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

NCT04168190 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: pPCV-001V116-001
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 20

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.

Conditions

Pneumonia, Pneumococcal

Outcome Measures

Primary Outcomes (8)

• 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.

  Up to 5 days post-vaccination

• 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.

  Up to 5 days post-vaccination

• 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.

  Up to Day 195

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

  Up to 5 days post-vaccination

• 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.

  Up to 5 days post-vaccination

• 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.

  Up to Day 293

• 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.

  30 days post vaccination

• 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.

  30 days post vaccination

Secondary Outcomes (11)

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

  30 days post vaccination

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

  30 days post vaccination

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

  30 days post vaccination

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

  30 days post vaccination

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

  Baseline (Day 1) and 30 days postvaccination

Study Arms (5)

Phase 1: V116 0.5 mL

EXPERIMENTAL

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

Biological: V116

Phase 1: V116 1.0 mL

EXPERIMENTAL

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

Biological: V116

Phase 1: Pneumovax™23

ACTIVE COMPARATOR

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

Biological: Pneumovax™23

Phase 2: V116

EXPERIMENTAL

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

Biological: V116

Phase 2: Pneumovax™23

ACTIVE COMPARATOR

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

Biological: Pneumovax™23

Interventions

V116 BIOLOGICAL

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

Also known as: Polyvalent pneumococcal conjugate vaccine (pPCV), Pneumococcal 21-valent Conjugate Vaccine

Phase 1: V116 0.5 mL; Phase 1: V116 1.0 mL; Phase 2: V116

Pneumovax™23 BIOLOGICAL

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

Also known as: PPSV23

Phase 1: Pneumovax™23; Phase 2: Pneumovax™23

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (20)

Simon Williamson Clinic ( Site 0004)

Birmingham, Alabama, 35211, United States

Location

Central Arizona Medical Associates ( Site 0003)

Mesa, Arizona, 85206, United States

Location

Clinical Research of South Florida ( Site 0008)

Coral Gables, Florida, 33134, United States

Location

Indago Research & Health Center, Inc ( Site 0011)

Hialeah, Florida, 33012, United States

Location

Research Centers of America, LLC ( Site 0001)

Hollywood, Florida, 33024, United States

Location

QPS Miami Research Associates ( Site 0016)

Miami, Florida, 33143, United States

Location

L&C Professional Medical Research Institute ( Site 0009)

Miami, Florida, 33144, United States

Location

Advanced Medical Research Institute ( Site 0010)

Miami, Florida, 33174, United States

Location

Optimal Research ( Site 0006)

Peoria, Illinois, 61614, United States

Location

Benchmark Research ( Site 0012)

Metairie, Louisiana, 70006, United States

Location

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

Troy, Michigan, 48098, United States

Location

Meridian Clinical Research, LLC ( Site 0024)

Norfolk, Nebraska, 68701, United States

Location

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

Las Vegas, Nevada, 89104, United States

Location

Meridian Clinical Research, LLC ( Site 0025)

Endwell, New York, 13760, United States

Location

Rochester Clinical Research, Inc. ( Site 0002)

Rochester, New York, 14609, United States

Location

PriMED Clinical Research ( Site 0021)

Dayton, Ohio, 45419, United States

Location

Advanced Medical Research ( Site 0017)

Maumee, Ohio, 43537, United States

Location

Kaiser Permanente Center for Health Research ( Site 0015)

Portland, Oregon, 97227, United States

Location

Diagnostics Research Group ( Site 0013)

San Antonio, Texas, 78229, United States

Location

Advanced Clinical Research ( Site 0022)

West Jordan, Utah, 84088, United States

Location

Related Publications (1)

• 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.

  PMID: 36116461 DERIVED

MeSH Terms

Conditions

Pneumonia, Pneumococcal

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 19, 2019
• Study Start: December 6, 2019
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: September 16, 2022
• Results First Posted: August 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

US (20)