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NCT05393037 Clinical Trial

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

Pneumococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05393037
Other study ID # V116-007
Secondary ID V116-0072021-006
Status Completed
Phase Phase 3
First received
Last updated
Start date July 13, 2022
Est. completion date January 16, 2024

Study information
Verified date January 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 313
Est. completion date January 16, 2024
Est. primary completion date July 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

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
• Placebo
Saline in each 0.5 mL sterile solution
• 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
• 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

Locations
Country Name City State
Belgium Insituut voor tropische Geneeskunde ( Site 0501) Antwerpen
Belgium CHU Saint-Pierre ( Site 0500) Brussels Bruxelles-Capitale, Region De
Chile Universidad San Sebastian - Providencia ( Site 0111) Providencia Region M. De Santiago
Chile Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0107) Santiago Region M. De Santiago
Chile Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0101) Temuco Araucania
France Hôpital Saint-Louis ( Site 0600) Paris Ile-de-France
France Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0601) Paris
South Africa Josha Research ( Site 0900) Bloemfontein Free State
South Africa Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 0906) Johannesburg Gauteng
South Africa Right To Care Research - Esizayo ( Site 0904) Johannesburg Gauteng
South Africa Be Part Yoluntu Centre ( Site 0902) Paarl Western Cape
Thailand Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 1100) Bangkok Krung Thep Maha Nakhon
Thailand Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 1101 Chiang Mai
United States North Texas Infectious Diseases Consultants, P.A ( Site 0001) Dallas Texas
United States Midway Immunology and Research Center ( Site 0003) Fort Pierce Florida
United States Texas Center for Infectious Disease Associates ( Site 0011) Fort Worth Texas
United States KC CARE Health Center ( Site 0013) Kansas City Missouri
United States Orlando Immunology Center ( Site 0004) Orlando Florida
United States Pueblo Family Physicians ( Site 0014) Phoenix Arizona
United States Whitman-Walker Institute ( Site 0009) Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Belgium,  Chile,  France,  South Africa,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Up to 5 days after each vaccination in Part A
Primary 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 Up to 5 days after each vaccination in Part A
Primary 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 Up to 194 days in Part A
Primary 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 Up to 114 days
Secondary 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 Up to 114 days
Secondary 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 Up to 114 days
Secondary 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 Up to 114 days
Secondary 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 Baseline and up to 114 days
Secondary 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 Baseline and up to 114 days
Secondary 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 Up to 5 days after vaccination in Part B
Secondary 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 Up to 5 days after vaccination in Part B
Secondary 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 Up to 44 days after vaccination in Part B
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Completed NCT04530838 - 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants Phase 3
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Completed NCT04526574 - Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age Phase 3
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Completed NCT01111214 - Child Pneumococcal Serotype Epidemiology In Greece N/A
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Completed NCT04830358 - Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults Phase 1
Completed NCT04379713 - 20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants Phase 3
Completed NCT04887948 - Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2 Phase 3
Completed NCT04382326 - 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants Phase 3
Not yet recruiting NCT00843895 - Multicenter Prospective Evaluation of the Incidence and Serotyes of Invasive Pneumoccocal Disease (IPD) Among Children Below 5 Years N/A
Completed NCT01734239 - A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018) Phase 3

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