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Pneumococcal VaccinesPhase 1IVT PCV-25NCT05540028

Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine

A Phase 1 study testing IVT PCV-25 and PCV 20 in people with Pneumococcal Vaccines, run by Inventprise Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Pneumococcal Vaccines
What is being tested?
IVT PCV-25 and PCV 20
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteCanada
Study dates
28 Sep 2022to 31 Jul 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Canadian Center for Vaccinology, IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

Other trials in Canada

About this study

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)

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)

Read the 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™.

Being tested
IVT PCV-25, PCV 20

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVT PCV-25Biological

    25 valent pneumococcal conjugate vaccine

  • PCV 20Biological

    20 valent pneumococcal conjugate vaccine

Study groups in NCT05540028
Study groupRoleWhat they receive
Adult Cohort Group 1ExperimentalParticipants will receive a single 0.5mL dose of IVT PCV-25 administered by intramuscular injection on Day 1
Receives: Biological: IVT PCV-25
Adult Cohort Group 2Active comparatorParticipants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
Receives: Biological: PCV 20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adult Safety: solicited local and systemic adverse events

    Number and severity of solicited local and systemic adverse events (AEs)

    Measured: 7 days post-vaccination (Day 8)

  2. Adult Safety: clinically significant hematological and biochemical measurements

    Number, severity, and relatedness of clinically significant hematological and biochemical measurements

    Measured: 7 days post-vaccination (Day 8)

  3. Adult Safety: unsolicited adverse events

    Number, severity, and relatedness of all unsolicited AEs

    Measured: 28 days post-vaccination (Day 29)

  4. Adult Safety: related serious adverse events

    Number, severity, and relatedness of serious adverse events (SAEs)

    Measured: through 6 months post last vaccination (Day 169)

  5. Adult Safety: newly diagnosed chronic medical conditions

    Number of newly diagnosed chronic medical conditions

    Measured: through 6 months post last vaccination (Day 169)

Secondary outcomes (4)

  1. Adult Immunogenicity: immunoglobulin G (IgG) geometric mean concentration (GMC)

    Serotype-specific IgG GMCs

    Measured: 28 days post-vaccination (Day 29)

  2. Adult Immunogenicity: Geometric Mean Fold Rise (GMFR)

    Geometric Mean Fold Rise (GMFR) from baseline in serotype-specific IgG GMCs

    Measured: 28 days post-vaccination (Day 29)

  3. Adult Immunogenicity: opsonophagocytosis assay (OPA) geometric mean titers (GMTs)

    Serotype-specific OPA GMTs

    Measured: 28 days post-vaccination (Day 29)

  4. Adult Immunogenicity: GMFR OPA GMTs

    GMFR (from baseline) in serotype-specific OPA GMTs

    Measured: 28 days post-vaccination (Day 29)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2022
  2. Study start28 Sep 2022
  3. Primary completion31 Jul 2023
  4. Study completion31 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05540028
Sponsor's protocol ID
CVIA 096
Acronym
IVT PCV-25
Status last verified
Aug 2023
First submitted
9 Sep 2022
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Plan to be defined at a later date

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.

    PubMed 41576705

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IVT PCV-25 and PCV 20 in people with Pneumococcal Vaccines, run by Inventprise Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adult Safety: solicited local and systemic adverse events (time frame: 7 days post-vaccination (Day 8)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05540028, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.

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