Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)

A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults Living With HIV

This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in persons living with human immunodeficiency virus (HIV), for the prevention of pneumococcal disease caused by the serotypes in the vaccine.

Inclusion Criteria:

• Is infected with HIV
• Is receiving combination anti-retroviral therapy (ART) for ≥6 weeks before study entry with no intended changes to combination ART therapy for 3 months after randomization.
• Is vaccine-naïve

Exclusion Criteria:

• Has a history of opportunistic infections ≤12 months before the first vaccination
• Has a history of noninfectious acquired immune deficiency syndrome-related illness
• Has a history of active hepatitis
• Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 2 (Day 1)
• Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including diphtheria toxoid
• Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
• Has a coagulation disorder contraindicating intramuscular vaccinations.
• Has a recent illness with fever
• Has a known cancer malignancy that is progressing or has required active treatment <3 years before enrollment
• Had prior administration of PCV15 or PCV20.
• Is expected to receive any pneumococcal vaccine during the study outside of the protocol
• Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥14 days before receipt of study vaccine
• Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
• Has received any non-live vaccine ≤14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine
• Has received any live virus vaccine ≤30 days before receipt of any study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of any study vaccine
• Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine
• Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.