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Efficacy of RTS,S/AS01E malaria vaccine: 4-year follow-up (FU)

1 of 2. Efficacy of RTS,S/AS01E malaria vaccine: 4-year follow-up (FU). 2-centre, double-blind RCT 1 (Kenya, Tanzania; 2007-2008; mean FU: 7.9 mo): N=447 children aged 5-17 months, randomised to: RTS,S/AS01E vaccine: 1 dose/mo for 3 mo (im): N=223

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Efficacy of RTS,S/AS01E malaria vaccine: 4-year follow-up (FU)

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  1. 1 of 2 Efficacy of RTS,S/AS01E malaria vaccine: 4-year follow-up (FU) 2-centre, double-blind RCT1 (Kenya, Tanzania; 2007-2008; mean FU: 7.9 mo): N=447 children aged 5-17 months, randomised to: RTS,S/AS01E vaccine: 1 dose/mo for 3 mo (im): N=223 Human diploid cell rabies vaccine: 1 dose/mo for 3 mo (im): N=224 Current study: Single-centre, 4-year FU study (Kenya only) Primary endpoint: Clinical malaria (≥37.5°C + Plasmodium falciparum parasitaemia density >2,500 parasites/mm3) Olotu A et al. N Engl J Med 2013;368:1111-20

  2. 2 of 2 Efficacy of RTS,S/AS01E malaria vaccine: 4-year follow-up (FU) The 4-yr efficacy of the RTS,S/AS01E malaria vaccine was 16.8%. Efficacy declined over time and with increasing malaria exposure Olotu A et al. N Engl J Med 2013;368:1111-20

  3. 1 of 2 Intravenous (iv) immunisation with PfSPZ vaccine: safety, immunogenicity and protective efficacy against malaria PfSPZ vaccine: radiation-attenuated, non-replicating, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites Open-label, dose-escalation, phase I study (2011-2012): N=57 adults: 40 received iv PfSPZ → 36 completed all scheduled vaccinations → 32 completed controlled human malaria infection (CHMI) Seder RA et al. Science 2013;341:1359-65

  4. 2 of 2 Intravenous (iv) immunisation with PfSPZ vaccine: safety, immunogenicity and protective efficacy against malaria • Most common AEs: increased ALT and/or AST (40%), upper respiratory tract infection (25%), anaemia (15%) • Only 2 SAEs: 1 person: colon cancer (withdrawn for CHMI); 1 subject: hospitalised for anxiety and headache due to chloroquine after CHMI • PfSPZ-specific antibody and T-cell responses were dose-dependent Iv immunisation with 4-5 doses of 1.35x105 PfSPZ seems to be well tolerated and may lead to high-level protection against malaria Seder RA et al. Science 2013;341:1359-65

  5. 1 of 2 Efficacy of topical paromomycin with or without gentamicin for cutaneous Leishmaniasis Multi-centre, phase III RCT (2008-2011;Tunisia): N=375 pts with 1-5 ulcerative lesions (1-5 cm diameter) from cutaneous leishmaniasis caused by Leishmania major Treated topically 1x day for 20 days with: Cream containing 15% paromomycin − 0.5% gentamicin (WR279,396) Cream containing 15% paromomycin alone Vehicle control (same base as other 2 creams, without paromomycin or gentamicin) Primary endpoint: Final clinical cure of the index lesion, defined as: Initial clinical improvement: ≥50% size reduction of index lesion by day 42 AND Initial clinical cure: complete reepithelialisation by day 98 AND Absence of relapse by day 168 (end of study) Ben Salah A et al. N Engl J Med 2013;368:524-32

  6. 2 of 2 Efficacy of topical paromomycin with or without gentamicin for cutaneous Leishmaniasis • 1 SAEs in paromomycin-gentamicin group: acute post-streptococcal glomerulonephritis: unrelated to study treatment (Tx) Topical paromomycin, alone or plus gentamicin, seems to be a simple, efficacious and well-tolerated Tx for ulcerative L. major disease Ben Salah A et al. N Engl J Med 2013;368:524-32

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