Phase 3
N=313
Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)
Pneumococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT05393037 ↗Enrolled (actual)
313
Serious AEs
2.5%
Results posted
Jul 2024
Primary outcome: Primary: Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A — 3.9; 11.0; 50.3; 82.6 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V116 (Biological); Placebo (Biological); PCV15 (Biological); PPSV23 (Biological); PCV15 - Part B (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A |
3.9; 11.0; 50.3; 82.6; 7.1; 20.6 | — |
| PRIMARY Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A |
30.3; 34.2; 21.9; 19.4; 12.3; 15.5 | — |
| PRIMARY Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through the Duration of Participation in Part A |
0.0; 0.0 | — |
| PRIMARY 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 |
170.7; 172.0; 3896.0; 3979.5; 3482.3; 3275.6 | — |
| SECONDARY 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 |
0.50; 0.58; 3.79; 2.80; 2.95; 1.81 | — |
| SECONDARY 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 |
5.5; 5.3; 14.3; 15.3; 12.3; 7.4 | — |
| SECONDARY Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 |
3.7; 4.0; 11.4; 9.2; 9.1; 5.7 | — |
| SECONDARY 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 |
58.7; 61.9; 73.8; 80.2; 69.0; 59.2 | — |
| SECONDARY 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 |
42.3; 50.4; 70.8; 68.2; 70.1; 57.9 | — |
| SECONDARY Percentage of Participants With Solicited Injection-site AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B |
3.2; 61.9; 6.3 | — |
| SECONDARY Percentage of Participants With Solicited Systemic AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B |
22.2; 14.3; 11.1; 0.8 | — |
| SECONDARY Percentage of Participants With Vaccine-related SAEs From Day 1 of Part B Through the Duration of Participation in Part B |
0.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05393037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.