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AnthraxPhase 1NCT02239172

PA83-FhCMB Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine

A Phase 1 study testing PA83-FhCMB in people with Anthrax, run by Fraunhofer, Center for Molecular Biotechnology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purposes of this study is to evaluate and compare the safety, reactogenicity, and tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Anthrax
What is being tested?
PA83-FhCMB
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Aug 2014to May 2015
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 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Citizen or permanent resident of the US
  • Male or female aged 18 to 49 years inclusive
  • Able to give written informed consent
  • Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline
  • Females should fulfill one of the following criteria:
  • At least one year post-menopausal
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  • Surgically sterile
  • Willing to use a medically approved form of contraception (eg, oral, implantable, transdermal, or injectable hormonal contraceptive; intrauterine device; barrier protection to include female condom, diaphragm, cervical cap, or male condoms in conjunction with spermicide) for 30 days prior to first vaccination and through the end of the study
  • Willing to abstain from sexual intercourse for 30 days prior to first vaccination and through the end of the study
  • Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose
  • Comprehension of the study requirements
  • Expressed availability for the required study period
  • Ability to attend scheduled visits and to be contacted by telephone throughout the follow-up period

Who cannot join

  • History of anthrax disease or receipt of anthrax vaccine
  • Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical or surgical treatment or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening
  • Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
  • Pregnancy or lactation
  • Cancer or treatment for cancer, within the previous 3 years, excluding basal cell carcinoma
  • Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus, per the investigator's discretion
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  • Presently receiving or history of receiving, during the preceding 3-month period, any medications or other treatments that may adversely affect the immune system
  • This includes allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids (oral or injectable; 20 mg/day x 14 days or longer)
  • Radiation therapy
  • Intranasal and topical corticosteroids will be allowed
  • Receipt or planned administration of a non study vaccine within 14 days prior to vaccination and throughout the study period (30 days for live vaccines) Immunization on an emergency basis with Tetanus Toxoids Adsorbed for adult use (Td or Tdap) or influenza vaccine up to 14 days before or at least 14 days after a dose of study vaccine will be allowed
  • History of anaphylactic type reaction to injected vaccines
  • History of drug or chemical abuse in the year before the study
  • Receipt of any investigational product or nonregistered drug within 30 days prior to vaccination or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing study period
  • Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the study period
  • Donation of blood or blood products within 8 weeks prior to vaccination or at any time during the study
  • Acute disease within 72 hours prior to vaccination
  • Acute disease is defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical examination) with or without fever (≥38°C; 100.4°F), or an oral temperature of ≥38°C orally
  • Study vaccine can be administered to persons with a minor illness
  • History of immunodeficiency, chronic illness requiring continuous or frequent medical intervention, autoimmune disease, use of immunosuppressive medications, or ongoing therapy with systemic corticosteroids within 3 months prior to any planned vaccine dose. Inhaled and topical steroids are permitted. "Burst" therapy of steroids is permitted except within 2 weeks prior to vaccination.
  • Evidence of psychiatric, medical and/or substance abuse problems during the past 6 months that the investigator believes would adversely affect the subject's ability to participate in the trial
  • Occupational or other responsibilities that would prevent completion of participation in the trial, including:
  • US military or reservists who may receive the licensed anthrax vaccine (BioThrax) or served during the Persian Gulf War between January and May, 1991. Such individuals may be enrolled only if they provide their medical records, which can then show proof that they have not received the licensed anthrax vaccine.
  • Postal and other workers who may be exposed to anthrax or may have to take BioThrax
  • Any condition that, in the opinion of the investigator, might interfere with interpretation of data supporting the primary study objectives

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Walter Reed Army Institute of Research, Clinical Trials Center

    Silver Spring, Maryland, 20910

Other trials in United States

About this study

Official title: A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine in Healthy Adults

The purposes of this study is to evaluate and compare the safety, reactogenicity, and tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel

Conditions
Anthrax
Being tested
PA83-FhCMB
Medical subject headings
Anthrax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PA83-FhCMBBiological

Study groups in NCT02239172
Study groupRoleWhat they receive
12.5 µg + AlhydrogelExperimentalvaccine
Receives: Biological: PA83-FhCMB
25 µg + AlhydrogelExperimentalvaccine
Receives: Biological: PA83-FhCMB
50 µg + AlhydrogelExperimentalvaccine
Receives: Biological: PA83-FhCMB
100 µg + AlhydrogelExperimentalvaccine
Receives: Biological: PA83-FhCMB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events

    Measured: Up to 3 months

Secondary outcomes (1)

  1. Change from Baseline in antibody titer after three immunizations

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

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
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02239172
Sponsor's protocol ID
FhCMB rPA83-001
Status last verified
May 2016
First submitted
13 Aug 2014
Last updated
12 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Paolino KM, Regules JA, Moon JE, Ruck RC, Bennett JW, Remich SA, Mills KT, Lin L, Washington CN, Fornillos GA, Lindsey CY, O'Brien KA, Shi M, Mark Jones R, Green BJ, Tottey S, Chichester JA, Streatfield SJ, Yusibov V. Safety and immunogenicity of a plant-derived recombinant protective antigen (rPA)-based vaccine against Bacillus anthracis: A Phase 1 dose-escalation study in healthy adults. Vaccine. 2022 Mar 15;40(12):1864-1871. doi: 10.1016/j.vaccine.2022.01.047. Epub 2022 Feb 10.

    PubMed 35153091

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PA83-FhCMB in people with Anthrax, run by Fraunhofer, Center for Molecular Biotechnology 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 13 inclusion and 25 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 12 May 2016. 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?

Number of Participants with Adverse Events (time frame: Up to 3 months). 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 NCT02239172, 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 12 May 2016.

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