Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-01 @ 7:48 AM
Study NCT ID:
NCT01764256
Status:
COMPLETED
Last Update Posted:
2019-03-12
First Post:
2013-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine
Sponsor:
PATH
Organization:
Study Overview
Official Title:
A Phase 1 Double Blinded, Randomized, Placebo-controlled Dose Escalation Study to Examine the Safety, Reactogenicity, Tolerability and Immunogenicity of the P2-VP8 Subunit Rotavirus Vaccine in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult volunteers to determine if it is safe and if the immune systems of healthy adults respond to this vaccine.
Detailed Description:
The trial will be a double-blinded, randomized, placebo-controlled dose-escalation study in which three dose-levels of vaccine will be tested in adults. Cohorts of 16 individuals (12 vaccine recipients and 4 placebo recipients) per dose level will receive three intramuscular injections four weeks apart. The three dose levels of vaccine to test will be 10 microgram (μg), 30 μg and 60 μg.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: