CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 313 enrolled
Drug / intervention
V116 +4 morebiological
Likely dose
V116: single 0.5 mL intramuscular injection containing 4 μg each of 21 pneumococcal polysaccharide antigensAI-extracted
Key inclusion· 3
  • ✓HIV infection confirmed
  • ✓Receiving combination antiretroviral therapy (ART) for ≥6 weeks before entry with no intended changes for 3 months post-randomization
  • ✓Vaccine-naïve to pneumococcal vaccines
Key exclusion· 10
  • ✕History of opportunistic infections within 12 months before first vaccination
  • ✕History of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease within 3 years before Day 1
  • ✕Known hypersensitivity to V116, PCV15, PPSV23 components, or diphtheria toxoid
  • ✕Congenital immunodeficiency, functional/anatomic asplenia, or history of autoimmune disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05393037
NCT05393037Phase 3Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted May 26, 2022·Updated Feb 5, 2026

In Brief

A Phase 3 clinical trial evaluating V116, Placebo, and 3 other interventions for Pneumococcal Disease. Completed, enrolled 313 participants across 20 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Disease
CountriesBelgium, Chile, France, South Africa, Thailand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMay 26, 2022
Enrollment StartJul 13, 2022
Primary CompletionJul 13, 2023
Study CompletionJan 25, 2024
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 4.1 years ago

Interventions

V116biological

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, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

Placebobiological

Saline in each 0.5 mL sterile solution

PCV15biological

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

PPSV23biological

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

PCV15 - Part Bbiological

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