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

NCT06077656 | Completed Phase 2 Results

• 1 other identifier: CVIA 105
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 4

Brief Summary

Phase 2 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 (4)

• 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 Outcomes (5)

• Geometric Mean Concentration (GMC) of IgG by Timepoint and Group

  Baseline (Day 1) and 28 days post-vaccination (Day 29)

• Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group

  28 days post-vaccination (Day 29)

• Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29

  28 days post-vaccination (Day 29)

• OPA Geometric Mean Concentration Titer (GMT)

  Baseline (Day 1) and 28 days post-vaccination (Day 29)

• Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group

  From Baseline (Day 1) to 28 days post-vaccination (Day 29)

Study Arms (4)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Group C

EXPERIMENTAL

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

Group D

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 Formulation A BIOLOGICAL

25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant

Group A

IVT PCV-25 Formulation B BIOLOGICAL

25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant

Group B

IVT PCV-25 Formulation C BIOLOGICAL

25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant

Group C

PCV 20 BIOLOGICAL

20 valent pneumococcal conjugate vaccine

Group D

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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 (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.

Sponsors & Collaborators

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

Study Sites (4)

Inventprise Clinical Site

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Inventprise Clinical Site

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Inventprise Clinical Site

Truro, Nova Scotia, B2N IL2, Canada

Location

Inventprise Clinical Site

Saint-Louis, Quebec, G1W 4R4, 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 Mar 7;75:128236. doi: 10.1016/j.vaccine.2026.128236. Epub 2026 Jan 22.

  PMID: 41576705 DERIVED

Related Links

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Inventprise

CVIA105@inventprise.com

866-306-5554

Study Officials

• Sybil Tasker, MD, MPH, FIDSA

  Inventprise Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: Multicenter, randomized, active-controlled, observer-blind study to evaluate safety, tolerability, and immunogenicity of three formulations of IVT PCV-25 in which healthy adult participants will be randomized in a 4:3:2:2 ratio to receive 1 of 3 formulations or control.

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: October 25, 2023
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: March 17, 2026
• Results First Posted: March 17, 2026

Record last verified: 2026-02

Data Sharing

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

Locations

CA (4)