Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
132 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-07-16
Study Completion Date
2014-03-18
Brief Summary
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The purpose of this study is to determine whether the norovirus vaccine is effective in preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge dose. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of the vaccine.
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Detailed Description
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Conditions
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Prevention From Norovirus Infection
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Norovirus Bivalent VLP Vaccine
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
Group Type
EXPERIMENTAL
Norovirus Bivalent Vaccine
Intervention Type
BIOLOGICAL
2 doses IM 28 days apart
Placebo
Saline Placebo (0.9% sodium chloride (NaCl) and preservative-free), intramuscular (IM), Days 0 and 28.
Group Type
PLACEBO_COMPARATOR
Saline Comparator
Intervention Type
BIOLOGICAL
2 doses IM 28 days apart
Interventions
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Norovirus Bivalent Vaccine
2 doses IM 28 days apart
Intervention Type
BIOLOGICAL
Saline Comparator
2 doses IM 28 days apart
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion Criteria
To be eligible to participate in this study, a subject must meet the following criteria:
1. Signed informed consent.
2. Age 18 to 50 years (e.g., not reached their 50th birthday).
3. Good general health as determined by a screening evaluation within 45 days of randomization.
4. Expressed interest, availability, and understanding to fulfill the study requirements including measures to prevent Norovirus contamination of the environment and spread of infection and illness to the community. The prospective subjects must pass (≥70 % correct answers) a written examination on all aspects of the study before enrollment.
5. Available to return for follow-up visits following discharge from the inpatient unit and able to deliver stool specimens to the investigative site promptly with no plan to move within the duration of the study.
6. Female subjects must be of non-childbearing potential, 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 during the study and for 60 days after the Challenge visit. Male subjects must agree not to father a child from the day of vaccination until 60 days after the Challenge visit.
7. Have a serum antibody titer of ≤1:1600 to the GII.4 Norovirus challenge strain as measured by Immunoglobulin G (IgG) P Particle Enzyme-Linked Immunosorbent Assay (ELISA.)
8. Demonstrated to be H Type 1 secretor positive by Histoblood Group Antigen (HBGA) binding assay of their saliva test. \[This saliva test may be done at anytime prior to enrollment and does not need to be repeated.\]
9. Negative serology for hepatitis C antibody, Human Immune Deficiency Virus (HIV) antibody, hepatitis B surface antigen, and Rapid Plasma Reagin (RPR).
10. Agrees not to participate in another clinical trial with an investigational product for the duration of the study (12 months after the last dose of study vaccine or placebo i.e. 393 days).
1. Signed informed consent.
2. Age 18 to 50 years (e.g., not reached their 50th birthday).
3. Good general health as determined by a screening evaluation within 45 days of randomization.
4. Expressed interest, availability, and understanding to fulfill the study requirements including measures to prevent Norovirus contamination of the environment and spread of infection and illness to the community. The prospective subjects must pass (≥70 % correct answers) a written examination on all aspects of the study before enrollment.
5. Available to return for follow-up visits following discharge from the inpatient unit and able to deliver stool specimens to the investigative site promptly with no plan to move within the duration of the study.
6. Female subjects must be of non-childbearing potential, 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 during the study and for 60 days after the Challenge visit. Male subjects must agree not to father a child from the day of vaccination until 60 days after the Challenge visit.
7. Have a serum antibody titer of ≤1:1600 to the GII.4 Norovirus challenge strain as measured by Immunoglobulin G (IgG) P Particle Enzyme-Linked Immunosorbent Assay (ELISA.)
8. Demonstrated to be H Type 1 secretor positive by Histoblood Group Antigen (HBGA) binding assay of their saliva test. \[This saliva test may be done at anytime prior to enrollment and does not need to be repeated.\]
9. Negative serology for hepatitis C antibody, Human Immune Deficiency Virus (HIV) antibody, hepatitis B surface antigen, and Rapid Plasma Reagin (RPR).
10. Agrees not to participate in another clinical trial with an investigational product for the duration of the study (12 months after the last dose of study vaccine or placebo i.e. 393 days).
Exclusion Criteria
To be eligible to participate in this study, a subject must NOT meet any of the following criteria:
1. Living with or having daily contact with children age 5 years or less or a woman known to be pregnant. This includes significant contact at home, school, day-care, or equivalent facilities.
2. Nursing mother.
3. Living with or having daily contact with childcare workers.
4. Living with or having daily contact with elderly persons aged 70 years or more, or infirmed, diapered individuals, persons with disabilities or incontinent persons. This includes work or visits to nursing homes and day-care or equivalent facilities.
5. History of any gastroenteritis suggestive of Norovirus illness since screening serum antibody IgG P Particle ELISA testing was done.
6. History of any gastroenteritis within the past 2 weeks.
7. History of chronic functional dyspepsia, chronic gastroesophageal reflux disease, peptic ulcer disease, gastrointestinal hemorrhage, gall bladder disease, inflammatory bowel disease, irritable bowel syndrome, frequent diarrhea, chronic constipation, malabsorption, maldigestion, major Gastrointestinal (GI) surgery, or diverticulitis anytime during the subject's lifetime or any other chronic GI disorders that would interfere with interpretation of symptoms or evaluation during the study.
8. Routine use of medication other than oral contraceptive agents, anti-hypertensives, anti-depressants, vitamins and minerals. The use of any other medications should be discussed with the Sponsor and/or Central Safety Monitor (CSM).
9. History of any of the following medical illnesses:
* Immunosuppression (disease or treatments that may affect immune system function)
* Diabetes (including gestational diabetes during the pregnancy that required treatment other than dietary).
* Cancer (malignancy other than a resolved or 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 \<5 years old)
* Asthma requiring treatment with inhaler or medication in the past 2 years.
* Neuro-inflammatory disease
* Autoimmune disease
* Eating disorder
* Chronic headaches associated with vomiting
* Chronic vomiting syndrome
10. Any current illness requiring daily medication other than vitamins, minerals, birth control, anti-hypertensives or anti-depressants. The use of any other medications should be discussed with the Sponsor and/or CSM.
11. Allergies or hypersensitivity to any component of the vaccine or challenge virus.
12. Any clinically significant abnormality detected on physical examination, including:
* Murmur (other than a functional, ie normal, murmur)
* Focal neurological abnormality
* Hepatosplenomegaly
* Lymphadenopathy
* Jaundice
13. Hypertension defined as BP \> 150/90 mm Hg on two separate measurements. Chronic stable well-controlled hypertension on medications is allowed.
14. History of 3 or more hospitalizations for invasive bacterial infections (pneumonia, meningitis), acute or chronic dermatitis (e.g. eczema, seborrhea, psoriasis) or collagen vascular disease (e.g. Systemic Lupus Erythematosus (SLE) or dermatomyositis).
15. Presence of serious chronic illness.
16. Positive stool/fecal culture for bacterial pathogens (salmonella, campylobacter, E. coli 0157:H7, yersinia, or shigella) or positive stool/fecal screen for ova and parasites.
17. Employment in the food service industry, such as restaurants or cafeteria facilities. Specifically, this will include persons whose employment requires food processing in the 4 weeks following challenge.
18. Health-care workers with patient contact expected in the 4 weeks following challenge.
19. Expected contact (through employment or at home) with immunocompromised persons (HIV-positive, receiving immunosuppressive medications such as oral steroids or anti-neoplastic agents) in the 4 weeks following challenge.
20. Employment as an airline flight attendant scheduled to work in the 4 weeks following challenge.
21. Persons planning on taking a cruise in the 4 weeks following challenge.
22. Persons who plan to be living in a confined environment (e.g. ship, camp, or dormitory) within 4 weeks following challenge.
23. Persons who have consumed or plan to consume raw shellfish (e.g. oysters) from screening through post challenge Day 30.
24. Any of the following lab abnormalities (per the site local laboratory):
* Absolute neutrophil count (ANC) outside the normal range
* Total White Blood Cell Count (WBC) outside the normal range
* Hemoglobin or hematocrit outside the normal range
* Platelet count outside the normal range
* Electrolytes \[Sodium (Na), Potassium (K), Chloride (Cl), Carbon dioxide (CO2)\], Blood Urea Nitrogen (BUN) and/or creatinine outside the normal range
* Screening glucose \> upper limit of normal (ULN). Fasting glucose is not required
* Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase, bilirubin (total and indirect), or Gamma Glutamyl Transferase (GGT) outside the upper limit of the normal range
* Screening urinalysis with a value higher than "trace" positive for urine protein or urine glucose, or urine Red Blood Cells (RBCs) (≥3; other than women during menses).
All of the above labs may be repeated if outside the normal limits. If repeated and continue outside site normal ranges, may enroll if determined by the Principal Investigator (PI) to be not clinically significant and discussed with the Sponsor and/or CSM.
25. For women of child bearing potential, positive serum pregnancy test within 14 days or positive urine pregnancy test within one day of randomization.
26. Temperature \> 100.4°F orally, or symptoms of an acute self-limited illness such as an upper respiratory infection within 3 days of administering either dose of Norovirus Bivalent VLP vaccine or placebo control or the challenge product.
27. Resting heart rate \>100 beats per minute or \<55 beats per minute, respiratory rate ≥ 20 breaths per minute. If heart rate \<55 beat per minute and the investigator determines that this is not clinically significant and heart rate increases \> 55 beats per minute on moderate exercise, subject will not be excluded. Vital signs may be repeated.
28. Clinically abnormal screening electrocardiogram (ECG) defined as pathologic Q waves and significant ST-T wave changes; criteria for left ventricular hypertrophy; and any non-sinus rhythm excluding isolated premature atrial contractions.
29. Previous participation in a study of experimental norovirus infection or norovirus vaccine.
30. Study site personnel or their family members
31. Significant history of psychiatric hospitalization, alcohol abuse, or illicit drug use.
32. Receipt of a licensed live vaccine within 28 days or a licensed inactivated vaccine within 14 days of administration of either dose of vaccine or placebo or the challenge product.
33. Completion of an investigational vaccine or drug study within 7 days of randomization.
34. Receipt of systemic corticosteroids for greater than 7 days within the past six months.
35. Regular use of laxatives or anti-motility agents.
36. Receipt of blood or blood products within the past six months.
37. Subjects who are unwilling or unable to cease smoking from entry to the inpatient facility until discharge from the inpatient facility.
38. 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 Vaccination stage or the evaluation of the Challenge stage.
1. Use of antibiotics within the 7 days prior to entry into the inpatient challenge facility.
2. Use of any H-2 receptor antagonists (e.g. Tagamet, Zantac, and Pepcid), proton pump inhibitors (e.g. Prilosec, Protonix, and Prevacid), or prescription acid suppression medication or over the counter antacids within 72 hours of the challenge.
3. Use of prescription or Over the Counter (OTC) medications containing acetaminophen, aspirin, ibuprofen, and/or other non-steroidal anti-inflammatory drugs within 48 hours prior to challenge.
1. Living with or having daily contact with children age 5 years or less or a woman known to be pregnant. This includes significant contact at home, school, day-care, or equivalent facilities.
2. Nursing mother.
3. Living with or having daily contact with childcare workers.
4. Living with or having daily contact with elderly persons aged 70 years or more, or infirmed, diapered individuals, persons with disabilities or incontinent persons. This includes work or visits to nursing homes and day-care or equivalent facilities.
5. History of any gastroenteritis suggestive of Norovirus illness since screening serum antibody IgG P Particle ELISA testing was done.
6. History of any gastroenteritis within the past 2 weeks.
7. History of chronic functional dyspepsia, chronic gastroesophageal reflux disease, peptic ulcer disease, gastrointestinal hemorrhage, gall bladder disease, inflammatory bowel disease, irritable bowel syndrome, frequent diarrhea, chronic constipation, malabsorption, maldigestion, major Gastrointestinal (GI) surgery, or diverticulitis anytime during the subject's lifetime or any other chronic GI disorders that would interfere with interpretation of symptoms or evaluation during the study.
8. Routine use of medication other than oral contraceptive agents, anti-hypertensives, anti-depressants, vitamins and minerals. The use of any other medications should be discussed with the Sponsor and/or Central Safety Monitor (CSM).
9. History of any of the following medical illnesses:
* Immunosuppression (disease or treatments that may affect immune system function)
* Diabetes (including gestational diabetes during the pregnancy that required treatment other than dietary).
* Cancer (malignancy other than a resolved or 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 \<5 years old)
* Asthma requiring treatment with inhaler or medication in the past 2 years.
* Neuro-inflammatory disease
* Autoimmune disease
* Eating disorder
* Chronic headaches associated with vomiting
* Chronic vomiting syndrome
10. Any current illness requiring daily medication other than vitamins, minerals, birth control, anti-hypertensives or anti-depressants. The use of any other medications should be discussed with the Sponsor and/or CSM.
11. Allergies or hypersensitivity to any component of the vaccine or challenge virus.
12. Any clinically significant abnormality detected on physical examination, including:
* Murmur (other than a functional, ie normal, murmur)
* Focal neurological abnormality
* Hepatosplenomegaly
* Lymphadenopathy
* Jaundice
13. Hypertension defined as BP \> 150/90 mm Hg on two separate measurements. Chronic stable well-controlled hypertension on medications is allowed.
14. History of 3 or more hospitalizations for invasive bacterial infections (pneumonia, meningitis), acute or chronic dermatitis (e.g. eczema, seborrhea, psoriasis) or collagen vascular disease (e.g. Systemic Lupus Erythematosus (SLE) or dermatomyositis).
15. Presence of serious chronic illness.
16. Positive stool/fecal culture for bacterial pathogens (salmonella, campylobacter, E. coli 0157:H7, yersinia, or shigella) or positive stool/fecal screen for ova and parasites.
17. Employment in the food service industry, such as restaurants or cafeteria facilities. Specifically, this will include persons whose employment requires food processing in the 4 weeks following challenge.
18. Health-care workers with patient contact expected in the 4 weeks following challenge.
19. Expected contact (through employment or at home) with immunocompromised persons (HIV-positive, receiving immunosuppressive medications such as oral steroids or anti-neoplastic agents) in the 4 weeks following challenge.
20. Employment as an airline flight attendant scheduled to work in the 4 weeks following challenge.
21. Persons planning on taking a cruise in the 4 weeks following challenge.
22. Persons who plan to be living in a confined environment (e.g. ship, camp, or dormitory) within 4 weeks following challenge.
23. Persons who have consumed or plan to consume raw shellfish (e.g. oysters) from screening through post challenge Day 30.
24. Any of the following lab abnormalities (per the site local laboratory):
* Absolute neutrophil count (ANC) outside the normal range
* Total White Blood Cell Count (WBC) outside the normal range
* Hemoglobin or hematocrit outside the normal range
* Platelet count outside the normal range
* Electrolytes \[Sodium (Na), Potassium (K), Chloride (Cl), Carbon dioxide (CO2)\], Blood Urea Nitrogen (BUN) and/or creatinine outside the normal range
* Screening glucose \> upper limit of normal (ULN). Fasting glucose is not required
* Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase, bilirubin (total and indirect), or Gamma Glutamyl Transferase (GGT) outside the upper limit of the normal range
* Screening urinalysis with a value higher than "trace" positive for urine protein or urine glucose, or urine Red Blood Cells (RBCs) (≥3; other than women during menses).
All of the above labs may be repeated if outside the normal limits. If repeated and continue outside site normal ranges, may enroll if determined by the Principal Investigator (PI) to be not clinically significant and discussed with the Sponsor and/or CSM.
25. For women of child bearing potential, positive serum pregnancy test within 14 days or positive urine pregnancy test within one day of randomization.
26. Temperature \> 100.4°F orally, or symptoms of an acute self-limited illness such as an upper respiratory infection within 3 days of administering either dose of Norovirus Bivalent VLP vaccine or placebo control or the challenge product.
27. Resting heart rate \>100 beats per minute or \<55 beats per minute, respiratory rate ≥ 20 breaths per minute. If heart rate \<55 beat per minute and the investigator determines that this is not clinically significant and heart rate increases \> 55 beats per minute on moderate exercise, subject will not be excluded. Vital signs may be repeated.
28. Clinically abnormal screening electrocardiogram (ECG) defined as pathologic Q waves and significant ST-T wave changes; criteria for left ventricular hypertrophy; and any non-sinus rhythm excluding isolated premature atrial contractions.
29. Previous participation in a study of experimental norovirus infection or norovirus vaccine.
30. Study site personnel or their family members
31. Significant history of psychiatric hospitalization, alcohol abuse, or illicit drug use.
32. Receipt of a licensed live vaccine within 28 days or a licensed inactivated vaccine within 14 days of administration of either dose of vaccine or placebo or the challenge product.
33. Completion of an investigational vaccine or drug study within 7 days of randomization.
34. Receipt of systemic corticosteroids for greater than 7 days within the past six months.
35. Regular use of laxatives or anti-motility agents.
36. Receipt of blood or blood products within the past six months.
37. Subjects who are unwilling or unable to cease smoking from entry to the inpatient facility until discharge from the inpatient facility.
38. 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 Vaccination stage or the evaluation of the Challenge stage.
1. Use of antibiotics within the 7 days prior to entry into the inpatient challenge facility.
2. Use of any H-2 receptor antagonists (e.g. Tagamet, Zantac, and Pepcid), proton pump inhibitors (e.g. Prilosec, Protonix, and Prevacid), or prescription acid suppression medication or over the counter antacids within 72 hours of the challenge.
3. Use of prescription or Over the Counter (OTC) medications containing acetaminophen, aspirin, ibuprofen, and/or other non-steroidal anti-inflammatory drugs within 48 hours prior to challenge.
Minimum Eligible Age
18 Years
Maximum Eligible Age
49 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Takeda
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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David Bernstein, MD
Role: PRINCIPAL_INVESTIGATOR
Cincinatti Children's Hospital
Mohamed S Al-Ibrahim, MB, ChB
Role: PRINCIPAL_INVESTIGATOR
SNBL Clinical Pharmacology Center
David Y Graham, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Robert L Atmar, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
G. Marshall Lyon, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
John J Treanor, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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Emory University
Atlanta, Georgia, United States
Site Status
SNBL
Baltimore, Maryland, United States
Site Status
University of Rochester
Rochester, New York, United States
Site Status
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Site Status
Baylor College of Medicine
Houston, Texas, United States
Site Status
Countries
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United States
References
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Bernstein DI, Atmar RL, Lyon GM, Treanor JJ, Chen WH, Jiang X, Vinje J, Gregoricus N, Frenck RW Jr, Moe CL, Al-Ibrahim MS, Barrett J, Ferreira J, Estes MK, Graham DY, Goodwin R, Borkowski A, Clemens R, Mendelman PM. Norovirus vaccine against experimental human GII.4 virus illness: a challenge study in healthy adults. J Infect Dis. 2015 Mar 15;211(6):870-8. doi: 10.1093/infdis/jiu497. Epub 2014 Sep 9.
Reference Type
RESULT
Atmar RL, Bernstein DI, Lyon GM, Treanor JJ, Al-Ibrahim MS, Graham DY, Vinje J, Jiang X, Gregoricus N, Frenck RW, Moe CL, Chen WH, Ferreira J, Barrett J, Opekun AR, Estes MK, Borkowski A, Baehner F, Goodwin R, Edmonds A, Mendelman PM. Serological Correlates of Protection against a GII.4 Norovirus. Clin Vaccine Immunol. 2015 Aug;22(8):923-9. doi: 10.1128/CVI.00196-15. Epub 2015 Jun 3.
Reference Type
DERIVED
Sundararajan A, Sangster MY, Frey S, Atmar RL, Chen WH, Ferreira J, Bargatze R, Mendelman PM, Treanor JJ, Topham DJ. Robust mucosal-homing antibody-secreting B cell responses induced by intramuscular administration of adjuvanted bivalent human norovirus-like particle vaccine. Vaccine. 2015 Jan 15;33(4):568-76. doi: 10.1016/j.vaccine.2014.09.073. Epub 2014 Nov 22.
Reference Type
DERIVED
Other Identifiers
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U1111-1177-4095
Identifier Type: REGISTRY
Identifier Source: secondary_id
LV03-105
Identifier Type: -
Identifier Source: org_study_id
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