Clinical trial NCT06077656: Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pneumococcal Vaccines
Lead sponsor: Inventprise Inc.
Sponsor class: INDUSTRY
Collaborators: name: Canadian Center for Vaccinology
name: Vaccine Evaluation Center, Canada
name: PATH
First posted: 2023-10-11
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief summary: Phase 2 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Solicited local adverse events (AEs)
timeFrame: 7 days post-vaccination (Day 8)
measure: Solicited systemic AEs
timeFrame: 7 days post-vaccination (Day 8)
measure: Unsolicited AEs
timeFrame: 28 days post-vaccination (Day 29)
measure: Severe adverse events (SAEs)
timeFrame: 6 months post-vaccination (Day 169)
Secondary outcomes:
measure: Immunoglobulin G (IgG) geometric mean concentration (GMC)
timeFrame: Baseline (Day 1) and 28 days post-vaccination (Day 29)
measure: IgG geometric mean fold rise (GMFR)
timeFrame: 28 days post-vaccination (Day 29)
measure: IgG four-fold rise
timeFrame: 28 days post-vaccination (Day 29)
measure: IgG GMC ratio
timeFrame: 28 days post-vaccination (Day 29)
measure: IgG GMFR ratio
timeFrame: 28 days post-vaccination (Day 29)
measure: OPA geometric mean titer (GMT)
timeFrame: Baseline (Day 1) and 28 days post-vaccination (Day 29)
measure: OPA GMFR
timeFrame: 28 days post-vaccination (Day 29)
measure: OPA GMT ratio
timeFrame: 28 days post-vaccination (Day 29)
measure: OPA GMFR ratio
timeFrame: 28 days post-vaccination (Day 29)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Inventprise Clinical Site
state: British Columbia
city: Halifax
country: Canada
facility: Inventprise Clinical Site
state: Nova Scotia
city: Truro
country: Canada
facility: Inventprise Clinical Site
state: Nova Scotia
city: Saint Louis
country: Canada
facility: Inventprise Clinical Site
state: Quebec
Study officials:
affiliation: Inventprise Inc.
name: Sybil Tasker, MD, MPH, FIDSA
role: STUDY_DIRECTOR
References: