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Overview Pediatric HIV Program & IMPAACT/ PACTG Vaccine Research Children’s National Medical Center, Washington, DC PowerPoint Presentation
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Overview Pediatric HIV Program & IMPAACT/ PACTG Vaccine Research Children’s National Medical Center, Washington, DC. Dr.Hans ML Spiegel Director Special Immunology Service/Division of Infectious Disease Children’s National Medical Center HSpiegel@cnmc.org 202-884-2980.

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Overview Pediatric HIV Program & IMPAACT/ PACTG Vaccine Research Children’s National Medical Center, Washington, DC


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Overview Pediatric HIV Program & IMPAACT/ PACTG Vaccine ResearchChildren’s National Medical Center,Washington, DC

Dr.Hans ML Spiegel

Director Special Immunology Service/Division of Infectious Disease

Children’s National Medical Center

HSpiegel@cnmc.org

202-884-2980

special immunology service sis
Special Immunology Service (SIS)
  • Comprehensive Infectious Disease Service and Ambulatory Service based program for infants and children with HIV infection and services for HIV exposed infants and children at-risk for HIV infection.
  • The SIS Clinic provides multi-disciplinary care for 170 HIV positive infants and children (96% African American, 4% hispanic, caucasian and other ethnicity)
  • Further annual evaluation of more than 150 infants with perinatal HIV exposure.
hiv infected youth in care burgess clinic washington d c

HIV Infected Youth in CareBurgess Clinic, Washington, D.C.

149 patients with HIV infection

80 (54%) female; 69(46%) male

81 (54%) acquired infection perinatally

Perinatally infected teens are now largest source of new patients

72 (48%) now defined as having AIDS

hiv resistance testing by genotype or phenotype all age groups 0 24 years
HIV Resistance Testing by Genotype or Phenotype All Age Groups (0-24 Years)
  • 162 of 301 active Patients (53.8%) had HIV Resistance testing by Phenotype or virtual Phenotype
  • 150 of 301 active Patients (49.8%) had HIV resistance testing by Genotype
cdc pediatric hiv classification clinical categories 1994 revised
CDC Pediatric HIV Classification/ Clinical Categories (1994 Revised)

CATEGORY N:Not Symptomatic

Children with no signs/symptoms OR

One sign/symptom in Category A

CATEGORY A:Mildly Symptomatic

Two or more of the following:

Lymphadenopathy; Hepatomegaly; Splenomegaly; Dermatitis; Parotitis; Recurrent/persistent URIs/sinusitis/otitis

CATEGORY B:Moderately Symptomatic

HIV-related signs/symptoms not in Category A/C

CATEGORY C:Severely Symptomatic

AIDS-defining disease (except LIP, which is CDC-B)

immune based therapy transdermal dna dendritic cell vaccine for children with hiv infection
Immune Based Therapy Transdermal DNA Dendritic Cell Vaccine For Children with HIV Infection
  • Dr. Julianna Lisziewicz et al. (Genetic Immunity ) have developed a novel shuttle system (DermaVirTM ) for the administration of DNA vaccines.
  • DNA vaccine in solution with polyethylenimine (PEI) mannose (PEIm) is applied to the surface of the skin, to target the mannose receptor of Langerhans cells (LC).
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STI-HAART does not Induce Immune Control during Treatment Interruptions in Macaques with AIDS

Lisziewicz J et al.

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IMPAACT P1049

A PHASE I/II STUDY OF THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF A TOPICAL THERAPEUTIC DNA DENDRITIC CELL VACCINE (DERMAVIR PATCH) IN CHILDREN, ADOLESCENTS AND YOUNG ADULTS WITH HIV-1 INFECTION ON HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)

Study Chair: Dr. Hans Spiegel

pediatric dermavir vaccine trial
Pediatric Dermavir Vaccine Trial

DESIGN: Phase I/II, age stratified, dose finding, open label trial

SAMPLE SIZE:32 evaluable subjects

  • POPULATION:HIV-1 infected children ≥6 years to <13 years and Adolescents/young adults ≥13 years to <24 years and
  • CDC clinical category N, A, B, C (excluding subjects with acute CDC-C complications) and
  • Documented CD4(+) T-cell count of ≥20% and ≥350 cells/mm3
  • HIV-1 RNA viral load <400 copies/mL for at least 12 months
  • Stable HAART regimen (drugs of at least 2 different classes) without interruptions for at least 6 months prior to study entry. Treatment regimen changes for dosing convenience and in response to toxicity are permitted.
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STRATIFICATIONGroups will be sequentially enrolled. The number of subjects aged 21-<24, will be limited to no more than 25% of the group that will be stratified as adolescents/young adults ≥13 years to <24 years.

DermaVir, a DNA vaccine for topical administration will be administered in the following doses (vaccine standard unit per patch: 0.1 mg DNA = 0.8 mL of DermaVir vaccine; patch size is 80 cm2):

Group A(low dose – 0.1 mg), 1 patch per vaccination day, on Day 0, 42, and 84 (adolescents/young adults first)

Group B(medium dose – 0.4 mg), 4 patches per vaccination day, on Day 0, 42, and 84

Group C(high dose – 0.4 mg), 4 patches per vaccination day, on Day 0, 7, 42, 49, 84, and 91