Status:
COMPLETED
Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2024
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT05393037
Start Date
July 13 2022
End Date
January 25 2024
Last Update
March 30 2025
Active Locations (20)
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1
Pueblo Family Physicians ( Site 0014)
Phoenix, Arizona, United States, 85015
2
Whitman-Walker Institute ( Site 0009)
Washington D.C., District of Columbia, United States, 20005
3
Midway Immunology and Research Center ( Site 0003)
Ft. Pierce, Florida, United States, 34982
4
Orlando Immunology Center ( Site 0004)
Orlando, Florida, United States, 32803