Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)
- Conditions
- Pneumococcal Disease
- Interventions
- Registration Number
- NCT05393037
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 313
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCV15 + PPSV23 PCV15 Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8. PCV15 + PPSV23 PPSV23 Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8. V116 + Placebo V116 Part A: Participants will receive a single intramuscular (IM) dose of V116 on Day 1, and a single IM dose of placebo on Week 8. Part B: Participants will receive a single IM dose of PCV15 between 10 to 18 months after V116. V116 + Placebo Placebo Part A: Participants will receive a single intramuscular (IM) dose of V116 on Day 1, and a single IM dose of placebo on Week 8. Part B: Participants will receive a single IM dose of PCV15 between 10 to 18 months after V116. V116 + Placebo PCV15 - Part B Part A: Participants will receive a single intramuscular (IM) dose of V116 on Day 1, and a single IM dose of placebo on Week 8. Part B: Participants will receive a single IM dose of PCV15 between 10 to 18 months after V116.
- Primary Outcome Measures
Name Time Method 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 An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.
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 An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
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 A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed.
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 to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.
- Secondary Outcome Measures
Name Time Method 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 The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
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, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23) The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex ECL assay. The percentage of participants who had ≥4-fold rise in IgG concentration was calculated from baseline to postvaccination with V116 and PCV15 + PPSV23
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 Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23) Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23.
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, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23) Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination with V116 and PCV15 + PPSV23
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23) The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23
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 An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. 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 An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia. 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 A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed. Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B
Trial Locations
- Locations (20)
Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0107)
🇨🇱Santiago, Region M. De Santiago, Chile
Be Part Yoluntu Centre ( Site 0902)
🇿🇦Paarl, Western Cape, South Africa
Josha Research ( Site 0900)
🇿🇦Bloemfontein, Free State, South Africa
Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 1101
🇹🇭Chiang Mai, Thailand
Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 1100)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Whitman-Walker Institute ( Site 0009)
🇺🇸Washington, District of Columbia, United States
CHU Saint-Pierre ( Site 0500)
🇧🇪Brussels, Bruxelles-Capitale, Region De, Belgium
Insituut voor tropische Geneeskunde ( Site 0501)
🇧🇪Antwerpen, Belgium
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0101)
🇨🇱Temuco, Araucania, Chile
Universidad San Sebastian - Providencia ( Site 0111)
🇨🇱Providencia, Region M. De Santiago, Chile
Hôpital Saint-Louis ( Site 0600)
🇫🇷Paris, Ile-de-France, France
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0601)
🇫🇷Paris, France
Midway Immunology and Research Center ( Site 0003)
🇺🇸Fort Pierce, Florida, United States
Texas Center for Infectious Disease Associates ( Site 0011)
🇺🇸Fort Worth, Texas, United States
Pueblo Family Physicians ( Site 0014)
🇺🇸Phoenix, Arizona, United States
Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 0906)
🇿🇦Johannesburg, Gauteng, South Africa
Orlando Immunology Center ( Site 0004)
🇺🇸Orlando, Florida, United States
Right To Care Research - Esizayo ( Site 0904)
🇿🇦Johannesburg, Gauteng, South Africa
KC CARE Health Center ( Site 0013)
🇺🇸Kansas City, Missouri, United States
North Texas Infectious Diseases Consultants, P.A ( Site 0001)
🇺🇸Dallas, Texas, United States