Extension Safety and Immunogenicity Study of GPNV-001

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

Detailed Description
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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.

Official Title
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A Safety and Immunogenicity Extension Study of GPNV-001

Conditions
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Pneumococcal Infections

Intervention / Treatment
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* Biological: Gamma-PN3
* Biological: Pneumovax-23
* Biological: Prevenar-13
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum IgG titre to Gamma-PN3 | Serum IgG titre to the vaccine | 6 months and 12 months | 
| Serious adverse events | Serious adverse events occurring after day 57 of study GPNV-001 | 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opsonophagocytic antibodies to pneumococcal strains | Serum OPA titres to up to 24 pneumococcal serotypes | 6 months and 12 months |