Back to resultsSafety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)
Primary Purpose
Pneumococcal Disease
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
V116
Placebo
PCV15
PPSV23
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Disease
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.
Sites / Locations
- Pueblo Family Physicians ( Site 0014)
- Whitman-Walker Institute ( Site 0009)
- Midway Immunology and Research Center ( Site 0003)
- Orlando Immunology Center ( Site 0004)
- KC CARE Health Center ( Site 0013)
- North Texas Infectious Diseases Consultants, P.A ( Site 0001)
- Texas Center for Infectious Disease Associates ( Site 0011)
- CHU Saint-Pierre ( Site 0500)
- Insituut voor tropische Geneeskunde ( Site 0501)
- Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0101)
- Universidad San Sebastian - Providencia ( Site 0111)
- Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0107)
- Hôpital Saint-Louis ( Site 0600)
- Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0601)
- Josha Research ( Site 0900)
- Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 0906)
- Right To Care Research - Esizayo ( Site 0904)
- Be Part Yoluntu Centre ( Site 0902)
- Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 1100)
- Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 1101
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
V116
PCV15 + PPSV23
Arm Description
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.
Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
Outcomes
Primary Outcome Measures
Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 postvaccination 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
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
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
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
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
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
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
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
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
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
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
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
Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05393037
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
July 13, 2023 (Actual)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
313 (Actual)
8. Arms, Groups, and Interventions
Arm Title
V116
Arm Type
Experimental
Arm Description
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.
Arm Title
PCV15 + PPSV23
Arm Type
Active Comparator
Arm Description
Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
Intervention Type
Biological
Intervention Name(s)
V116
Other Intervention Name(s)
Pneumococcal 21-valent Conjugate Vaccine
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Saline in each 0.5 mL sterile solution
Intervention Type
Biological
Intervention Name(s)
PCV15
Other Intervention Name(s)
VAXNEUVANCE™;
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
PPSV23
Other Intervention Name(s)
PNEUMOVAX™23
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 postvaccination in Part A
Description
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
Title
Percentage of participants with solicited systemic AEs from Day 1 through Day 5 postvaccination in Part A
Description
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
Title
Percentage of participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in Part A
Description
Percentage of participants with vaccine-related SAEs from Day 1 through the duration of participation in Part A
Time Frame
Up to 194 days in Part A
Title
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
Description
Serotype-specific OPA 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
Secondary Outcome Measure Information:
Title
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
Description
Serotype-specific IgG 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
Title
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
Description
Serotype-specific OPA 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
Title
Serotype-specific IgG GMFRs postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
Description
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
Title
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
Description
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
Title
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
Description
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
Title
Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B
Description
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
Title
Percentage of participants with solicited systemic AEs from Day 1 of Part B through Day 5 postvaccination in Part B
Description
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
Title
Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Pueblo Family Physicians ( Site 0014)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Whitman-Walker Institute ( Site 0009)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20005
Country
United States
Facility Name
Midway Immunology and Research Center ( Site 0003)
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Orlando Immunology Center ( Site 0004)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
KC CARE Health Center ( Site 0013)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
North Texas Infectious Diseases Consultants, P.A ( Site 0001)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Center for Infectious Disease Associates ( Site 0011)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
CHU Saint-Pierre ( Site 0500)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Insituut voor tropische Geneeskunde ( Site 0501)
City
Antwerpen
ZIP/Postal Code
2000
Country
Belgium
Facility Name
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0101)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4781151
Country
Chile
Facility Name
Universidad San Sebastian - Providencia ( Site 0111)
City
Providencia
State/Province
Region M. De Santiago
ZIP/Postal Code
7500000
Country
Chile
Facility Name
Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0107)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8380420
Country
Chile
Facility Name
Hôpital Saint-Louis ( Site 0600)
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75010
Country
France
Facility Name
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0601)
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Josha Research ( Site 0900)
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 0906)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1862
Country
South Africa
Facility Name
Right To Care Research - Esizayo ( Site 0904)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2087
Country
South Africa
Facility Name
Be Part Yoluntu Centre ( Site 0902)
City
Paarl
State/Province
Western Cape
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 1100)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 1101
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
Learn more about this trial
Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)
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