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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gamma-PN3 50 mcg | Experimental | In GPNV-001 participants will have received 2 doses of 50 mcg Gamma-PN3 at intervals of 4 weeks |
|
| Gamma-PN3 250 mcg | Experimental | In GPNV-001 participants will have received 2 doses of 250 mcg Gamma-PN3 at intervals of 4 weeks |
|
| Gamma-PN3 1000 mcg | Experimental | In GPNV-001 participants will have received 2 doses of 1000 mcg Gamma-PN3 at intervals of 4 weeks |
|
| Pneumovax 23 | Active Comparator | In GPNV-001 participants will have received one 0.5ml dose of Pneumovax-23 followed by saline placebo 4 weeks later |
|
| Prevenar-13 | Active Comparator | In GPNV-001 participants will have received one 0.5ml dose of Prevenar-13 followed by saline placebo 4 weeks later |
|
| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma-PN3 | Biological | Experimental whole-cell pneumococcal vaccine |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Opsonophagocytic antibodies to pneumococcal strains | Serum OPA titres to up to 24 pneumococcal serotypes | 6 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Adelaide | Adelaide | South Australia | 5005 | Australia |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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In GPNV-001 participants will have received two doses of 0.5 ml saline placebo at intervals of 4 weeks. |
|
| Pneumovax-23 | Biological | Licensed pneumococcal vaccine |
|
| Prevenar-13 | Biological | Licensed pneumococcal vaccine |
|
| Placebo | Biological | Saline placebo |
|
| D007239 | Infections |