- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01150695
Phase II Tularemia Vaccine Comparison
A Phase II, Multi-Center, Double-Blind, Randomized Trial Comparing the Safety and Immunogenicity of a Francisella Tularensis Live Vaccine Strain (LVS) Vaccine Produced by DynPort Vaccine Company (DVC-LVS) to a LVS Vaccine in Use by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID-LVS)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Georgia
-
Decatur, Georgia, United States, 30030-1705
- Emory Vaccine Center - The Hope Clinic
-
-
Iowa
-
Iowa City, Iowa, United States, 52242-2600
- University of Iowa - Vaccine Research & Education Unit
-
-
Maryland
-
Baltimore, Maryland, United States, 21201-1509
- University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
-
-
Missouri
-
Saint Louis, Missouri, United States, 63104-1015
- Saint Louis University - Center for Vaccine Development
-
-
Texas
-
Houston, Texas, United States, 77030-3411
- Baylor College of Medicine - Molecular Virology and Microbiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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)
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A (DVC-LVS)
Single dose of the Dynport Vaccine Company Live Vaccine Strain (DVC-LVS) product in one arm and normal saline (NS) control in the other arm on Day 0.
|
Normal saline will be administered to all subjects as a control and will be given at the same visit as the vaccine (Day 0).
Undiluted Francisella tularensis live attenuated vaccine [approximately 1x10^9 colony forming units (cfu)/mL] produced by Dynport Vaccine Company.
Administered by scarification in the ulnar aspect of the volar surface (palm side) of the forearm midway between the wrist and the elbow.
Undiluted Francisella tularensis live attenuated vaccine (approximately 1x10^9 cfu/mL) in use by the United States Army Medical Research Institute of Infectious Diseases.
Administered by scarification in the ulnar aspect of the volar surface (palm side) of the forearm midway between the wrist and the elbow.
|
Experimental: Group B (USAMRIID-LVS)
Single dose of the United States Army Medical Research Institute of Infectious Diseases Live Vaccine Strain (USAMRIID-LVS) product in one arm and normal saline (NS) control in the other arm on Day 0.
|
Normal saline will be administered to all subjects as a control and will be given at the same visit as the vaccine (Day 0).
Undiluted Francisella tularensis live attenuated vaccine [approximately 1x10^9 colony forming units (cfu)/mL] produced by Dynport Vaccine Company.
Administered by scarification in the ulnar aspect of the volar surface (palm side) of the forearm midway between the wrist and the elbow.
Undiluted Francisella tularensis live attenuated vaccine (approximately 1x10^9 cfu/mL) in use by the United States Army Medical Research Institute of Infectious Diseases.
Administered by scarification in the ulnar aspect of the volar surface (palm side) of the forearm midway between the wrist and the elbow.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: incidence of vaccine-associated serious adverse events (SAEs).
Time Frame: Throughout the course of the study.
|
Throughout the course of the study.
|
Immunogenicity: proportion of subjects that seroconvert (greater than or equal to 4-fold rise in antibody titer) as measured by a tularemia-specific microagglutination assay.
Time Frame: Visits 7 or 8 post vaccination (Day 28 or Day 56).
|
Visits 7 or 8 post vaccination (Day 28 or Day 56).
|
Safety: incidence of Grade 3 or 4 laboratory values.
Time Frame: Through Day 28 of the study.
|
Through Day 28 of the study.
|
Proportion of subjects that develop a positive "take" response, as assessed by the clinical site, defined as the development of an erythematous papule, vesicle, and/or eschar with or without underlying induration.
Time Frame: By study Visit 5 (7-9 days post vaccination).
|
By study Visit 5 (7-9 days post vaccination).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Take: proportion of subjects that develop a positive "take" response, as assessed by an independent blinded "take committee," following review of photographs taken of the vaccination and placebo sites.
Time Frame: Study Visit 5 (7-9 days post vaccination).
|
Study Visit 5 (7-9 days post vaccination).
|
Safety: occurrence of solicited systemic AEs.
Time Frame: Within 28 days post vaccination.
|
Within 28 days post vaccination.
|
Take: difference in the proportion of subjects that develop a positive "take" response between the two vaccine groups as assessed by an independent blinded "take committee".
Time Frame: Study Visit 5 (7-9 days post vaccination).
|
Study Visit 5 (7-9 days post vaccination).
|
Safety: occurrence of solicited local adverse events (AE)s.
Time Frame: Within 28 days post vaccination.
|
Within 28 days post vaccination.
|
Immunogenicity: geometric mean titers (GMT) of peak microagglutination titer for each arm of the study. For each subject, the peak titer is defined by the maximum titer among all the available measures.
Time Frame: Visits 6, 7 and 8 post vaccination (Day 14, Day 28 and Day 56)..
|
Visits 6, 7 and 8 post vaccination (Day 14, Day 28 and Day 56)..
|
Take: difference in the proportion of subjects that develop a positive "take" response between the two vaccine groups as assessed by the clinical site.
Time Frame: Study Visit 5 (7-9 days post vaccination).
|
Study Visit 5 (7-9 days post vaccination).
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-0006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States