from 9 yrs HPV bival from 10 yrs 9 or 10 years HPV quad from 9 yrs HPV bival from 10 yrs 12 years Td (2) TdaP-IPV TdaP-IPV 12 years TdaP-IPV

3 BCG Catch-up immunization within EPI Catch-up BCG vaccination may be administered up to the age of 12 months. Before catch-up BCG is administered the HIV status of the child should be established. CHILDREN WITH CONFIRMED HIV INFECTION SHOULD NOT RECEIVE BCG IMMUNISATION Rotavirus PCV DTaP- IPV/Hib Catch-up Rotavirus vaccination may be considered up to the age of 6 months with the following provisos: Do not give the 1 st dose if the child is above 14 weeks of age Do not give the 2 nd dose if the child is above 24 weeks of age Children < 1 year: Administer 1 st dose as soon as possible Administer 2 nd dose at least 4 weeks after the first dose Administer 3 rd dose at 9 months of age or older, at least 8 weeks after the 2 nd dose Give all missed doses (maximum of 4 doses) at least 4 weeks apart if the child is < 24 months old; DTaP-IPV//Hib SHOULD NOT BE ADMINISTERED BEYOND THE AGE OF 24 MONTHS Children > 24 months who missed DTaP-IPV//Hib and other vaccines: administer OPV, Measles, Hepatitis B vaccine and tetanus toxoid (TT) at the same time point Currently, a suitable DTP-Hib combination for children > 24 months of age is not available in South Africa NDoH. New EPI vaccine guidelines, November 2009

4 Catch-up immunization within EPI (2) HBV Administer all missed doses (maximum of 3 doses) in children less than 5 years of age Measles Td Children <17 months who missed the 9 month measles dose should receive the 1 st dose as soon as possible and the 2 nd dose at 18 months of age Children 17 months of age who missed the 1 st measles vaccine dose immediately and their 2 nd dose 4 weeks later NB: LIVE ATTENUATED MEASLES VACCINE IS CONTRAINDICATED IN CHILDREN WITH ADVANCED HIV INFECTION/AIDS Administer outstanding doses of Td from 6 years of age. NDoH. New EPI vaccine guidelines, November 2009

5 BCG immunisation WHO position (2007) 1 BCG should not be given to children who are known to be HIVinfected Adverse events in HIV infection Increased risk for A/Es Disseminated BCG infection: 992 per IRIS events: 6% (95% CI: %) 3 Role of early HAART 4 Position of the NDoH Conditions for implementing selectively delayed BCG immunisation are currently not optimal Declining HIV vertical transmission rate 1. WHO, Wkly Epidemiol Rec 2007;82: Hesseling A et al, WHO Bull 2009 ; 87: Nuttall J et al, Int J Infect Dis 2008;12:e99 4. Rabie H, et al. Int J Tuberc Lung Dis 2011;15: Hesseling A et al, S Afr Med J 2009;99:88

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7 OPV / IPV and cvdpvs Risk of OPV: 1 case of vaccine-associated polio every 2.5 million doses Adequacy of mucosal immunity with IPV (Salk) vaccine S. Africa EPI schedule includes OPV and IPV to harness benefits of both vaccines AFP surveillance WHO, CDC, UNICEF:

8 Rotavirus vaccine Routine vaccination at 6 and 14 weeks commenced in August 2009, based on results of a S Africa / Malawi trial evaluating vaccination at 10 & 14 weeks vs 6, 10 & 14 weeks vs placebo Placebo-controlled trial (efficacy until 1 year of age) 1 - Efficacy against severe RVGE in Malawi than S. Africa was 49.4% & 76.9% - Severe GE prevented in Malawi & S Africa: 6.7 & 4.2 episodes/100 infant-yrs - Efficacy against severe RVGE of 2 or 3 RV doses was 58.7% & 63.7% RV in HIV-infected children: Safe & immunogenic 2 Sentinel surveillance at 5 hospitals 3 - Total diarrhoea cases: 887 (2009), 617 (2010), 513 (2011): 42% decline -Rotavirus cases: decreased from 426 (2009) to 150 (2011); 65% decrease Efficacy of 2 or 3 doses during two consecutive rotavirus seasons 1,4 -Efficacy against severe RVGE: 77% (56-88%) during 1 st year of life and 59% (1-83%) over two successive RV seasons - Efficacy against severe RVGE of 2 or 3 RV doses over 2 seasons was 32% & 85%, respectively [Note: study not powered for this comparison] Rotavirus vaccine contraindicated in children with SCID 5 1 Madhi SA, et al. N Engl J Med 2010;362: Steele AD, et al. Pediatr Infect Dis J 2011;30: Tshangela A, et al. Com Dis Surv Bull 2012;10: Madhi SA, et al. Vaccine 2012;30S:A44-A51 5 Patel NC, et al. N Engl J Med 2010;263:314-9

9 Efficacy of pneumococcal conjugate vaccine against IPD Study Vaccine serotypes All serotypes South Africa 1 HIV-infected 65% (CI: 24-86) 53% (CI: 21-73) HIV-uninfected 83% (CI: 39-97) 42% (CI: ) South Africa# 2 HIV-infected 39% (CI: -8-65) 46% (CI: 19-64) HIV-uninifected 78% (CI: 34-93) 35% (CI: ) Gambia 3 92% (CI: 44-99) 45% (CI: 19-63) African trials: 9-valent vaccine (serotypes: 1, 4, 5, 9V, 14, 19F, 23F, 6B, 18C) Follow up until age 2.5 years #Follow-up until age 6 years 1. Klugman K, et al. N Engl J Med 2003;349: Madhi SA, et al. Vaccine 2007;25: Cutts FT, et al. Lancet 2005;365:1139

10 Pneumococal conjugate vaccine 93 immunologically distinct capsular polysaccharides within 45 serogroups have been characterised Routine immunization with the 7-valent vaccine (serotypes: 4, 6B, 9V, 14, 18C, 19F, 23F) commenced from 1 April 2009 In April 2012 this vaccine was replaced with the 13-valent vaccine (serotypes: 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 5, 7F, 19A, 3, 6A) National surveillance data suggested that the 7-valent vaccine could prevent ±70% of IPD Case-control study: Effectiveness of 2 doses against vaccine serotypes in 133 HIV uninfected cases & 535 controls, and 83 HIVinfected cases & 254 controls - 68% (CI: 4, 89) in HIV uninfected and -18% (CI: -303, 65) in HIVinfected children

11 Acellular pertussis Whole cell DTP vaccine: 37-92% effective Multi-component ( 3) ap vaccine: 84-85% for preventing typical whooping cough & 71-78%for preventing mild pertussis 1-2 component ap vaccine: 59-75% for preventing typical whooping cough & 13-54% for preventing mild pertussis Adolescent & adult booster doses of dtap to counteract waning immunity and reduce the adolescent/adult reservoir Zhang L, et al. Cochrane Database of Systematic reviews : CD Committee on Infectious Diseases. Pediatr 2011;128:809

12 Measles Epidemic, (n=18,290) RCWMCH: 1861 cases, of which 552 (30%) required admission, resulting in 18 deaths (3% of all the admissions); HIV-infection, aor: 7.55, % female gender, aor: 3.86, were associated with death NICD, 7 December 2010 Le Roux D, et al. S Afr J Med 2012;102:760-4

13 Factors contributing to epidemic Vaccine efficacy & coverage After 1 dose at 9 mo: 80-85% seroconversion 1 After 1 dose at mo: 95-98% seroconversion 1 After 2 doses 4 wks apart: seroconversion approaches 99% epidemic, Cape Town: effectiveness: 79% [CI: 55-90%] 2 Coverage in Western Cape (2004): MV 1 : 92.7% [CI: 91-94] & MV 2 : 60% [CI: 56-64] 3 HSRC survey (2008) 4 : Vaccine Confirmation method Sample size Percentage coverage [95% CI] Measles Card [ ] Measles Recall/history [ ] Measles Card & history [ ] 1 WHO. Wkly Epidemiol Rec 2009;84: Coetzee N, et al. S Afr Med J 1994;84: Corrigall J, et al. S Afr Med J 2008;98: HSRC. SA National HIV Prevalence, Incidence, Behaviour & Communication Survey 2008

14 Factors contributing to epidemic (2) Kinetics of decline of maternal antibodies Vaccine-induced maternal antibodies decay faster than disease induced antibodies French study (2008) 1 : GMT decays rapidly from 1,740 miu/ml in infants aged 0-1 month to 223 miu/ml for infants aged 5-6 months 90% are not protected by 6 months Antwerp, Belgium (2010) 2 : Vaccinated women lower GMT: 779 miu/ml vs 2687 miu/ml Median time to loss of immunity: 0.97 months for infants of vaccinated women and 3.78 months for infants of naturally immune women 1 Gagneur A, et al. Clin Vaccine Immunol 2008;15: Leuridan E, et al. Br Med J 2010;340:

15 Factors contributing to epidemic (3) Effect of HIV epidemic Negative maternal serum measles IgG titre 1 : HIV- mothers: 8.9% (9/101) HIV+ mothers: 11.1% (21/1900 Negative cord serum measles IgG titre 1 : HIV unexposed: 11.9% (12/101) HIV exposed: 25.3% (48/190) Loss of maternal antibody decay by 6 months of age %of HIV-infected infants 83.3%of HIV-exposed but uninfected children 57.7%of HIV-negative infants Vaccine effectiveness in HIV-infected children: 63% ( epidemic, JHB) 3 1 Cutland C, Vaccinology 2010 Conference, October R Scott, et al. Clin Infect Dis 2007;45: McMorrow LC, et al. S Afr Med J 2009;99:

16 Influenza immunisation 1. Persons (adults or children) who are at high risk for influenza & its complications because of underlying medical conditions and who are receiving regular medical care for conditions such as chronic pulmonary and cardiac diseases, chronic renal diseases, diabetes mellitus and similar metabolic disorders, individuals who are immunosuppressed (including HIVinfected person with CD4 counts above 100 cells/µl), individuals who are morbidly obese (BMI 40). 2. Pregnant women irrespective of stage of pregnancy. 3. Residents of old-age homes, chronic care and rehabilitation institutions. 4. Children on long-term aspirin therapy. 5. Medical and nursing staff in contact with high-risk cases. 6. Adults and children who are family contacts of high-risk cases. 7. All persons over the age of 65 years. 8. Any persons wishing to protect themselves from the risk of contracting influenza, especially in industrial settings, where large-scale absenteeism could cause significant economic losses. Schoub B. S Afr Med J 2012;102;73

17 Future considerations for EPI Review of catch-up guidelines is needed Booster acellular pertussis immunisation in older children / adolescents 1 Human Papilloma Virus (HPV) immunisation 2 Immunisation of HIV-infected children 3 1. Wilson DR. J Pediatr Health Care 2006;20(4): Denny L. Reprod Health Matters 2008;16(32): Eley B. Drugs 2008;68(11):1473

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