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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Disease
• Intervention / Treatment: Biological: Placebo; Biological: PCV15; Biological: PPSV23; Biological: V116; Biological: PCV15 - Part B

• Study Type: Interventional
• Enrollment (Actual): 313
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2000
    • Insituut voor tropische Geneeskunde ( Site 0501)
  • Bruxelles-Capitale, Region de
    • Brussels, Bruxelles-Capitale, Region de, Belgium, 1000
      • CHU Saint-Pierre ( Site 0500)
• Chile
  • Region M. de Santiago
    • Providencia, Region M. de Santiago, Chile, 7500000
      • Universidad San Sebastian - Providencia ( Site 0111)
    • Santiago, Region M. de Santiago, Chile, 8380420
      • Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0107)
  • Región de la Araucanía
    • Temuco, Región de la Araucanía, Chile, 4781151
      • Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0101)
• France
  • Paris, France, 75014
    • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0601)
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75010
      • Hôpital Saint-Louis ( Site 0600)
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9300
      • Josha Research ( Site 0900)
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1862
      • Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 0906)
    • Johannesburg, Gauteng, South Africa, 2087
      • Right To Care Research - Esizayo ( Site 0904)
  • Western Cape
    • Paarl, Western Cape, South Africa, 7646
      • Be Part Yoluntu Centre ( Site 0902)
• Thailand
  • Chiang Mai, Thailand, 50200
    • Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 1101
  • Bangkok
    • Bangkok, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 1100)
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Pueblo Family Physicians ( Site 0014)
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20005
      • Whitman-Walker Institute ( Site 0009)
  • Florida
    • Ft. Pierce, Florida, United States, 34982
      • Midway Immunology and Research Center ( Site 0003)
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center ( Site 0004)
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • KC CARE Health Center ( Site 0013)
  • Texas
    • Dallas, Texas, United States, 75246
      • North Texas Infectious Diseases Consultants, P.A ( Site 0001)
    • Fort Worth, Texas, United States, 76104
      • Texas Center for Infectious Disease Associates ( Site 0011)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PCV15 + PPSV23; Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.	Biological: 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; Other Names: VAXNEUVANCE™; Biological: 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; Other Names: PNEUMOVAX™23
Experimental: 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.	Biological: Placebo; Saline in each 0.5 mL sterile solution; Biological: 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; Other Names: Pneumococcal 21-valent Conjugate Vaccine; Biological: 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 Names: VAXNEUVANCE™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A	An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.	Up to 5 days after each vaccination in Part A
Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A	An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.	Up to 5 days after each vaccination in Part A
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through the Duration of Participation in Part A	A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed.	Up to 194 days in Part A
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116	Serotype-specific OPA to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.	Up to 114 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116	The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.	Up to 114 days
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116	Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23.	Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116	The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23	Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116	Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination with V116 and PCV15 + PPSV23	Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116	The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex ECL assay. The percentage of participants who had ≥4-fold rise in IgG concentration was calculated from baseline to postvaccination with V116 and PCV15 + PPSV23	Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
Percentage of Participants With Solicited Injection-site AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B	An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B.	Up to 5 days after vaccination in Part B
Percentage of Participants With Solicited Systemic AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B	An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia. Percentage of participants with solicited systemic AEs from Day 1 of Part B through Day 5 postvaccination in Part B	Up to 5 days after vaccination in Part B
Percentage of Participants With Vaccine-related SAEs From Day 1 of Part B Through the Duration of Participation in Part B	A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed. Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B	Up to 44 days after vaccination in Part B

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Actual): July 13, 2023
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections; Immunologic Factors; Physiological Effects of Drugs; 23-valent pneumococcal capsular polysaccharide vaccine
• Other Study ID Numbers: V116-007 (Other Identifier: MSD); 2021-006710-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No