Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine
NCT ID: NCT06077656
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
220 participants
INTERVENTIONAL
2023-10-25
2024-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group A
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
IVT PCV-25 Formulation A
25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
Group B
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
IVT PCV-25 Formulation B
25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
Group C
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
IVT PCV-25 Formulation C
25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
Group D
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
PCV 20
20 valent pneumococcal conjugate vaccine
Interventions
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IVT PCV-25 Formulation A
25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
IVT PCV-25 Formulation B
25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
IVT PCV-25 Formulation C
25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
PCV 20
20 valent pneumococcal conjugate vaccine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
49 Years
ALL
Yes
Sponsors
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Canadian Center for Vaccinology
OTHER
Vaccine Evaluation Center, Canada
OTHER
PATH
OTHER
Inventprise Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sybil Tasker, MD, MPH, FIDSA
Role: STUDY_DIRECTOR
Inventprise Inc.
Locations
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Inventprise Clinical Site
Vancouver, British Columbia, Canada
Inventprise Clinical Site
Halifax, Nova Scotia, Canada
Inventprise Clinical Site
Truro, Nova Scotia, Canada
Inventprise Clinical Site
Saint-Louis, Quebec, Canada
Countries
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Other Identifiers
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CVIA 105
Identifier Type: -
Identifier Source: org_study_id