NCT05393037View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

313

Participants

Timeline

Start Date

July 13, 2022

Primary Completion Date

July 13, 2023

Study Completion Date

January 25, 2024

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

BIOLOGICAL

Placebo

Saline in each 0.5 mL sterile solution

BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

PCV15 - Part B

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

Trial Locations (20)

1000

CHU Saint-Pierre ( Site 0500), Brussels

1862

Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 0906), Johannesburg

2000

Insituut voor tropische Geneeskunde ( Site 0501), Antwerp

2087

Right To Care Research - Esizayo ( Site 0904), Johannesburg

7646

Be Part Yoluntu Centre ( Site 0902), Paarl

9300

Josha Research ( Site 0900), Bloemfontein

10700

Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 1100), Bangkok

20005

Whitman-Walker Institute ( Site 0009), Washington D.C.

32803

Orlando Immunology Center ( Site 0004), Orlando

34982

Midway Immunology and Research Center ( Site 0003), Ft. Pierce

50200

Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 1101, Chiang Mai

64111

KC CARE Health Center ( Site 0013), Kansas City

75010

Hôpital Saint-Louis ( Site 0600), Paris

75014

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0601), Paris

75246

North Texas Infectious Diseases Consultants, P.A ( Site 0001), Dallas

76104

Texas Center for Infectious Disease Associates ( Site 0011), Fort Worth

85015

Pueblo Family Physicians ( Site 0014), Phoenix

4781151

Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0101), Temuco

7500000

Universidad San Sebastian - Providencia ( Site 0111), Providencia

8380420

Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0107), Santiago

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY