Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines

NCT04875676 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: VXA-NVV-105
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the immunogenicity of VXA-G1.1-NN with repeat-dose administration at Day 1 and varying boost schedules (Week 4, 8 or 12 post initial dose) in healthy adults aged 18-55, inclusive, and to assess the safety and tolerability of VXA- G1.1-NN with repeat-dose administration at varying boost schedules (Week 4, 8 or 12) in healthy adults aged 18-55, inclusive

Conditions

Norovirus Infections

Outcome Measures

Primary Outcomes (4)

• Viral-capsid Protein 1 (VP1)-Specific Antibody Secreting Cells (ASC) by Enzyme-linked Immunospot (ELISpot) Assay

  Comparison of VPI specific immunoglobin A (IgA) ASC levels between the 3 study cohorts by enzyme-linked immunospot (ELISpot) assay

  Day 1 (Initial Vaccination) through Day 8 post boost (Second Vaccination)

• Norovirus G1.1 Histo-blood Group Antigen (HBGA) Blocking Antibodies (BT50) Assay

  Comparison of subjects with a ≥2-, 3- or 4-fold increase over baseline titer of GI.1 histo-blood group antigen (HBGA) blocking antibodies (BT50) levels between the 3 study cohorts.

  Day 1 (Initial Vaccination) through Day 29 post boost (Second Vaccination)

• VP1 Serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) Assay

  Comparison of VPI specific immunoglobin A (IgA) ASC levels by Mesoscale Discovery (MSD) assay between the 3 study cohorts

  Day 1 (Initial Vaccination) through Day 29 post boost (Second Vaccination)

• Norovirus G1.1 Histo-blood Group Antigen (HBGA) Blocking Antibodies (BT50) Assay

  Comparison of GI.1 histo-blood group antigen (HBGA) blocking antibodies (BT50) levels between the 3 study cohorts

  Day 1 (Initial Vaccination) through Day 29 post boost (Second Vaccination)

Secondary Outcomes (1)

• Solicited Symptoms of Reactogenicity

  Day 1 (Vaccination) to Day 8 post each vaccination

Other Outcomes (2)

• Unsolicited Adverse Events (AEs)

  Day 1 (Vaccine) through 28 days following boost (Second Vaccination)

• Long-term Safety

  Day 1 (Vaccine) through 6 months following boost (Second Vaccination)

Study Arms (3)

Cohort 1 (4-week boost vaccination)

ACTIVE COMPARATOR

(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4

Biological: VXA-G1.1-NN

Cohort 2 (8-week boost vaccination)

ACTIVE COMPARATOR

(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8

Biological: VXA-G1.1-NN

Cohort 3 (12-week boost vaccination)

ACTIVE COMPARATOR

(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12

Biological: VXA-G1.1-NN

Interventions

VXA-G1.1-NN BIOLOGICAL

Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant

Cohort 1 (4-week boost vaccination); Cohort 2 (8-week boost vaccination); Cohort 3 (12-week boost vaccination)

Eligibility Criteria

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

You may qualify if:

• To be eligible for this study, participants must meet all the following:
• Age
• to 55 years old inclusive at the time of signing the Informed Consent Form (ICF).
• Type of Participants
• 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
• 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 Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• a. 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 an alternative medical cause).
• Women under 60 years will need to verify post-menopausal status via a follicle-stimulating hormone (FSH) test if another option to prevent potential pregnancy will not be utilized for 30 days prior to baseline vaccination and until 60 days after the last vaccination.
• 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).

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 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.
• 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)

WCCT Global, Inc.

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Caliciviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Vice President Regulatory
• Organization: Vaxart

mdrayton@vaxart.com

(650) 747-6028

Study Officials

• Helen Paguntalan, MD

  Icon, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: May 6, 2021
• Study Start: April 30, 2021
• Primary Completion: October 30, 2021
• Study Completion: February 16, 2022
• Last Updated: May 22, 2024
• Results First Posted: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)