A Study of Anthrax Vaccines Px563L and RPA563 in Healthy Adult Subjects
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
1 other identifier
interventional
54
1 country
1
Brief Summary
The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2015
1 active site
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
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 12, 2016
CompletedFirst Posted
Study publicly available on registry
January 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 11, 2017
July 1, 2017
1.5 years
January 12, 2016
July 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events (AE) and adverse events of special interest (AESI) for vaccines
393 days
Secondary Outcomes (1)
Anthrax toxin neutralizing antibody (TNA) 50% neutralization factor (NF50) value
182 days
Study Arms (3)
Cohort 1 of Px563L, RPA563, or placebo
EXPERIMENTALIntramuscular injections of Px563L, RPA563, or placebo
Cohort 2 of Px563L, RPA563, or placebo
EXPERIMENTALIntramuscular injections of Px563L, RPA563, or placebo
Cohort 3 of Px563L, RPA563, or placebo
EXPERIMENTALIntramuscular injections of Px563L, RPA563, or placebo
Interventions
Two intramuscular injections
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfenex, Inclead
- Department of Health and Human Servicescollaborator
Study Sites (1)
Quintiles Phase One Services
Overland Park, Kansas, 66211, United States
Related Publications (1)
Schneider JC, Chen HC, Bautista E, Retallack D. Safety and immunogenicity of Px563L, a recombinant anthrax vaccine candidate, in a two-dose regimen for post-exposure prophylaxis in healthy adults. Vaccine. 2021 Oct 8;39(42):6333-6339. doi: 10.1016/j.vaccine.2021.08.075. Epub 2021 Sep 17.
PMID: 34544599DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara K Lomeli, M.D.
Quintiles Phase One Services, LLC
- STUDY DIRECTOR
Hubert C Chen, M.D.
Pfenex, Inc
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
January 12, 2016
First Posted
January 14, 2016
Study Start
December 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
July 11, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will share