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

• ClinicalTrials.gov Identifier: NCT05393037
• Recruitment Status: Completed
• First Posted: May 26, 2022
• Last Update Posted: January 26, 2024
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: May 23, 2022
• First Posted Date: May 26, 2022
• Last Update Posted Date: January 26, 2024
• Actual Study Start Date: July 13, 2022
• Actual Primary Completion Date: July 13, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 23, 2022)

• Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 postvaccination in Part A [ Time Frame: Up to 5 days after each vaccination in Part A ]
  Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 postvaccination in Part A
• Percentage of participants with solicited systemic AEs from Day 1 through Day 5 postvaccination in Part A [ Time Frame: 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
• Percentage of participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in Part A [ Time Frame: Up to 194 days in Part A ]
  Percentage of participants with vaccine-related SAEs from Day 1 through the duration of participation 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 [ Time Frame: Up to 114 days ]
  Serotype-specific OPA GMT postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 23, 2022)

• 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 [ Time Frame: Up to 114 days ]
  Serotype-specific IgG GMC postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
• 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 [ Time Frame: Up to 114 days ]
  Serotype-specific OPA GMFRs postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
• Serotype-specific IgG GMFRs postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 [ Time Frame: Up to 114 days ]
  Serotype-specific IgG GMFRs postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
• 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 [ Time Frame: Baseline and up to 114 days ]
  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
• 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 [ Time Frame: Baseline and up to 114 days ]
  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
• Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B [ Time Frame: Up to 5 days after vaccination in Part B ]
  Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B
• Percentage of participants with solicited systemic AEs from Day 1 of Part B through Day 5 postvaccination in Part B [ Time Frame: 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
• Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B [ Time Frame: Up to 44 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)
• Official Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Pneumococcal Disease

Intervention

• 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, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
  Other Name: Pneumococcal 21-valent Conjugate Vaccine
• Biological: Placebo
  Saline in each 0.5 mL sterile solution
• 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 Name: 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 Name: PNEUMOVAX™23

Study Arms

• Experimental: V116
  Participants will receive a single intramuscular (IM) dose of V116 on Day 1, a single IM dose of placebo for PPSV23 on Week 8, and a single IM dose of PCV15 between 10 to 18 months after V116.
  Interventions:

  • Biological: V116
  • Biological: Placebo
  • Biological: PCV15
• 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.
  Interventions:

  • Biological: PCV15
  • Biological: PPSV23

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 19, 2023): 313
• Original Estimated Enrollment (submitted: May 23, 2022): 300
• Actual Study Completion Date: January 16, 2024
• Actual Primary Completion Date: July 13, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Chile, France, South Africa, Thailand, United States

Administrative Information

• NCT Number: NCT05393037
• Other Study ID Numbers: V116-007; V116-007 ( Other Identifier: Merck ); 2021-006710-36 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Current Responsible Party: Merck Sharp & Dohme LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Merck Sharp & Dohme LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

• PRS Account: Merck Sharp & Dohme LLC
• Verification Date: January 2024