Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine (IVT PCV-25)

A Phase 1, Multicenter, Randomized, Active-Controlled, Observer-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Inventprise's 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults (18 Through 40 Years)

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)

Study Overview

• Status: Completed
• Conditions: Pneumococcal Vaccines
• Intervention / Treatment: Biological: IVT PCV-25; Biological: PCV 20

Detailed Description

A first-in-human, multicenter, randomized, active-controlled, observer-blind Phase 1 study of IVT PCV-25 designed to evaluate the safety, tolerability, and immunogenicity of the vaccine. Adult subjects will be randomized 1:1 to receive either IVT PCV-25 or Prevnar 20™.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Canadian Center for Vaccinology, IWK Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 36 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Any screening laboratory test result outside the normal range and with toxicity score ≥ 2, unless allowed by the PI and PATH Medical Officer when a toxicity score and the normal range overlap significantly. A subject may repeat each laboratory assessment once during the screening period, with the most recent laboratory value being used for evaluation of exclusion criteria.
• A positive serologic test for human immunodeficiency virus (HIV)-1 or HIV-2 (HIV 1/2 Ab), hepatitis B (HBsAg) or hepatitis C (HCV Ab).
• History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ.
• Recent history (within the past year) or signs of alcohol or substance abuse.
• History of major psychiatric disorder.
• Female adult subjects who are pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adult Cohort Group 1; Participants will receive a single 0.5mL dose of IVT PCV-25 administered by intramuscular injection on Day 1	Biological: IVT PCV-25; 25 valent pneumococcal conjugate vaccine
Active Comparator: Adult Cohort Group 2; Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1	Biological: PCV 20; 20 valent pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adult Immunogenicity: immunoglobulin G (IgG) geometric mean concentration (GMC)	Serotype-specific IgG GMCs	28 days post-vaccination (Day 29)
Adult Immunogenicity: Geometric Mean Fold Rise (GMFR)	Geometric Mean Fold Rise (GMFR) from baseline in serotype-specific IgG GMCs	28 days post-vaccination (Day 29)
Adult Immunogenicity: opsonophagocytosis assay (OPA) geometric mean titers (GMTs)	Serotype-specific OPA GMTs	28 days post-vaccination (Day 29)
Adult Immunogenicity: GMFR OPA GMTs	GMFR (from baseline) in serotype-specific OPA GMTs	28 days post-vaccination (Day 29)

Collaborators and Investigators

• Sponsor: Inventprise Inc.
• Collaborators: PATH; Canadian Center for Vaccinology; Vaccine Evaluation Center, Canada
• Investigators: Principal Investigator: Joanne Langley, MD, MSc, FRCPC, Canadian Center for Vaccinology

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CVIA 096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan to be defined at a later date
• IPD Sharing Time Frame: Plan to be defined at a later date
• IPD Sharing Access Criteria: Plan to be defined at a later date
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No