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Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines (VXA-NVV-103)

Primary Purpose

Norovirus Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VXA-G1.1-NN

VXA-G2.4-NS

Placebo Tablets

About this trial

This is an interventional prevention trial for Norovirus Infection

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Rapid Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Monovalent GI.1

Monovalent GII.4

Bivalent GI.1 and GII.4 vaccine group

Placebo

Arm Description

Monovalent GI.1 tableted vaccine group

Monovalent GII.4 tableted vaccine group

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

Placebo tablets

Outcomes

Primary Outcome Measures

Rate of Solicited Adverse Events

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

Rate of Unsolicited Adverse Events

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

Immunogenicity - VP1 Specific IgA ASC

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

Immunogenicity - BT50 Assay

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

Secondary Outcome Measures

Immunogenicity - VP1 specific serum IgG

LS Mean difference in VP1 specific serum IgG between vaccine and placebo groups

Full Information

NCT ID

NCT03897309

First Posted

March 28, 2019

Last Updated

September 19, 2022

Sponsor

Vaxart

1. Study Identification

Unique Protocol Identification Number

NCT03897309

Brief Title

Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines

Acronym

VXA-NVV-103

Official Title

A Ph 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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

March 20, 2019 (Actual)

Primary Completion Date

January 15, 2021 (Actual)

Study Completion Date

April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vaxart

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

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 with will enroll 86 subjects: Part 1 - Double Blind Period: Post confirmation of eligibility subjects will be randomized in a double-blinded manner to one of four treatment arms. Treatment Group 1 will contain an open-label sentinel group of 6 subjects to be enrolled prior to initiation of subsequent treatment groups. After review of the safety data and confirmation the dose is well tolerated through Study Day 8, the rest of the study will proceed in a double-blinded, randomized fashion. The 6 sentinel subjects will not be part of the 16 subjects in Treatment Group 1 to be enrolled in the double-blinded placebo-controlled cohort; randomization will be 1:1:2:1 for Treatment Groups 1 through 4 respectively. Study Design and Vaccine Groups Monovalent GII.4 VXA-G2.4-NS (6 sentinels / 16 randomized) Monovalent GI.1 VXA-G1.1-NN (16 randomized) Bivalent GII.4/GI.1 VXA-G2.4-NS + VXA-G1.1-NN (32 randomized) Placebo Tablets no vaccine (16 randomized) Subjects will be followed for ~4 weeks post vaccination for safety and immunogenicity. The study database will be locked post completion of Day 29 visits. Part 2 will consist of an open label booster vaccination for the bivalent treatment group ~4 months post initial vaccination. Subjects will be followed for safety and immunogenicity for ~4 weeks post the boost. All subjects will be followed for long term safety for 1 year post initial vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Norovirus Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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)

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Monovalent GI.1

Arm Type

Experimental

Arm Description

Monovalent GI.1 tableted vaccine group

Arm Title

Monovalent GII.4

Arm Type

Experimental

Arm Description

Monovalent GII.4 tableted vaccine group

Arm Title

Bivalent GI.1 and GII.4 vaccine group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablets

Intervention Type

Biological

Intervention Name(s)

VXA-G1.1-NN

Other Intervention Name(s)

GI.1 oral vaccine tablet

Intervention Description

Monovalent GI.1 tableted vaccine

Intervention Type

Biological

Intervention Name(s)

VXA-G2.4-NS

Other Intervention Name(s)

GII.4 oral vaccine tablet

Intervention Description

Monovalent GII.4 tableted vaccine

Intervention Type

Biological

Intervention Name(s)

Placebo Tablets

Other Intervention Name(s)

Oral tablets for control arm

Intervention Description

Tablets matching in number and appearance to active vaccine doses

Primary Outcome Measure Information:

Title

Rate of Solicited Adverse Events

Description

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

Time Frame

Day 1 (Vaccination) to 7 days post vaccination

Title

Rate of Unsolicited Adverse Events

Description

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

Time Frame

Day 1 (Vaccination) to 28 days post vaccination

Title

Immunogenicity - VP1 Specific IgA ASC

Description

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

Time Frame

Day 1 (vaccination) to 7 days post-vaccination

Title

Immunogenicity - BT50 Assay

Description

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

Time Frame

Day 1 (vaccination) to 28 days post-vaccination

Secondary Outcome Measure Information:

Title

Immunogenicity - VP1 specific serum IgG

Description

LS Mean difference in VP1 specific serum IgG between vaccine and placebo groups

Time Frame

Day 1 (vaccination) to 7 days post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Beth Manning, MD

Organizational Affiliation

Rapid Medical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rapid Medical Research

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Study results will be summarized and presented by treatment arm comparisons. Individual subject data will not be shared with other researchers.

Learn more about this trial

Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines

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