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Extension Safety and Immunogenicity Study of GPNV-001

NCT ID: NCT05982314

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-17

Study Completion Date

2024-08-30

Brief Summary

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A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine.

Detailed Description

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A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine. Up to 20 participants per cohort will be invited.

Conditions

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Pneumococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gamma-PN3 50 mcg

In GPNV-001 participants will have received 2 doses of 50 mcg Gamma-PN3 at intervals of 4 weeks

Group Type EXPERIMENTAL

Gamma-PN3

Intervention Type BIOLOGICAL

Experimental whole-cell pneumococcal vaccine

Gamma-PN3 250 mcg

In GPNV-001 participants will have received 2 doses of 250 mcg Gamma-PN3 at intervals of 4 weeks

Group Type EXPERIMENTAL

Gamma-PN3

Intervention Type BIOLOGICAL

Experimental whole-cell pneumococcal vaccine

Gamma-PN3 1000 mcg

In GPNV-001 participants will have received 2 doses of 1000 mcg Gamma-PN3 at intervals of 4 weeks

Group Type EXPERIMENTAL

Gamma-PN3

Intervention Type BIOLOGICAL

Experimental whole-cell pneumococcal vaccine

Pneumovax 23

In GPNV-001 participants will have received one 0.5ml dose of Pneumovax-23 followed by saline placebo 4 weeks later

Group Type ACTIVE_COMPARATOR

Pneumovax-23

Intervention Type BIOLOGICAL

Licensed pneumococcal vaccine

Prevenar-13

In GPNV-001 participants will have received one 0.5ml dose of Prevenar-13 followed by saline placebo 4 weeks later

Group Type ACTIVE_COMPARATOR

Prevenar-13

Intervention Type BIOLOGICAL

Licensed pneumococcal vaccine

Placebo

In GPNV-001 participants will have received two doses of 0.5 ml saline placebo at intervals of 4 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Saline placebo

Interventions

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Gamma-PN3

Experimental whole-cell pneumococcal vaccine

Intervention Type BIOLOGICAL

Pneumovax-23

Licensed pneumococcal vaccine

Intervention Type BIOLOGICAL

Prevenar-13

Licensed pneumococcal vaccine

Intervention Type BIOLOGICAL

Placebo

Saline placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Completion of study GPNV-001 as per protocol with no significant deviations.
2. Has provided written informed consent.

Exclusion Criteria

1. Potential participants will be excluded if they have received a pneumococcal vaccine since the end of study visit for study GPNV-001
2. A potential participant has had an episode of pneumonia since completing Study GPNV-001
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GPN Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Adelaide

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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GPNV-002

Identifier Type: -

Identifier Source: org_study_id