Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine

Pneumococcal Vaccines Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06077656
• Other study ID #: CVIA 105
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 25, 2023
• Est. completion date: May 24, 2024

Study information

• Verified date: December 2023
• Source: Inventprise Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 2 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: May 24, 2024
• Est. primary completion date: May 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• 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.

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 (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.

Related Conditions & MeSH terms

• Pneumococcal Vaccines

Intervention

Biological:
• 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

Locations

Country	Name	City	State
Canada	Inventprise Clinical Site	Halifax	Nova Scotia
Canada	Inventprise Clinical Site	Saint Louis	Quebec
Canada	Inventprise Clinical Site	Truro	Nova Scotia
Canada	Inventprise Clinical Site	Vancouver	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Inventprise Inc.	Canadian Center for Vaccinology, PATH, Vaccine Evaluation Center, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Solicited local adverse events (AEs)	Number and severity of solicited local AEs	7 days post-vaccination (Day 8)
Primary	Solicited systemic AEs	Number and severity of solicited systemic AEs	7 days post-vaccination (Day 8)
Primary	Unsolicited AEs	Number and severity of unsolicited AEs	28 days post-vaccination (Day 29)
Primary	Severe adverse events (SAEs)	Number of SAEs	6 months post-vaccination (Day 169)
Secondary	Immunoglobulin G (IgG) geometric mean concentration (GMC)	Serotype-specific IgG GMCs	Baseline (Day 1) and 28 days post-vaccination (Day 29)
Secondary	IgG geometric mean fold rise (GMFR)	IgG GMFR as measured by serotype-specific IgG GMCs from baseline	28 days post-vaccination (Day 29)
Secondary	IgG four-fold rise	Percentage of participants with four-fold IgG GMC rise or greater as measured by serotype-specific IgG GMCs from baseline	28 days post-vaccination (Day 29)
Secondary	IgG GMC ratio	IgG GMC ratio between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific IgG GMCs	28 days post-vaccination (Day 29)
Secondary	IgG GMFR ratio	IgG GMFR ratio between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific IgG GMCs	28 days post-vaccination (Day 29)
Secondary	OPA geometric mean titer (GMT)	Serotype-specific OPA GMTs	Baseline (Day 1) and 28 days post-vaccination (Day 29)
Secondary	OPA GMFR	OPA GMFR between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific OPA GMTs from baseline	28 days post-vaccination (Day 29)
Secondary	OPA GMT ratio	OPA GMT ratio between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific OPA GMTs	28 days post-vaccination (Day 29)
Secondary	OPA GMFR ratio	OPA GMFR ratio between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific OPA GMTs	28 days post-vaccination (Day 29)