Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine

NCT05540028 | Completed Phase 1 DMC

• 1 other identifier: CVIA 096
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

A first-in-human, Phase 1 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)

Conditions

Pneumococcal Vaccines

Outcome Measures

Primary Outcomes (5)

• Adult Safety: solicited local and systemic adverse events

  Number and severity of solicited local and systemic adverse events (AEs)

  7 days post-vaccination (Day 8)

• Adult Safety: clinically significant hematological and biochemical measurements

  Number, severity, and relatedness of clinically significant hematological and biochemical measurements

  7 days post-vaccination (Day 8)

• Adult Safety: unsolicited adverse events

  Number, severity, and relatedness of all unsolicited AEs

  28 days post-vaccination (Day 29)

• Adult Safety: related serious adverse events

  Number, severity, and relatedness of serious adverse events (SAEs)

  through 6 months post last vaccination (Day 169)

• Adult Safety: newly diagnosed chronic medical conditions

  Number of newly diagnosed chronic medical conditions

  through 6 months post last vaccination (Day 169)

Secondary Outcomes (4)

• Adult Immunogenicity: immunoglobulin G (IgG) geometric mean concentration (GMC)

  28 days post-vaccination (Day 29)

• Adult Immunogenicity: Geometric Mean Fold Rise (GMFR)

  28 days post-vaccination (Day 29)

• Adult Immunogenicity: opsonophagocytosis assay (OPA) geometric mean titers (GMTs)

  28 days post-vaccination (Day 29)

• Adult Immunogenicity: GMFR OPA GMTs

  28 days post-vaccination (Day 29)

Study Arms (2)

Adult Cohort Group 1

EXPERIMENTAL

Participants will receive a single 0.5mL dose of IVT PCV-25 administered by intramuscular injection on Day 1

Biological: IVT PCV-25

Adult Cohort Group 2

ACTIVE COMPARATOR

Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1

Biological: PCV 20

Interventions

IVT PCV-25 BIOLOGICAL

25 valent pneumococcal conjugate vaccine

Adult Cohort Group 1

PCV 20 BIOLOGICAL

20 valent pneumococcal conjugate vaccine

Adult Cohort Group 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults who are 18 through 40 years old on the day of randomization (Day 1).
• Subject, or subject's LAR, must provide voluntary written informed consent for the subject to participate in the study.
• Subject or subject's LAR must be able to comprehend and comply with study requirements and procedures and must be willing and able to return for all scheduled follow-up visits.
• There will be an allowance though not a requirement for COVID-19 vaccination in all participants in compliance with Canadian national recommendations.
• Adult female subjects who are not surgically sterile must have a negative serum pregnancy test at screening and negative urine pregnancy test prior to vaccination.

You may not qualify if:

• Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation.
• Adults who have previously been vaccinated against S. pneumoniae.
• History of microbiologically confirmed invasive disease caused by S. pneumoniae.
• History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines.
• Known or suspected allergy to PEG.
• History of angioedema.
• Any abnormal vital sign deemed clinically relevant by the PI.
• Acute illness (moderate or severe) and/or fever (body temperature of ≥ 38.0°C)
• Use of antibiotics (oral or parenteral) within 5 days of randomization.
• History of administration of any non-study vaccine (e.g. influenza; COVID-19 vaccine) within 14 days of first administration of study vaccine or planned vaccination prior to 14 days post-vaccination blood draw.
• Chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune modifying drugs prior to the administration of the study vaccine (and within the 6 months prior to administration of the study vaccine in the case of adults), including the use of glucocorticoids. The use of topical and inhaled glucocorticoids will be permitted.
• Administration of immunoglobulins and/or any blood products within the 6 months prior to administration of the study vaccine, or anticipation of such administration during the study period.
• History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., thalassemia, coagulation factor deficiencies, severe anemia).
• Any medical or social condition that in the opinion of the PI , may interfere with the study objectives, pose a risk to the subject, or prevent the subject from completing the study follow-up.
• Subject is an employee of, or direct descendant (child or grandchild) of any person employed by the Sponsor, PATH, the CRO, the PI.

Sponsors & Collaborators

• Inventprise Inc.: lead
• Canadian Center for Vaccinology: collaborator
• Vaccine Evaluation Center, Canada: collaborator
• PATH: collaborator

Study Sites (1)

Canadian Center for Vaccinology, IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (1)

• Langley JM, Sadarangani M, Ockenhouse C, Barreto L, Ye L, Tang Y, Breeze JL, Feser J, Hosken NA, Andi-Lolo I, Tasker SA, Halperin SA; Canadian Immunization Research Network. Safety and immunogenicity of a 25-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive healthy adults: Results from 2 randomised, controlled clinical trials. Vaccine. 2026 Jan 22;75:128236. doi: 10.1016/j.vaccine.2026.128236. Online ahead of print.

  PMID: 41576705 DERIVED

Study Officials

• Joanne Langley, MD, MSc, FRCPC

  Canadian Center for Vaccinology

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single center, randomized, active-controlled, observer-blind Phase 1study in which adults were randomized in a 1:1 ratio to evaluate safety and tolerability of IVT PCV 25 to comparator.

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 14, 2022
• Study Start: September 28, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Plan to be defined at a later date
• Access Criteria: Plan to be defined at a later date

Locations

CA (1)