Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911)
- Conditions
- Pneumococcal Infection
- Interventions
- Biological: Placebo for V110Biological: Placebo for V114
- Registration Number
- NCT05158140
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to evaluate the concomitant and non-concomitant use of messenger ribonucleic acid (mRNA) mRNA-1273, the nucleoside-modified mRNA vaccine for active immunization to prevent coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), with a 23-valent pneumococcal polysaccharide vaccine (V110) for the prevention of pneumococcal disease, or a 15-valent pneumococcal conjugate vaccine (V114) indicated for the prevention of invasive pneumococcal disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 850
- Is in good health
- Any underlying chronic illness must be documented to be in stable condition
- Has received a 2-dose primary series of the Moderna mRNA SARS-CoV-2 vaccine ≥5 months before receipt of study vaccine at Visit 1
- May have received either: a) A first booster dose of the Moderna mRNA SARS-CoV-2 vaccine ≥4 months before receipt of study vaccine at Visit 1, or b) No booster dose of the Moderna mRNA SARS-CoV-2 vaccine
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using an acceptable contraceptive method, or is abstinent from heterosexual intercourse
- Has a current SARS-CoV-2 infection or a known history of SARS-CoV-2 infection <3 months before receipt of study vaccine at Visit 1
- Has a history of myocarditis and/or pericarditis
- Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
- Has a coagulation disorder contraindicating intramuscular vaccinations
- Had a recent illness with fever (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C]; axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for an acute illness occurring <72 hours before receipt of study vaccine
- Has a known malignancy that is progressing or has required active treatment <3 years before receipt of study vaccine at Visit 1
- Received prior administration of a pneumococcal polysaccharide vaccine <5 years before study enrollment or is expected to receive a pneumococcal polysaccharide vaccine during the study outside the protocol
- Received prior administration of a PCV <1 year before receipt of study vaccine at Visit 1 or is expected to receive a PCV during the study outside the protocol
- Received prior administration of any SARS-CoV-2 vaccine other than the 2-dose primary series of the Moderna mRNA vaccine with or without a first booster dose, or is expected to receive any SARS-CoV-2 vaccine during the study outside the protocol
- Received prior monoclonal antibody treatment for SARS-CoV-2 infection
- Received antiviral treatment for SARS-CoV-2 infection <3 months before receipt of study vaccine at Visit 1
- Received systemic corticosteroids for ≥14 consecutive days and has not completed intervention ≥30 days before receipt of study vaccine at Visit 1
- Received systemic corticosteroids exceeding physiologic replacement doses ≤14 days before receipt of study vaccine
- Is currently receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
- Received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of study vaccine. Exception: Inactivated influenza vaccine allowed if given ≥7 days before or ≥15 days after receipt of study vaccine
- Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine
- Received a blood transfusion or blood products (including globulin) ≤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 V110 Concomitant with mRNA-1273 (V110 Concomitant) Placebo for V110 Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30. V114 Nonconcomitant with mRNA-1273 (V114 Nonconcomitant) V114 Participants received single 0.5 mL IM injection of placebo for V114 on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273, followed by a single 0.5 mL IM injection of V114 on Day 30. V114 Nonconcomitant with mRNA-1273 (V114 Nonconcomitant) Placebo for V114 Participants received single 0.5 mL IM injection of placebo for V114 on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273, followed by a single 0.5 mL IM injection of V114 on Day 30. V110 Nonconcomitant with mRNA-1273 (V110 Nonconcomitant) mRNA-1273 Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273, followed by a single 0.5 mL IM injection of V110 on Day 30. V114 Concomitant with mRNA-1273 (V114 Concomitant) V114 Participants received a single 0.5 mL IM injection of V114 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V114 on Day 30. V110 Nonconcomitant with mRNA-1273 (V110 Nonconcomitant) Placebo for V110 Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273, followed by a single 0.5 mL IM injection of V110 on Day 30. V114 Concomitant with mRNA-1273 (V114 Concomitant) mRNA-1273 Participants received a single 0.5 mL IM injection of V114 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V114 on Day 30. V114 Concomitant with mRNA-1273 (V114 Concomitant) Placebo for V114 Participants received a single 0.5 mL IM injection of V114 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V114 on Day 30. V114 Nonconcomitant with mRNA-1273 (V114 Nonconcomitant) mRNA-1273 Participants received single 0.5 mL IM injection of placebo for V114 on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273, followed by a single 0.5 mL IM injection of V114 on Day 30. V110 Concomitant with mRNA-1273 (V110 Concomitant) mRNA-1273 Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30. V110 Concomitant with mRNA-1273 (V110 Concomitant) V110 Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30. V110 Nonconcomitant with mRNA-1273 (V110 Nonconcomitant) V110 Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273, followed by a single 0.5 mL IM injection of V110 on Day 30.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 Up to Day 7 After Any Vaccination (Up to Study Day 37) An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness, swelling, pain/tenderness, and underarm gland swelling or tenderness/lymphadenopathy at the injection site. The percentage of participants with one or more solicited injection-site AEs following any vaccination was reported.
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 Up to Day 7 After Any Vaccination (Up to Study Day 37) An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Systemic adverse events (AEs) include headache, tiredness/fatigue, muscle aches all over body/myalgia, joint pain/arthralgia, nausea, vomiting, and chills. The percentage of participants with solicited systemic AEs following any vaccination was reported.
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 Up to Day 7 After Any Vaccination (Up to Study Day 37) An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness, swelling, pain/tenderness, and underarm gland swelling or tenderness/lymphadenopathy at the injection site. The percentage of participants with one or more solicited injection-site AEs following any vaccination was reported.
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 Up to Day 7 After Any Vaccination (Up to Study Day 37) An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Systemic adverse events (AEs) include headache, tiredness/fatigue, muscle aches all over body/myalgia, joint pain/arthralgia, nausea, vomiting, and chills. The percentage of participants with solicited systemic AEs following any vaccination was reported.
Serotype-specific OPA GMT in Participants Administered V114 Up to 30 days postvaccination with V114 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively) Serotype-specific OPA GMTs for 15 of the serotypes contained in V114 were determined using a MOPA at 30 days postvaccination with V114. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
SARS-CoV-2-specific Binding Antibody (bAb) GMT in Participants Administered Either V110 or V114 Up to 30 days postvaccination with mRNA-1273 (Study Day 30) Sera from participants were used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein at 30 days post vaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo).
Percentage of Participants With Vaccine-Related Serious AEs (SAEs) Among Participants Administered V110 Up to Month 6 Serious adverse events (SAEs) are defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of a participant, or other important medical events. V110 vaccine-related SAEs as determined by investigator are summarized.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Up to 30 days postvaccination with V110 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively) Serotype-specific OPA GMTs for 14 of the serotypes contained in V110 were determined using a multiplexed opsonophagocytic assay (MOPA) at 30 days postvaccination with V110. The within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Percentage of Participants With Vaccine-Related SAEs Among Participants Administered V114 Up to Month 6 SAEs are defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of a participant, or other important medical events. V114 vaccine-related SAEs as determined by investigator are summarized.
- Secondary Outcome Measures
Name Time Method Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Baseline and 30 days postvaccination with V110 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively) Serotype-specific OPA for 14 of the serotypes contained in V110 was determined using a MOPA. GMFR is the geometric mean fold rise from baseline to 30 days postvaccination. The within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Serotype-specific OPA GMFR in Participants Administered V114 Baseline and 30 days postvaccination with V114 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively) Serotype-specific OPA for all 15 of the serotypes contained in V114 were determined using a MOPA. GMFR is the geometric mean fold rise from baseline to 30 days postvaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Baseline and 30 days postvaccination with V114 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively) Serotype-specific OPA for all 15 of the serotypes in V114 were determined using a MOPA. The percentage of participants who achieved a ≥4-fold rise in OPA titer from baseline to 30 days postvaccination were calculated. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
SARS-CoV-2-specific Binding Antibody (bAb) GMFR in Participants Administered Either V110 or V114 Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively) Sera from participants was used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein. GMFR is the geometric mean fold rise from baseline to 30 days postvaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo).
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Baseline and 30 days postvaccination with V110 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively) Serotype-specific OPA for 14 of the serotypes contained in V110 was determined using a MOPA. The percentage of participants who achieved a ≥4-fold rise in OPA titer from baseline to 30 days postvaccination were calculated. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Percentage of Participants With ≥4 Fold Rise From Baseline in SARS-CoV-2-specific bAb Response Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively) Sera from participants was used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein. The percentage of participants who achieved a ≥4-fold rise in bAb titer from baseline to 30 days postvaccination were calculated. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo).
Trial Locations
- Locations (46)
Valley Clinical Trials Inc. ( Site 0002)
🇺🇸Northridge, California, United States
CAIMED Center - Ponce School of Medicine ( Site 0103)
🇵🇷Ponce, Puerto Rico
Charlottesville Medical Research Center, LLC ( Site 0008)
🇺🇸Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc. ( Site 0014)
🇺🇸Newport News, Virginia, United States
Cooperativa de Facultad Medica SANACOOP ( Site 0104)
🇵🇷Bayamon, Puerto Rico
Caparra Internal Medicine Research Center. PSC ( Site 0102)
🇵🇷Rio Grande, Puerto Rico
Clinical Research Puerto Rico ( Site 0105)
🇵🇷San Juan, Puerto Rico
Center for Clinical Trials, LLC ( Site 0022)
🇺🇸Paramount, California, United States
Alliance for Multispecialty Research, LLC ( Site 0036)
🇺🇸Coral Gables, Florida, United States
Alliance for Multispecialty Research LLC (AMR - Norfolk) ( Site 0057)
🇺🇸Norfolk, Virginia, United States
Diablo Clinical Research, Inc ( Site 0043)
🇺🇸Walnut Creek, California, United States
Crossroads Clinical Research LLC ( Site 0020)
🇺🇸Victoria, Texas, United States
Velocity Clinical Research, Salt Lake City ( Site 0035)
🇺🇸West Jordan, Utah, United States
Carbon Health ( Site 0045)
🇺🇸North Hollywood, California, United States
Indago Research and Health Center Inc ( Site 0006)
🇺🇸Hialeah, Florida, United States
Optimal Research LLC ( Site 0019)
🇺🇸Melbourne, Florida, United States
Lakes Research LLC ( Site 0012)
🇺🇸Miami Lakes, Florida, United States
Atlanta Center For Medical Research ( Site 0053)
🇺🇸Atlanta, Georgia, United States
Optimal Research ( Site 0054)
🇺🇸Peoria, Illinois, United States
Community Clinical Research Center ( Site 0032)
🇺🇸Marlborough, Massachusetts, United States
Centennial Medical Group ( Site 0016)
🇺🇸Elkridge, Maryland, United States
Wake Research Clinical Research Center of Nevada, LLC ( Site 0021)
🇺🇸Las Vegas, Nevada, United States
AXCES Research Group ( Site 0017)
🇺🇸Santa Fe, New Mexico, United States
Certified Research Associates ( Site 0042)
🇺🇸Cortland, New York, United States
Rochester Clinical Research, Inc. ( Site 0010)
🇺🇸Rochester, New York, United States
Corning Center for Clinical Research ( Site 0052)
🇺🇸Horseheads, New York, United States
Velocity Clinical Research- Cleveland ( Site 0023)
🇺🇸Cleveland, Ohio, United States
Velocity Clinical Research-Providence ( Site 0015)
🇺🇸East Greenwich, Rhode Island, United States
Coastal Carolina Research Center ( Site 0044)
🇺🇸North Charleston, South Carolina, United States
South Texas Clinical Research ( Site 0033)
🇺🇸Corpus Christi, Texas, United States
Benchmark Research ( Site 0039)
🇺🇸Fort Worth, Texas, United States
University of Texas Medical Branch at Galveston ( Site 0037)
🇺🇸Galveston, Texas, United States
Texas Center For Drug Development ( Site 0013)
🇺🇸Houston, Texas, United States
Wellness Clinical Research Associates ( Site 0051)
🇺🇸McKinney, Texas, United States
DM Clinical Research ( Site 0025)
🇺🇸Tomball, Texas, United States
Artemis Institute for Clinical Research ( Site 0024)
🇺🇸San Diego, California, United States
California Research Foundation ( Site 0004)
🇺🇸San Diego, California, United States
Advanced Medical Research, LLC ( Site 0030)
🇺🇸Miami, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0018)
🇺🇸Newton, Kansas, United States
Millennium Clinical Trials ( Site 0027)
🇺🇸Simi Valley, California, United States
Accellacare - Winston-Salem ( Site 0049)
🇺🇸Winston-Salem, North Carolina, United States
Diagnostics Research Group ( Site 0001)
🇺🇸San Antonio, Texas, United States
Alliance for Multispecialty Research, LLC ( Site 0011)
🇺🇸Kansas City, Missouri, United States
Benchmark Research ( Site 0007)
🇺🇸Austin, Texas, United States
Clinical Research Partners, LLC. ( Site 0005)
🇺🇸Richmond, Virginia, United States
AMR Lexington ( Site 0055)
🇺🇸Lexington, Kentucky, United States