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

NCT ID: NCT02868073

Last Updated: 2018-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-29
• Study Completion Date: 2017-10-01

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

Detailed 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.

Conditions

Norovirus Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

H1N1 (high dose) Oral Vaccine Tablet

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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

H1N1 (low dose) Oral Vaccine Tablet

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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

Placebo Tablets

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.

Group Type: PLACEBO_COMPARATOR

VXA Placebo Tablets

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: OTHER

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

H1N1 (high dose) Oral Vaccine Tablet; Placebo Control; H1N1 (low dose) Oral Vaccine Tablet

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vaxart

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Sterling, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Celerion

Locations

Celerion, Inc.

Lincoln, Nebraska, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29997294 (View on PubMed)

Other Identifiers

VXA-G11-101

Identifier Type: -

Identifier Source: org_study_id