Extension Safety and Immunogenicity Study of GPNV-001

GPN Vaccines60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Pneumococcal Infections

Interventions

Gamma-PN3BIOLOGICAL

Experimental whole-cell pneumococcal vaccine

Pneumovax-23BIOLOGICAL

Licensed pneumococcal vaccine

Prevenar-13BIOLOGICAL

Licensed pneumococcal vaccine

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Adelaide

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Serum IgG titre to Gamma-PN3

Serum IgG titre to the vaccine

Time frame: 6 months and 12 months

Serious adverse events

Serious adverse events occurring after day 57 of study GPNV-001

Time frame: 6 months and 12 months

Secondary Outcomes

Opsonophagocytic antibodies to pneumococcal strains

Serum OPA titres to up to 24 pneumococcal serotypes

Time frame: 6 months and 12 months

Data from ClinicalTrials.gov

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