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

Respiratory Syncytial Virus (RSV) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830932
• Other study ID #: VXA-RSV-101
• Status: Completed
• Phase: Phase 1
• Start date: June 22, 2016
• Est. completion date: September 20, 2017

Study information

• Verified date: August 2018
• Source: Vaxart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 20, 2017
• Est. primary completion date: September 16, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus (RSV)

Intervention

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:
• 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.

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

Locations

Country	Name	City	State
United States	Optimal Research	Melbourne	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vaxart

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic Reactogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet.	Number of Patients with Systemic Reactogenicity Symptoms	Day 7
Secondary	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
Secondary	Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMT)	Mean Geometric Mean Titer	Days 7 and 28
Secondary	Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMFR)	Mean Geometric Mean Fold Rise	Days 7 and 28