Bivalent Norovirus Vaccine Study

Completed · Phase 1

Conditions studied: Gastroenteritis

In brief

Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with MPL and Al(OH)3 compared to controls. Participants will receive two doses, by 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 Al(OH)3. * 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.

Key facts

Study ID: NCT01168401
Run by: Takeda
People needed: 102
Starts: 2010-09-03
Expected to finish: 2013-01-09
Last updated by the study team: 2018-11-23

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Participants must meet all of the inclusion criteria listed below:
Signed written informed consent.
Age:
Cohort A: 18-49 years, inclusive
Cohort B: 50-64 years, inclusive
Cohort C: 65-85 years, inclusive
Cohort D: 18-49 years, inclusive
Health Status:
Cohort A and D: 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.
Expressed interest and availability to fulfill the study requirements.
Female participants must be of non-childbearing potential (surgically sterile or post-menopausal for greater than or equal to [>=] 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 (example 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 participants 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.
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 that is 393 days.
Agrees to storage of unused clinical specimens for an indefinite period of time for future norovirus research or research on other gastrointestinal pathogens.

You may not qualify if…

Participants who meet any of the exclusion criteria at baseline will be excluded from study participation. The exclusion criteria are:
History of any of the following medical illnesses:
Diabetes
Cancer (malignancy other than resolved/excised skin lesion)
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 less than [<] 5 years old)
Recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
Any condition associated with immunodeficiency or participants taking immunosuppressant medication
Neuroinflamatory or auto-immune disease
Any current illness requiring daily medication other than the following:
Cohort A and D: Vitamins, birth control, anti-hypertensive medication, antihistamines or anti-depressant medication. The Principal Investigator (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 criteria 3. The PI should consult with the Central Safety Monitor and/or the sponsor for any clarification of medications allowable.
Allergies or hypersensitivity to any component of the vaccine including MPL and Al(OH)3 adjuvants.
Any clinically significant abnormality detected on physical examination, including:
Murmur (other than a functional murmur)
Focal neurological abnormality
Hepatosplenomegaly
Lymphadenopathy
Jaundice
Hypertension (Blood Pressure [BP] greater than [>] 140/90 millimeter of mercury [mm Hg] on two separate days)
Any lab abnormality (per the site local laboratory), as listed below:
Absolute Neutrophil Count (ANC) outside the normal range (may be repeated if outside this limit)
Total white blood cells (WBC) outside the normal range (may be repeated if outside this limit)
Hemoglobin outside the normal range (may be repeated if outside this limit)

Where it is running

Navy Medical Research Center — Silver Springs, Maryland, United States
Saint Louis University — St Louis, Missouri, United States
University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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