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					    BCG ADVERSE EVENTS IN
   PERINATALLY HIV-INFECTED
          CHILDREN

Maria Rosa Agosti1, Mariel Karina Garcia1, Juan Carlos
Morales1, Valeria Uriarte1, Ana Aguirre2, Silvia González
                         Ayala1

    1 Department of Infectious Diseases, Sor María Ludovica
      Children´s Hospital, La Plata, Argentina

    2 Reference Laboratory for Mycobacteriaceae, San Juan de Dios
      Hospital, La Plata, Argentina
               Background
 Bacillus     Calmette-Guérin     (BCG),     an
attenuated strain of Mycobacterium bovis, is
used as immunoprophylaxis against severe
tuberculosis disease around the world

 BCG is included in Argentinean National
Immunization    Calendar    :    newborns    and
premature > 2000 g during the first week of life
          Objective


To     report        the      BCG
complications   in      perinatally
HIV-infected children
        Material and Methods
 Retrospective study (period 1987-2007) of
localized and disseminated adverse events in
BCG vaccinated perinatally-HIV infected children

 Blood, gastric fluids, bone marrow and lymph
nodes samples were cultured

 Biochemical identification and susceptibility
tests were performed at a National Reference
Laboratory
       Material and Methods
Definitions

 Localized adverse event: abscess at
the site of vaccination or ipsilateral
adenitis (supraclavicular or axillar)

 Disseminated Infection: others sites
involved     (multiple lymph   nodes,
pneumonitis, caseum areas in spleen,
liver, and bone)
                        Results

487 BCG-vaccinated             31 Adverse
HIV infected children         Events (6,4%)
BCG Disseminated Infection: 13%

 Patients    Viral Load   CD4 T-cell   Fatality
  (N)       (Copies/mL)    count (%)   rate (%)

    4         > 500000        <8          75




Diagnosis of HIV Infection in all of them,
because of BCG disseminated infection
 Local Adverse Event: 87%

Patients         Local Adverse Events
   N
  26       Axillar     or     supraclavicular
           adenitis ipsilateral to vaccination
           site

   1       Chronic suppurative axillary
           adenitis (immune reconstitution
           syndrome after beginning of
           HAART)
                               Discussion
 BCG ADVERSE EVENT                         LOCALIZED               DISSEMINATED

 INCIDENCE
 GENERAL POPULATION                              0,04%                  0,0001 %

 ARGENTINEAN AUTHORS                             7,8%                   1,3 - 1,8 %
 PREVIOUS REPORT IN
 HIV INFECTED CHILDREN
 (Fallo et al *)

 INCIDENCE
 PRESENT STUDY                                   5,3%                     0,8%


* 3rd Conference on HIV Pathogenesis and Treatment. IAS 2005. Río de Janeiro
              Conclusions
•A several hundreds-fold increased of
complications was observed in our
perinatally    HIV-infected        children
population, in comparison with the
incidence of localized and diseminated
BCG     adverse   events      in   general
population.
             Conclusions

•Efficacy of BCG vaccination in children
 living with HIV is unknown.

•Risks and efficacy of BCG vaccination in
HIV-infected children must be assessed by
controlled population-based studies