Prevention of viral infections. Prof. Per Ljungman Department of Hematology Karolinska University Hospital Stockholm, Sweden

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1 Prevention of viral infections Prof. Per Ljungman Department of Hematology Karolinska University Hospital Stockholm, Sweden

2 Pneumonia Encephalitis Hepatitis GI disease CMV CMV CMV CMV Influenza Adenovirus EBV HSV Adenovirus HSV Adenovirus Adenovirus RSV VZV HBV EBV Parainfluenza HHV-6 HCV VZV Metapneumovirus Measles VZV Rotaviruses Measles JCV HAV Noroviruses VZV EBV HSV EBV Rabies HHV-6 (?) New respiratory viruses Some viruses important for differential diagnoses in SCT patients West Nile virus

3 Some principles Protection against viral infection is different from protection from viral disease! Antibodies mainly protect against primary infection The innate and adaptive cell-mediated immunity mainly protect against severe disease (T-cells, NK-cells)

4 How can we manage viral infections? Prevent a patient being infected Prevent an infected patient to develop disease (Treat an established viral disease)

5 Prevention of infection Select the right donor Safe blood products Infection control Antiviral prophylaxis Vaccination

6 Select the right donor! Viral infections that might be transmitted through the donor: CMV HIV EBV HBV HHV-6 HCV West Nile virus HTLV-1/2 Other viruses that give viremia Influenza (?), adeno (?), parvo B19 (?)

7 Prevention of disease Select the right donor Early diagnosis Monitoring of patients Antiviral prophylaxis Vaccination

8 Select the right donor! Viral immunity might also be transferred from the donor HBV CMV EBV Adeno

9 Timing of management options Treatment of established disease Viral replication Prophylaxis Pre-emptive therapy viral disease Diagnosis of viral infection Time Grafting Alain, ILTS 2008

10 Examples CMV Varicella Respiratory viruses Influenza

11 CMV The troll of transplantation

12 Select the correct donor CMV negative donor to CMV negative patient All agree CMV positive donor to CMV positive patient Controversial

13 Probability of CMV disease, 2, 1 Rec pos Don pos / rec neg Don neg / rec neg Days after SCT

14 Effect of a CMV seropositive donor in a CMV seronegative recipient Nichols et al JID 2002

15 Donor influence in CMV pos patients Negative donors: Higher transplant related mortality 39% CMV + donor p = % CMV donor More repeated CMV reactivations More courses of antiviral therapy More CMV disease

16 Strategies for prevention of CMV disease Treat all patients prophylaxis at risk for CMV Treat some patients with asymptomatic CMV infection preemptive therapy Treat few patients symptomatic CMV CMV disease

17 Monitoring strategies M Boeckh and P Ljungman; Blood 2009

18 Repeated CMV reactivations Common in high risk patients Frequently poor activity/tolerability of existing antiviral drugs Associated with poor T-cell control of CMV How shall we manage these patients?

19 New drugs/options Maribavir AiCuris (AIC247) CMX001 - finished phase III - in phase II - in phase II CMV specific T-cell infusions CMV vaccines - phase I/II - finished phase II

20 Primary endpoint: Confirmed CMV disease, ITT 50 Patients with event (%) Maribavir Placebo Study day Marty et al, Lancet ID 2011

21 CMV infection or disease: Infection assessed by pp65vs PCR, ITT pp65 Ag PCR Patients with event (%) Maribavir Placebo Patients with event (%) Maribavir Placebo Study day Study day

22 Will there be a useful CMV vaccine? A couple of candidates in trials gb vaccine DNA-vaccines

23 Vical CMV DNA vaccine - phase II in HSCT recipients Single-vial formulation Two plasmids: gb + pp65 (5 mg total DNA in 1-mL dose) Completed Phase 1 & Phase 2 in HCT Successfully dose-escalated up to 5 mg DNA dose Induces T-cell and antibody responses Safe and well-tolerated ~50% efficacy in immunosuppressed patients following HCT

24 Immune responses SFU/106 PBMC Median pp65 IFN-g ELISPOT Response Days TransVax Placebo

25 Freedom from viremia

26 VZV Both primary and reactivated infections can cause severe disease Primary infection (usually children) is a serious complication VZV disease without skin lesions can occur (GI, liver, CNS) Severe abdominal pains Increasing liver function tests Neurological symptoms VZV visceral disease has high mortality

27 Long term ACV/VCV prophylaxis; probability of VZV disease Group 1: 30 days Group 2: 1 year Group 3: > 1 year Erard et al Blood 2007

28 Respiratory viruses Old RSV Parainfluenza Influenza Rhino Corona New Metapneumo Boca Papova Avian influenza Mimi

29 Respiratory virus infections Frequency of infections associated to the epidemiological situation in the community Major risk for nosocomial transmission within units No controlled studies Varying treatment schedules and combinations

30 Impact of resp.viral infections From J Englund, E Whimbey In Transplant inrections Bowden, Ljungman, Snydman 2010

31 RSV infection Severe immunodef. Moderate immunodef UTI Treatment 9 5 Progression 2 0 Death 1 0 LTI 10 2 Treatment 10 2 Death 5 0 Khanna et al CID 2008

32 Nosocomial spread of RSV From April 2001 to October 2002, RSV was identified in 42 symptomatic HSCT recipients. Seven RSV strains from 2001 and 12 RSV strains from 2002 were sequenced. Of the 7 strains analyzed in 2001, 2 were group B and 5 group A. 3/7 strains were identical and were from recipients receiving outpatient care. Of the 12 strains analyzed in 2002, 3 were group A and 9 group B. 7/9 were identical and from recipients receiving outpatient care. Machado et al BBMT 2008

33 Parainfluenza viruses Can cause infections any time of the year Can be a major nosocomial problem Asymptomatic infections can contribute to nosocomial spread (Peck et al Blood 2007) Can result in LRT infection and respiratory failure (mainly para 3) Corticosteroid dose risk factor for LRT infection Data suggest poor effect of ribavirin (Nichols et al Blood 2001)

34 Influenza

35 Previous data on influenza in transplant recipients GETH Study Neuramidase inhibitors LRT Death Whimbey 1994 HSCT No 75% 17% Ljungman 2001 HSCT No 15% Nicholls 2004 HSCT Yes No 0% 28% Machado 2004 HSCT Yes 5.1% 0% Kumar 2010 SOT Yes 31.7% 4% Tramontana 2010 HSCT+HM Yes 22% 0% 9%

36 Outcome of H1N1 infection EBMT/GETH survey (n=286) Symptom No of patients % LRT disease Mechanical ventilation Neurological symptoms Death from H1N Death from other causes Time to H1N1 from HSCT in fatal cases: Median 1.1 years (0 15.3)

37 Options for prevention GETH Infection control Antiviral prophylaxis Vaccination

38 Infection control measures Handwashing Avoidance of infected persons Vaccination against influenza Patients Family Staff

39 Recommendations Regarding Community Respiratory Virus Infections HCT centers should institute appropriate infection control measures for preventing transmission of CRV among hospitalized HCT recipients and candidates undergoing conditioning therapy (AIII). HCT recipients or candidates with URI or LRI symptoms due to suspected CRV infection should be placed on contact plus droplet precautions until a pathogen has been identified.

40 Pathogen-specific CRV isolation precautions include: Contact precautions for RSV and parainfluenza Droplet precautions for influenza Droplet plus contact precautions for adenovirus; Personal protective equipment (e.g., gown, gloves, surgical mask, and eye protection) should be donned prior to entering a patient s room Personal protective equipment is always changed between patients (AIII).

41

42 Immune response to vaccination Pre vacc After 1:st vacc After 2:d vacc < 1:10 (seroneg) 48.7% 32.5% 25.6% 1:10 1: % 20.8% 25.6% 1: % 44.2% 48.8% Seroconversion 32.5% 41.9% Seroconv. of seroneg pat. 16.7% 41.7%

43 Haematologica 2011; 96:

44 Immune responses Only time after HSCT had a significant effect on seroconversion

45 Clinical efficacy of vaccination SCT recipients Risk factors for influenza during an epidemic in Brazil 177 patients were analyzed Vaccination recommended at 6 months Compliance 44% Among vaccinated patients, the protection rate was 80% Machado et al 2005

46 Thank you for your attention!

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