Contact PI/Project LeaderMCFARLAND, ELIZABETH JANE
Awardee OrganizationUNIVERSITY OF COLORADO DENVER
Description
Abstract Text
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
PACTG P1047 is a Phase II, randomized, double-blind, placebo-controlled safety and immunogenicity study of an investigational vaccine, GARDASILTM (a prophylactic Quadrivalent HPV [Types 6, 11, 16, 18] L1 Virus-Like Particle [VLP] vaccine), in HIV-infected children. This vaccine has demonstrated efficacy and the manufacturer has submitted an application for liscensure for use in healthy people aged 9yr to adult has been submitted to the FDA. Studies in immunocompromised people, including those with HIV, have not yet been performed. The primary objectives of this study are to determine the safety, tolerability and immunogenicity of GARDASILTM in HIV-infected children aged 7-12 years. The secondary objectives are to relate the safety and immunogenicity of GARDASILTM to the immune status at the time of vaccination; to further characterize the nature of the immune response; and to determine the response to a fourth (booster) dose of vaccine. The study will enroll 120 children > 7 to < 12 years of age nationally and 13 children locally to be randomized to receive GARDASILTM or vaccine-matched aluminum placebo in a 3:1 ratio. Ninety children will receive GARDASILTM and 30 children will receive placebo, 0.5 mL IM at Entry and at 8 and 24 weeks. Subsequent safety assessments and sample collections will extend until Week 96. Subjects will be unblinded at Week 96. Those who received GARDASILTM will receive an additional dose of GARDASILTM. Those who received placebo will begin a full 3-dose regimen of GARDASILTM. The study design requires that all subjects be enrolled within 12 months of initiating accrual, in order to ensure data entry and clean-up prior to unblinding the first subject at the Week 96 visit.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AdultAge-YearsAluminumChildComputer Retrieval of Information on Scientific Projects DatabaseDataDoseDouble-Blind MethodEnrollmentEnsureFundingGrantHIVHuman PapillomavirusImmuneImmune responseImmunocompromised HostInstitutionManufacturer NameNaturePhasePlacebo ControlPlacebosRandomizedResearchResearch DesignResearch PersonnelResourcesSafetySourceTimeTreatment ProtocolsUnited States Food and Drug AdministrationUnited States National Institutes of HealthVaccinationVaccinesVirus-like particleVisitWeekagedimmunogenicityprophylacticresponsesample collection
No Sub Projects information available for 5M01RR000069-45 7057
Publications
Publications are associated with projects, but cannot be identified with any particular year of the project or fiscal year of funding. This is due to the continuous and cumulative nature of knowledge generation across the life of a project and the sometimes long and variable publishing timeline. Similarly, for multi-component projects, publications are associated with the parent core project and not with individual sub-projects.
No Publications available for 5M01RR000069-45 7057
Patents
No Patents information available for 5M01RR000069-45 7057
Outcomes
The Project Outcomes shown here are displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed are those of the PI and do not necessarily reflect the views of the National Institutes of Health. NIH has not endorsed the content below.
No Outcomes available for 5M01RR000069-45 7057
Clinical Studies
No Clinical Studies information available for 5M01RR000069-45 7057
News and More
Related News Releases
No news release information available for 5M01RR000069-45 7057
History
No Historical information available for 5M01RR000069-45 7057
Similar Projects
No Similar Projects information available for 5M01RR000069-45 7057