A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers

NCT05213728 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: VXA-NVV-106
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at Day 180 and Day 365.

Conditions

Norovirus Infections

Outcome Measures

Primary Outcomes (5)

• Rate of Solicited Symptoms of Reactogenicity

  To assess the safety and tolerability of an oral tableted vaccine by collection of solicited symptoms of vaccine reactogenicity recorded daily using a subject diary card for 1 week post initial vaccination at Day 1.

  Up to Day 8

• To assess the induction of VP1-specific Immunoglobin A (IgA) antibody-secreting cells (ASC) by ELISpot assay

  Change from baseline in VP1-specific Immunogolobin A (IgA) antibody-secreting cells (ASC) by ELISpot assay will be evaluated at Day 8

  Change from baseline at Day 8

• To assess histo-blood group antigen (HBGA) blocking antibodies by blockade titer (BT50)

  Change from baseline in histo-blood group antigen (HBGA) blocking antibodies evaluated at Day 29

  Change from baseline at Day 29

• To assess VP1-specific serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) assay

  Change from baseline in VP1-specific Immunoglobin G (IgG) by Mesoscale Discovery (MSD) assay will be evaluated at Day 29

  Change from baseline at Day 29

• To assess the VP1-specific serum Immunoglobin A (IgA) by Mesoscale Discovery (MSD) assay

  Change from baseline in VP1-specific serum IgG by Mesoscale Discovery (MSD) will be evaluated at Day 29

  Change from baseline at Day 29

Study Arms (1)

Cohort 1

EXPERIMENTAL

Single 1E11 dose administered via multiple sub-doses over a 4-hour period in adults (18-55 yrs).

Biological: VXA-G1.1-NN

Interventions

VXA-G1.1-NN BIOLOGICAL

Norovirus GI.1 Norwalk VP1 Vaccine (VXA-G1.1-NN) E1/E3-Deleted Replication-Defective Recombinant Adenovirus 5 with Adjuvant Oral Tablet Vaccine.

Also known as: Oral Tableted Ad5 Norovirus GI.1 Vaccine

Cohort 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 55 years old, inclusive, at day of signing Informed Consent Form (ICF)
• General good health, without significant uncontrolled medical illness, based on medical history, physical examination, vital signs, and clinical laboratories (CBC, chemistry, and urinalysis) as determined by the investigator in consultation with the Research Monitor and Sponsor
• Body mass index (BMI) between 17 and 35 kg/m2 at screening
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
• 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)
• Female participants must provide a negative pregnancy test at each required visit and fulfill one of the following criteria:
• At least 1 year post-menopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening without alternative medical cause)
• Surgically sterile
• Use of oral, implantable, transdermal or injectable contraceptives for 30 days prior to initial vaccination and until 60 days after the last vaccination. The form of contraception must be approved by the Investigator
• A reliable form of contraception must be approved by the Investigator (e.g., double barrier method, Depo-Provera, intrauterine device, Norplant, oral contraceptives, contraceptive patches)
• Not be sexually active (abstinent) or be in a relationship with partner who is sterile (must be discussed with site staff and documented)
• Male participants must agree not to father a child or donate sperm, as well as to use contraception/barrier (a male condom) or be abstinent from heterosexual intercourse during the study active period (Day 29)

You may not qualify if:

• 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 received treatment for cancer, 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 1 and 2
• 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 Norwalk GI.1 (VXA-G1.1-NN) Protocol No. VXA-NVV-106
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• 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 (1)

AltaSciences LA

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Caliciviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Study Officials

• James Cummings, MD

  Vaxart, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 28, 2022
• Study Start: January 24, 2022
• Primary Completion: February 1, 2022
• Study Completion: February 24, 2022
• Last Updated: June 21, 2024

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)