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

Phase 1

Completed

• Conditions: Respiratory Syncytial Virus (RSV)
• Interventions: Biological: VXA-RSV-f Tablets (high dose); Other: VXA Placebo Tablets; Biological: VXA-RSV-f Tablets (low dose)

• Registration Number: NCT02830932
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2016-03-23
• Study Start: 2016-06-22
• Study First Submitted QC: 2016-07-09
• Study First Posted: 2016-07-13
• Primary Completion: 2016-09-16
• Study Completion: 2017-09-20
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VXA-RSV-f Tablets (high dose)	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.
VXA Placebo Tablets	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.
VXA-RSV-f Tablets (low dose)	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.

Primary Outcome Measures

Name	Time	Method
Systemic Reactogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet.	Day 7	Number of Patients with Systemic Reactogenicity Symptoms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Optimal Research; 🇺🇸 Melbourne, Florida, United States