OVERVIEW ON HUMAN VACCINES
AGAINST LEPTOSPIROSIS
Jérôme DENIS, Ph.D.
Associate Director of development
18/11/2013
IMAXIO S...
VACCINES :
For who ? For what (in which
epidemiological context) ?
Which Efficacy/Safety ?
FOR WHO / FOR WHAT ?
CASE 1

Endemic disease / Strain involved
well identified

High public health priority

Development o...
FOR WHO / FOR WHAT ?
CASE 2
Disease on specific overexposed
workers / Strain involved well
identified

Workers health prio...
GENERAL CONSIDERATIONS

 Same technical approach (« Old fashion » - no recombinant
technology) : inactivated bacteria
 M...
FOR WHO / FOR WHAT ?
CASE 1 / VaxSpiral ®, Cuba



Vaccine : 3 strains + adjuvant
Control
group
N
Number of
leptospirosis...
FOR WHO / FOR WHAT ?
CASE 1 / VaxSpiral ®, Cuba

%
Malaise

32

Headache

15-20 %

Fever

10 %

Erythema/Oedema/induration...
FOR WHO / FOR WHAT ?
CASE 2 / SPIROLEPT ®, France

Launched in 1979 in France

1 ml/syringe
Inactivated bacteria Serovar I...
FOR WHO / FOR WHAT ?
CASE 2 / SPIROLEPT ®, France


No leptospirosis cases in a followed sewers population (between 600 e...
FOR WHO / FOR WHAT ?
CASE 2 / SPIROLEPT ®, France
Study

Number of
vaccinees
/vaccinations

Local reactions

Systemic
reac...
FOR WHO / FOR WHAT ?
CASE 2 / SPIROLEPT ®, France

SINCE 1979

More than 800 000 distributed doses

From 1 to 16 injection...
CONCLUSION AND DISCUSSION

• HUMAN VACCINES AGAINST LEPTO HAS BEEN WIDELY USED
IN DIFFERENT COUNTRIES, DIFFERENT EPIDEMIOL...
CONCLUSION AND DISCUSSION

Progress in disease
knowledge

Progress in lepto research
(microbiology, immunology)

Epidemiol...
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OVERVIEW ON HUMAN VACCINES AGAINST LEPTOSPIROSIS

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GRF 2nd One Health Summit 2013: Presentation by Jérôme Denis, IMAXIO SA

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OVERVIEW ON HUMAN VACCINES AGAINST LEPTOSPIROSIS

  1. 1. OVERVIEW ON HUMAN VACCINES AGAINST LEPTOSPIROSIS Jérôme DENIS, Ph.D. Associate Director of development 18/11/2013 IMAXIO SA
  2. 2. VACCINES : For who ? For what (in which epidemiological context) ? Which Efficacy/Safety ?
  3. 3. FOR WHO / FOR WHAT ? CASE 1 Endemic disease / Strain involved well identified High public health priority Development of human vaccines by national institute Mass vaccination in specific areas (general population – child/adults)
  4. 4. FOR WHO / FOR WHAT ? CASE 2 Disease on specific overexposed workers / Strain involved well identified Workers health priority Development of human vaccines by national institute or private company Vaccination on specific workers populations (adults) Target workers populations : farmers, sewer workers
  5. 5. GENERAL CONSIDERATIONS  Same technical approach (« Old fashion » - no recombinant technology) : inactivated bacteria  Most of these vaccines : were not developped as pharmaceutical products with a market authorization dossier (Australie, Israel) (exception : France, Japon) Are not available anymore (Japan) With an unknown status (Russia, China)  None of them protect against all circulating strains but focused on most important one
  6. 6. FOR WHO / FOR WHAT ? CASE 1 / VaxSpiral ®, Cuba  Vaccine : 3 strains + adjuvant Control group N Number of leptospirosis cases  Vaccine group VACCINE EFFICACY App. 50 000 people App. 50 000 people 56 12 78% Global impact :  1996—2001 : 1,7 millions vaccinated people in Cuba  Incidence rate : divided by 5 from 1994 to 2001 (Martinez et al., 2004) (Gonzales et al., 2004)
  7. 7. FOR WHO / FOR WHAT ? CASE 1 / VaxSpiral ®, Cuba % Malaise 32 Headache 15-20 % Fever 10 % Erythema/Oedema/induration 3-5 % Pain 10-15 % SAFETY : Difficult to conclude (statistics on 950 people only / quite high levels / no long term datas) but no severe adverse effects reported during the clinical trial (Martinez et al., 2004) (Gonzales et al., 2004)
  8. 8. FOR WHO / FOR WHAT ? CASE 2 / SPIROLEPT ®, France Launched in 1979 in France 1 ml/syringe Inactivated bacteria Serovar Icterohaemorrhagiae strain Verdun Subcutaneus injection Conservative : Thiomersal No Adjuvant Vaccination protocol : D0 / D15/ Month 4-6 / Every 2 years Target populations : Exposed (adult) populations (sewage/pisciculture/agriculture/building workers/fireman)
  9. 9. FOR WHO / FOR WHAT ? CASE 2 / SPIROLEPT ®, France  No leptospirosis cases in a followed sewers population (between 600 et 800 people) : from 1.3 case/year (1951-1979) to 0 case/year (1981-1988) (Baranton, 1990).  No leptospirosis cases in the vaccinated population reported to our laboratory or the french regulatory agency (ANSM)
  10. 10. FOR WHO / FOR WHAT ? CASE 2 / SPIROLEPT ®, France Study Number of vaccinees /vaccinations Local reactions Systemic reactions CONCLUSION (from the authors) Mailloux and al. 1982 N=454/1157 injections 7 (not described) 3 cases (nausea) « good tolerance except local reactions during the 4 th boost » Benbrick and al. 2001 N=50 Pouliquen et Catalina, 2000 N=7375 -12531 0.33-0.56% 0.25-0.42% « its has a good safety profile in routine use » Laurichesse and al., 2007 N=60 (SC/IM) 40-60% sc 13-20% im 0-4% sc 0-13% im “The results of this prospective clinical trial confirm the good safety profile of the anti-leptospiral Vaccine » 3/50 skin erythema and induration « good tolerance […] but necessity to have datas after the 1st boost » CONSISTENT with our pharmacovigilance database
  11. 11. FOR WHO / FOR WHAT ? CASE 2 / SPIROLEPT ®, France SINCE 1979 More than 800 000 distributed doses From 1 to 16 injections / person Good efficacy profile in target populations Good safety profile
  12. 12. CONCLUSION AND DISCUSSION • HUMAN VACCINES AGAINST LEPTO HAS BEEN WIDELY USED IN DIFFERENT COUNTRIES, DIFFERENT EPIDEMIOLOGICAL CONTEXTS • THEIR EFFICACY AND SAFETY PROFILE ARE GOOD • THEIR CONTRIBUTION IN LEPTO PREVENTION IN TARGET POPULATION WAS SCHOWN TO BE SIGNIFICATIVE PROPOSITION FOR GLEAN (PREVENTION PILAR) THE POSSIBLE CONTRIBUTION OF A VACCINE AS SPIROLEPT COULD BE TO PROTECT PEOPLE : OVEREXPOSED DURING OUTBREAKS (RESCUE PEOPLE, FIREMAN) OVEREXPOSED BY THEIR JOB (SEWERS WORKERS) BASED ON THE FRENCH EXPERIENCE
  13. 13. CONCLUSION AND DISCUSSION Progress in disease knowledge Progress in lepto research (microbiology, immunology) Epidemiology/ diagnostic tools Collaboration with veterinary industry « Universal » vaccines development Public health authorities support

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