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Dose-Ranging Trial of Safety & Immunogenicity of an Oral Adenoviral-Vector Based RSV Vaccine (VXA-RSV-f)

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ClinicalTrials.gov Identifier: NCT02830932
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Vaxart

Brief Summary:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Respiratory Syncytial Virus (RSV) F Protein Vaccine (VXA-RSV-f) Expressing Protein F and dsRNA Adjuvant Administered Orally to Healthy Volunteers

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus (RSV) Biological: VXA-RSV-f Tablets (high dose) Other: VXA Placebo Tablets Biological: VXA-RSV-f Tablets (low dose) Phase 1

Detailed Description:

The study will enroll 66 subjects in four cohorts. All subjects will receive a single administration of VXA-RSV-f at a low dose, a high dose or placebo.

Two sentinel groups will enroll 3 subjects each in an open-label manner (Cohorts 1 and 3) to receive VXA-RSV-f prior to enrolling either of the randomized, controlled cohorts (Cohorts 2 and 4). Within the double-blinded Cohorts (2 and 4), placebo subjects will receive the same number of tablets as the vaccine subjects in that Cohort. Subjects will be enrolled and dosed in the low dose groups prior to initiation of dosing in the high dose group.

Cohort 1: 3 subjects at low dose Cohort 2: 20 subjects at low dose and 10 placebo Cohort 3: 3 subjects at high dose Cohort 4: 20 subjects at low dose and 10 placebo

Subjects will be followed for 28 days post vaccination for preliminary immunogenicity. Subjects will continue to be followed for 1 year post-vaccination for long term safety.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Respiratory Syncytial Virus (RSV) F Protein Vaccine (VXA-RSV-f) Expressing Protein F and dsRNA Adjuvant Administered Orally to Healthy Volunteers
Actual Study Start Date : June 22, 2016
Actual Primary Completion Date : September 16, 2016
Actual Study Completion Date : September 20, 2017

Arm Intervention/treatment
Experimental: VXA-RSV-f Tablets (high dose)
Singe dose of orally administered VXA-RSV-f Tablets (high dose). VXA-RSV-f is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of respiratory illness caused by RSV. The vaccine vector encodes for a full-length F protein gene from RSV.
Biological: VXA-RSV-f Tablets (high dose)
The drug product will be provided as small white enteric-coated tablets. Multiple tablets may be administered to delivered the high dose.
Other Name: RSV (high dose) Oral Vaccine Tablet

Experimental: VXA-RSV-f Tablets (low dose)
Singe dose of VXA-RSV-f Tablets (low dose).VXA-RSV-f is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of respiratory illness caused by RSV. The vaccine vector encodes for a full-length F protein gene from RSV.
Biological: VXA-RSV-f Tablets (low dose)
The drug product will be provided as small white enteric-coated tablets. Multiple tablets may be administered to delivered the low dose
Other Name: RSV (low dose) Oral Vaccine Tablet

Placebo Comparator: VXA Placebo Tablets
Singe dose of matching placebo tablets. The placebo tablets are small off-white tablets that are similar in size and number to the active vaccine dose being delivered.
Other: VXA Placebo Tablets
The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.
Other Name: Placebo Control




Primary Outcome Measures :
  1. Systemic Reactogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet. [ Time Frame: Day 7 ]
    Number of Patients with Systemic Reactogenicity Symptoms


Secondary Outcome Measures :
  1. Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet. [ Time Frame: Day 28 ]
    Number of Patients with a >/= 4-fold Increase in Serum Neutralizing Antibodies from Baseline as determined by PRNT Assay

  2. Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMT) [ Time Frame: Days 7 and 28 ]
    Mean Geometric Mean Titer

  3. Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMFR) [ Time Frame: Days 7 and 28 ]
    Mean Geometric Mean Fold Rise



Information from the National Library of Medicine

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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:

  1. Male or female volunteers aged 18 - 49 years, inclusive
  2. Able to give written informed consent
  3. Healthy (no clinically significant health concerns)
  4. Safety laboratory values within the following range criteria normal range
  5. Body mass index between 17 and 35 at screening

Exclusion Criteria:

  1. Receipt of any investigational RSV vaccine within two years prior to study
  2. Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination
  3. Administration of any licensed vaccine within 30 days prior to study
  4. 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
  5. History of drug, alcohol or chemical abuse within 1 year prior to vaccination
  6. Presence of a fever ≥ 38oC measured orally at baseline
  7. Stool sample with occult blood at screening

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): NCT02830932


Locations
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United States, Florida
Optimal Research
Melbourne, Florida, United States, 32934
Sponsors and Collaborators
Vaxart
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Responsible Party: Vaxart
ClinicalTrials.gov Identifier: NCT02830932    
Other Study ID Numbers: VXA-RSV-101
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data may be made available to subjects following the 1 year safety follow-up period.
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs