Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-24 @ 1:40 PM
NCT ID:
NCT01150695
Eligibility Criteria:
Inclusion Criteria:
* Males and non-pregnant females between the ages of 18 and 45 years, at the day of vaccination
* If the subject is female and of childbearing potential, negative serum pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to vaccination.
* If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men (vaginal penetration by a penis, coitus) or use acceptable contraception, for 56 days following vaccination in order to avoid pregnancy:
1. A woman is considered of childbearing potential unless post-menopausal (greater than or equal to 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
2. Acceptable contraception methods are restricted to effective devices \[intrauterine devices (IUDs), NuvaRing®\] or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, condoms with spermicidal agents, monogamous relationship with a vasectomized partner or successful Essure placement with documented confirmation test at least 3 months after the procedure.
* All clinical laboratory values must be within normal limits for age and gender with the following exceptions:
* White Blood Cell Count: 3.0-10.8 thou/mcl.
* Absolute Neutrophil count: \>/= 1.5 thou/mcl
* ALT, AST and LDH \</= 1.25 x ULN
* Glucose: \</= 115 mg/dl
* Creatinine: values lower than the normal range are not exclusionary
* Completion of Volunteer Questionnaire
* Willingness to comply with protocol requirements
* Provides informed consent before any protocol procedures are performed
* Availability for follow up for 6 months after vaccination
Exclusion Criteria:
* Current use of antibiotics or antibiotic treatment within last 7 days.
* Current treatment with chemotherapy.
* Use of immunosuppressive or immunomodulatory agents including parenteral, inhaled, or oral corticosteroids within the last 4-weeks. Use of corticosteroid nasal sprays is permissible. Persons who have used topical steroid can be enrolled after their therapy is completed.
* History of splenectomy.
* Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years. ((Subjects with a psychiatric disorder (not meeting exclusion criteria, e.g. attention-deficit hyperactivity disorder) that is controlled for a minimum of 3 months and the investigator has determined that the subject's mental status will not compromise the subject's ability to comply with protocol requirements may be enrolled)).
* The subject is taking any of the following psychiatric drugs:
aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate.
* The subject is taking more than one antidepressant drug not included in the list above ((Subjects taking only one antidepressant drug (not listed in excluded psychiatric drugs) who are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study provided the investigator determines the subjects' mental status will not compromise the subjects' ability to comply with protocol requirements.
* History of receiving blood or blood products (such as blood transfusion, platelet transfusion, immunoglobulins, hyperimmune serum) in the previous three months.
* Receipt of licensed inactivated vaccine 14 days prior to vaccination or planned receipt of licensed inactivated vaccine within 14 days post vaccination.
* Receipt of licensed live attenuated vaccine within 30 days prior to vaccination or planned receipt of licensed live attenuated vaccine within 28 days post vaccination.
* Use of any other experimental agent within 30 days prior to vaccination and for the duration of the study.
* Previous vaccination against tularemia.
* Previous treatment for tularemia or history of exposure to tularin.
* Known hypersensitivity to gelatin or other components contained in the vaccine (e.g. glucose cysteine hemin agar).
* History of sensitivity to streptomycin or tetracyclines (including doxycycline).
* History of a chronic medical conditions including, but not limited to, disorders of the liver, kidney, lung, heart or nervous system, or other metabolic and autoimmune/inflammatory conditions that would either interfere with the accurate assessment of the safety, "take" or immunogenicity objectives.
* Presence of an acute condition, including, but not limited to, disorders of the liver, kidney, lung, heart, nervous system, or metabolic and autoimmune inflammatory condition that would interfere with the accurate assessment of the safety, "take" and immunogenicity objectives.
* History of anaphylaxis or serious adverse events following immunization.
* History of alcohol or drug abuse in the past five years or current abuse of alcohol or drugs that in the opinion of the Investigator may interfere with the subject's ability to comply with trial procedures.
* Women that are lactating.
* Acute illness including temperature \>100.4 degrees Fahrenheit within one week of vaccination.
* Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antibody (HBsAg).
* Household contact with infants (children \< 1 year), pregnant women, or immunosuppressed individuals, or occupation involving significant contact (e.g., HIV clinic nurse) with infants (children \< 1 year), pregnant women, or immunosuppressed individuals, expected to occur in the 14 days after vaccination.
* Identification of any condition that, in the opinion of the investigator, would jeopardize the safety of the subject following vaccination.
* Significant dermatologic disorder (such as eczema, psoriasis). Significant dermatologic disorder includes a history of keloid formation.
* Tattoo(s) in the area of the vaccination sites or evidence of prior injury or damage of the skin at the vaccination sites (e.g. scarring subsequent to burn).
* The presence of any prosthetic implant (such as joint, ventriculoperitoneal shunt, cardiac valve).
* History of malignancy, including hematologic, melanoma skin cancer. Subjects with squamous cell or basal cell carcinoma are eligible provided the areas affected are not in close proximity to the vaccination sites and any sites that were resected are well healed.
* Donation of a unit of blood within 56 days prior to vaccination and/or planned blood donation within 56 days after vaccination (prior to Visit 8).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01150695
Study Brief:
Protocol Section:
NCT01150695