Extension Safety and Immunogenicity Study of GPNV-001

GPN Vaccines

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pneumococcal Infections

Treatments: Biological: Prevenar-13; Biological: Pneumovax-23; Biological: Placebo; Biological: Gamma-PN3

Study type: Interventional

Funder types: Industry

Identifiers

NCT05982314

GPNV-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 6 patient groups, including a placebo group

Gamma-PN3 50 mcg

Experimental group

Description:

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

Treatment:

Biological: Gamma-PN3

Gamma-PN3 250 mcg

Experimental group

Description:

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

Treatment:

Biological: Gamma-PN3

Gamma-PN3 1000 mcg

Experimental group

Description:

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

Treatment:

Biological: Gamma-PN3

Pneumovax 23

Active Comparator group

Description:

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

Treatment:

Biological: Pneumovax-23

Prevenar-13

Active Comparator group

Description:

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

Treatment:

Biological: Prevenar-13

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo