Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine
Phase 1
Completed
- Conditions
- Pneumococcal Vaccines
- Interventions
- Biological: IVT PCV-25Biological: PCV 20
- Registration Number
- NCT05540028
- Lead Sponsor
- Inventprise Inc.
- 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™.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adult Cohort Group 1 IVT PCV-25 Participants will receive a single 0.5mL dose of IVT PCV-25 administered by intramuscular injection on Day 1 Adult Cohort Group 2 PCV 20 Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
- Primary Outcome Measures
Name Time Method Adult Safety: solicited local and systemic adverse events 7 days post-vaccination (Day 8) Number and severity of solicited local and systemic adverse events (AEs)
Adult Safety: unsolicited adverse events 28 days post-vaccination (Day 29) Number, severity, and relatedness of all unsolicited AEs
Adult Safety: newly diagnosed chronic medical conditions through 6 months post last vaccination (Day 169) Number of newly diagnosed chronic medical conditions
Adult Safety: clinically significant hematological and biochemical measurements 7 days post-vaccination (Day 8) Number, severity, and relatedness of clinically significant hematological and biochemical measurements
Adult Safety: related serious adverse events through 6 months post last vaccination (Day 169) Number, severity, and relatedness of serious adverse events (SAEs)
- Secondary Outcome Measures
Name Time Method Adult Immunogenicity: Geometric Mean Fold Rise (GMFR) 28 days post-vaccination (Day 29) Geometric Mean Fold Rise (GMFR) from baseline in serotype-specific IgG GMCs
Adult Immunogenicity: opsonophagocytosis assay (OPA) geometric mean titers (GMTs) 28 days post-vaccination (Day 29) Serotype-specific OPA GMTs
Adult Immunogenicity: immunoglobulin G (IgG) geometric mean concentration (GMC) 28 days post-vaccination (Day 29) Serotype-specific IgG GMCs
Adult Immunogenicity: GMFR OPA GMTs 28 days post-vaccination (Day 29) GMFR (from baseline) in serotype-specific OPA GMTs
Trial Locations
- Locations (1)
Canadian Center for Vaccinology, IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada