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Norovirus InfectionPhase 1VXA-NVV-103NCT03897309

Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines

A Phase 1 study testing VXA-G1.1-NN and VXA-G2.4-NS in people with Norovirus Infection, run by Vaxart at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Norovirus Infection
What is being tested?
VXA-G1.1-NN and VXA-G2.4-NS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
1 siteUnited States
Study dates
20 Mar 2019to 1 Apr 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rapid Medical Research

    Cleveland, Ohio, 44122

Other trials in United States

About this study

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

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.

Read the 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

  1. Monovalent GII.4 VXA-G2.4-NS (6 sentinels / 16 randomized)
  2. Monovalent GI.1 VXA-G1.1-NN (16 randomized)
  3. Bivalent GII.4/GI.1 VXA-G2.4-NS + VXA-G1.1-NN (32 randomized)
  4. 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.

Being tested
VXA-G1.1-NN, VXA-G2.4-NS, Placebo Tablets
Medical subject headings
Caliciviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VXA-G1.1-NNBiological

    Also called GI.1 oral vaccine tablet

    Monovalent GI.1 tableted vaccine

  • VXA-G2.4-NSBiological

    Also called GII.4 oral vaccine tablet

    Monovalent GII.4 tableted vaccine

  • Placebo TabletsBiological

    Also called Oral tablets for control arm

    Tablets matching in number and appearance to active vaccine doses

Study groups in NCT03897309
Study groupRoleWhat they receive
Monovalent GI.1ExperimentalMonovalent GI.1 tableted vaccine group
Receives: Biological: VXA-G1.1-NN; Biological: Placebo Tablets
Monovalent GII.4ExperimentalMonovalent GII.4 tableted vaccine group
Receives: Biological: VXA-G2.4-NS; Biological: Placebo Tablets
Bivalent GI.1 and GII.4 vaccine groupExperimentalBivalent vaccine group consisting of co-administration of GI.1 and GII.4 vaccine
Receives: Biological: VXA-G1.1-NN; Biological: VXA-G2.4-NS
PlaceboPlacebo comparatorPlacebo tablets
Receives: Biological: Placebo Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Solicited Adverse Events

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

    Measured: Day 1 (Vaccination) to 7 days post vaccination

  2. Rate of Unsolicited Adverse Events

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

    Measured: Day 1 (Vaccination) to 28 days post vaccination

  3. Immunogenicity - VP1 Specific IgA ASC

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

    Measured: Day 1 (vaccination) to 7 days post-vaccination

  4. Immunogenicity - BT50 Assay

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

    Measured: Day 1 (vaccination) to 28 days post-vaccination

Secondary outcomes (1)

  1. Immunogenicity - VP1 specific serum IgG

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

    Measured: Day 1 (vaccination) to 7 days post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2019
  2. Study start20 Mar 2019
  3. Primary completion15 Jan 2021
  4. Study completion1 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label sentinel followed by Randomized, double-blind, placebo-controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03897309
Sponsor's protocol ID
VXA-NVV-103
Acronym
VXA-NVV-103
Status last verified
Sep 2022
First submitted
28 Mar 2019
Last updated
21 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Study results will be summarized and presented by treatment arm comparisons. Individual subject data will not be shared with other researchers.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VXA-G1.1-NN and VXA-G2.4-NS in people with Norovirus Infection, run by Vaxart at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Solicited Adverse Events (time frame: Day 1 (Vaccination) to 7 days post vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03897309.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.

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