NCT02830932

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 22, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2017

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

March 23, 2016

Last Update Submit

August 14, 2018

Conditions

Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (1)

  • Systemic Reactogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet.

    Number of Patients with Systemic Reactogenicity Symptoms

    Day 7

Secondary Outcomes (3)

  • Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet.

    Day 28

  • Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMT)

    Days 7 and 28

  • Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMFR)

    Days 7 and 28

Study Arms (3)

VXA-RSV-f Tablets (high dose)

EXPERIMENTAL

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)

VXA-RSV-f Tablets (low dose)

EXPERIMENTAL

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)

VXA Placebo Tablets

PLACEBO COMPARATOR

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

Interventions

VXA-RSV-f Tablets (high dose)BIOLOGICAL

The drug product will be provided as small white enteric-coated tablets. Multiple tablets may be administered to delivered the high dose.

Also known as: RSV (high dose) Oral Vaccine Tablet
VXA-RSV-f Tablets (high dose)
VXA Placebo TabletsOTHER

The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.

Also known as: Placebo Control
VXA Placebo Tablets
VXA-RSV-f Tablets (low dose)BIOLOGICAL

The drug product will be provided as small white enteric-coated tablets. Multiple tablets may be administered to delivered the low dose

Also known as: RSV (low dose) Oral Vaccine Tablet
VXA-RSV-f Tablets (low dose)

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optimal Research

Melbourne, Florida, 32934, United States

Location

MeSH Terms

Interventions

Vaccines

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

July 13, 2016

Study Start

June 22, 2016

Primary Completion

September 16, 2016

Study Completion

September 20, 2017

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

US(1)