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Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine (VXA-NVV-104)

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ClinicalTrials.gov Identifier: NCT04854746
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Vaxart

Brief Summary:
A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 2 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old)

Condition or disease Intervention/treatment Phase
Norovirus Infections Biological: VXA-GI.1.NN Biological: Placebo Tablet Phase 1

Detailed Description:

A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 2 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old).

Subjects will we randomized in the study utilizing an age and dose escalation schedule. A Safety Monitoring Committee will provide oversight of the trial throughout the duration of the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Determine the Safety and Immunogenicity of an Adenoviral-vector Based Oral Norovirus Vaccine Expressing GI.1 VP1 Administered Orally to Health Stable Older Adult Volunteers 55-80 Years of Age
Actual Study Start Date : April 26, 2021
Estimated Primary Completion Date : August 11, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1 Low Dose Active
VXA-GI.1-NN tableted vaccine group, 2 doses (Day 1 and Day 29) at 1x10Log10
Biological: VXA-GI.1.NN
GI.1 oral vaccine tablet

Experimental: Cohort 2 High Dose Active
VXA-GI.1 tableted vaccine group, 2 doses (Day 1 and Day 29) at 1x10Log11
Biological: VXA-GI.1.NN
GI.1 oral vaccine tablet

Placebo Comparator: Cohort 1 Low Dose Placebo
Placebo tablets matching in number and appearance to active vaccine doses.
Biological: Placebo Tablet
Tablets matching in number and appearance to active vaccine tablets

Placebo Comparator: Cohort 2 High Dose Placebo
Placebo tablets matching in number and appearance to active vaccine doses.
Biological: Placebo Tablet
Tablets matching in number and appearance to active vaccine tablets




Primary Outcome Measures :
  1. Rate of Solicited Adverse Events [ Time Frame: Day 1 (Vaccination) to 7 days post vaccination ]
    Comparison of rate of occurrence and severity of Solicited Adverse Events observed between treatment groups

  2. Rate of Unsolicited Adverse Events [ Time Frame: Day 1 (Vaccination) to 28 days post vaccination ]
    Comparison of the rate of occurrence and severity of unsolicited Adverse Events observed between treatment groups


Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: Day 1 (Vaccination) to 7 days post vaccination ]
    VP1 specific IgA ASC

  2. Immunogenicity [ Time Frame: Day 1 (Vaccination) to 7 days post vaccination ]
    Norovirus GI.1 histo-blood group antigen GBGA blocking antibodies (BT50)

  3. Immunogenicity [ Time Frame: Day 1 (Vaccination) to 7 days post vaccination ]
    VP1 specific serum IgG



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

To be eligible for this study, participants must meet all the following:

Age

  1. 55 to 80 years old inclusive at the time of signing the Informed Consent Form (ICF).

    Type of Participants

  2. In stable and good general health, without significant medical illness, based on medical history, physical examination and vital signs at screening
  3. Safety laboratory values within the following range criteria at screening:

    1. Laboratory value of < grade 1 elevation from normal or decrease from normal with no clinical significance (NCS) for alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin,
    2. Laboratory value of < grade 1 from normal with no NCS for:

      • decreased: albumin, magnesium, total protein and phosphorous
      • elevated: amylase, BUN, CPK and creatine and;
      • elevated or decreased: calcium, glucose, potassium and sodium;
  4. Body mass index (BMI) between 17 and 35 kg/m2 at screening
  5. 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

  6. Male or female participants Female participants must provide a negative pregnancy test at screening and baseline or be at least one year post-menopausal or surgically sterile. Female participants of childbearing potential must be willing to use a reliable oral, implantable, transdermal or injectable contraceptive for 30 days prior to and until 60 days post last study drug administration. The form of contraception must be approved by the Investigator Contraception use by men should be consistent with local regulations regarding the methods of contraception for participants in clinical studies.

    Informed Consent

  7. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria

The participants must be excluded from participating in the study if they meet any of the following:

Medical Conditions

  1. 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
  2. Cancer, or treatment for cancer treatment, within past 3 years (excluding basal cell carcinoma or squamous cell carcinoma)
  3. Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus
  4. 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:

    1. Esophageal Motility Disorder
    2. Malignancy
    3. Malabsorption
    4. Pancreaticobiliary disorders
    5. Irritable bowel syndrome
    6. Inflammatory Bowel Disease
    7. Surgical Resection
    8. GERD
    9. Hiatal Hernia
    10. Peptic Ulcer (History of cholecystectomy is not exclusionary)
  5. History of any form of angioedema
  6. History of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives or abdominal pain
  7. Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic
  8. Any condition that resulted in the absence or removal of the spleen
  9. Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical exam). (Assessment may be repeated during screening period.)
  10. Presence of a fever ≥ 38oC measured orally at baseline (Assessment may be repeated during screening period)
  11. Any significant hospitalization within the last year which in the opinion of the investigator or sponsor could interfere with study participation.
  12. Any other condition that in the clinical judgment of the investigator would jeopardize the safety or rights of a participant taking in the study, would render the participant unable to comply with the protocol or would interfere with the evaluation of the study endpoints

    Diagnostic Assessments

  13. Positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) tests at the screening visit
  14. Stool sample with occult blood at screening
  15. Positive urine drug screen for drugs of abuse at screening
  16. Positive breath or urine alcohol test at screening and baseline
  17. Positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by reverse transcription polymerase chain reaction (RT-PCR) at screening and by SARS- CoV-2 Rapid Antigen Test at baseline. If Rapid Antigen Test is positive, the test can be repeated using RT-PCR at baseline. If retest by PCR is also positive, the subject is ineligible.

    Prior/Concurrent Therapy

  18. Receipt of a licensed vaccine within 14 days prior to baseline vaccination or planned administration during the study active period (Day 57)
  19. Use of antibiotics, proton pump inhibitors, H2 blockers or antacids within 7 days prior to study drug administration or planned use during the active study period (Day 57)
  20. Use of medications known to affect the immune function (e.g., systemic corticosteroids and others) within 2 weeks before study drug administration or planned use during the active study period (Day 57)
  21. Daily use of nonsteroidal anti-inflammatory drugs within 7 days prior to study drug administration or planned use during the active study period (Day 57)
  22. Administration of any investigational vaccine, drug or device within 8 weeks preceding study drug administration, or planned use within the duration of the study

    Other Exclusions

  23. Donation or use of blood or blood products within 30 days prior to study drug administration or planned donation during the active study period (Day 57)
  24. History of drug, alcohol or chemical abuse within 1 year of screening
  25. History of hypersensitivity or allergic reaction to any component of the investigational vaccine, including but not limited to fish gelatin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854746


Contacts
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Contact: Shaily J Garg 650-521-4496 sgarg@vaxart.com
Contact: Christian Hummel 415-407-8331 chummel@vaxart.com

Locations
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United States, Louisiana
Benchmark Research Recruiting
New Orleans, Louisiana, United States, 70006
Contact: Michael Cotungo       michaelcotungo@benchmarkresearch.net   
Sponsors and Collaborators
Vaxart
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Responsible Party: Vaxart
ClinicalTrials.gov Identifier: NCT04854746    
Other Study ID Numbers: VXA-NVV-104
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study results will be summarized and presented by treatment arm comparisons. Individual subject data will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vaxart:
norovirus, oral vaccine, elderly
Additional relevant MeSH terms:
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Caliciviridae Infections
RNA Virus Infections
Virus Diseases