Clinical trial NCT05393037: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-05-26
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A
timeFrame: Up to 5 days after each vaccination in Part A
measure: Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A
timeFrame: Up to 5 days after each vaccination in Part A
measure: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through the Duration of Participation in Part A
timeFrame: Up to 194 days in Part A
measure: 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
timeFrame: Up to 114 days
Secondary outcomes:
measure: 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
timeFrame: Up to 114 days
measure: 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
timeFrame: Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
measure: Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
timeFrame: Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
measure: 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
timeFrame: Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
measure: 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
timeFrame: Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
measure: Percentage of Participants With Solicited Injection-site AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B
timeFrame: Up to 5 days after vaccination in Part B
measure: Percentage of Participants With Solicited Systemic AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B
timeFrame: Up to 5 days after vaccination in Part B
measure: Percentage of Participants With Vaccine-related SAEs From Day 1 of Part B Through the Duration of Participation in Part B
timeFrame: Up to 44 days after vaccination in Part B
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pueblo Family Physicians ( Site 0014)
state: Arizona
city: Washington
country: United States
facility: Whitman-Walker Institute ( Site 0009)
state: District of Columbia
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center ( Site 0003)
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center ( Site 0004)
state: Florida
city: Kansas City
country: United States
facility: KC CARE Health Center ( Site 0013)
state: Missouri
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants, P.A ( Site 0001)
state: Texas
city: Fort Worth
country: United States
facility: Texas Center for Infectious Disease Associates ( Site 0011)
state: Texas
city: Brussels
country: Belgium
facility: CHU Saint-Pierre ( Site 0500)
state: Bruxelles-Capitale, Region De
city: Antwerpen
country: Belgium
facility: Insituut voor tropische Geneeskunde ( Site 0501)
city: Temuco
country: Chile
facility: Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0101)
state: Araucania
city: Providencia
country: Chile
facility: Universidad San Sebastian - Providencia ( Site 0111)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0107)
state: Region M. De Santiago
city: Paris
country: France
facility: Hôpital Saint-Louis ( Site 0600)
state: Ile-de-France
city: Paris
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0601)
city: Bloemfontein
country: South Africa
facility: Josha Research ( Site 0900)
state: Free State
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 0906)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Right To Care Research - Esizayo ( Site 0904)
state: Gauteng
city: Paarl
country: South Africa
facility: Be Part Yoluntu Centre ( Site 0902)
state: Western Cape
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 1100)
state: Krung Thep Maha Nakhon
city: Chiang Mai
country: Thailand
facility: Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 1101
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: