Trial record 2 of 4 for:    norovirus ligocyte

Bivalent Norovirus Vaccine Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LigoCyte Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01168401
First received: July 21, 2010
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention Phase
Gastroenteritis
Infection
Biological: Bivalent Norovirus Vaccine
Biological: Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by LigoCyte Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety as determined by the occurrence of local and systemic signs and symptoms [ 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. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 28 days post dose 1 and 28 days post dose 2 ] [ Designated as safety issue: No ]
    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.


Enrollment: 102
Study Start Date: August 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Norovirus Bivalent (GI.1 and GII.4) VLP Vaccine Biological: Bivalent Norovirus Vaccine

2 Doses 28 days apart Cohort A: 18-49 Years

Cohort A1: IM Norovirus Bivalent VLP Vaccine (5/5 mcg)

Cohort A2: IM Norovirus Bivalent VLP Vaccine (15/15 mcg)

Cohort A3: IM Norovirus Bivalent VLP Vaccine (50/50 mcg)

Cohort A4: IM Norovirus Bivalent VLP Vaccine (150/150 mcg)

Cohort B: 50-64 years IM Norovirus Bivalent VLP Vaccine at the chosen dose from Cohort A

Cohort C: 65-85 years IM Norvirus Bivalent VLP Vaccine at the chosen dosage from Cohort A

Cohort D: 18-49 Years of Age IM Norovirus Bivalent VLP Vaccine at the Chosen Dosage from Cohort A

Placebo Comparator: Saline Biological: Saline
Two doses 28 days apart

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168401

Locations
United States, Maryland
Navy Medical Research Center
Silver Springs, Maryland, United States, 20910
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
LigoCyte Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: LigoCyte Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01168401     History of Changes
Other Study ID Numbers: LV03-104
Study First Received: July 21, 2010
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by LigoCyte Pharmaceuticals, Inc.:
Prevention of acute gastroenteritis due to infection with noroviruses

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Monophosphoryl lipid A
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014