Extension Safety and Immunogenicity Study of GPNV-001

• Sponsor: GPN Vaccines (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05982314
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 14.5
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Infections	Biological: Gamma-PN3; Biological: Pneumovax-23; Biological: Prevenar-13; Biological: Placebo	Phase 1/Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Safety and Immunogenicity Extension Study of GPNV-001
• Actual Study Start Date: Jul 17, 2023
• Anticipated Primary Completion Date: Sep 30, 2024
• Anticipated Study Completion Date: Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gamma-PN3 50 mcg In GPNV-001 participants will have received 2 doses of 50 mcg Gamma-PN3 at intervals of 4 weeks	Biological: Gamma-PN3; Experimental whole-cell pneumococcal vaccine
Experimental: Gamma-PN3 250 mcg In GPNV-001 participants will have received 2 doses of 250 mcg Gamma-PN3 at intervals of 4 weeks	Biological: Gamma-PN3; Experimental whole-cell pneumococcal vaccine
Experimental: Gamma-PN3 1000 mcg In GPNV-001 participants will have received 2 doses of 1000 mcg Gamma-PN3 at intervals of 4 weeks	Biological: Gamma-PN3; Experimental whole-cell pneumococcal vaccine
Active Comparator: Pneumovax 23 In GPNV-001 participants will have received one 0.5ml dose of Pneumovax-23 followed by saline placebo 4 weeks later	Biological: Pneumovax-23; Licensed pneumococcal vaccine
Active Comparator: Prevenar-13 In GPNV-001 participants will have received one 0.5ml dose of Prevenar-13 followed by saline placebo 4 weeks later	Biological: Prevenar-13; Licensed pneumococcal vaccine
Placebo Comparator: Placebo In GPNV-001 participants will have received two doses of 0.5 ml saline placebo at intervals of 4 weeks.	Biological: Placebo; Saline placebo

Outcome Measures

Primary Outcome Measures

1. Serum IgG titre to Gamma-PN3 [6 months and 12 months]

   Serum IgG titre to the vaccine

2. Serious adverse events [6 months and 12 months]

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

Secondary Outcome Measures

1. Opsonophagocytic antibodies to pneumococcal strains [6 months and 12 months]

   Serum OPA titres to up to 24 pneumococcal serotypes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Adelaide	Adelaide	South Australia	Australia	5005

Sponsors and Collaborators

• GPN Vaccines

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GPN Vaccines
• ClinicalTrials.gov Identifier: NCT05982314
• Other Study ID Numbers: GPNV-002
• First Posted: Aug 8, 2023
• Last Update Posted: Aug 8, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumococcal Infections; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

No Results Posted as of Aug 8, 2023