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Completed

NCT Number: NCT05393037

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

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.

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Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Saint-Pierre ( Site 0500), Brussels, Bruxelles-Capitale, Region de, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Pneumococcal 21-valent Conjugate Vaccine

Placebo

Biological

Saline in each 0.5 mL sterile solution

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

Other names: VAXNEUVANCE™;

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

Other names: PNEUMOVAX™23

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

Other names: VAXNEUVANCE™

Primary outcomes

  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

    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.

  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

    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.

  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

    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.

  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 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.

Secondary outcomes

  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

    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.

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

    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.

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

    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

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

    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

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

    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

  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

    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.

  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

    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

  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

    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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 26, 2022
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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