A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001)

Phase 1

Completed

Conditions: Pneumonia, Pneumococcal

Interventions: Biological: V116
Biological: Pneumovax™23

Registration Number: NCT04168190

Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary: This Phase 1 and Phase 2 study will evaluate the safety, tolerability and immunogenicity of V116 when administered to adults. Phase 1 has no formal hypothesis. The primary hypotheses for Phase 2 are: V116 is noninferior to Pneumovax™23 as measured by the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for the common serotypes at 30 days postvaccination and that the serotype-specific OPA GMTs for the unique serotypes in V116 at 30 days postvaccination are statistically significantly greater following vaccination with V116 than those following vaccination with Pneumovax™23.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 1: V116 1.0 mL	V116	Participants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 1
Phase 1: Pneumovax™23	Pneumovax™23	Participants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 2: Pneumovax™23	Pneumovax™23	Participants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 2
Phase 1: V116 0.5 mL	V116	Participants will receive a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1
Phase 2: V116	V116	Participants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 2

Primary Outcome Measures

Name	Time	Method
Phase 1: Percentage of Participants With a Solicited Systemic AE	Up to 5 days post-vaccination	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. Systemic AEs solicited on the VRC were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was assessed.
Phase 2: Percentage of Participants With Vaccine-related SAEs	Up to Day 293	An SAE is an AE that results in death, 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. The percentage of participants who experienced at least one SAE that were assessed by the investigator to be at least possibly related to the study vaccination were reported.
Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116	30 days post vaccination	GMTs for the serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Up to 5 days post-vaccination	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. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed.
Phase 1: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)	Up to Day 195	A serious adverse event (SAE) is an AE that results in death, 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. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination were reported.
Phase 2: Percentage of Participants With a Solicited Systemic AE	Up to 5 days post-vaccination	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. Systemic AEs solicited on the VRC were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with 1 or more solicited systemic AE was assessed.
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23	30 days post vaccination	GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the muliplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated.
Phase 2: Percentage of Participants With a Solicited Injection-site AE	Up to 5 days post-vaccination	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. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed.

Secondary Outcome Measures

Name	Time	Method
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23	30 days post vaccination	Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23	30 days post vaccination	Serotype-specific pneumococcal IgG antibodies were measured using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23	30 days post vaccination	GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA	Baseline (Day 1) and 30 days postvaccination	GMTs for the serotypes in V116 and Pneumovax™23 were determined using the MOPA at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated.
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG	Baseline (Day 1) and 30 days post vaccination	GMCs for the serotypes in V116 and Pneumovax™23 were measured by PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMC/Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116	30 days post vaccination	Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23	30 days post vaccination	GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG	Baseline (Day 1) and 30 days post vaccination	GMCs for each serotype common in V116 and Pneumovax™23 were measured using PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMC/Day 1 GMC.
Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116	30 days post vaccination	Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA	Baseline (Day 1) and 30 days post vaccination	GMTs for the serotypes in V116 and Pneumovax™23 were determined using the MOPA at baseline and at 30 days post vaccination and derived from a cLDA model. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMT/Day 1 GMT.
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination	Baseline (Day 1) and 30 days post vaccination	The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined by the MOPA and derived from a cLDA model.

Trial Locations

Locations (20): Central Arizona Medical Associates ( Site 0003)
🇺🇸
Mesa, Arizona, United States
Indago Research & Health Center, Inc ( Site 0011)
🇺🇸
Hialeah, Florida, United States
Research Centers of America, LLC ( Site 0001)
🇺🇸
Hollywood, Florida, United States
Advanced Medical Research Institute ( Site 0010)
🇺🇸
Miami, Florida, United States
Advanced Medical Research ( Site 0017)
🇺🇸
Maumee, Ohio, United States
QPS Miami Research Associates ( Site 0016)
🇺🇸
Miami, Florida, United States
Advanced Clinical Research ( Site 0022)
🇺🇸
West Jordan, Utah, United States
Wake Research Clinical Research Center of Nevada, LLC ( Site 0014)
🇺🇸
Las Vegas, Nevada, United States
Simon Williamson Clinic ( Site 0004)
🇺🇸
Birmingham, Alabama, United States
Diagnostics Research Group ( Site 0013)
🇺🇸
San Antonio, Texas, United States
Kaiser Permanente Center for Health Research ( Site 0015)
🇺🇸
Portland, Oregon, United States
Clinical Research of South Florida ( Site 0008)
🇺🇸
Coral Gables, Florida, United States
Benchmark Research ( Site 0012)
🇺🇸
Metairie, Louisiana, United States
Optimal Research ( Site 0006)
🇺🇸
Peoria, Illinois, United States
L&C Professional Medical Research Institute ( Site 0009)
🇺🇸
Miami, Florida, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)
🇺🇸
Troy, Michigan, United States
Meridian Clinical Research, LLC ( Site 0024)
🇺🇸
Norfolk, Nebraska, United States
PriMED Clinical Research ( Site 0021)
🇺🇸
Dayton, Ohio, United States
Meridian Clinical Research, LLC ( Site 0025)
🇺🇸
Endwell, New York, United States
Rochester Clinical Research, Inc. ( Site 0002)
🇺🇸
Rochester, New York, United States