NorovirusPhase 1NCT00806962
Phase 1 Norwalk Vaccine Study
A Phase 1 study testing Adjuvant/Excipients and Norwalk VLP Vaccine in people with Norovirus, run by LigoCyte Pharmaceuticals, Inc. at 4 sites in United States.
Trial summary
Randomized, double blind, multi-site, study in healthy adults, comparing safety and immunogenicity of two dosage levels of Norwalk VLP Vaccine with adjuvant/excipients and with placebo controls Primary Objective: Safety as determined by occurrence of local intranasal symptoms or other symptoms as reported by a… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Norovirus
- What is being tested?
- Adjuvant/Excipients and Norwalk VLP Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2008to Oct 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed written informed consent
- Age 18 - 50 years, inclusive
- Good general health as determined by a screening evaluation within 30 days before administration of Norwalk VLP Vaccine, adjuvant/excipients or placebo
- Expressed interest and availability to fulfill the study requirements
- Agrees not to become pregnant from the time of study enrollment until at least 56 days after the last administration of Norwalk VLP Vaccine, adjuvant/excipients or placebo; if a woman is sexually active and capable of conception (i.e., no history of hysterectomy or tubal ligation), she must agree to use hormonal or barrier birth control. A woman is eligible if she is monogamous with a male who has had a vasectomy.
- Demonstrated to be an H type-1 antigen secretor
- Agrees not to participate in another clinical trial with an investigational product for the entire duration of the study (six months after the last study dose i.e. 201 days)
- Agrees to storage of unused clinical specimens for an indefinite period of time only for those specimens collected by the University of Maryland CVD for use in future research at the CVD. [A University of Maryland site-specific inclusion criterion]
Who cannot join
- History of any of the following medical illnesses
- Chronic rhinitis, runny nose, sneezing
- Clinically significant nose bleed within the last year
- Diabetes
- Cancer
- Heart disease (hospitalization for a heart attack, arrhythmia, or syncope)
Show all 37Show fewer
- 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)
- Asthma requiring treatment with inhaler or medication
- Any current illness requiring daily medication other than vitamins, birth control, or anti-depressant
- Blood Type B or AB, regardless of Rh + or -
- Allergies or hypersensitivity to chitosan, shrimp, other shellfish or any component of the vaccine, adjuvant/excipients or placebo
- History of nasal surgery of any type (including tonsilectomy/adenoidectomy)
- Any clinically significant abnormality detected on physical examination, including:
- Murmur (other than a functional murmur)
- Focal neurological abnormality
- Hepatosplenomegaly
- Lymphadenopathy
- Jaundice
- Hypertension (BP > 140/90 mm Hg on two separate days)
- Any lab abnormality, as listed below:
- Neutrophils (WBC) outside the normal range
- Hemoglobin outside the normal range (may be repeated once if outside this limit)
- Platelet count outside the normal range (may be repeated once if outside this limit)
- Creatinine outside the normal range (may be repeated once if outside this limit)
- Glucose > upper limit of normal (may be repeated once if outside this limit)
- AST or ALT outside the normal range (may be repeated once if outside this limit)
- Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen
- For women, positive serum pregnancy test within 7 days and urine pregnancy test within 24 hours of administering either dose of Norwalk VLP Vaccine, adjuvant/excipients or placebo
- Nursing mother
- Temperature > 38.0 degrees C (100.4 degrees F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 3 days of administration of Norwalk VLP Vaccine, adjuvant/excipients or placebo
- Previous participation in a study of Norovirus vaccines
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
- Receipt of an investigational vaccine or drug within 28 days before administration of Norwalk VLP Vaccine, adjuvant/excipients or placebo
- 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
- Failure to pass written examination about this study (70% correct answers required to pass)[A University of Maryland site-specific exclusion criterion]
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Maryland Center for Vaccine Development
Baltimore, Maryland
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
University of Rochester Medical Center
Rochester, New York, 14642
Saint Louis University
St Louis, Missouri, 63104
About this study
Official title: Randomized Double-Blind Placebo-Controlled Phase 1, Safety and Immunogenicity Study of Two Dosages of Intranasal Norwalk Virus-like Particle Vaccine ( Norwalk VLP Antigen, MPL®, Chitosan, Mannitol, and Sucrose) Compared to Adjuvant/Excipients (MPL®, Chitosan, Mannitol, and Sucrose) and to Placebo (Empty Device
Randomized, double blind, multi-site, study in healthy adults, comparing safety and immunogenicity of two dosage levels of Norwalk VLP Vaccine with adjuvant/excipients and with placebo controls
Primary Objective:
Read more
- Safety as determined by occurrence of local intranasal symptoms or other symptoms as reported by a self-administered memory aid for 7 days after each vaccination and hematology, blood chemistry and physical examinations performed by the clinical research staff
- Subjects will also be monitored for Serious Adverse Events (SAEs), and onset of any new medical conditions for 180 days following the last study vaccinations (Day 201).
Secondary Objectives
Evaluations of immunogenicity as determined by:
- Geometric mean titers and seroconversion rate of serum anti- Norwalk VLP IgG and IgA
- Stimulation of anti-Norwalk VLP IgA antibody secreting cells (ASC)
- Presence of antigen specific memory B-cell response
Cells will be collected and stored for possible future evaluation of Norwalk VLP-specific cell-mediated immune (CMI) responses
Study Hypothesis:
The incidence of adverse events after intranasal Norwalk VLP Vaccine will be the same as the incidence of adverse events after intranasal adjuvant/excipients alone. Norwalk VLP Vaccine and adjuvant/excipients will have a higher incidence of mild to moderate nasal adverse events compared to placebo but similar incidence of other adverse events.
Two doses of the 100 µg of Norwalk VLP Vaccine will be more immunogenic than two doses of 50 µg of Norwalk VLP Vaccine. The post-vaccination serum antibody responses, the number of antibody secreting cells (ASC) and IgG and IgA memory B-cell responses directed against Norwalk Virus antigen will be increased after Norwalk VLP Vaccine compared to adjuvant/excipients and to placebo.
- Conditions
- Norovirus
- Being tested
- Adjuvant/Excipients, placebo, Norwalk VLP Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant/ExcipientsDrug
intranasal,14 mg chitosan, 3 mg mannitol, 3 mg sucrose and 50 mcg of MPL, 2 doses 21 days apart
placeboDevice
intranasal, puff of air, 2 doses, 21 days apart
Norwalk VLP VaccineBiological
intranasal, 50mcg, 2 doses--21 days apart
Norwalk VLP VaccineBiological
Intranasal, 100 mcg, 2 doses, 21 days apart
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Arm 1 | Experimental | 50 µg Norwalk VLP Vaccine + Adjuvant/Excipients Receives: Biological: Norwalk VLP Vaccine |
| Vaccine Arm 2 | Experimental | 100 µg Norwalk VLP Vaccine + Adjuvant/Excipients Receives: Biological: Norwalk VLP Vaccine |
| Adjuvant/Excipients (MPL) | Active comparator | 14 mg chitosan, 3 mg mannitol, 3 mg sucrose, and 50 mcg MPL Receives: Drug: Adjuvant/Excipients |
| Empty device | Sham comparator | Empty device that contains no dry powder formulation. Actuation of the empty intranasal delivery device will deliver a puff of air per device. Receives: Device: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Measured: seven days
Secondary outcomes (1)
immunogenicity
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NorovirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- LigoCyte Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John J Treanor, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806962
- Sponsor's protocol ID
- LV01-102
- Status last verified
- May 2015
- First submitted
- 10 Dec 2008
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El-Kamary SS, Pasetti MF, Mendelman PM, Frey SE, Bernstein DI, Treanor JJ, Ferreira J, Chen WH, Sublett R, Richardson C, Bargatze RF, Sztein MB, Tacket CO. Adjuvanted intranasal Norwalk virus-like particle vaccine elicits antibodies and antibody-secreting cells that express homing receptors for mucosal and peripheral lymphoid tissues. J Infect Dis. 2010 Dec 1;202(11):1649-58. doi: 10.1086/657087. Epub 2010 Oct 27.
PubMed 20979455
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Placebo-Controlled Phase 1, Safety and Immunogenicity Study of Two Dosages of Intranasal Norwalk Virus-like Particle Vaccine ( Norwalk VLP Antigen, MPL®, Chitosan, Mannitol, and Sucrose) Compared to Adjuvant/Excipients (MPL®, Chitosan, Mannitol, and Sucrose) and to Placebo (Empty Device
- ClinicalTrials.gov ID
- NCT00806962
- Acronym / sponsor ID
- LV01-102
- Conditions
- Norovirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- LigoCyte Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double blind, multi-site, study in healthy adults, comparing safety and immunogenicity of two dosage levels of Norwalk VLP Vaccine with adjuvant/excipients and with placebo controls
Primary Objective:
- Safety as determined by occurrence of local intranasal symptoms or other symptoms as reported by a self-administered memory aid for 7 days after each vaccination and hematology, blood chemistry and physical examinations performed by the clinical research staff
- Subjects will also be monitored for Serious Adverse Events (SAEs), and onset of any new medical conditions for 180 days following the last study vaccinations (Day 201).
Secondary Objectives
Evaluations of immunogenicity as determined by:
- Geometric mean titers and seroconversion rate of serum anti- Norwalk VLP IgG and IgA
- Stimulation of anti-Norwalk VLP IgA antibody secreting cells (ASC)
- Presence of antigen specific memory B-cell response
Cells will be collected and stored for possible future evaluation of Norwalk VLP-specific cell-mediated immune (CMI) responses
Study Hypothesis:
The incidence of adverse events after intranasal Norwalk VLP Vaccine will be the same as the incidence of adverse events after intranasal adjuvant/excipients alone. Norwalk VLP Vaccine and adjuvant/excipients will have a higher incidence of mild to moderate nasal adverse events compared to placebo but similar incidence of other adverse events.
Two doses of the 100 µg of Norwalk VLP Vaccine will be more immunogenic than two doses of 50 µg of Norwalk VLP Vaccine. The post-vaccination serum antibody responses, the number of antibody secreting cells (ASC) and IgG and IgA memory B-cell responses directed against Norwalk Virus antigen will be increased after Norwalk VLP Vaccine compared to adjuvant/excipients and to placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vaccine Arm 1 | Experimental | Biological: Norwalk VLP Vaccine50 µg Norwalk VLP Vaccine + Adjuvant/Excipients |
| Vaccine Arm 2 | Experimental | Biological: Norwalk VLP Vaccine100 µg Norwalk VLP Vaccine + Adjuvant/Excipients |
| Adjuvant/Excipients (MPL) | Active comparator | Drug: Adjuvant/Excipients14 mg chitosan, 3 mg mannitol, 3 mg sucrose, and 50 mcg MPL |
| Empty device | Sham comparator | Device: placeboEmpty device that contains no dry powder formulation. Actuation of the empty intranasal delivery device will deliver a puff of air per device. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed written informed consent
- Age 18 - 50 years, inclusive
- Good general health as determined by a screening evaluation within 30 days before administration of Norwalk VLP Vaccine, adjuvant/excipients or placebo
- Expressed interest and availability to fulfill the study requirements
- Agrees not to become pregnant from the time of study enrollment until at least 56 days after the last administration of Norwalk VLP Vaccine, adjuvant/excipients or placebo; if a woman is sexually active and capable of conception (i.e., no history of hysterectomy or tubal ligation), she must agree to use hormonal or barrier birth control. A woman is eligible if she is monogamous with a male who has had a vasectomy.
Key exclusion criteria (37 listed)
- History of any of the following medical illnesses
- Blood Type B or AB, regardless of Rh + or -
- Allergies or hypersensitivity to chitosan, shrimp, other shellfish or any component of the vaccine, adjuvant/excipients or placebo
- History of nasal surgery of any type (including tonsilectomy/adenoidectomy)
- Any clinically significant abnormality detected on physical examination, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant/Excipientsintranasal,14 mg chitosan, 3 mg mannitol, 3 mg sucrose and 50 mcg of MPL, 2 doses 21 days apart | Drug | Adjuvant/Excipients (MPL) |
| placebointranasal, puff of air, 2 doses, 21 days apart | Device | Empty device |
| Norwalk VLP Vaccineintranasal, 50mcg, 2 doses--21 days apart | Biological | Vaccine Arm 1 |
| Norwalk VLP VaccineIntranasal, 100 mcg, 2 doses, 21 days apart | Biological | Vaccine Arm 2 |
Primary outcome
adverse events
Time frame: seven days
1 secondary outcome
immunogenicity
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Derived from this study: PubMed 20979455El-Kamary SS, Pasetti MF, Mendelman PM, Frey SE, Bernstein DI, Treanor JJ, Ferreira J, Chen WH, Sublett R, Richardson C, Bargatze RF, Sztein MB, Tacket CO. Adjuvanted intranasal Norwalk virus-like particle vaccine elicits antibodies and antibody-secreting cells that express homing receptors for mucosal and peripheral lymphoid tissues. J Infect Dis. 2010 Dec 1;202(11):1649-58. doi: 10.1086/657087. Epub 2010 Oct 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J Treanor, MD principal investigator
University of Rochester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adjuvant/Excipients and Norwalk VLP Vaccine in people with Norovirus, run by LigoCyte Pharmaceuticals, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00806962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.