ClinicalTrials.gg
CompletedNCT05540028IVT PCV-25Updated Aug 30, 2023

Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine

A Phase 1 interventional study of IVT PCV-25 and PCV 20 in Pneumococcal Vaccines, sponsored by Inventprise Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by Inventprise Inc. · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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™.

02

Conditions studied

  • Pneumococcal Vaccines
03

In context

Lead sponsor

Inventprise Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

  • Use of any 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 to any component of the study vaccines.
  • Known or suspected allergy to PEG.
  • History of angioedema.
  • Any abnormal vital sign deemed 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 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 . 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 (HIV)-1 or HIV-2 (HIV 1/2 Ab), (HBsAg) or (HCV Ab).
  • History of , 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
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Adult Cohort Group 1

    Participants will receive a single 0.5mL dose of IVT PCV-25 administered by intramuscular injection on Day 1

    Biological: IVT PCV-25

  • Active comparator
    Adult Cohort Group 2

    Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1

    Biological: PCV 20

Interventions

  • BiologicalIVT PCV-25

    25 valent pneumococcal conjugate vaccine

  • BiologicalPCV 20

    20 valent pneumococcal conjugate vaccine

06

What researchers measure

Primary outcomes

  1. Adult Safety: solicited local and systemic adverse events

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

    Time frame: 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

    Time frame: 7 days post-vaccination (Day 8)

  3. Adult Safety: unsolicited adverse events

    Number, severity, and relatedness of all unsolicited AEs

    Time frame: 28 days post-vaccination (Day 29)

  4. Adult Safety: related serious adverse events

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

    Time frame: through 6 months post last vaccination (Day 169)

  5. Adult Safety: newly diagnosed chronic medical conditions

    Number of newly diagnosed chronic medical conditions

    Time frame: through 6 months post last vaccination (Day 169)

Secondary outcomes

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

    Serotype-specific IgG GMCs

    Time frame: 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

    Time frame: 28 days post-vaccination (Day 29)

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

    Serotype-specific OPA GMTs

    Time frame: 28 days post-vaccination (Day 29)

  4. Adult Immunogenicity: GMFR OPA GMTs

    GMFR (from baseline) in serotype-specific OPA GMTs

    Time frame: 28 days post-vaccination (Day 29)

07

Study locations

1 site
  • Canadian Center for Vaccinology, IWK Health Centre
    Halifax, Nova Scotia B3K 6R8, Canada
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — Plan to be defined at a later date

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Plan to be defined at a later date

Access criteria: Plan to be defined at a later date

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2022 to primary completion in Jul 2023, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2022
First posted
Sep 14, 2022
StartActual
Sep 28, 2022
Primary completionActual
Jul 31, 2023
CompletionActual
Jul 31, 2023
Last update
Aug 30, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05540028
Lead sponsor
Inventprise Inc.
Collaborators
Canadian Center for Vaccinology, Vaccine Evaluation Center, Canada, PATH
Responsible party
Sponsor
First posted
Sep 14, 2022
Start date
Sep 28, 2022
Primary completion
Jul 31, 2023
Completion
Jul 31, 2023
Last update
Aug 30, 2023

Study contacts

Joanne Langley, MD, MSc, FRCPC
principal investigator · Canadian Center for Vaccinology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion