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HPTN 027
A Phase I Study to Evaluate
the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1
Infected Women in Uganda
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What is HPTN 027?
The majority of HIV-1 infected
women reside in the developing world where breastfeeding is practiced nearly
universally, often for 1 to 2 years after delivery.
The impact of perinatal antiretroviral therapies may be diminished in
breastfeeding populations with continual exposure of the infant to HIV-1 through
breast milk. The high cost and
difficult logistics of continuing antiretroviral therapy in the infant or mother
for the duration of breast-feeding is likely to prohibit widespread and routine
use in resource poor countries. There
is, therefore, an urgent need for alternative interventions that provide
protection from HIV infection to infants during breastfeeding.
Trials
of preventive and therapeutic HIV-1 vaccines in pediatric populations are
underway. Many uncertainties remain about the most appropriate
vaccines, the most effective timing of the immunizations, the ability of the
neonatal immune system to respond to active HIV-1 immunization, the duration of
any present response, and the efficacy of HIV-1 vaccination in preventing
vertical transmission. The goal of
a vaccine intervention for the protection of infants from HIV-1 infection
perinatally and through breast milk must be to produce the broadest and most
effective immune response as quickly as possible without jeopardizing vaccine
immunogenicity with an administration schedule that is too accelerated.
The
principal aim of HPTN 027 is to determine the safety and immunogenicity of ALVAC-HIV
vCP1521 in infants born to HIV-1 infected women in Uganda.
The general clinical approach is to identify a safe, simple, cost
efficient intervention to prevent mother to infant HIV transmission while
allowing for breastfeeding.
Chemoprophylaxis of the mother and infant during the antepartum and/or
peripartum period with antiretroviral therapy such as AZT or Nevirapine combined
with immunoprophylaxis during the breastfeeding period with a recombinant ALVAC
HIV-1 vaccine could be a safe, effective, feasible, and relatively inexpensive
intervention for prevention of vertical HIV transmission while affording the
well known benefits of breastfeeding.
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Protocol Status:
Closed to Accrual
Study Summary
Study Purpose: To evaluate the safety and immunogenicity of ALVAC-HIV vCP1521 in infants born to HIV-1 infected women in Uganda
Study Design: The study will be a Phase I, randomized, double blind, placebo-controlled trial.
Study Population: Infants born to HIV-1 infected Ugandan women with CD4 counts > 500 cells/uL attending the antenatal clinics at Mulago Hospital in Kampala, Uganda
Study Size: 50 fully evaluable infants (40 immunogen, 10 control)
Study Duration: Enrollment: 6 months; Follow-up: 24 months
Treatment Regimen: Eligible infants will be randomized after birth to one of two study arms in a ratio of 4:1. Infants in Arm A will be given the active study vaccine (ALVAC-HIV vCP1521), and infants in Arm B will be given a placebo vaccine (sodium chloride injection USP, 0.9%). For infants in both study arms, the vaccine dose will be given on or before Day 3 after birth, and at 4, 8 and 12 weeks postpartum.
Primary Objectives: 1) To evaluate the safety and tolerance of ALVAC-HIV vCP1521 in infants born to HIV-1 infected Ugandan women with CD4 counts > 500 cells/uL.
2) To evaluate the immunogenicity (humoral and cell-mediated responses) of ALVAC-HIV vCP1521 in infants born to HIV-1 infected Ugandan women with CD4 counts > 500 cells/uL.
Secondary Objectives: 1) To monitor absolute CD4 cell counts in all vaccinated infants
2) To evaluate the impact of receipt of ALVAC-HIV vCP 1521 on the infant’s immune response to standard UNEPI immunizations given in the first few months of life.
SDMC Protocol Specialist:
Lynda Marie Emel
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Protocol Statistician:
Lei Wang
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Protocol Chair:
Laura Guay
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DAIDS Medical Officer:
Sheryl Zwerski
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CORE Protocol Specialist:
Missie Allen
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CORE Protocol Specialist:
Philip Andrew
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