Clinical trial NCT04168190: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pneumonia, Pneumococcal
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-11-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
timeFrame: Up to 5 days post-vaccination
measure: Phase 1: Percentage of Participants With a Solicited Systemic AE
timeFrame: Up to 5 days post-vaccination
measure: Phase 1: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
timeFrame: Up to Day 195
measure: Phase 2: Percentage of Participants With a Solicited Injection-site AE
timeFrame: Up to 5 days post-vaccination
measure: Phase 2: Percentage of Participants With a Solicited Systemic AE
timeFrame: Up to 5 days post-vaccination
measure: Phase 2: Percentage of Participants With Vaccine-related SAEs
timeFrame: Up to Day 293
measure: Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23
timeFrame: 30 days post vaccination
measure: Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116
timeFrame: 30 days post vaccination
Secondary outcomes:
measure: Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23
timeFrame: 30 days post vaccination
measure: Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116
timeFrame: 30 days post vaccination
measure: Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23
timeFrame: 30 days post vaccination
measure: Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23
timeFrame: 30 days post vaccination
measure: Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
timeFrame: Baseline (Day 1) and 30 days postvaccination
measure: Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG
timeFrame: Baseline (Day 1) and 30 days post vaccination
measure: Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23
timeFrame: 30 days post vaccination
measure: Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116
timeFrame: 30 days post vaccination
measure: Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
timeFrame: Baseline (Day 1) and 30 days post vaccination
measure: Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG
timeFrame: Baseline (Day 1) and 30 days post vaccination
measure: 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
timeFrame: Baseline (Day 1) and 30 days post vaccination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Simon Williamson Clinic ( Site 0004)
state: Alabama
city: Mesa
country: United States
facility: Central Arizona Medical Associates ( Site 0003)
state: Arizona
city: Coral Gables
country: United States
facility: Clinical Research of South Florida ( Site 0008)
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc ( Site 0011)
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America, LLC ( Site 0001)
state: Florida
city: Miami
country: United States
facility: QPS Miami Research Associates ( Site 0016)
state: Florida
city: Miami
country: United States
facility: L&C Professional Medical Research Institute ( Site 0009)
state: Florida
city: Miami
country: United States
facility: Advanced Medical Research Institute ( Site 0010)
state: Florida
city: Peoria
country: United States
facility: Optimal Research ( Site 0006)
state: Illinois
city: Metairie
country: United States
facility: Benchmark Research ( Site 0012)
state: Louisiana
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)
state: Michigan
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC ( Site 0024)
state: Nebraska
city: Las Vegas
country: United States
facility: Wake Research Clinical Research Center of Nevada, LLC ( Site 0014)
state: Nevada
city: Endwell
country: United States
facility: Meridian Clinical Research, LLC ( Site 0025)
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc. ( Site 0002)
state: New York
city: Dayton
country: United States
facility: PriMED Clinical Research ( Site 0021)
state: Ohio
city: Maumee
country: United States
facility: Advanced Medical Research ( Site 0017)
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research ( Site 0015)
state: Oregon
city: San Antonio
country: United States
facility: Diagnostics Research Group ( Site 0013)
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research ( Site 0022)
state: Utah
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
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.