Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine
Study Details
Study Description
Brief Summary
Phase 2 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1 |
Biological: IVT PCV-25 Formulation A
25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
|
| Experimental: Group B Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1 |
Biological: IVT PCV-25 Formulation B
25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
|
| Experimental: Group C Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1 |
Biological: IVT PCV-25 Formulation C
25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
|
| Active Comparator: Group D Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1 |
Biological: PCV 20
20 valent pneumococcal conjugate vaccine
|
Outcome Measures
Primary Outcome Measures
- 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
- Unsolicited AEs [28 days post-vaccination (Day 29)]
Number and severity of unsolicited AEs
- Severe adverse events (SAEs) [6 months post-vaccination (Day 169)]
Number of SAEs
Secondary Outcome Measures
- Immunoglobulin G (IgG) geometric mean concentration (GMC) [Baseline (Day 1) and 28 days post-vaccination (Day 29)]
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 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 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 [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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy adults who are 18 through 49 years old on the day of randomization (Day 1).
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Participant must provide voluntary written informed consent to participate in the study.
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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.
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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:
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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.
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Adults who have previously been vaccinated against S. pneumoniae.
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History of microbiologically confirmed invasive disease caused by S. pneumoniae.
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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.
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Any abnormal vital sign deemed clinically relevant by the PI.
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Acute illness at time of randomization (moderate or severe) and/or fever (body temperature of ≥ 38.0°C)
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History of any non-study vaccine administration within 14 days of study vaccine administration.
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No planned vaccines until after Day 29 (Visit 3).
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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.
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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.
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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.
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Any screening laboratory test result outside the normal range and with toxicity score ≥ 2, unless allowed by study team.
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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).
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History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ.
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Recent history (within the past year) or signs of alcohol or substance abuse.
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History of major psychiatric disorder.
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Female adult participants who are pregnant or breastfeeding.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inventprise Clinical Site | Vancouver | British Columbia | Canada | V5Z 4H4 |
| 2 | Inventprise Clinical Site | Halifax | Nova Scotia | Canada | B3K 6R8 |
| 3 | Inventprise Clinical Site | Truro | Nova Scotia | Canada | B2N IL2 |
| 4 | Inventprise Clinical Site | Saint Louis | Quebec | Canada | G1W 4R4 |
Sponsors and Collaborators
- Inventprise Inc.
- Canadian Center for Vaccinology
- Vaccine Evaluation Center, Canada
- PATH
Investigators
- Study Director: Sybil Tasker, MD, MPH, FIDSA, Inventprise Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CVIA 105