A Phase 1 interventional study of AVA and Ad4-PA-1 in Anthrax Infection, sponsored by Emergent BioSolutions. Completed at 4 sites in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Emergent BioSolutions · Phase 1, Interventional, and Prevention
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.
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.
75 studies on the registry are indexed under Anthrax; 12 are open to participants now.
This study's enrollment of 120 is above the median of 100 across 57 interventional studies indexed under Anthrax.
Browse Anthrax studies →Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anthrax Vaccine Adsorbed (0.5 mL) as the placebo control on Days 1, 15 and 29
Biological: AVA
Given at 10\^9, 10\^10 and 10\^11 vp Ad4-PA at Day 1 + oral placebo on Day 15 + AVA boost at Day 29
Biological: AVA · Biological: Ad4-PA-1
Given at 10\^9, 10\^10 and 10\^11 vp Ad4-PA at Days 1, 15 and 29
Biological: Ad4-PA-1
Ad4 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
Biological: AVA · Biological: Ad4-PA-1
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
Biological: AVA · Biological: Ad4-PA-GPI-1
Given 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
Biological: AVA · Biological: Ad4-PA-GPI-1
Given at 10\^9, 10\^10 and 10\^11 viral particles Ad4-PA-GPI at Days 1, 15 and 29
Biological: Ad4-PA-GPI-1
Anthrax Vaccine Adsorbed (0.5 mL) as the placebo control on Days 1, 15 and 29
Also known as: Anthrax vaccine adsorbed (BioThrax)
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
Also known as: Adenovirus serotype 4 vector vaccine 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
Also known as: Adenovirus anthrax vaccine serotype 4 against anthrax PA
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).
Time frame: Day 1 through Day 211
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
Time frame: Day 1 through Day 85 (Day 211 if Day 85 is positive)
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.
Time frame: Days 1 through 85 (Day 211 if Day 85 is positive)
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).
Time frame: Days 1 through 85 (Day 211 if Day 85 is positive)
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
Time frame: Days 1 through 85 (Day 211 if Day 85 is positive)
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
Time frame: Days 1 through 85 (Day 211 if Day 85 is positive)
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
Time frame: Days 1 through 85 (Day 211 if Day 85 is positive)
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
Time frame: Days 1 through 211
Systemic PA-specific cellular immune response induced by Ad4-PA and Ad4-PA-GPI
The systemic PA-specific cellular immune response induced by Ad4-PA and Ad4-PA-GPI will be measured via cell-based assay on peripheral blood mononuclear cells(PBMCs). The tests will be performed on Days 1, 15, 29 and 43.
Time frame: Days 1 through 43
Mucosal PA-ELISA antibody responses induced by Ad4-PA and Ad4 PA-GPI
PA antibody titers from mucosal samples will be obtained on Days 1 and 29 and titers will be compared among the 2 vaccine candidates.
Time frame: Days 1 through 29
The record gives a start of Nov 2013, a primary completion of Oct 2014 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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