Healthy Volunteers - San Antonio TX

Summary:

ICON Early Phase Services is conducting a research study for healthy adults ages 18-49. This is a first in human study to test the immunogenicity of an investigational drug being developed as an anthrax vaccine.  The study drugs will be administered as a nasal spray or as a subcutaneous injection. 

Vital signs, ECGs, physical examinations and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study.

Participants will complete:

You will be assigned to one of the following dosing regimens on Day 1:

intranasal dosing

• 1 screening visit
• 1 dosing day
• 1 phone call
• 9 outpatient visits
• a diary

Qualified participants may be compensated up to $1,250 for time and travel.

subcutaneous injection

• 1 screening visit
• 3 dosing days
• 3 phone calls
• 8 outpatient visits
• a diary

To determine if you fully qualify, it will be necessary to obtain blood samples after an 8- hour fast.  You have the option to come in fasting or return for a second screening to complete lab tests. You may need to provide medical records to participate in this study.  For more information, see below.

You may need to provide medical records to participate in this study.  For more information, see below.

If you are able to answer “YES” to the following statements, you may qualify for this study.

• I am a healthy adult, meaning no significant medical conditions

• I am between 18 and 49 years old

• My BMI is < 35 kg/m2   

• I do not smoke or use any tobacco or nicotine products (e.g., cigarettes, electronic cigarettes, marijuana) and I have not used any of these products within 30 days before Day 1.  I agree not to smoke for the duration of the study and to abide by the rules of the clinic, which is a non-smoking facility.

• I have not received any investigational study drug in a clinical trial within 30 days before Day 1

• If Female, I am not pregnant or breastfeeding   

• If Male or Female, all subjects agree to practice a highly effective method of contraception: abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide through 28 days after the last dose

• I am able to communicate effectively in English with the study personnel

• I do not have household contact with pregnant women, children < 5 years of age, or immunocompromised individuals for the period up through 2 weeks post-vaccination

• I do not care for pregnant women, children < 5 years of age, or immunocompromised individuals for the period up through 2 weeks post-vaccination

• I do not have any past use, or any current use, of intranasal illicit drugs

• I am not immunocompromised and have not used corticosteroids (including intranasal steroids), alkylating drugs, antimetabolites, radiation, immunemodulating biologics, or other immunomodulating therapies within 90 days before Day 1 and  do not plan to use them during the study

• I have not used a statin medication within 30 days before Day 1

• I have received any intranasal medications (including over-the-counter medications) within 30 days before Day 1

• I have not received any vaccine within 30 days before Day 1

• I have not received any intranasal vaccine within 90 days before Day 1

• I have not received any licensed or investigational anthrax vaccine

• I have not had any change in medication for a chronic medical condition within 30 days before Day 1

• I do not have asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are any of these events within the past year:
  •   Daily symptoms
  •   Daily use of short acting beta 2 agonists
  •   Use of inhaled steroids or theophylline
  •   Use of pulse systemic steroids
  •   Emergency care or hospitalization related to asthma or other chronic lung disease
  •   Systemic steroids for asthma exacerbation

• I do not have a history of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range), coronary artery disease, arrhythmia, or congestive heart failure, poorly controlled hypertension, anaphylaxis or angioedema

• I do not have a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, nasal surgery, nasal cauterization or other nasal abnormality

• I have not had any symptoms of upper respiratory infection or temperature within 3 days before Day 1

• I have not had any symptoms within 24 hours before Day 1 of upper respiratory illness or allergy flare-up

• I do not have a known or suspected malignancy, excluding non-melanoma skin cancers and other early stage surgically excised malignancies

• I do not have a history of any severe or life-threatening allergies or sensitivity to foods, drugs or latex

• I tolerate oral medication well

• I have not had problems having blood drawn in either arm, venous access or finger pricks.

Qualified Participants May Receive:

Qualified participants may be compensated up to $200 for each completed visit and up to $2,000 for time and travel.