Bivalent Norovirus Vaccine Study (NCT01168401) | Clinical Trial Compass
CompletedPhase 1
Bivalent Norovirus Vaccine Study
United States102 participantsStarted 2010-09-03
Plain-language 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 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent.
✓. Age:
✓. Health Status:
✓. 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.
What they're measuring
1
Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1
Timeframe: Day 0 up to Day 7
2
Number of Participants With Solicited Local AEs Post Dose 2
Timeframe: Day 28 up to Day 35
3
Number of Participants With Solicited Systemic AEs Post Dose 1
Timeframe: Day 0 up to Day 7
4
Number of Participants With Solicited Systemic AEs Post Dose 2
Timeframe: Day 28 up to Day 35
5
Number of Participants With Unsolicited AEs Post Dose 1
Timeframe: Baseline up to Day 28 (Pre-dose 2)
6
Number of Participants With Unsolicited AEs Post Dose 2
Timeframe: Day 28 up to Day 56 (Post dose 2)
7
Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values
Timeframe: Baseline up to Day 35
8
Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI)
✕. History of any of the following medical illnesses:
✕. Any current illness requiring daily medication other than the following:
✕. 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:
✕. 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:
✕. Positive serology for hepatitis C or Human Immunodeficiency Virus (HIV) antibody or hepatitis B surface antigen.
✕. 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.
Timeframe: Baseline up to 365 Days after post dose 2 (Day 393)