NCT02868073

Brief Summary

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

August 11, 2016

Last Update Submit

May 29, 2018

Conditions

Norovirus Gastroenteritis

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment Emergent Solicited and Unsolicited Adverse Events

    Solicited Symptoms of Reactogenicity (thru Day 8); unsolicited Adverse Events thru Day 28 post vaccination

    Day 1 thru Day 28

Study Arms (3)

H1N1 (high dose) Oral Vaccine Tablet

EXPERIMENTAL

Singe dose of orally administered VXA-G1.1-NN (high dose) Oral Vaccine Tablet. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk.

Biological: VXA-G1.1-NN (high dose) Oral Vaccine Tablet

H1N1 (low dose) Oral Vaccine Tablet

EXPERIMENTAL

Singe dose of orally administered VXA-G1.1-NN (low dose) Oral Vaccine Tablet. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk.

Biological: VXA-G1.1-NN (low dose) Oral Vaccine Tablet

Placebo Tablets

PLACEBO COMPARATOR

Singe dose of VXA Placebo tablets. The placebo tablets are small off-white tablets that are similar in size and number to the active vaccine dose being delivered.

Other: VXA Placebo Tablets

Interventions

VXA-G1.1-NN (high dose) Oral Vaccine TabletBIOLOGICAL

The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high dose.

Also known as: H1N1 (high dose) Oral Vaccine Tablet
H1N1 (high dose) Oral Vaccine Tablet
VXA Placebo TabletsOTHER

The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.

Also known as: Placebo Control
Placebo Tablets
VXA-G1.1-NN (low dose) Oral Vaccine TabletBIOLOGICAL

The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the low dose.

Also known as: H1N1 (low dose) Oral Vaccine Tablet
H1N1 (low dose) Oral Vaccine Tablet

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female volunteers aged 18 - 49 years, inclusive
  • Able to give written informed consent
  • Healthy (no clinically significant health concerns)
  • Safety laboratory values within the following range criteria normal range
  • Body mass index between 17 and 35 at screening

You may not qualify if:

  • Receipt of any investigational norovirus vaccine within two years prior to study
  • Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination
  • Administration of any licensed vaccine within 30 days prior to study
  • Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline
  • History of drug, alcohol or chemical abuse within 1 year prior to vaccination
  • Presence of a fever ≥ 38oC measured orally at baseline
  • Stool sample with occult blood at screening -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Location

Related Publications (1)

  • Kim L, Liebowitz D, Lin K, Kasparek K, Pasetti MF, Garg SJ, Gottlieb K, Trager G, Tucker SN. Safety and immunogenicity of an oral tablet norovirus vaccine, a phase I randomized, placebo-controlled trial. JCI Insight. 2018 Jul 12;3(13):e121077. doi: 10.1172/jci.insight.121077.

    PMID: 29997294DERIVED

MeSH Terms

Interventions

Vaccines

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • Laura Sterling, MD, PhD

    Celerion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

July 29, 2016

Primary Completion

October 5, 2016

Study Completion

October 1, 2017

Last Updated

May 31, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)