Phase 1 Norwalk Vaccine Study

NCT00806962 | Completed Phase 1 DMC

• 1 other identifier: LV01-102
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 4

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• adverse events

  seven days

Secondary Outcomes (1)

• immunogenicity

  28 days

Study Arms (4)

Vaccine Arm 1

EXPERIMENTAL

50 µg Norwalk VLP Vaccine + Adjuvant/Excipients

Biological: Norwalk VLP Vaccine

Vaccine Arm 2

EXPERIMENTAL

100 µg Norwalk VLP Vaccine + Adjuvant/Excipients

Biological: Norwalk VLP Vaccine

Adjuvant/Excipients (MPL)

ACTIVE COMPARATOR

14 mg chitosan, 3 mg mannitol, 3 mg sucrose, and 50 mcg MPL

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.

Device: placebo

Interventions

Adjuvant/Excipients DRUG

intranasal,14 mg chitosan, 3 mg mannitol, 3 mg sucrose and 50 mcg of MPL, 2 doses 21 days apart

Adjuvant/Excipients (MPL)

placebo DEVICE

intranasal, puff of air, 2 doses, 21 days apart

Empty device

Norwalk VLP Vaccine BIOLOGICAL

intranasal, 50mcg, 2 doses--21 days apart

Vaccine Arm 1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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:

Sponsors & Collaborators

• LigoCyte Pharmaceuticals, Inc.: lead

Study Sites (4)

University of Maryland Center for Vaccine Development

Baltimore, Maryland, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 20979455 DERIVED

MeSH Terms

Interventions

Adjuvants, Pharmaceutic; Excipients

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Pharmaceutical Vehicles

Study Officials

• John J Treanor, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 6, 2015

Record last verified: 2015-05

Locations

US (4)