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

Primary Purpose

Pneumonia, Pneumococcal

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

V116

Pneumovax™23

About this trial

This is an interventional prevention trial for Pneumonia, Pneumococcal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

Phase 1:
Male or female, from 18 years to 49 years of age inclusive
Phase 2:
Male or female ≥50 years of age Phase 1 and Phase 2
Males: refrain from donating sperm, remain abstinent during study or agree to use condom
Females: Not pregnant. If a woman of childbearing potential, agree to use contraception or remain abstinent

Exclusion Criteria

History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years of screening
Known hypersensitivity to any component of the pPCV, or any diphtheria toxoid-containing vaccine
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
Coagulation disorder contraindicating IM vaccination
Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours of screening
Known malignancy that is progressing or has required active treatment within 3 years.(Note: participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ [eg, breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded)
Pregnant
Received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study, outside of the protocol.
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 a blood transfusion or blood products, including immunoglobulin, 6 months before study vaccination or is scheduled to receive a blood transfusion or blood product

Sites / Locations

Simon Williamson Clinic ( Site 0004)
Central Arizona Medical Associates ( Site 0003)
Clinical Research of South Florida ( Site 0008)
Indago Research & Health Center, Inc ( Site 0011)
Research Centers of America, LLC ( Site 0001)
QPS Miami Research Associates ( Site 0016)
L&C Professional Medical Research Institute ( Site 0009)
Advanced Medical Research Institute ( Site 0010)
Optimal Research ( Site 0006)
Benchmark Research ( Site 0012)
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)
Meridian Clinical Research, LLC ( Site 0024)
Wake Research Clinical Research Center of Nevada, LLC ( Site 0014)
Meridian Clinical Research, LLC ( Site 0025)
Rochester Clinical Research, Inc. ( Site 0002)
PriMED Clinical Research ( Site 0021)
Advanced Medical Research ( Site 0017)
Kaiser Permanente Center for Health Research ( Site 0015)
Diagnostics Research Group ( Site 0013)
Advanced Clinical Research ( Site 0022)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Phase 1: V116 0.5 mL

Phase 1: V116 1.0 mL

Phase 1: Pneumovax™23

Phase 2: V116

Phase 2: Pneumovax™23

Arm Description

Participants will receive a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1

Participants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 1

Participants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 1

Participants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 2

Participants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 2

Outcomes

Primary Outcome Measures

Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

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 a Solicited Systemic AE

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 1: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)

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 Injection-site AE

Phase 2: Percentage of Participants With a Solicited Systemic AE

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: Percentage of Participants With Vaccine-related SAEs

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 Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23

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: Serotype-specific OPA GMTs for the Unique Serotypes in V116

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.

Secondary Outcome Measures

Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23

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 Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116

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 Common Serotypes in V116 and Pneumovax™23

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: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23

Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA

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

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 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23

Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116

Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA

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: GMFR From Baseline in GMCs of Serotype-specific IgG

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: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 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.

Full Information

NCT ID

NCT04168190

First Posted

November 18, 2019

Last Updated

September 1, 2022

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT04168190

Brief Title

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

Official Title

A Phase 1/Phase 2, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Adults.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

December 6, 2019 (Actual)

Primary Completion Date

July 12, 2021 (Actual)

Study Completion Date

July 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia, Pneumococcal

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

600 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1: V116 0.5 mL

Arm Type

Experimental

Arm Description

Participants will receive a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1

Arm Title

Phase 1: V116 1.0 mL

Arm Type

Experimental

Arm Description

Participants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 1

Arm Title

Phase 1: Pneumovax™23

Arm Type

Active Comparator

Arm Description

Participants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 1

Arm Title

Phase 2: V116

Arm Type

Experimental

Arm Description

Participants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 2

Arm Title

Phase 2: Pneumovax™23

Arm Type

Active Comparator

Arm Description

Participants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 2

Intervention Type

Biological

Intervention Name(s)

V116

Other Intervention Name(s)

Polyvalent pneumococcal conjugate vaccine (pPCV), Pneumococcal 21-valent Conjugate Vaccine

Intervention Description

Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

Intervention Type

Biological

Intervention Name(s)

Pneumovax™23

Other Intervention Name(s)

PPSV23

Intervention Description

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

Primary Outcome Measure Information:

Title

Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

Description

Time Frame

Up to 5 days post-vaccination

Title

Phase 1: Percentage of Participants With a Solicited Systemic AE

Description

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.

Time Frame

Up to 5 days post-vaccination

Title

Phase 1: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)

Description

Time Frame

Up to Day 195

Title

Phase 2: Percentage of Participants With a Solicited Injection-site AE

Description

Time Frame

Up to 5 days post-vaccination

Title

Phase 2: Percentage of Participants With a Solicited Systemic AE

Description

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.

Time Frame

Up to 5 days post-vaccination

Title

Phase 2: Percentage of Participants With Vaccine-related SAEs

Description

Time Frame

Up to Day 293

Title

Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23

Description

Time Frame

30 days post vaccination

Title

Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116

Description

Time Frame

30 days post vaccination

Secondary Outcome Measure Information:

Title

Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23

Description

Time Frame

30 days post vaccination

Title

Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116

Description

Time Frame

30 days post vaccination

Title

Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23

Description

Time Frame

30 days post vaccination

Title

Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23

Description

Time Frame

30 days post vaccination

Title

Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA

Description

Time Frame

Baseline (Day 1) and 30 days postvaccination

Title

Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG

Description

Time Frame

Baseline (Day 1) and 30 days post vaccination

Title

Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23

Description

Time Frame

30 days post vaccination

Title

Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116

Description

Time Frame

30 days post vaccination

Title

Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA

Description

Time Frame

Baseline (Day 1) and 30 days post vaccination

Title

Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG

Description

Time Frame

Baseline (Day 1) and 30 days post vaccination

Title

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

Description

Time Frame

Baseline (Day 1) and 30 days post vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Phase 1: Male or female, from 18 years to 49 years of age inclusive Phase 2: Male or female ≥50 years of age Phase 1 and Phase 2 Males: refrain from donating sperm, remain abstinent during study or agree to use condom Females: Not pregnant. If a woman of childbearing potential, agree to use contraception or remain abstinent Exclusion Criteria History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years of screening Known hypersensitivity to any component of the pPCV, or any diphtheria toxoid-containing vaccine 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 Coagulation disorder contraindicating IM vaccination Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours of screening Known malignancy that is progressing or has required active treatment within 3 years.(Note: participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ [eg, breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded) Pregnant Received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study, outside of the protocol. 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 a blood transfusion or blood products, including immunoglobulin, 6 months before study vaccination or is scheduled to receive a blood transfusion or blood product

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

Simon Williamson Clinic ( Site 0004)

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35211

Country

United States

Facility Name

Central Arizona Medical Associates ( Site 0003)

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85206

Country

United States

Facility Name

Clinical Research of South Florida ( Site 0008)

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Indago Research & Health Center, Inc ( Site 0011)

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Research Centers of America, LLC ( Site 0001)

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

QPS Miami Research Associates ( Site 0016)

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

L&C Professional Medical Research Institute ( Site 0009)

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Advanced Medical Research Institute ( Site 0010)

City

Miami

State/Province

Florida

ZIP/Postal Code

33174

Country

United States

Facility Name

Optimal Research ( Site 0006)

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61614

Country

United States

Facility Name

Benchmark Research ( Site 0012)

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)

City

Troy

State/Province

Michigan

ZIP/Postal Code

48098

Country

United States

Facility Name

Meridian Clinical Research, LLC ( Site 0024)

City

Norfolk

State/Province

Nebraska

ZIP/Postal Code

68701

Country

United States

Facility Name

Wake Research Clinical Research Center of Nevada, LLC ( Site 0014)

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89104

Country

United States

Facility Name

Meridian Clinical Research, LLC ( Site 0025)

City

Endwell

State/Province

New York

ZIP/Postal Code

13760

Country

United States

Facility Name

Rochester Clinical Research, Inc. ( Site 0002)

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

PriMED Clinical Research ( Site 0021)

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45419

Country

United States

Facility Name

Advanced Medical Research ( Site 0017)

City

Maumee

State/Province

Ohio

ZIP/Postal Code

43537

Country

United States

Facility Name

Kaiser Permanente Center for Health Research ( Site 0015)

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

Diagnostics Research Group ( Site 0013)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Advanced Clinical Research ( Site 0022)

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

36116461

Citation

Platt H, Omole T, Cardona J, Fraser NJ, Mularski RA, Andrews C, Daboul N, Gallagher N, Sapre A, Li J, Polis A, Fernsler D, Tamms G, Xu W, Murphy R, Skinner J, Joyce J, Musey L. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in healthy adults: phase 1/2, randomised, double-blind, active comparator-controlled, multicentre, US-based trial. Lancet Infect Dis. 2023 Feb;23(2):233-246. doi: 10.1016/S1473-3099(22)00526-6. Epub 2022 Sep 15.

Results Reference

derived

Learn more about this trial

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

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