AnthraxPhase 1NCT02655549
A Study of Anthrax Vaccines Px563L and RPA563 in Healthy Adult Subjects
A Phase 1 study of Anthrax, run by Pfenex, Inc at 1 site in United States.
Trial summary
The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anthrax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase One Services
Overland Park, Kansas, 66211
About this study
Official title: 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.
Read the 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.
- Conditions
- Anthrax
- Being tested
- Px563L, RPA563, or placebo
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Px563L, RPA563, or placeboBiological
Two intramuscular injections
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 of Px563L, RPA563, or placebo | Experimental | Intramuscular injections of Px563L, RPA563, or placebo Receives: Biological: Px563L, RPA563, or placebo |
| Cohort 2 of Px563L, RPA563, or placebo | Experimental | Intramuscular injections of Px563L, RPA563, or placebo Receives: Biological: Px563L, RPA563, or placebo |
| Cohort 3 of Px563L, RPA563, or placebo | Experimental | Intramuscular injections of Px563L, RPA563, or placebo Receives: Biological: Px563L, RPA563, or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE) and adverse events of special interest (AESI) for vaccines
Measured: 393 days
Secondary outcomes (1)
Anthrax toxin neutralizing antibody (TNA) 50% neutralization factor (NF50) value
Measured: 182 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnthraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfenex, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Barbara K Lomeli, M.D., Principal investigator, Quintiles Phase One Services, LLCHubert C Chen, M.D., Study director, Pfenex, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655549
- Sponsor's protocol ID
- PF563-101
- Status last verified
- Jul 2017
- First submitted
- 12 Jan 2016
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34544599
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02655549
- Acronym / sponsor ID
- PF563-101
- Conditions
- Anthrax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Pfenex, IncIndustry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Study start
- Dec 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 of Px563L, RPA563, or placebo | Experimental | Biological: Px563L, RPA563, or placeboIntramuscular injections of Px563L, RPA563, or placebo |
| Cohort 2 of Px563L, RPA563, or placebo | Experimental | Biological: Px563L, RPA563, or placeboIntramuscular injections of Px563L, RPA563, or placebo |
| Cohort 3 of Px563L, RPA563, or placebo | Experimental | Biological: Px563L, RPA563, or placeboIntramuscular injections of Px563L, RPA563, or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Px563L, RPA563, or placeboTwo intramuscular injections | Biological | Cohort 1 of Px563L, RPA563, or placebo, Cohort 2 of Px563L, RPA563, or placebo, Cohort 3 of Px563L, RPA563, or placebo |
Primary outcome
Adverse events (AE) and adverse events of special interest (AESI) for vaccines
Time frame: 393 days
1 secondary outcome
Anthrax toxin neutralizing antibody (TNA) 50% neutralization factor (NF50) value
Time frame: 182 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Derived from this study: PubMed 34544599Schneider 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara K Lomeli, M.D. principal investigator
Quintiles Phase One Services, LLC
Hubert C Chen, M.D. study director
Pfenex, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Anthrax, run by Pfenex, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AE) and adverse events of special interest (AESI) for vaccines (time frame: 393 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02655549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.