A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114; Prevnar 13™; PNEUMOVAX™23
Intervention description: 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose; 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose; 23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F (25 mcg each) 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: Double (Participant, Investigator)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Conjugate pneumococcal vaccine, 15-valent, 22F, 33F

Summary:

      This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114
      and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the
      safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after
      receipt of either V114 or Prevnar 13™.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infected with human immunodeficiency virus (HIV) and Cluster of
             Differentiation 4+ (CD4+) cell count ≥50 cells/µL and plasma HIV ribonucleic acid
             (RNA) <50,000 copies/mL

          -  Receiving combination anti-retroviral therapy (ART) for at least 6 weeks before
             enrollment with no intention of changing therapy for 3 months after randomization

          -  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 study vaccine.

        Exclusion Criteria:

          -  History of opportunistic infections within 12 months before the first study
             vaccination

          -  History of non-infectious acquired immune deficiency syndrome-related illness such as
             Kaposi's sarcoma, wasting syndrome, or HIV-associated nephropathy

          -  History of invasive pneumococcal disease

          -  Known hypersensitivity to any vaccine component

          -  Known or suspected congenital immunodeficiency, functional or anatomic asplenia, or
             history of autoimmune disease

          -  Coagulation disorder contraindicating intramuscular vaccination

          -  History of malignancy ≤5 years before enrollment, except for adequately treated basal
             cell or squamous cell skin cancer or in situ cervical cancer

          -  Female participant: positive urine or serum pregnancy test

          -  Prior administration of any pneumococcal vaccine

          -  Received systemic corticosteroids for ≥14 consecutive days and have not completed
             within 30 days of enrollment

          -  Received immunosuppressive therapy

          -  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 recent history of drug or alcohol
             abuse or dependence.