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

Inventprise

Status and phase: Active, not recruiting; Phase 2

Conditions: Pneumococcal Vaccines

Treatments: Biological: IVT PCV-25 Formulation B; Biological: IVT PCV-25 Formulation A; Biological: PCV 20; Biological: IVT PCV-25 Formulation C

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06077656

CVIA 105

Details and patient eligibility

About

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

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

220 participants in 4 patient groups

Group A

Experimental group

Description:

Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1

Treatment:

Biological: IVT PCV-25 Formulation A

Group B

Experimental group

Description:

Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1

Treatment:

Biological: IVT PCV-25 Formulation B

Group C

Experimental group

Description:

Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1

Treatment:

Biological: IVT PCV-25 Formulation C

Group D

Active Comparator group

Description:

Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1

Treatment:

Biological: PCV 20