Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine

Norovirus Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868073
• Other study ID #: VXA-G11-101
• Status: Completed
• Phase: Phase 1
• Start date: July 29, 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: May 2018
• Source: Vaxart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The study will enroll 66 subjects in four cohorts. All subjects will receive a single administration of VXA-G1.1-NN at a low dose, a high dose or placebo.

Two sentinel groups will enroll 3 subjects each in an open-label manner (Cohorts 1 and 3) to receive VXA-G1.1-NN prior to enrolling either of the randomized, controlled cohorts (Cohorts 2 and 4). Within the double-blinded Cohorts (2 and 4), placebo subjects will receive the same number of tablets as the vaccine subjects in that Cohort. Subjects will be enrolled and dosed in the low dose groups prior to initiation of dosing in the high dose group.

Cohort 1: 3 subjects at low dose Cohort 2: 20 subjects at low dose and 10 placebo Cohort 3: 3 subjects at high dose Cohort 4: 20 subjects at low dose and 10 placebo

Subjects will be followed for 28 days post vaccination for preliminary immunogenicity. Subjects will continue to be followed for 1 year post-vaccination for long term safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 1, 2017
• Est. primary completion date: October 5, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

1. Male or female volunteers aged 18 - 49 years, inclusive

2. Able to give written informed consent

3. Healthy (no clinically significant health concerns)

4. Safety laboratory values within the following range criteria normal range

5. Body mass index between 17 and 35 at screening

Exclusion Criteria:

1. Receipt of any investigational norovirus vaccine within two years prior to study

2. Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination

3. Administration of any licensed vaccine within 30 days prior to study

4. 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

5. History of drug, alcohol or chemical abuse within 1 year prior to vaccination

6. Presence of a fever = 38oC measured orally at baseline

7. Stool sample with occult blood at screening -

Related Conditions & MeSH terms

• Gastroenteritis
• Norovirus Gastroenteritis

Intervention

Biological:
• VXA-G1.1-NN (high dose) Oral Vaccine Tablet
The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high dose.

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

Biological:
• VXA-G1.1-NN (low dose) Oral Vaccine Tablet
The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the low dose.

Locations

Country	Name	City	State
United States	Celerion, Inc.	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Vaxart

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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