A First-in-Human Safety and Dose-Finding Study of New Type-16 Human Rhinovirus (RG-HRV16) Inoculum in Healthy Volunteers

NCT01769573 | Completed Phase 1 Results DMC

• 2 other identifiers: 2012-1036IND15328
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This research study will test different doses of RG-HRV16 to find the minimum dose needed to give research subjects cold symptoms of at least moderate intensity. The study will also test the safety of RG-HRV16. This information will be used in future studies (for example, to test antiviral preparations, sprays that could protect from getting a cold or decrease cold symptoms or to understand more about how rhinovirus can lead to asthma worsening). RG-HRV16 is a common cold virus that has been made in a new way and has not been used in humans before.

Conditions

Healthy Volunteers

Keywords

normal

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Colds With at Least Moderate Intensity

  The percentage of colds of at least moderate intensity examined by RG-HRV16 dose; this will be measured by the number of subjects per RG-HRV16 dose group who have maximum weekly cold symptom score of ≥7 out of 39 on the modified Jackson criteria during the first week after inoculation

  1 week

• Frequency of Adverse Events

  Safety as determined by the frequency of adverse event reporting examined by RG-HRV16 dose.

  4 weeks

Secondary Outcomes (2)

• Mean Cold Symptom Score

  4 weeks

• Infection Rate

  4 weeks

Study Arms (5)

100 TCID50

EXPERIMENTAL

RG-HRV16 dose of 100 TCID50 administered intranasally (0.25ml per nostril) one time.

Biological: RG-HRV16

1,000 TCID50

EXPERIMENTAL

RG-HRV16 dose of 1,000 TCID50 administered intranasally (0.25ml per nostril) one time.

Biological: RG-HRV16

10,000 TCID50

EXPERIMENTAL

RG-HRV16 dose of 10,000 TCID50 administered intranasally (0.25ml per nostril) one time.

Biological: RG-HRV16

Placebo

PLACEBO COMPARATOR

Diluent administered intranasally (0.25ml per nostril) one time.

Drug: Placebo

500 TCID50

EXPERIMENTAL

RG-HRV16 dose of 500 TCID50 administered intranasally (0.25ml per nostril) one time.

Biological: RG-HRV16

Interventions

RG-HRV16 BIOLOGICAL

A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin

Also known as: Rhinovirus type 16

1,000 TCID50; 10,000 TCID50; 100 TCID50; 500 TCID50

Placebo DRUG

The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml.

Placebo

Eligibility Criteria

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

You may qualify if:

• Capable and willing to grant written informed consent (in English) and cooperate with study procedures and requirements including willingness to avoid cold symptom medications during the study.
• Age between 18 and 50 years (children and older adults will be excluded from the study due to the possibility of greater morbidity associated with upper respiratory infections in these age groups).
• Absence of HRV16 neutralizing antibody.
• Subjects must be willing to refrain from taking nasal decongestants, antihistamines or cough/cold preparations (this includes dietary supplements and homeopathic preparations used specifically for cold/flu e.g., vitamin C, zinc, echinacea) within the 7 days prior to Visit 1 and throughout the study until after the completion of Visit 5.

You may not qualify if:

• A chronic medical condition, which may increase risk or interfere with the conduct of the study, including, but not limited to heart disease, Type I of II diabetes mellitus, asthma, COPD, other chronic lung disease, perennial rhinitis and chronic rhinosinusitis.
• Subjects with household contacts who are pregnant or planning a pregnancy during the main subject's participation, who have chronic respiratory disease, who are children under the age of 2 years, or who are adults over 50 years of age.
• Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
• Subjects with seasonal allergies will be excluded only if allergy symptoms are present at baseline, or are anticipated to occur during the study period.
• Smoking within the past 6 months.
• Subjects who have received immunosuppressive treatment within the last 12 months.
• Upper respiratory infection (URI or sinusitis) in the past 4 weeks.
• Subjects with a history of a significant adverse reaction or intolerance to a previous live, attenuated vaccine.
• Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study.
• Unwillingness of study participants to use adequate birth control methods during the course of the study. Adequate birth control methods include oral contraceptives, injections such as Depo-Provera, an intrauterine device or double-barrier contraception (combination of condom and contraceptive sponge or cervical cap and spermicide or another combination approved in writing by the Principal Investigator).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Limitations and Caveats

Limitations include inclusion of healthy adults as study subjects; it is possible that individuals with chronic respiratory disease (e.g. asthma, COPD) could develop milder colds and lower respiratory infections with lower doses of virus.

Results Point of Contact

• Title: Gina Crisafi
• Organization: UW Madison

gmc@medicine.wisc.edu

608-262-5240

Study Officials

• James Gern, MD

  UW Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 16, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2017
• Last Updated: June 3, 2019
• Results First Posted: June 3, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)