Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children
Condition: HIV Infections; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety of and immune response to a new human
      papillomavirus (HPV) vaccine in HIV (Human immunodeficiency virus) infected children between
      the ages of 7 and 12 years.
    

Detailed description: 
      Genital HPV infection is the most common sexually transmitted infection in the world and may
      lead to genital warts, anogenital dysplasias, and invasive cancers. HIV infected people and
      others with compromised immunity are at greater risk for HPV-related complications. In
      particular, researchers are concerned about the risk of HPV infection to women, who may be
      infected by their male partners, especially if these partners engage in anal intercourse. HIV
      infected women tend to have multiple types of HPV (associated with a greater risk of
      HPV-related disease), are less likely to clear HPV-related conditions, and are more likely to
      progress to HPV-related disease. The quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like
      particle (VLP) vaccine to be tested in this study was safe and generally well tolerated in
      previous studies conducted in healthy and HPV-exposed adolescents, young adults, and older
      women. However, it is still unclear if the vaccine will be safe and will elicit a similar
      immune response in younger children. The purpose of this study is to evaluate the safety and
      immunogenicity of the novel quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine in HIV
      infected children 7 to 12 years of age.

      This study had two stages and lasted at least 108 weeks. In Stage I, participants were
      stratified by CD4 percentage (CD4%) nadir and CD4% at study screening (Stratum A: CD4% Nadir
      < 15 and CD4% ≥ 15 at screening, Stratum B: CD4% Nadir ≥ 15 and < 25 and CD4% ≥ 15 at
      screening, Stratum C: CD4% Nadir ≥ 25 and CD4% ≥ 25 at screening). Within each stratification
      group, they were randomly assigned to one of two arms. During Stage I, Arm A
      (QHPV:Quadrivalent human papillomavirus vaccine) participants received 3 doses of vaccine,
      while Arm B (Placebo/QHPV) participants received 3 doses of placebo. Participants did not
      know whether they were receiving vaccine or placebo. Participants received their assigned
      intervention at study entry and Weeks 8 and 24. At Week 96, Stage II began, and all study
      participants were told if they received vaccine or placebo in Stage I. Arm A participants
      received an additional dose of vaccine at Week 96; Arm B participants received doses of
      vaccine at Weeks 96, 104, and 120. Over the course of the study, there were at least 12 study
      visits. A physical exam and blood collection occurred at most visits; medical history
      occurred at selected visits.

      After each vaccination, participants were observed for at least 30 minutes to monitor for any
      allergic reactions possibly resulting from the vaccination. For 15 days following
      vaccination, parents or guardians were asked to complete a "report card" with details of each
      child's signs and symptoms. Three days after each vaccination, parents or guardians of study
      participants were contacted by telephone and asked about any adverse events that a child may
      have experienced.
    

Intervention name(s): Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV); Placebo/QHPV
Intervention type(s): Biological; Other
Intervention description(s): QHPV at week 0, 8, 24 and 96.; Placebo at week 0, 8, 24 and QHPV at week 96, 104, 120.
Other intervention name(s): QHPV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HPV