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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pneumococcal Disease

In brief

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.

Key facts

Study ID

NCT05393037

Run by

Merck Sharp & Dohme LLC

People needed

313

Starts

2022-07-13

Expected to finish

2024-01-25

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Pueblo Family Physicians ( Site 0014) — Phoenix, Arizona, United States
• Whitman-Walker Institute ( Site 0009) — Washington D.C., District of Columbia, United States
• Midway Immunology and Research Center ( Site 0003) — Ft. Pierce, Florida, United States
• Orlando Immunology Center ( Site 0004) — Orlando, Florida, United States
• KC CARE Health Center ( Site 0013) — Kansas City, Missouri, United States
• North Texas Infectious Diseases Consultants, P.A ( Site 0001) — Dallas, Texas, United States
• Texas Center for Infectious Disease Associates ( Site 0011) — Fort Worth, Texas, United States
• CHU Saint-Pierre ( Site 0500) — Brussels, Bruxelles-Capitale, Region de, Belgium
• Insituut voor tropische Geneeskunde ( Site 0501) — Antwerp, Belgium
• Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0101) — Temuco, Araucania, Chile
• Universidad San Sebastian - Providencia ( Site 0111) — Providencia, Region M. de Santiago, Chile
• Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0107) — Santiago, Region M. de Santiago, Chile
• Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0601) — Paris, France
• Hôpital Saint-Louis ( Site 0600) — Paris, Île-de-France Region, France
• Josha Research ( Site 0900) — Bloemfontein, Free State, South Africa
• Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 0906) — Johannesburg, Gauteng, South Africa
• Right To Care Research - Esizayo ( Site 0904) — Johannesburg, Gauteng, South Africa
• Be Part Yoluntu Centre ( Site 0902) — Paarl, Western Cape, South Africa
• Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 1100) — Bangkok, Bangkok, Thailand
• Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 1101 — Chiang Mai, Thailand

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.