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

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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus (RSV)
• Intervention / Treatment: Biological: VXA-RSV-f Tablets (high dose); Biological: VXA-RSV-f Tablets (low dose); Other: VXA Placebo Tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Melbourne, Florida, United States, 32934
      • Optimal Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Placebo Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic Reactogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet.	Number of Patients with Systemic Reactogenicity Symptoms	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet.	Number of Patients with a >/= 4-fold Increase in Serum Neutralizing Antibodies from Baseline as determined by PRNT Assay	Day 28
Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMT)	Mean Geometric Mean Titer	Days 7 and 28
Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMFR)	Mean Geometric Mean Fold Rise	Days 7 and 28

Collaborators and Investigators

• Sponsor: Vaxart

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2016
• Primary Completion (Actual): September 16, 2016
• Study Completion (Actual): September 20, 2017

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: July 9, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: VXA-RSV-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data may be made available to subjects following the 1 year safety follow-up period.