| Eligibility |
Inclusion Criteria:
1. Provide written informed consent prior to initiation of any study procedures.
2. Understand and comply with planned study procedures, including completion of the
electronic memory aid, and be available for all study visits.
3. Agree to the collection of venous blood, per protocol.
4. Have adequate venous access for phlebotomies.
5. Be a male or non-pregnant female, 18 to 45 years of age, inclusive, at the time of
enrollment.
6. Be in good health.*
* As determined by medical history and physical examination to evaluate acute or
currently ongoing chronic medical diagnoses or conditions, which would affect the
assessment of the safety of participants or the immunogenicity of study vaccinations.
Chronic medical diagnoses or conditions, defined as those that have been present for
at least 90 days, should be stable (not worsening) for the last 60 days (no
hospitalizations, emergency room or urgent care for condition, or invasive medical
procedure and no adverse symptoms that need medical intervention such as medication
change indicative of worsening/supplemental oxygen). This includes no change in
chronic prescription medication, dose or frequency, indicative of worsening disease,
in the 60 days prior to enrollment. Any prescription change that is due to change of
health care provider, insurance company, etc., or that is done for financial reasons,
will not be considered a deviation of this inclusion criterion. Participants may be on
chronic or as needed (prn) medications if, in the opinion of the site PI or
appropriate sub-investigator, they pose no additional risk to participant safety or
assessment of reactogenicity and immunogenicity and do not indicate a worsening or
treatment of continued symptoms of medical diagnosis or condition. Herbals, vitamins,
and supplements are permitted.
7. Have an oral temperature less than 100.0 degrees Fahrenheit.
8. Have a pulse 51 to 100 beats per minute, inclusive.
9. Have a systolic blood pressure 85 to 140 mmHg, inclusive.
10. Have a diastolic blood pressure 55 to 90 mmHg, inclusive.
11. Have a calculated body mass index (BMI) less than or equal to 35.0 kg/m2 at screening.
12. Screening laboratories are within acceptable parameters:
- BUN <23 mg/dL
- Serum creatinine (female) <1.3 mg/dL
- Serum creatinine (male) < 1.4 mg/dL
- Alkaline phosphatase (female) <147 U/L
- Alkaline phosphatase (male) <192 U/L
- ALT (aka SGPT) <68 U/L
- Total bilirubin < 1.3 mg/dL
- Hemoglobin (female) >10.9 g/dL
- Hemoglobin (male) > 12.4 g/dL
- White blood cell count 3000-12,000 cells/mm3
- Absolute eosinophil count <1201 cells/mm3
- Absolute neutrophil count >1200 cells/mm3
- Platelets >126,000 cells/mm3
- Hemoglobin A1C <6.5%
- Urine for Drugs of Abuse (amphetamines, barbiturates, benzodiazepines, cocaine,
methadone, opiates, oxycodone/oxymorphone, phencyclidine (PCP), and
propoxyphene). All negative
- HBsAg Non-reactive
- HCV antibodies Negative
- HIV 4th generation test Negative
13. Have no clinically significant findings on 12-lead electrocardiogram.*
* Clinical significance will be determined by a cardiologist. Examples of findings
that will lead to exclusion are significant left ventricular hypertrophy, right or
left bundle branch block, advanced A-V heart block, non-sinus rhythm (excluding
isolated premature atrial contractions), pathologic Q wave abnormalities, significant
ST-T wave changes, prolonged QTc interval.
14. Heterosexually active females of childbearing potential* must use an acceptable
contraception method** from at least 30 days before the first until 60 days after the
second study vaccination.
- Not sterilized via bilateral oophorectomy, salpingectomy, hysterectomy, or
successful Essure(R) placement (permanent, non-surgical, non-hormonal
sterilization) with documented radiological confirmation test at least 90 days
after the procedure, and still menstruating or <1 year has passed since the last
menses, if menopausal.
- Includes full abstinence from sexual intercourse with a male partner,
monogamous relationship with vasectomized partner who has been vasectomized
for 180 days or more or shown to be azoospermic prior to the participant
receiving the study vaccination, barrier methods such as condoms or
diaphragms/cervical cap, intrauterine devices, NuvaRing(R), tubal ligation,
and licensed hormonal methods such as implants, injectables or oral
contraceptives ("the pill").
15. Females of childbearing potential must have a negative serum pregnancy test at
screening and a negative urine pregnancy test within 24 hours prior to each study
vaccination.
16. For a female with potential to become pregnant, she understands that in the event of
pregnancy during the study she will be asked to allow us to follow her during
pregnancy through outcome.
17. Must agree to have blood collected, stored, and potentially used for auto-antibody
studies (if a suspected Potentially Immune-Mediated Medical Conditions (PIMMC) occurs
in this participant).
Exclusion Criteria:
1. Have an acute illness*, as determined by the site principal investigator (PI) or
appropriate sub-investigator, within 72 hours prior to study vaccination.
*An acute illness which is nearly resolved with only minor residual symptoms remaining
is allowable if, in the opinion of the site PI or appropriate sub-investigator, the
residual symptoms will not interfere with the ability to assess safety parameters and
systemic reactogenicity events as required by the protocol.
2. Have any medical disease or condition that, in the opinion of the site PI or
appropriate sub-investigator, is a contraindication to study participation.*
*Including acute, subacute, intermittent, or chronic medical disease or condition that
would place the participant at an unacceptable risk of injury, render the participant
unable to meet the requirements of the protocol, or may interfere with the evaluation
of responses or the participant's successful completion of this trial.
3. Have immunosuppression as a result of an underlying illness or treatment, a recent
history or current use of immunosuppressive or immunomodulating disease therapy.*
*These include oral or parenteral (including intra-articular) corticosteroids of any
dose within 30 days prior to study vaccination, or high-dose inhaled corticosteroids
within 30 days prior to study vaccination, with high-dose defined as per age as using
inhaled high-dose per reference chart in the National Heart, Lung and Blood Institute
Guidelines for the Diagnosis and Management of Asthma (EPR-3) or other lists published
in UPTODATE. Intranasal corticosteroids are not exclusionary. Low and moderate potency
topical corticosteroids are permitted.
4. Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior
to study vaccination.
5. Have known active or recently active (12 months) neoplastic disease or a history of
any hematologic malignancy. Non-melanoma treated skin cancers are permitted.
6. Have known human immunodeficiency virus (HIV), chronic hepatitis B, or hepatitis C
infection.
7. Have known hypersensitivity or allergy to any components of the study vaccines
(Anthrax Vaccine Adsorbed (AVA), CPG adjuvants, aluminum, benzethonium chloride
[phemerol], formaldehyde).
8. Have a history of receipt or plan to receive, while enrolled in this study, a licensed
or unlicensed anthrax vaccine (except for the vaccines under study herein).
9. Have a history of Potentially Immune-Mediated Medical Conditions (PIMMCs).*
*Adverse Events of Special Interest
10. Have a history of alcohol or drug abuse within 5 years prior to study enrollment or
test positive on the screening urine test for drugs of abuse.
11. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other
psychiatric diagnosis that may interfere* with participant compliance or safety
evaluations.
*As determined by the site PI or appropriate sub-investigator.
12. Have been hospitalized for psychiatric illness, history of suicide attempt, or
confinement for danger to self or others within 5 years prior to study vaccination.
13. Received or plan to receive a licensed, live vaccine within 30 days before or after
each study vaccination.
14. Received or plan to receive a licensed, inactivated vaccine within 14 days before or
after each study vaccination.
15. Have a known history of documented anthrax disease or suspected exposure to anthrax.
16. Received immunoglobulin or other blood products, except Rho(D) immunoglobulin, within
90 days prior to study vaccination.
17. Received an experimental agent* within 30 days prior to the study vaccination or
expect to receive another experimental agent** during the trial-reporting period.***
- Including vaccine, drug, biologic, device, blood product, or medication.
- Other than from participation in this trial. ***Approximately 12 months
after the second study vaccination.
18. Are participating or plan to participate in another clinical trial with an
interventional agent* that will be received during the trial-reporting period.**
*Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or
medication.
**Approximately 12 months after the second study vaccination.
19. Female participants who are breastfeeding or plan to breastfeed from the time of the
first study vaccination through 30 days after the second study vaccination.
20. Planning to donate blood within 4 months following second vaccination.
21. Planned elective surgery during study participation.
22. Member or immediate family member of the site research staff found on the delegation
log.
23. Previously served in the military any time after 1990 and/or plan to enlist in the
military at any time during the study.
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