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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 3

Conditions

Pneumococcal Disease

Treatments

Biological: PCV15
Biological: Placebo
Biological: V116
Biological: PPSV23

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

313 participants in 2 patient groups

V116
Experimental group
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.
Treatment:
Biological: V116
Biological: Placebo
Biological: PCV15
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: PPSV23
Biological: PCV15

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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