Clinical trial NCT05540028: Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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: 2022-09-14
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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)

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™.

Eligibility criteria: 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

Primary outcomes:
measure: Adult Safety: solicited local and systemic adverse events
timeFrame: 7 days post-vaccination (Day 8)
measure: Adult Safety: clinically significant hematological and biochemical measurements
timeFrame: 7 days post-vaccination (Day 8)
measure: Adult Safety: unsolicited adverse events
timeFrame: 28 days post-vaccination (Day 29)
measure: Adult Safety: related serious adverse events
timeFrame: through 6 months post last vaccination (Day 169)
measure: Adult Safety: newly diagnosed chronic medical conditions
timeFrame: through 6 months post last vaccination (Day 169)
Secondary outcomes:
measure: Adult Immunogenicity: immunoglobulin G (IgG) geometric mean concentration (GMC)
timeFrame: 28 days post-vaccination (Day 29)
measure: Adult Immunogenicity: Geometric Mean Fold Rise (GMFR)
timeFrame: 28 days post-vaccination (Day 29)
measure: Adult Immunogenicity: opsonophagocytosis assay (OPA) geometric mean titers (GMTs)
timeFrame: 28 days post-vaccination (Day 29)
measure: Adult Immunogenicity: GMFR OPA GMTs
timeFrame: 28 days post-vaccination (Day 29)
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology, IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: Canadian Center for Vaccinology
name: Joanne Langley, MD, MSc, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: