TularaemiaPhase 2NCT01150695
Phase II Tularemia Vaccine Comparison
A Phase 2 study testing Undiluted Francisella tularensis live attenuated vaccine in people with Tularaemia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial summary
The purpose of this study is to compare 2 experimental vaccines that could provide protection from the disease, tularemia. This research will compare the ability of the vaccines to cause the body to develop an immune (protective) response and obtain more information on side effects of the vaccines. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tularaemia
- What is being tested?
- Undiluted Francisella tularensis live attenuated vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2010to Jan 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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:
Show all 30Show fewer
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, 21201-1509
Emory Vaccine Center - The Hope Clinic
Decatur, Georgia, 30030-1705
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, 77030-3411
University of Iowa - Vaccine Research & Education Unit
Iowa City, Iowa, 52242-2600
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, 63104-1015
About this study
Official title: 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)
The purpose of this study is to compare 2 experimental vaccines that could provide protection from the disease, tularemia. This research will compare the ability of the vaccines to cause the body to develop an immune (protective) response and obtain more information on side effects of the vaccines. About 220 male and non-pregnant female volunteers 18 to 45 years will participate. Volunteers will be assigned to 1 of 2 vaccine groups by chance. About half of the volunteers will be placed in the DVC-LVS vaccine group and half of volunteers will be placed in the USAMRIID-LVS vaccine group. Additionally, both groups will receive an injection of placebo (inactive salt water). Study procedures include physical exam and blood and urine samples. Evaluation of the vaccination sites will be performed as well as blood samples to measure the body's response to the vaccine. Participants will be involved in the study for about 6 months.
Read the detailed description
Francisella (F.) tularensis is the organism responsible for tularemia. The organism can infect many different vertebrate and invertebrate hosts, but mostly rodents and lagomorphs. Transmission to humans is generally via an insect vector, such as ticks, mosquitoes, and biting flies, or from handling contaminated animal products or carcasses. F. tularensis is a highly infectious bacterium, with human infection and disease occurring with as few as 10 organisms, and mortality rates approaching 30 percent if untreated. Clinical presentation of tularemia varies in severity depending on the virulence of the organism, the route of entry, the extent of system involvement, and the immune status of the host. Following an incubation period of 3 to 5 days, individuals have an abrupt onset of fever, chills, headache, malaise, anorexia, and fatigue. The clinical presentation of the disease can include one or more the following forms: ulceroglandular (the most common form of the disease), glandular, oculoglandular, pharyngeal, gastrointestinal, pneumonic or typhoidal. This study is 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 Group A will include 110 volunteers who will be vaccinated with a single dose of the DVC LVS product in one arm and normal saline (NS) control in the other arm on Day 0. Group B will include 110 volunteers who will be vaccinated with a single dose of the USAMRIID-LVS product in one arm and normal saline (NS) control in the other arm on Day 0. Both vaccines will be administered by scarification. Approximately 100 microliters aliquot will be withdrawn and placed on the skin, a bifurcated needle will then be used to puncture the skin 15 times through the droplet. The primary objectives are: (Safety): assess the frequency of serious adverse events (SAEs) and Grade 3 and 4 laboratory values following vaccination with either DVC-LVS or USAMRIID-LVS vaccine; (Take): assess the frequency of "take" (defined as the development of an erythematous papule, vesicle, and/or eschar with or without underlying induration) following vaccination with either the DVC-LVS or USAMRIID-LVS vaccine; and (Immunogenicity): assess the rate of seroconversion following vaccination with either the DVC-LVS or the USAMRIID-LVS vaccine as measured by a tularemia-specific microagglutination assay. The secondary objectives are: (Safety): assess the incidence of adverse events (AEs) following vaccination with either the DVC-LVS or the USAMRIID-LVS vaccine; (Take): assess "take" frequency and difference between vaccine groups as assessed by an independent committee following vaccination with either the DVC-LVS or USAMRIID- LVS vaccine; and (Immunogenicity): assess antibody responses for each group following vaccination with DVC-LVS or USAMRIID-LVS vaccine as measured by a tularemia-specific microagglutination assay. Parent protocol to sub-study 10-0019.
- Conditions
- Tularaemia
- Being tested
- Placebo, Undiluted Francisella tularensis live attenuated vaccine
- Keywords
- vaccine, Francisella tularensis, Tularemia, rabbit fever, parent protocol
- Medical subject headings
- Tularemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
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 vaccineBiological
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 vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (DVC-LVS) | Experimental | 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. Receives: Other: Placebo; Biological: Undiluted Francisella tularensis live attenuated vaccine |
| Group B (USAMRIID-LVS) | Experimental | 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. Receives: Other: Placebo; Biological: Undiluted Francisella tularensis live attenuated vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: incidence of vaccine-associated serious adverse events (SAEs).
Measured: 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.
Measured: Visits 7 or 8 post vaccination (Day 28 or Day 56).
Safety: incidence of Grade 3 or 4 laboratory values.
Measured: 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.
Measured: By study Visit 5 (7-9 days post vaccination).
Secondary outcomes (6)
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.
Measured: Study Visit 5 (7-9 days post vaccination).
Safety: occurrence of solicited systemic AEs.
Measured: 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".
Measured: Study Visit 5 (7-9 days post vaccination).
Safety: occurrence of solicited local adverse events (AE)s.
Measured: 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.
Measured: 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.
Measured: Study Visit 5 (7-9 days post vaccination).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TularaemiaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150695
- Sponsor's protocol ID
- 08-0006
- Status last verified
- Mar 2013
- First submitted
- 24 Jun 2010
- Last updated
- 13 Jan 2016
- Results posted
- No
Publications
Goll JB, Bosinger SE, Jensen TL, Walum H, Grimes T, Tharp GK, Natrajan MS, Blazevic A, Head RD, Gelber CE, Steenbergen KJ, Patel NB, Sanz P, Rouphael NG, Anderson EJ, Mulligan MJ, Hoft DF. The Vacc-SeqQC project: Benchmarking RNA-Seq for clinical vaccine studies. Front Immunol. 2023 Jan 19;13:1093242. doi: 10.3389/fimmu.2022.1093242. eCollection 2022.
PubMed 36741404Mulligan MJ, Stapleton JT, Keitel WA, Frey SE, Chen WH, Rouphael N, Edupuganti S, Beck A, Winokur PL, El Sahly HM, Patel SM, Atmar RL, Graham I, Anderson E, El-Kamary SS, Pasetti MF, Sztein MB, Hill H, Goll JB; DMID 08-0006 Tularemia Vaccine Study Group. Tularemia vaccine: Safety, reactogenicity, "Take" skin reactions, and antibody responses following vaccination with a new lot of the Francisella tularensis live vaccine strain - A phase 2 randomized clinical Trial. Vaccine. 2017 Aug 24;35(36):4730-4737. doi: 10.1016/j.vaccine.2017.07.024. Epub 2017 Jul 24.
PubMed 28750854
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01150695
- Acronym / sponsor ID
- 08-0006
- Conditions
- Tularaemia
- Keywords
- vaccine, Francisella tularensis, Tularemia, rabbit fever, parent protocol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare 2 experimental vaccines that could provide protection from the disease, tularemia. This research will compare the ability of the vaccines to cause the body to develop an immune (protective) response and obtain more information on side effects of the vaccines. About 220 male and non-pregnant female volunteers 18 to 45 years will participate. Volunteers will be assigned to 1 of 2 vaccine groups by chance. About half of the volunteers will be placed in the DVC-LVS vaccine group and half of volunteers will be placed in the USAMRIID-LVS vaccine group. Additionally, both groups will receive an injection of placebo (inactive salt water). Study procedures include physical exam and blood and urine samples. Evaluation of the vaccination sites will be performed as well as blood samples to measure the body's response to the vaccine. Participants will be involved in the study for about 6 months.
Detailed description
Francisella (F.) tularensis is the organism responsible for tularemia. The organism can infect many different vertebrate and invertebrate hosts, but mostly rodents and lagomorphs. Transmission to humans is generally via an insect vector, such as ticks, mosquitoes, and biting flies, or from handling contaminated animal products or carcasses. F. tularensis is a highly infectious bacterium, with human infection and disease occurring with as few as 10 organisms, and mortality rates approaching 30 percent if untreated. Clinical presentation of tularemia varies in severity depending on the virulence of the organism, the route of entry, the extent of system involvement, and the immune status of the host. Following an incubation period of 3 to 5 days, individuals have an abrupt onset of fever, chills, headache, malaise, anorexia, and fatigue. The clinical presentation of the disease can include one or more the following forms: ulceroglandular (the most common form of the disease), glandular, oculoglandular, pharyngeal, gastrointestinal, pneumonic or typhoidal. This study is 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 Group A will include 110 volunteers who will be vaccinated with a single dose of the DVC LVS product in one arm and normal saline (NS) control in the other arm on Day 0. Group B will include 110 volunteers who will be vaccinated with a single dose of the USAMRIID-LVS product in one arm and normal saline (NS) control in the other arm on Day 0. Both vaccines will be administered by scarification. Approximately 100 microliters aliquot will be withdrawn and placed on the skin, a bifurcated needle will then be used to puncture the skin 15 times through the droplet. The primary objectives are: (Safety): assess the frequency of serious adverse events (SAEs) and Grade 3 and 4 laboratory values following vaccination with either DVC-LVS or USAMRIID-LVS vaccine; (Take): assess the frequency of "take" (defined as the development of an erythematous papule, vesicle, and/or eschar with or without underlying induration) following vaccination with either the DVC-LVS or USAMRIID-LVS vaccine; and (Immunogenicity): assess the rate of seroconversion following vaccination with either the DVC-LVS or the USAMRIID-LVS vaccine as measured by a tularemia-specific microagglutination assay. The secondary objectives are: (Safety): assess the incidence of adverse events (AEs) following vaccination with either the DVC-LVS or the USAMRIID-LVS vaccine; (Take): assess "take" frequency and difference between vaccine groups as assessed by an independent committee following vaccination with either the DVC-LVS or USAMRIID- LVS vaccine; and (Immunogenicity): assess antibody responses for each group following vaccination with DVC-LVS or USAMRIID-LVS vaccine as measured by a tularemia-specific microagglutination assay. Parent protocol to sub-study 10-0019.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (DVC-LVS) | Experimental | Other: Placebo, Biological: Undiluted Francisella tularensis live attenuated vaccineSingle 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. |
| Group B (USAMRIID-LVS) | Experimental | Other: Placebo, Biological: Undiluted Francisella tularensis live attenuated vaccineSingle 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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:
- All clinical laboratory values must be within normal limits for age and gender with the following exceptions:
- Completion of Volunteer Questionnaire
Key exclusion criteria (30 listed)
- 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)).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboNormal saline will be administered to all subjects as a control and will be given at the same visit as the vaccine (Day 0). | Other | Group A (DVC-LVS), Group B (USAMRIID-LVS) |
| Undiluted Francisella tularensis live attenuated vaccineUndiluted 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. | Biological | Group A (DVC-LVS) |
| Undiluted Francisella tularensis live attenuated vaccineUndiluted 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. | Biological | Group B (USAMRIID-LVS) |
Primary outcome
Safety: incidence of vaccine-associated serious adverse events (SAEs).
Time frame: 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).
Safety: incidence of Grade 3 or 4 laboratory values.
Time frame: 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).
6 secondary outcomes
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).
Safety: occurrence of solicited systemic AEs.
Time frame: 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).
Safety: occurrence of solicited local adverse events (AE)s.
Time frame: 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)..
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Derived from this study: PubMed 36741404Goll JB, Bosinger SE, Jensen TL, Walum H, Grimes T, Tharp GK, Natrajan MS, Blazevic A, Head RD, Gelber CE, Steenbergen KJ, Patel NB, Sanz P, Rouphael NG, Anderson EJ, Mulligan MJ, Hoft DF. The Vacc-SeqQC project: Benchmarking RNA-Seq for clinical vaccine studies. Front Immunol. 2023 Jan 19;13:1093242. doi: 10.3389/fimmu.2022.1093242. eCollection 2022.
- Derived from this study: PubMed 28750854Mulligan MJ, Stapleton JT, Keitel WA, Frey SE, Chen WH, Rouphael N, Edupuganti S, Beck A, Winokur PL, El Sahly HM, Patel SM, Atmar RL, Graham I, Anderson E, El-Kamary SS, Pasetti MF, Sztein MB, Hill H, Goll JB; DMID 08-0006 Tularemia Vaccine Study Group. Tularemia vaccine: Safety, reactogenicity, "Take" skin reactions, and antibody responses following vaccination with a new lot of the Francisella tularensis live vaccine strain - A phase 2 randomized clinical Trial. Vaccine. 2017 Aug 24;35(36):4730-4737. doi: 10.1016/j.vaccine.2017.07.024. Epub 2017 Jul 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Undiluted Francisella tularensis live attenuated vaccine in people with Tularaemia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: incidence of vaccine-associated serious adverse events (SAEs). (time frame: Throughout the course of the study.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01150695, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.