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Anthrax InfectionPhase 1NCT01979406

A Phase 1 Ascending Dose Study to Assess the Safety and Immunogenicity of Adenovirus Anthrax Vector Candidate Vaccines

A Phase 1 study testing AVA, Ad4-PA-1 and Ad4-PA-GPI-1 in people with Anthrax Infection, run by Emergent BioSolutions at 4 sites 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 purpose of this study is to evaluate 2 vaccine candidates against anthrax compared to the positive (vaccine) control as studied in normal healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Anthrax Infection
What is being tested?
AVA, Ad4-PA-1 and Ad4-PA-GPI-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
4 sitesUnited States
Study dates
Nov 2013to Sep 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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Able to understand the study and give written informed consent.
  • Healthy men or women aged 18-40 years old,
  • BMI between 18 to 36 kg/m2
  • Women of child bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to vaccination on all vaccination days; they must also be willing to use adequate birth control for the duration of the study and have additional pregnancy tests if indicated.
  • Intact upper arms with sufficient muscular tissue in the deltoid region for IM vaccine administration.
  • Subject must be available for the study duration
  • Subject must avoid strenuous exercise for at least 72 hours prior to each study vaccine administration.

Who cannot join

  • Subject is a healthcare worker who has direct contact with patients or has an household contact (HHC) who is immunodeficient or HIV-positive, pregnant, has an unstable medical condition, or is under the age of 18.
  • Subject is a childcare worker or a parent who has direct contact with children 5 years old and younger.
  • Subject directly prepares food in the food industry.
  • Pregnant or breastfeeding throughout the duration of the study until the final visit
  • Military service between 1971 and 1999, or after 2012 when Ad4 vaccine was/is routinely given
  • Employment in an industry involved in contact with ruminant animals, veterinary sciences, or other potential exposure to B. anthracis
Show all 31Show fewer
  • Received previous Ad4 vaccination or experimental Ad4 vector vaccines
  • Received previous anthrax vaccine
  • Received or plans to receive any other approved or investigational vaccines from 30 days prior to the first study vaccination until 30 days after the final study vaccination for live attenuated vaccines and from 15 days prior to the first study vaccination until 15 days after the final study vaccination for inactivated vaccines
  • HIV or Hepatitis B or C positive
  • Immunodeficient or has an unstable medical condition including psychiatric conditions
  • Active or past history of acute or chronic gastrointestinal conditions
  • Active or past history of cancer except basal cell carcinoma
  • Recipient of bone marrow or solid organ transplant
  • Received or plans to receive systemic antiviral medication, within 30 days prior to the first study vaccination
  • Known allergy to any component of the study vaccine
  • Known allergy to, or known medical condition that precludes use of any systemic antiviral medication
  • Received or plans to receive medications indicated for decreasing acidity of stomach including:
  • Proton pump inhibitors or antacids or histamine 2-receptor antagonists
  • Received or plans to receive immunoglobulin or other blood products within 60 days prior to the first study vaccination
  • Received or plans to receive other investigational drugs within 30 days prior to the first study vaccination
  • Received or plans to receive systemic immunosuppressive therapy, radiation therapy, or inhaled steroids within 30 days prior to the first study vaccination
  • Asthmatic or requires asthmatic medications on a daily basis
  • Use of systemic chemotherapy within 5 years prior to study
  • Body temperature >38.1°C or acute illness within 3 days prior to vaccination
  • History of excessive alcohol consumption, drug abuse, or significant psychiatric illness
  • History of Guillain-Barré Syndrome
  • Blood donation within 2 months prior to first study vaccination
  • Expected to be noncompliant with study visits or plans to move away or be living with different HHCs during the next 8 months
  • Drinks more than 1200 mL of tea/coffee/cocoa/cola or other caffeinated beverage per day.
  • Any condition or finding that in the view of the primary investigator would impede full study participation

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • The Center for Pharmaceutical Research

    Kansas City, Kansas, 64114

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Walter Reed Army Institute for Research

    Silver Spring, Maryland, 20910

  • St. Louis University

    St Louis, Missouri, 63104

Other trials in United States

About this study

Official title: A Phase 1 Randomized Double-Blind Positive-Controlled Ascending Dose Study to Evaluate the Safety and Immunogenicity of a Replication-Competent Adenovirus Serotype 4 Anthrax Vector Candidate Vaccines - Ad4-PA (Protective Antigen)and Ad4-PA-GPI (Glycosylphosphatidylinositol)

The purpose of this study is to evaluate 2 vaccine candidates against anthrax compared to the positive (vaccine) control as studied in normal healthy volunteers.

Read the detailed description

A Phase 1, randomized, double-blind, positive controlled, increasing dose clinical trial in healthy adult subjects at multiple sites. The study will assess safety and immunogenicity of two adenovirus vaccine candidates against anthrax compared to the positive control, Anthrax Vaccine Adsorbed (AVA). The trial will enroll 108 subjects in the anthrax vector vaccine arms and 12 subjects in the AVA positive control subjects. The study will look at three different dose of oral dosages of Ad4-PA (protective antigen) and Ad4-PA-GPI (10^9, 10^10, 10^11 vp/dose)as well as 3 vaccine administration schedules (1 and 15 days; 1 and 29 days; 1, 15, and 29 days); 2 of 3 schedules will include an intramuscular (IM) AVA booster immunization, 1 schedule will include 3 vaccine administrations of Ad4-PA or Ad4-PA-GPI (glycosylphosphatidylinositol) alone, and 1 schedule will include 3 vaccine administrations of AVA alone.

Being tested
AVA, Ad4-PA-1, Ad4-PA-GPI-1
Keywords
Anthrax vaccine
Medical subject headings
Anthrax

What participants receive

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

  • AVABiological

    Also called Anthrax vaccine adsorbed (BioThrax)

    Anthrax Vaccine Adsorbed (0.5 mL) as the placebo control on Days 1, 15 and 29

  • Ad4-PA-1Biological

    Also called Adenovirus serotype 4 vector vaccine against anthrax PA

    Ad4-PA will be given at 10^9, 10^10 and 10^11 on Day, followed by an oral placebo on Day 15 and an AVA boost on Day 29

  • Ad4-PA-GPI-1Biological

    Also called Adenovirus anthrax vaccine serotype 4 against anthrax PA

    Given at 10^9, 10^10 and 10^11 viral particles

    Ad4 PA-GPI at Day 1 + oral placebo on Day 29 + AVA boost at Day 15

Study groups in NCT01979406
Study groupRoleWhat they receive
AVAActive comparatorAnthrax Vaccine Adsorbed (0.5 mL) as the placebo control on Days 1, 15 and 29
Receives: Biological: AVA
Ad4-PA-1ExperimentalGiven at 10^9, 10^10 and 10^11 vp Ad4-PA at Day 1 + oral placebo on Day 15 + AVA boost at Day 29
Receives: Biological: AVA; Biological: Ad4-PA-1
Ad4-PA-2ExperimentalGiven at 10^9, 10^10 and 10^11 vp Ad4-PA at Days 1, 15 and 29
Receives: Biological: Ad4-PA-1
Ad4-PA-3ExperimentalAd4 given at 10^9, 10^10 and 10^11 vp Ad4 PA-GPI at Day 1 + AVA boost at Day 15 + placebo on Day 29
Receives: Biological: AVA; Biological: Ad4-PA-1
Ad4-PA-GPI-1ExperimentalGiven at 10^9, 10^10 and 10^11 viral particles Ad4 PA-GPI at Day 1 + oral placebo on Day 29 + AVA boost at Day 15
Receives: Biological: AVA; Biological: Ad4-PA-GPI-1
Ad4 PA-GPI-2ExperimentalGiven at 10^9, 10^10 and 10^11 viral particles Ad4 PA-GPI at Day 1 + placebo on Day 15 + AVA boost at Day 29
Receives: Biological: AVA; Biological: Ad4-PA-GPI-1
Ad4-PA-GPI -3ExperimentalGiven at 10^9, 10^10 and 10^11 viral particles Ad4-PA-GPI at Days 1, 15 and 29
Receives: Biological: Ad4-PA-GPI-1

What is being measured

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

  1. The safety, tolerability and immunogenicity of the Ad4 PA and Ad4 PA GPI vaccines across a range of dosages and schedules.

    Safety will be measured by looking at safety labs, Adverse Events (AEs) and vaccine reactogenicity data from Baseline through Day 211. Immunogenicity will be measured by the peak serum antibody response to the PA transgene defined as the highest toxin-neutralizing antibody (TNA) titer achieved by a subject at any time between the first post-vaccination visit though Day 85 (and Day 211 if Day 85 is positive).

    Measured: Day 1 through Day 211

Secondary outcomes (7)

  1. Antibody response of the Ad4-PA formulation to Ad4 PA GPI

    Antibody response will be tested via enzyme-linked immunosorbent assay (ELISA) and the peak PA-ELISA titer defined as the highest ELISA titer achieved by a subject at any time between the first post-vaccination visit and Day 85

    Measured: Day 1 through Day 85 (Day 211 if Day 85 is positive)

  2. Antibody response of the Ad4-PA and Ad4-PA-GPI vaccination regimens to the anticipated AVA PEP regimen.

    Antibody response will be tested via ELISA and the peak PA-ELISA titer defined as the highest ELISA titer achieved by a subject at any time between the first post-vaccination visit and Day 85.

    Measured: Days 1 through 85 (Day 211 if Day 85 is positive)

  3. Antibody response induced by 3 different dosages of Ad4 PA and Ad4 PA GPI.

    Antibody response will be tested via ELISA and the peak PA-ELISA titer defined as the highest ELISA titer achieved by a subject at any time between the first post-vaccination visit and Day 85 and titers will be compared across the 3 different dosages of Ad4 PA and Ad4 PA GPI (10^9, 10^10, 10^11).

    Measured: Days 1 through 85 (Day 211 if Day 85 is positive)

  4. TNA and antibody response induced by Ad4 PA and Ad4 PA GPI on 3 different vaccination schedules.

    Antibody response will be tested via ELISA and the peak PA-ELISA titer defined as the highest ELISA titer achieved by a subject at any time between the first post-vaccination visit and Day 85, and compared among 3 vaccine schedules:

    1. Day 1: Ad4-PA or Ad4-PA-GPI, Day 15 placebo Day 29 AVA boost;
    2. Day 1:Ad4-PA or Ad4-PA-GPI, Day 15 AVA boost + Placebo; and
    3. Days 1, 15 and 29: Ad4-PA or Ad4-PA-GPI

    Measured: Days 1 through 85 (Day 211 if Day 85 is positive)

  5. Pre-existing Ad4 immunity on TNA and PA-ELISA response induced by Ad4 PA and Ad4 PA GPI.

    Antibody response will be tested via ELISA and the impact of pre-existing Ad4 serostatus (positive/negative) on TNA and PA-ELISA will be evaluated

    Measured: Days 1 through 85 (Day 211 if Day 85 is positive)

  6. Evaluate the kinetics of the TNA and PA-ELISA antibody response induced by 3 different doses of Ad4 PA and Ad4 PA GPI on 3 different administration schedules.

    TNA and PA-ELISA titer at each post-vaccination visit as measured by ELISA will be compared across each dose group (10^9, 10^10 and 10^11 vp) and dosing schedule. In addition, the time to peak pre-boost TNA titer and to peak pre-boost PA-ELISA titer will be compared across each dose group and dosing schedule. Cumulative TNA and PA-ELISA seroconversion through each post-vaccination visit and through Day 85

    Measured: Days 1 through 85 (Day 211 if Day 85 is positive)

  7. In vivo replication/excretion of the Ad4 PA and Ad4 PA GPI vaccines

    The duration of in vivo replication/excretion will be measured by the Ad4 MN seroconversion and titer measured via ELISA testing. Vaccine take defined as either Ad4 micro-neutralizing (MN) seroconversion and/or detection of vaccine shedding measured by polymerase chain reaction (PCR) and confirmed by culture at any time point from Day 1 through Day 211

    Measured: Days 1 through 211

Timeline

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

  1. First posted8 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionOct 2014
  4. Study completionSep 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
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01979406
Sponsor's protocol ID
PXVX-PA-100-001
Status last verified
Mar 2024
First submitted
16 Oct 2013
Last updated
18 Mar 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AVA, Ad4-PA-1 and Ad4-PA-GPI-1 in people with Anthrax Infection, run by Emergent BioSolutions at 4 sites 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 7 inclusion and 31 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 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The safety, tolerability and immunogenicity of the Ad4 PA and Ad4 PA GPI vaccines across a range of dosages and schedules. (time frame: Day 1 through Day 211). 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 NCT01979406.

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 18 Mar 2024.

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