Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines

NCT03897309 | Completed Phase 1 FDA Drug

• 1 other identifier: VXA-NVV-103
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 with Monovalent or Bivalent Dosing in Healthy Adult Volunteers. The study consists of 2 parts: Part 1 is the double-blinded portion where subjects will be randomized to one of two monovalent vaccine groups, bivalent vaccine group or placebo. Subjects will be followed for \~4 weeks post vaccination for safety and immunogenicity. Part 2 will consist of an open label booster vaccination for the bivalent treatment group \~4 months post initial vaccination. All subjects will be followed for long term safety for 1 year post initial vaccination.

Conditions

Norovirus Infection

Outcome Measures

Primary Outcomes (4)

• Rate of Solicited Adverse Events

  Comparison of rate of occurance and severity of Solicited Adverse Events observed between treatment groups

  Day 1 (Vaccination) to 7 days post vaccination

• Rate of Unsolicited Adverse Events

  Comparison of the rate of occurrence and severity of unsolicited Adverse Events observed between treatment groups

  Day 1 (Vaccination) to 28 days post vaccination

• Immunogenicity - VP1 Specific IgA ASC

  LS Mean difference in VP1 specific IgA ASC between vaccine and placebo group

  Day 1 (vaccination) to 7 days post-vaccination

• Immunogenicity - BT50 Assay

  Difference in HBGA blocking antibodies (by blocking titer fifty assay \[BT50\]) between vaccine and placebo groups

  Day 1 (vaccination) to 28 days post-vaccination

Secondary Outcomes (1)

• Immunogenicity - VP1 specific serum IgG

  Day 1 (vaccination) to 7 days post-vaccination

Study Arms (4)

Monovalent GI.1

EXPERIMENTAL

Monovalent GI.1 tableted vaccine group

Biological: VXA-G1.1-NN; Biological: Placebo Tablets

Monovalent GII.4

EXPERIMENTAL

Monovalent GII.4 tableted vaccine group

Biological: VXA-G2.4-NS; Biological: Placebo Tablets

Bivalent GI.1 and GII.4 vaccine group

EXPERIMENTAL

Bivalent vaccine group consisting of co-administration of GI.1 and GII.4 vaccine

Biological: VXA-G1.1-NN; Biological: VXA-G2.4-NS

Placebo

PLACEBO COMPARATOR

Placebo tablets

Biological: Placebo Tablets

Interventions

VXA-G1.1-NN BIOLOGICAL

Monovalent GI.1 tableted vaccine

Also known as: GI.1 oral vaccine tablet

Bivalent GI.1 and GII.4 vaccine group; Monovalent GI.1

VXA-G2.4-NS BIOLOGICAL

Monovalent GII.4 tableted vaccine

Also known as: GII.4 oral vaccine tablet

Bivalent GI.1 and GII.4 vaccine group; Monovalent GII.4

Placebo Tablets BIOLOGICAL

Tablets matching in number and appearance to active vaccine doses

Also known as: Oral tablets for control arm

Monovalent GI.1; Monovalent GII.4; Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between the ages of 18 to 49 years, inclusive
• General good health, without significant medical illness, based on medical history, physical examination, vital signs, and clinical laboratories
• Demonstrate comprehension of the protocol procedures and willingness to adhere to all visits and assessments
• Body mass index between 17 and 35 at screening
• Female subjects must have a negative pregnancy test at screening and before each vaccination and fulfill protocol specified criteria for adequate birth control.

You may not qualify if:

• Presence of a significant medical condition which in the opinion of the investigator precludes participation in the study
• History of cancer or cancer treatment within past 3 years
• Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus or angioedema
• Donation or use of blood/blood products within 4 weeks prior to vaccination
• Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic.
• Any condition that resulted in the absence or removal of the spleen
• Positive HIV, HBsAg or HCV tests at the screening visit
• Use of antibiotics, proton pump inhibitors, H2 blockers or antacids within 7 days of vaccination
• Use of medications known to affect the immune function within 14 days of vaccination
• Use of NSAIDs, sulfonylureas, and angiotensin II blockers within 7 days of vaccination
• Evidence of recent or of current nonbacterial gastroenteritis suggestive of NV infection to any gastroenteritis within 2 weeks of vaccination
• History of drug, alcohol or chemical abuse within 1 year of screening or positive urine drug test at screening
• Consistent/habitual smoking within 2 months as per medical history
• History of hypersensitivity or allergic reaction to any component of the investigational vaccine or placebo
• Use of any investigational vaccine, drug or device within 8 weeks preceding vaccination, or planned use of the above stated for the duration of the study

Sponsors & Collaborators

• Vaxart: lead

Study Sites (1)

Rapid Medical Research

Cleveland, Ohio, 44122, United States

Location

MeSH Terms

Conditions

Caliciviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Mary Beth Manning, MD

  Rapid Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study subjects, study site and study team will remain blinded to treatment during study period 1 (initial vaccination through Day 29 visits and subsequent database lock)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label sentinel followed by Randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 1, 2019
• Study Start: March 20, 2019
• Primary Completion: January 15, 2021
• Study Completion: April 1, 2021
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)