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NCT05982314 Clinical Trial

Extension Safety and Immunogenicity Study of GPNV-001

Pneumococcal Infections Clinical Trial

Official title:
A Safety and Immunogenicity Extension Study of GPNV-001

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05982314
Other study ID # GPNV-002
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 17, 2023
Est. completion date September 30, 2024

Study information
Verified date July 2023
Source GPN Vaccines
Contact Paul Rolan, MD
Phone +61 405 670 420
Email paul@gpnvaccines.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 69 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Gamma-PN3
Experimental whole-cell pneumococcal vaccine
• Pneumovax-23
Licensed pneumococcal vaccine
• Prevenar-13
Licensed pneumococcal vaccine
• Placebo
Saline placebo

Locations
Country Name City State
Australia University of Adelaide Adelaide South Australia

Sponsors (1)
Lead Sponsor Collaborator
GPN Vaccines

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum IgG titre to Gamma-PN3 Serum IgG titre to the vaccine 6 months and 12 months
Primary Serious adverse events Serious adverse events occurring after day 57 of study GPNV-001 6 months and 12 months
Secondary Opsonophagocytic antibodies to pneumococcal strains Serum OPA titres to up to 24 pneumococcal serotypes 6 months and 12 months
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