Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine

NCT04854746 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: VXA-NVV-104
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

Brief Summary

A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 3 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old)

Conditions

Norovirus Infections

Keywords

norovirus, oral vaccine, elderly

Outcome Measures

Primary Outcomes (2)

• Rate of Solicited Adverse Events

  Safety

  Day 1 (Vaccination) to 7 days post vaccination

• Rate of Unsolicited Adverse Events

  Safety

  Day 1 (Vaccination) to 28 days post vaccination

Secondary Outcomes (3)

• VP1 specific IgA ASC

  Day 1 (Vaccination) to 7 days post vaccination

• Norovirus GI.1 histo-blood group antigen GBGA blocking antibodies (BT50)

  Day 1 (Vaccination) to 7 days post vaccination

• VP1 specific serum IgG

  Day 1 (Vaccination) to 7 days post vaccination

Study Arms (6)

Cohort 1 Low Dose Active

ACTIVE COMPARATOR

VXA-GI.1-NN tableted vaccine group, 2 doses (Day 1 and Day 29) at 1x10Log10

Biological: VXA-GI.1.NN

Cohort 3 High Dose Active

ACTIVE COMPARATOR

VXA-GI.1 tableted vaccine group, 2 doses (Day 1 and Day 29) at 1x10Log11

Biological: VXA-GI.1.NN

Cohort 1 Low Dose Placebo

PLACEBO COMPARATOR

Placebo tablets matching in number and appearance to active vaccine doses.

Biological: Placebo Tablet

Cohort 3 High Dose Placebo

PLACEBO COMPARATOR

Placebo tablets matching in number and appearance to active vaccine doses.

Biological: Placebo Tablet

Cohort 2 Medium Dose Active

ACTIVE COMPARATOR

VXA-GI.1 tableted vaccine group, 2 doses (Day 1 and Day 29) at 3x10Log10

Biological: VXA-GI.1.NN

Cohort 2 Medium Dose Placebo

PLACEBO COMPARATOR

Placebo tablets matching in number and appearance to active vaccine doses.

Biological: Placebo Tablet

Interventions

VXA-GI.1.NN BIOLOGICAL

GI.1 oral vaccine tablet

Cohort 1 Low Dose Active; Cohort 2 Medium Dose Active; Cohort 3 High Dose Active

Placebo Tablet BIOLOGICAL

Tablets matching in number and appearance to active vaccine tablets

Cohort 1 Low Dose Placebo; Cohort 2 Medium Dose Placebo; Cohort 3 High Dose Placebo

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for this study, participants must meet all the following:
• Age
• to 80 years old inclusive at the time of signing the Informed Consent Form (ICF).
• Type of Participants
• In stable and good general health, without significant medical illness, based on medical history, physical examination and vital signs at screening
• Safety laboratory values within the following range criteria at screening:
• Laboratory value of \< grade 1 elevation from normal or decrease from normal with no clinical significance (NCS) for alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin,
• Laboratory value of \< grade 1 from normal with no NCS for:
• decreased: albumin, magnesium, total protein and phosphorous
• elevated: amylase, BUN, CPK and creatine and;
• elevated or decreased: calcium, glucose, potassium and sodium;
• Body mass index (BMI) between 17 and 35 kg/m2 at screening
• Available for all planned visits and phone calls, and willing to complete all protocol- defined procedures and assessments (including ability and willingness to swallow multiple small enteric-coated tablets per study dose).
• Gender and Reproductive Considerations
• Male or female participants Female participants must provide a negative pregnancy test at screening and baseline or be at least one year post-menopausal or surgically sterile. Female participants of childbearing potential must be willing to use a reliable oral, implantable, transdermal or injectable contraceptive for 30 days prior to and until 60 days post last study drug administration. The form of contraception must be approved by the Investigator Contraception use by men should be consistent with local regulations regarding the methods of contraception for participants in clinical studies.

You may not qualify if:

• The participants must be excluded from participating in the study if they meet any of the following:
• Medical Conditions
• 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
• Cancer, or treatment for cancer treatment, within past 3 years (excluding basal cell carcinoma or squamous cell carcinoma)
• Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus
• History of irritable bowel disease or other inflammatory digestive or gastrointestinal condition that could affect the distribution/safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine.
• Such conditions may include but are not limited to:
• Esophageal Motility Disorder
• Malignancy
• Malabsorption
• Pancreaticobiliary disorders
• Irritable bowel syndrome
• Inflammatory Bowel Disease
• Surgical Resection
• GERD

Sponsors & Collaborators

• Vaxart: lead

Study Sites (3)

WCCT

Cypress, California, 90630, United States

Location

Benchmark Research

New Orleans, Louisiana, 70006, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Caliciviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Study Officials

• David Liebowitz, MD, PhD

  Vaxart, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: April 26, 2021
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)