Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine

A Phase 2, Multicenter, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults

Phase 2 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: PCV 20; Biological: IVT PCV-25 Formulation A; Biological: IVT PCV-25 Formulation B; Biological: IVT PCV-25 Formulation C

Detailed Description

A Phase 2 multicenter, randomized, active-controlled, observer-blind study to evaluate safety, tolerability, and immunogenicity of three formulations of IVT PCV-25, a 25 valent conjugated pneumococcal vaccine with adjuvant. Adult participants will be randomized in a 4:3:2:2 ratio to receive 1 of 3 formulations or control.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4H4
      • Inventprise Clinical Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Inventprise Clinical Site
    • Truro, Nova Scotia, Canada, B2N IL2
      • Inventprise Clinical Site
  • Quebec
    • Saint-Louis, Quebec, Canada, G1W 4R4
      • Inventprise Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adults who are 18 through 49 years old on the day of randomization (Day 1).
• Participant must provide voluntary written informed consent to participate in the study.
• Participant must be able to comprehend and comply with study requirements and procedures and be willing and able to return for all scheduled follow-up visits.
• Adult female participants who are not surgically sterile must have a negative pregnancy test at screening and negative pregnancy test prior to vaccination and must agree to employ a highly effective method to avoid pregnancy through Day 57 of the study.

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 (including angioedema) or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines, including PEG.
• Any abnormal vital sign deemed clinically relevant by the PI.
• Acute illness at time of randomization (moderate or severe) and/or fever (body temperature of ≥ 38.0°C)
• History of any non-study vaccine administration within 14 days of study vaccine administration.
• No planned vaccines until after Day 29 (Visit 3).
• 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), 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.
• Any medical or social condition that in the opinion of the PI , may interfere with the study objectives, pose a risk to the participant, or prevent the participant from completing the study follow-up.
• Any screening laboratory test result outside the normal range and with toxicity score ≥ 2, unless allowed by study team.
• 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 participants who are pregnant or breastfeeding.
• Participant is an employee of, or direct descendant (child or grandchild) of any person employed by the Sponsor, PATH, the Contract Research Organization (CRO), the PI.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1	Biological: IVT PCV-25 Formulation A; 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
Experimental: Group B; Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1	Biological: IVT PCV-25 Formulation B; 25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
Experimental: Group C; Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1	Biological: IVT PCV-25 Formulation C; 25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
Active Comparator: Group D; 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
Solicited Local Adverse Events (AEs)	Number and severity of solicited local AEs (redness, swelling, and pain at the injection site) by group	7 days post-vaccination (Day 8)
Solicited Systemic AEs	Number and severity of solicited systemic AEs within 7 days after vaccination by group	7 days post-vaccination (Day 8)
Unsolicited AEs	Number and severity of unsolicited AEs within 28 days after vaccination by group	28 days post-vaccination (Day 29)
Severe Adverse Events (SAEs)	Number of SAEs within 6 months after vaccination by group	6 months post-vaccination (Day 169)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group	Geometric mean concentrations (GMC) of serotype-specific IgG at Day 1 and Day 29 by group	Baseline (Day 1) and 28 days post-vaccination (Day 29)
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group	Geometric Mean Fold Rise in serotype specific IgG GMC's from baseline (D1) to Day 29 after vaccination by group	28 days post-vaccination (Day 29)
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29	Percentage of participants achieving a > 4-fold IgG rise from baseline to Day 29 by treatment group	28 days post-vaccination (Day 29)
OPA Geometric Mean Concentration Titer (GMT)	Geometric mean titer of serotype-specific OPA antibodies by group and timepoint	Baseline (Day 1) and 28 days post-vaccination (Day 29)
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group	Geometric mean fold rise (GMFR) of serotype-specific OPA antibodies from baseline to 28 days post-vaccination by group	From Baseline (Day 1) to 28 days post-vaccination (Day 29)

Collaborators and Investigators

• Sponsor: Inventprise Inc.
• Collaborators: PATH; Canadian Center for Vaccinology; Vaccine Evaluation Center, Canada
• Investigators: Study Director: Sybil Tasker, MD, MPH, FIDSA, Inventprise Inc.

Publications and helpful links

General Publications

• 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 Mar 7;75:128236. doi: 10.1016/j.vaccine.2026.128236. Epub 2026 Jan 22.

Helpful Links

• Safety and immunogenicity of a 25-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive healthy adults: Results from 2 randomised, controlled clinical trials

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Actual): May 24, 2024
• Study Completion (Actual): May 24, 2024

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CVIA 105

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

Drug and device information, study documents

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