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Completed

NCT Number: NCT05982314

Extension Safety and Immunogenicity Study of GPNV-001

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

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Adelaide

Adelaide, South Australia, 5005, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Gamma-PN3

Biological

Experimental whole-cell pneumococcal vaccine

Pneumovax-23

Biological

Licensed pneumococcal vaccine

Prevenar-13

Biological

Licensed pneumococcal vaccine

Placebo

Biological

Saline placebo

Primary outcomes

  1. Serum IgG titre to Gamma-PN3

    Time frame: 6 months and 12 months

    Serum IgG titre to the vaccine

  2. Serious adverse events

    Time frame: 6 months and 12 months

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

Secondary outcomes

  1. Opsonophagocytic antibodies to pneumococcal strains

    Time frame: 6 months and 12 months

    Serum OPA titres to up to 24 pneumococcal serotypes

Sponsors and collaborators

Lead sponsor

GPN Vaccines

Industry

Registry information

Official study title

A Safety and Immunogenicity Extension Study of GPNV-001

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2023
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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