A Study of Anthrax Vaccines Px563L and RPA563 in Healthy Adult Subjects

July 7, 2017 updated by: Pfenex, Inc

A Phase 1a Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study Assessing Safety and Immunogenicity of Px563L and RPA563 Administered by Intramuscular Injection in Healthy Adult Volunteers

The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of Px563L or RPA563 administered intramuscularly. All subjects will be followed for safety and tolerability for 393 days after the initial vaccination. Immunogenicity analyses will be performed for up to 182 days, including an interim analysis based on Day 70 results, after the initial vaccination.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Quintiles Phase One Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing and able to read and understand the consent process and sign an informed consent form (ICF).
  • Females or males between the ages of 18 and 55, inclusive, at the time of informed consent.
  • Healthy or with stable medical conditions not requiring continuous medication.

Exclusion Criteria:

  • Female subjects who are pregnant or breastfeeding.
  • A history of anthrax disease or receipt of an anthrax vaccine at any time in the past, exposure to or infection with B. anthracis, or has received any investigational anthrax vaccine or treatment (e.g., monoclonal antibodies, anthrax immune globulin).
  • Positive test for human immunodeficiency virus (HIV), hepatitis C or hepatitis B (surface antigen).
  • History of any malignant neoplasm or receipt of anti-neoplastic agents within the last 5 years, with the exception of adequately treated, localized or in situ non-melanoma of the skin (e.g., basal cell carcinoma) or of the cervix.
  • History of immunodeficiency, chronic illness requiring continuous or frequent medical intervention, autoimmune disease, bleeding disorder, hemoglobinopathy, prior solid organ or bone marrow transplant, or any known history in the past 5 years of cardiac disease.
  • Evidence of alcohol abuse (i.e., requiring treatment) or substance abuse (i.e., any use of illicit drugs) within 6 months prior to screening.
  • History of severe allergy (e.g., anaphylaxis) to latex or rubber.
  • Subjects who have significant scarring, tattoos, abrasions, rash, or other skin abnormality at the planned vaccination site that could interfere with evaluation of injection site..
  • Use of any systemic steroids or other immunosuppressive agents within 2 years prior to screening; or use of topical, intranasal, or inhaled corticosteroids for ≥10 consecutive days within 1 year prior to screening.
  • Administration of any licensed vaccines within 30 days prior to screening.
  • History of anaphylaxis or other serious adverse reaction to vaccines.
  • Donation or loss of >500 mL of blood or donation of plasma within 2 months of screening, or recipient of blood or blood products within 2 months of screening.
  • Present or former member of US military or reservist who may have or will receive the licensed anthrax vaccine, or who has served in any military arena from January 1990 through present time.
  • May be at risk for exposure to anthrax or may be required to receive the licensed anthrax vaccine (e.g., postal workers).
  • Has previously participated in any anthrax vaccine or anti-protective antigen (PA) monoclonal antibody clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1 of Px563L, RPA563, or placebo
Intramuscular injections of Px563L, RPA563, or placebo
Biological: Px563L, RPA563, or placebo
Two intramuscular injections
Experimental: Cohort 2 of Px563L, RPA563, or placebo
Intramuscular injections of Px563L, RPA563, or placebo
Biological: Px563L, RPA563, or placebo
Two intramuscular injections
Experimental: Cohort 3 of Px563L, RPA563, or placebo
Intramuscular injections of Px563L, RPA563, or placebo
Biological: Px563L, RPA563, or placebo
Two intramuscular injections

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Adverse events (AE) and adverse events of special interest (AESI) for vaccines
Time Frame: 393 days
393 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Anthrax toxin neutralizing antibody (TNA) 50% neutralization factor (NF50) value
Time Frame: 182 days
182 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfenex, Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Department of Health and Human Services

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Barbara K Lomeli, M.D., Quintiles Phase One Services, LLC
  • Study Director: Hubert C Chen, M.D., Pfenex, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PF563-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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