Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)
Condition: Pneumococcal Infections
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Pneumococcal Infections
Intervention: V114; Prevnar 13™; PNEUMOVAX™23
Intervention description: 15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL dose.; 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each 0.5 mL dose.; 23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 407.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pneumococcal conjugate vaccine (PCV), 15-valent, 22F, 33F

Summary:

      This is a study of V114 in children infected with HIV. Participants will be randomly assigned
      in a 1:1 ratio to receive either V114 or Prevnar 13™ followed 8 weeks later by a single dose
      of PNEUMOVAX™23. The primary objectives of this study are to evaluate the safety and
      tolerability of V114 in children 6 to 17 years of age inclusive infected with HIV and to
      evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG)
      Geometric Mean Concentrations (GMCs) at 30 days following vaccination with V114 or Prevnar
      13™ by each vaccination group. There are no formal hypotheses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between the ages of 6 and 17 years (inclusive) infected with HIV and
             has a Cluster of Differentiation 4+ (CD4+) T-cell count ≥200 cells/µL and plasma HIV
             ribonucleic acid (RNA) <50,000 copies/mL

          -  Is Pneumococcal Conjugate Vaccine (PCV) naïve, previously vaccinated with a <13-valent
             PCV, partially vaccinated with Prevnar 13™, or has a history of previous Prevnar 13™
             vaccination ≥3 years before Visit 2 (Day 1)

          -  Is PnPs vaccine naïve or has a history of 1 previous PnPs vaccination ≥5 years before
             Visit 2 (Day 1)

          -  Female participant: not pregnant, not breastfeeding and 1) not of childbearing
             potential, or 2) of childbearing potential and agrees to practice contraception
             through 6 weeks after administration of last dose of the study vaccine.

        Exclusion Criteria:

          -  History of World Health Organization (WHO) HIV classification of clinical Stage 4
             disease within the past 12 months

          -  History of invasive pneumococcal disease

          -  Known hypersensitivity to any vaccine component

          -  Known or suspected congenital immunodeficiency (other than HIV infection), functional
             or anatomic asplenia, or history of autoimmune disease

          -  Bleeding disorder contraindicating intramuscular vaccinations

          -  History of malignancy ≤5 years prior to signing informed consent/assent, except for
             adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer

          -  Female participant: positive urine or serum pregnancy test

          -  Expect to receive any pneumococcal vaccine during the study outside of the protocol

          -  Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat
             cancer or other conditions, and interventions associated with organ or bone marrow
             transplantation, or autoimmune disease

          -  Received a blood transfusion or blood products within 6 months of enrollment

          -  Participated in another clinical study of an investigational product within 2 months
             of enrollment

          -  Current user of recreational or illicit drugs or history of drug or alcohol abuse or
             dependence