Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine
- Conditions
- Pneumococcal Vaccines
- Interventions
- Biological: IVT PCV-25 Formulation CBiological: IVT PCV-25 Formulation ABiological: PCV 20Biological: IVT PCV-25 Formulation B
- Registration Number
- NCT06077656
- Lead Sponsor
- Inventprise Inc.
- Brief Summary
Phase 2 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)
- Detailed Description
A Phase 2 multicenter, randomized, active-controlled, observer-blind study to evaluate safety, tolerability, and immunogenicity of three formulations of IVT PCV-25, a 25 valent conjugated pneumococcal vaccine with adjuvant. Adult participants will be randomized in a 4:3:2:2 ratio to receive 1 of 3 formulations or control.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 220
- Healthy adults who are 18 through 49 years old on the day of randomization (Day 1).
- 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.
- 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 (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C IVT PCV-25 Formulation C Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1 Group A IVT PCV-25 Formulation A Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1 Group D PCV 20 Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1 Group B IVT PCV-25 Formulation B Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
- Primary Outcome Measures
Name Time Method Solicited local adverse events (AEs) 7 days post-vaccination (Day 8) Number and severity of solicited local AEs
Solicited systemic AEs 7 days post-vaccination (Day 8) Number and severity of solicited systemic AEs
Severe adverse events (SAEs) 6 months post-vaccination (Day 169) Number of SAEs
Unsolicited AEs 28 days post-vaccination (Day 29) Number and severity of unsolicited AEs
- Secondary Outcome Measures
Name Time Method IgG GMC ratio 28 days post-vaccination (Day 29) IgG GMC ratio between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific IgG GMCs
IgG geometric mean fold rise (GMFR) 28 days post-vaccination (Day 29) IgG GMFR as measured by serotype-specific IgG GMCs from baseline
IgG four-fold rise 28 days post-vaccination (Day 29) Percentage of participants with four-fold IgG GMC rise or greater as measured by serotype-specific IgG GMCs from baseline
IgG GMFR ratio 28 days post-vaccination (Day 29) IgG GMFR ratio between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific IgG GMCs
OPA geometric mean titer (GMT) Baseline (Day 1) and 28 days post-vaccination (Day 29) Serotype-specific OPA GMTs
OPA GMFR ratio 28 days post-vaccination (Day 29) OPA GMFR ratio between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific OPA GMTs
Immunoglobulin G (IgG) geometric mean concentration (GMC) Baseline (Day 1) and 28 days post-vaccination (Day 29) Serotype-specific IgG GMCs
OPA GMFR 28 days post-vaccination (Day 29) OPA GMFR between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific OPA GMTs from baseline
OPA GMT ratio 28 days post-vaccination (Day 29) OPA GMT ratio between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific OPA GMTs
Trial Locations
- Locations (1)
Inventprise Clinical Site
🇨🇦Saint Louis, Quebec, Canada