NCT03220048

Brief Summary

Phase 2 study, looking at the prophylactic efficacy, safety and tolerability to a repeated nasal dose of study drug after being infected with Influenza A/Perth/16/2009 (H3N2) virus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

November 12, 2019

Completed
Last Updated

November 12, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

June 13, 2017

Results QC Date

September 12, 2019

Last Update Submit

October 23, 2019

Conditions

Influenza A H3N2

Outcome Measures

Primary Outcomes (1)

  • Primary Efficacy Endpoint: The Area Under the Curve (AUC) of Total Symptom Score From Day 1 (Post Viral Challenge) to Day 8 (Quarantine Discharge).

    Area Under the Curve (AUC) of total symptom scores (upper respiratory tract (URT), lower respiratory tract (LRT) and systemic viral symptoms (SVS)). Total symptom scores (from the symptom diary card) were used to calculate the AUC. The time unit used was minutes. Thus, the AUC unit is the total symptom score multiplied by the time period from first to last assessment in minutes (i.e score\*mins). The minimum AUC value would be 0, for a subject who did not report any symptoms. The maximum AUC value is not provided as it would be theoretical only, with no real meaning in terms of severity. Higher scores indicate worse outcome than lower scores.

    8 days

Secondary Outcomes (5)

  • Secondary Efficacy Endpoint: Symptom Scores: Peak Symptoms Score

    8 days

  • Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Viral Shedding

    8 days

  • Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Seroconversion

    8 days

  • Secondary Efficacy Endpoint: Viral Load Parameters: Area Under the Curve (AUC) of Viral Load, as Measured by Nasopharyngeal Swab RT-qPCR.

    8 days

  • Secondary Efficacy Endpoint: Total Weight of Nasal Discharge Produced Post Viral Challenge to Quarantine Discharge

    8 days

Study Arms (3)

Cohort A: Sentinel Group

OTHER

Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0.

Other: Placebo Comparator

Cohort B: PrEP-001

EXPERIMENTAL

PrEP-001 6400μg dose administered equally over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.

Drug: PrEP-001

Cohort B: Placebo

EXPERIMENTAL

Nasal dose of placebo Comparator equally divided over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.

Other: Placebo Comparator

Interventions

PrEP-001DRUG
Also known as: JNJ-43260295-AAM
Cohort B: PrEP-001
Placebo ComparatorOTHER
Also known as: G-004
Cohort A: Sentinel GroupCohort B: Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.
  • Female subjects were required to provide of a history of reliable contraceptive practice.

You may not qualify if:

  • Subjects who have a significant history of any tobacco use at any time.
  • Any history or evidence of any clinically significant cardiovascular, dermatological gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal disease.
  • Abnormal ECG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hVIVO Services Ltd, QMB Bioenterprise building

London, E1 2AX, United Kingdom

Location

Related Publications (1)

  • Malcolm BA, Aerts CA, Dubois KJ, Geurts FJ, Marien K, Rusch S, Van Dijck AH, Verloes R, Vingerhoets J. PrEP-001 prophylactic effect against rhinovirus and influenza virus - RESULTS of 2 randomized trials. Antiviral Res. 2018 May;153:70-77. doi: 10.1016/j.antiviral.2018.03.005. Epub 2018 Mar 19.

    PMID: 29567461DERIVED

MeSH Terms

Interventions

G004 compound

Results Point of Contact

Title
Tim Sharpington
Organization
hVIVO
t.sharpington@hvivo.com
02071480862

Study Officials

  • John Efthimiou

    Sponsor's representative

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2017

First Posted

July 18, 2017

Study Start

September 16, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

November 12, 2019

Results First Posted

November 12, 2019

Record last verified: 2019-10

Locations

GB(1)