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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05393037
Recruitment Status : Completed
First Posted : May 26, 2022
Last Update Posted : January 26, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: V116 Biological: Placebo Biological: PCV15 Biological: PPSV23 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : July 13, 2022
Actual Primary Completion Date : July 13, 2023
Actual Study Completion Date : January 16, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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™;
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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05393037


Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05393037    
Other Study ID Numbers: V116-007
V116-007 ( Other Identifier: Merck )
2021-006710-36 ( EudraCT Number )
First Posted: May 26, 2022    Key Record Dates
Last Update Posted: January 26, 2024
Last Verified: January 2024
Individual Participant Data (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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs