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Completed

NCT Number: NCT02868073

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

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

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Key information

Conditions

Norovirus Gastroenteritis

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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 -

Treatment and study plan

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

Biological

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

Other names: H1N1 (high dose) Oral Vaccine Tablet

VXA Placebo Tablets

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.

Other names: Placebo Control

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

Biological

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

Other names: H1N1 (low dose) Oral Vaccine Tablet

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vaxart

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Aug 16, 2016
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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