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

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ClinicalTrials.gov Identifier: NCT03897309
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Vaxart

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.

Condition or disease Intervention/treatment Phase
Norovirus Infection Biological: VXA-G1.1-NN Biological: VXA-G2.4-NS Biological: Placebo Tablets Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label sentinel followed by Randomized, double-blind, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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)
Primary Purpose: Prevention
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
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Monovalent GI.1
Monovalent GI.1 tableted vaccine group
Biological: VXA-G1.1-NN
Monovalent GI.1 tableted vaccine
Other Name: GI.1 oral vaccine tablet

Biological: Placebo Tablets
Tablets matching in number and appearance to active vaccine doses
Other Name: Oral tablets for control arm

Experimental: Monovalent GII.4
Monovalent GII.4 tableted vaccine group
Biological: VXA-G2.4-NS
Monovalent GII.4 tableted vaccine
Other Name: GII.4 oral vaccine tablet

Biological: Placebo Tablets
Tablets matching in number and appearance to active vaccine doses
Other Name: Oral tablets for control arm

Experimental: Bivalent GI.1 and GII.4 vaccine group
Bivalent vaccine group consisting of co-administration of GI.1 and GII.4 vaccine
Biological: VXA-G1.1-NN
Monovalent GI.1 tableted vaccine
Other Name: GI.1 oral vaccine tablet

Biological: VXA-G2.4-NS
Monovalent GII.4 tableted vaccine
Other Name: GII.4 oral vaccine tablet

Placebo Comparator: Placebo
Placebo tablets
Biological: Placebo Tablets
Tablets matching in number and appearance to active vaccine doses
Other Name: Oral tablets for control arm




Primary Outcome Measures :
  1. Rate of Solicited Adverse Events [ Time Frame: Day 1 (Vaccination) to 7 days post vaccination ]
    Comparison of rate of occurance 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

  3. Immunogenicity - VP1 Specific IgA ASC [ Time Frame: Day 1 (vaccination) to 7 days post-vaccination ]
    LS Mean difference in VP1 specific IgA ASC between vaccine and placebo group

  4. Immunogenicity - BT50 Assay [ Time Frame: Day 1 (vaccination) to 28 days post-vaccination ]
    Difference in HBGA blocking antibodies (by blocking titer fifty assay [BT50]) between vaccine and placebo groups


Secondary Outcome Measures :
  1. Immunogenicity - VP1 specific serum IgG [ Time Frame: Day 1 (vaccination) to 7 days post-vaccination ]
    LS Mean difference in VP1 specific serum IgG between vaccine and placebo groups



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:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03897309


Contacts
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Contact: Shaily J Garg 650-550-3534 sgarg@vaxart.com
Contact: Eric Wenzel 650-550-3521 ewenzel@vaxart.com

Locations
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United States, Ohio
Rapid Medical Research Recruiting
Cleveland, Ohio, United States, 44122
Contact: Lisa Hoagland, BSN, CCRC    216-682-0342 ext 242    lisa.hoagland@rapidmedicalresearch.com   
Sponsors and Collaborators
Vaxart
Investigators
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Principal Investigator: Mary Beth Manning, MD Rapid Medical Research

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Responsible Party: Vaxart
ClinicalTrials.gov Identifier: NCT03897309     History of Changes
Other Study ID Numbers: VXA-NVV-103
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
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
Additional relevant MeSH terms:
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Caliciviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs