Pneumococcal Infections
Conditions
Brief summary
A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine.
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.
Interventions
BIOLOGICALGamma-PN3
Experimental whole-cell pneumococcal vaccine
BIOLOGICALPneumovax-23
Licensed pneumococcal vaccine
BIOLOGICALPrevenar-13
Licensed pneumococcal vaccine
BIOLOGICALPlacebo
Saline placebo
Sponsors
GPN Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum IgG titre to Gamma-PN3 | 6 months and 12 months | Serum IgG titre to the vaccine |
| Serious adverse events | 6 months and 12 months | Serious adverse events occurring after day 57 of study GPNV-001 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opsonophagocytic antibodies to pneumococcal strains | 6 months and 12 months | Serum OPA titres to up to 24 pneumococcal serotypes |
Countries
Australia
Outcome results
None listed