Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)
NCT ID: NCT05393037
Last Updated: 2026-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
313 participants
INTERVENTIONAL
2022-07-13
2024-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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V116 + Placebo
Part A: Participants will receive a single intramuscular (IM) dose of V116 on Day 1, and a single IM dose of placebo on Week 8. Part B: Participants will receive a single IM dose of PCV15 between 10 to 18 months after V116.
V116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Placebo
Saline in each 0.5 mL sterile solution
PCV15 - Part B
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 μg of PnPs antigen 6B in each 0.5 mL sterile suspension
PCV15 + PPSV23
Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
PCV15
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 μg of PnPs antigen 6B in each 0.5 mL sterile suspension
PPSV23
Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
Interventions
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V116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Placebo
Saline in each 0.5 mL sterile solution
PCV15
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 μg of PnPs antigen 6B in each 0.5 mL sterile suspension
PPSV23
Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
PCV15 - Part B
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 μg of PnPs antigen 6B in each 0.5 mL sterile suspension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
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
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0101)
Temuco, Región de la Araucanía, 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
Countries
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References
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Pathirana J, Ramgopal M, Martin C, Lombaard JJ, Chahin C, Launay O, Ratanasuwan W, Greenberg D, Grijalva CG, Orenstein WA, Shenkerman A, Hall L, Fernsler D, Kim Y, Li J, Platt HL; STRIDE-7 Study Group. Safety, tolerability, and immunogenicity of an adult-specific pneumococcal conjugate vaccine, V116, in people living with HIV (STRIDE-7): a two-part, parallel-group, randomised, active comparator-controlled, international, phase 3 trial. Lancet HIV. 2025 Oct;12(10):e679-e690. doi: 10.1016/S2352-3018(25)00165-1. Epub 2025 Sep 12.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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V116-007
Identifier Type: OTHER
Identifier Source: secondary_id
2021-006710-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V116-007
Identifier Type: -
Identifier Source: org_study_id
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