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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Disease

Treatments: Biological: Placebo; Biological: V116; Biological: PPSV23; Biological: PCV15 - Part B; Biological: PCV15

Study type: Interventional

Funder types: Industry

Identifiers

NCT05393037

V116-007 (Other Identifier)

2021-006710-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 313 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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313 participants in 2 patient groups

V116 + Placebo

Experimental group

Description:

Part A: Participants will receive a single intramuscular (IM) dose of V116 on Day 1, and a single IM dose of placebo on Week 8. Part B: Participants will receive a single IM dose of PCV15 between 10 to 18 months after V116.

Treatment:

Biological: PCV15 - Part B

Biological: V116

Biological: Placebo

PCV15 + PPSV23

Active Comparator group

Description:

Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.

Treatment:

Biological: PCV15

Biological: PPSV23