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

NCT05393037 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: V116-0072021-006710-36
• Study Type: interventional
• Target: 313
• Locations: 6 countries
• Sites: 20

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 of pneumococcal disease caused by the serotypes in the vaccine.

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

  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

  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

  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

  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

  Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)

Study Arms (2)

V116 + Placebo

EXPERIMENTAL

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: V116; Biological: Placebo; Biological: PCV15 - Part B

PCV15 + PPSV23

ACTIVE COMPARATOR

Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.

Biological: PCV15; Biological: PPSV23

Interventions

V116 BIOLOGICAL

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

Also known as: Pneumococcal 21-valent Conjugate Vaccine

V116 + Placebo

Placebo BIOLOGICAL

Saline in each 0.5 mL sterile solution

V116 + Placebo

PCV15 BIOLOGICAL

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

Also known as: VAXNEUVANCE™;

PCV15 + PPSV23

PPSV23 BIOLOGICAL

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

Also known as: PNEUMOVAX™23

PCV15 + PPSV23

PCV15 - Part B BIOLOGICAL

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

Also known as: VAXNEUVANCE™

V116 + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (20)

Pueblo Family Physicians ( Site 0014)

Phoenix, Arizona, 85015, United States

Location

Whitman-Walker Institute ( Site 0009)

Washington D.C., District of Columbia, 20005, United States

Location

Midway Immunology and Research Center ( Site 0003)

Ft. Pierce, Florida, 34982, United States

Location

Orlando Immunology Center ( Site 0004)

Orlando, Florida, 32803, United States

Location

KC CARE Health Center ( Site 0013)

Kansas City, Missouri, 64111, United States

Location

North Texas Infectious Diseases Consultants, P.A ( Site 0001)

Dallas, Texas, 75246, United States

Location

Texas Center for Infectious Disease Associates ( Site 0011)

Fort Worth, Texas, 76104, United States

Location

CHU Saint-Pierre ( Site 0500)

Brussels, Bruxelles-Capitale, Region de, 1000, Belgium

Location

Insituut voor tropische Geneeskunde ( Site 0501)

Antwerp, 2000, Belgium

Location

Universidad San Sebastian - Providencia ( Site 0111)

Providencia, Region M. de Santiago, 7500000, Chile

Location

Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0107)

Santiago, Region M. de Santiago, 8380420, Chile

Location

Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0101)

Temuco, Región de la Araucanía, 4781151, Chile

Location

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0601)

Paris, 75014, France

Location

Hôpital Saint-Louis ( Site 0600)

Paris, Île-de-France Region, 75010, France

Location

Josha Research ( Site 0900)

Bloemfontein, Free State, 9300, South Africa

Location

Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 0906)

Johannesburg, Gauteng, 1862, South Africa

Location

Right To Care Research - Esizayo ( Site 0904)

Johannesburg, Gauteng, 2087, South Africa

Location

Be Part Yoluntu Centre ( Site 0902)

Paarl, Western Cape, 7646, South Africa

Location

Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 1100)

Bangkok, Bangkok, 10700, Thailand

Location

Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 1101

Chiang Mai, 50200, Thailand

Location

Related Publications (1)

• 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.

  PMID: 40953572 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: MSD

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: July 13, 2022
• Primary Completion: July 13, 2023
• Study Completion: January 25, 2024
• Last Updated: February 5, 2026
• Results First Posted: July 25, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

TH (2); CL (3); FR (2); US (7); BE (2); ZA (4)