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Trial #NCT01168401
Gastroenteritis Clinical Trials

Bivalent Norovirus Vaccine Study


Phase 1, Randomized Controlled Dose Escalation, Safety and Immunogenicity Study of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine Adjuvanted With Monophosphoryl Lipid A (MPL) and Aluminum Hydroxide (AlOH) in Adults
Study ID: LV03-104; Source: LigoCyte Pharmaceuticals, Inc.
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Completed
Country United States
Study type Interventional
Enrollment 102
Start date August 2010
Completion date January 2013
Phase Phase 1
Sponsor LigoCyte Pharmaceuticals, Inc.
Summary:
Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four
dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with
monophosphoryl lipid A (MPL) and aluminum hydroxide (AlOH) compared to controls. Subjects
will receive two doses, by intramuscular (IM) injection, 28 days apart.

The hypotheses for this study are:

- The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP
Vaccine will be similar to the incidence of adverse events after other IM vaccines
including CERVARIX® which contains MPL and AlOH.

- Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose.

- The post-vaccination serum antibody responses, the number of antibody secreting cells
(ASC), including homing markers, and memory B-cell responses directed against norovirus
antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to
controls.
Eligibility:
Gender: Both
Age: 18 Years - 85 Years
Inclusion Criteria:
Subjects must meet all of the inclusion criteria listed below:
1. Signed written informed consent.
2. Age:
- Cohort A: 18-49 years, inclusive
- Cohort B: 50-64 years, inclusive
- Cohort C: 65-85 years, inclusive
3. Health Status:
- Cohort A: In good health as determined by a screening evaluation that includes vital signs, medical history, and physical exam within 45 days before administration of IM Norovirus Bivalent VLP Vaccine or control.
- Cohorts B and C: In good health as determined by a screening evaluation that includes vital signs, medical history, and physical exam within 45 days before administration of IM Norovirus Bivalent VLP Vaccine or control. Any existing medical diagnoses or conditions must be stable based on medical history and targeted physical examination. A stable medical condition is defined as: (A) Clinically acceptable health outcomes for the specific condition over the prior 6 months and (B) No change in prescription medication(s), dose, or frequency over the prior 3 months. Acceptable changes in medications are: a change of health care provider or insurance company or that is made for financial reasons as long as the medications are in the same class and/or a change due to improvement in a disease outcome.
4. Expressed interest and availability to fulfill the study requirements
5. Female subjects must be of non-childbearing potential (surgically sterile or post-menopausal for = 12 months), or if of childbearing potential (as determined by the investigator) must be practicing abstinence or using an effective licensed method of birth control (e.g. oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream, or foam; intrauterine contraceptive device, or Depo-Provera; skin patch; vaginal ring or cervical cap) for 30 days prior to vaccination and must agree to continue such precautions for at least 60 days after the last vaccination. A woman is eligible if she is monogamous with a male who has had a vasectomy. Male subjects must agree not to father a child for at least 60 days after the last vaccination and to practice abstinence or use an effective method of birth control as noted above.
6. Agrees not to participate in another clinical trial with an investigational product for the entire duration of the study one year after the last study dose i.e. 393 days.
7. Agrees to storage of unused clinical specimens for an indefinite period of time for future norovirus research or research on other gastrointestinal pathogens.
Exclusion Criteria:
Subjects who meet any of the exclusion criteria at baseline will be excluded from study participation. The exclusion criteria are:
1. History of any of the following medical illnesses:
- Diabetes
- Cancer
- Heart disease (hospitalization for a heart attack, arrhythmia, or syncope)
- Unconsciousness (other than a single brief "concussion")
- Seizures (other than febrile seizures as a child <5 years old)
- Recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
- Neuroinflamatory or auto-immune disease
2. Any current illness requiring daily medication other than the following:
- Cohort A: Vitamins, birth control, anti-hypertensive medication, antihistamines or anti-depressant medication. The PI should consult with the Central Safety Monitor and/or the sponsor for any clarification of medications allowable.
- Cohorts B and C: Vitamins, birth control, anti-hypertensive medication, antihistamines or anti-depressant medication or any current illness requiring daily medication other than as noted above in inclusion # 3. The PI should consult with the Central Safety Monitor and/or the sponsor for any clarification of medications allowable.
3. Allergies or hypersensitivity to any component of the vaccine including MPL and AlOH adjuvants.
4. Any clinically significant abnormality detected on physical examination, including:
- Murmur (other than a functional murmur)
- Focal neurological abnormality
- Hepatosplenomegaly
- Lymphadenopathy
- Jaundice
5. Hypertension (BP > 140/90 mm Hg on two separate days)
6. Any lab abnormality (per the site local laboratory), as listed below:
- Neutrophils (WBC) outside the normal range (may be repeated if outside this limit)
- Hemoglobin outside the normal range (may be repeated if outside this limit)
- Platelet count outside the normal range (may be repeated if outside this limit)
- BUN > upper limit of normal (ULN) (may be repeated if outside this limit)
- Creatinine > upper limit of normal (ULN) (may be repeated if outside this limit)
- Glucose (fasting or random) outside the normal range (may be repeated if outside this limit)
- ALT, AST > upper limit of the normal (ULN) (may be repeated if outside this limit)
7. Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen.
8. For women of child bearing potential, positive serum pregnancy test within 14 days and urine pregnancy test within 24 hours of administering either dose of IM Norovirus Bivalent VLP Vaccine or control.
9. Nursing mother.
10. Temperature > 100.4oF or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 3 days of administration of IM Norovirus Bivalent VLP Vaccine or control.
11. Previous participation in a Norovirus vaccine or challenge study.
12. Study site personnel or their family members.
13. Significant history of psychiatric hospitalization, alcohol abuse, or illicit drug use in the prior 5 years.
14. Completion of an investigational vaccine or drug study within 28 days before administration of IM Norovirus Bivalent VLP Vaccine or control.
15. Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
16. Other condition that in the clinical judgment of the investigator would jeopardize the safety or rights of a subject participating in the trial, would render the subject unable to comply with the protocol or would interfere with the evaluation of the vaccine.
-
Outcome:
Primary outcome
  • Safety as determined by the occurrence of local and systemic signs and symptoms
    Safety as determined by the occurrence of local and systemic signs and symptoms within seven days after vaccination as self reported by subjects via memory aid (Days 0 through 7 post each dose) and incidence of abnormal hematology and serum chemistry laboratory values. Safety will also be assessed by occurrence of Serious Adverse Events (SAEs) and onset of any significant new medical conditions for 365 days following the last study vaccination.
    Time frame: seven days after vaccination for local signs and symptoms and 28 days post each dose for other adverse events. One year followup after last dose for SAEs and significant new medical conditions.
Secondary outcome
  • Immunogenicity
    Immunogenicity as determined by geometric mean titers, geometric mean fold rises, and seroconversion rate (4-fold rises) of anti-Norovirus VLP IgG, IgA and IgM antibody titers against the G I.1 and GII.4 VLPs separately before and after each dose.
    Time frame: 28 days post dose 1 and 28 days post dose 2
Location Country Status
Navy Medical Research Center Silver Springs, Maryland United States
Saint Louis University Saint Louis, Missouri United States
University of Rochester Medical Center Rochester, New York United States
Sponsors:
  • LigoCyte Pharmaceuticals, Inc. - (Lead Sponsor)

Terms
  • Prevention of acute gastroenteritis due to infection with noroviruses
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