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Extension Safety and Immunogenicity Study of GPNV-001

PHASE1PHASE2RECRUITING

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

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Study details:

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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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-07-17

Primary completion: 2024-09-30

Study completion finish: 2024-09-30

Study type

PREVENTION

Phase

PHASE1

PHASE2

Trial ID

NCT05982314

Intervention or treatment

BIOLOGICAL: Gamma-PN3

BIOLOGICAL: Pneumovax-23

BIOLOGICAL: Prevenar-13

BIOLOGICAL: Placebo

Conditions

• Pneumococcal Infections

Image related to Pneumococcal Infections

Condition: Pneumococcal Infections
BIOLOGICAL: Gamma-PN3 and other drugs
Adelaide, South Australia, Australia
Sponsor: GPN Vaccines

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

University of Adelaide

Research sites nearby

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University of Adelaide
Adelaide, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Extension Safety and Immunogenicity Study of GPNV-001