Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: V116 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. |
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, 20, 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
Other Names:
|
| Active Comparator: PCV15 + PPSV23 Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8. |
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
Other Names:
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 postvaccination in Part A [Up to 5 days after each vaccination in Part A]
Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 postvaccination in Part A
- Percentage of participants with solicited systemic AEs from Day 1 through Day 5 postvaccination in Part A [Up to 5 days after each vaccination in Part A]
Percentage of participants with solicited systemic AEs from Day 1 through Day 5 postvaccination in Part A
- Percentage of participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in Part A [Up to 194 days in Part A]
Percentage of participants with vaccine-related SAEs from Day 1 through the duration of participation in Part A
- 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 [Up to 114 days]
Serotype-specific OPA GMT postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
Secondary Outcome Measures
- 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 [Up to 114 days]
Serotype-specific IgG GMC postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
- 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 [Up to 114 days]
Serotype-specific OPA GMFRs postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
- Serotype-specific IgG GMFRs postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 [Up to 114 days]
Serotype-specific IgG GMFRs postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
- 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 [Baseline and up to 114 days]
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
- 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 [Baseline and up to 114 days]
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
- Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B [Up to 5 days after vaccination in Part B]
Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B
- Percentage of participants with solicited systemic AEs from Day 1 of Part B through Day 5 postvaccination in Part B [Up to 5 days after vaccination in Part B]
Percentage of participants with solicited systemic AEs from Day 1 of Part B through Day 5 postvaccination in Part B
- Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B [Up to 44 days after vaccination in Part B]
Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B
Eligibility Criteria
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
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Has a coagulation disorder contraindicating intramuscular vaccinations.
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Has a recent illness with fever
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pueblo Family Physicians ( Site 0014) | Phoenix | Arizona | United States | 85015 |
| 2 | Whitman-Walker Institute ( Site 0009) | Washington | District of Columbia | United States | 20005 |
| 3 | Midway Immunology and Research Center ( Site 0003) | Fort Pierce | Florida | United States | 34982 |
| 4 | Orlando Immunology Center ( Site 0004) | Orlando | Florida | United States | 32803 |
| 5 | KC CARE Health Center ( Site 0013) | Kansas City | Missouri | United States | 64111 |
| 6 | North Texas Infectious Diseases Consultants, P.A ( Site 0001) | Dallas | Texas | United States | 75246 |
| 7 | Texas Center for Infectious Disease Associates ( Site 0011) | Fort Worth | Texas | United States | 76104 |
| 8 | Universidad San Sebastian - Providencia ( Site 0111) | Providencia | Region M. De Santiago | Chile | 7500000 |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V116-007
- V116-007
- 2021-006710-36