NCT01764256

A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rotavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	P2-VP8 subunit rotavirus vaccine	P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration.
OTHER	placebo	Sodium Chloride 0.9%, USP for Injection was used to dilute the active P2-VP8 vaccine to final dosing concentration and was used for the Placebo for the study.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-06-01
• Completion: 2013-09-01
• First posted: 2013-01-09
• Last updated: 2019-03-12
• Results posted: 2019-02-15

Locations

1 site across 1 country: United States