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

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ClinicalTrials.gov Identifier: NCT02868073
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Vaxart

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

Condition or disease Intervention/treatment Phase
Norovirus Gastroenteritis Biological: VXA-G1.1-NN (high dose) Oral Vaccine Tablet Other: VXA Placebo Tablets Biological: VXA-G1.1-NN (low dose) Oral Vaccine Tablet Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : July 29, 2016
Actual Primary Completion Date : October 5, 2016
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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 Name: H1N1 (high dose) Oral Vaccine Tablet

Experimental: 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.
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.
Other Name: H1N1 (low dose) Oral Vaccine Tablet

Placebo Comparator: 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.
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.
Other Name: Placebo Control




Primary Outcome Measures :
  1. Incidence of Treatment Emergent Solicited and Unsolicited Adverse Events [ Time Frame: Day 1 thru Day 28 ]
    Solicited Symptoms of Reactogenicity (thru Day 8); unsolicited Adverse Events thru Day 28 post vaccination



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868073


Locations
United States, Nebraska
Celerion, Inc.
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Vaxart
Investigators
Principal Investigator: Laura Sterling, MD, PhD Celerion

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vaxart
ClinicalTrials.gov Identifier: NCT02868073     History of Changes
Other Study ID Numbers: VXA-G11-101
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs