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Completed

NCT Number: NCT03220048

Study Examining PrEP-001 in Healthy Subjects

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.

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Key information

Conditions

Influenza A H3N2

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

hVIVO Services Ltd, QMB Bioenterprise building

London, E1 2AX, United Kingdom

About this study

Screening took place up to 90 days before quarantine. Volunteers completed an informed consent and underwent screening assessments to determine their eligibility.

There were 2 study groups:

Cohort A: (Sentinel): determined the Challenge Virus infection rate after inoculation with Influenza Virus on Day 0. There was 12 subjects (open label, no randomisation) invited to attend Quarantine on Day -2 or -1.

Cohort B: Examined the prophylactic efficacy, safety and tolerability of PrEP-001 compared to placebo (randomised 1:1). Subjects attended on Day -4/-3, dosed with PrEP-001 or Placebo on Day -2 AND Day-1 and then challenged with virus (volume confirmed from Cohort A) on Day 0.

Volunteers remained in quarantine unit for 8 days after inoculation.

At day 28, end of study visit, volunteers seen and assessed by a study physician for well-being, on-going symptoms and adverse events.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

PrEP-001

Drug

Other names: JNJ-43260295-AAM

Placebo Comparator

Other

Other names: G-004

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).

    Time frame: 8 days

    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.

Secondary outcomes

  1. Secondary Efficacy Endpoint: Symptom Scores: Peak Symptoms Score

    Time frame: 8 days

    Using the scheduled protocol assessments from Day 1 to Day 8, this endpoint represented the highest total symptom score (defined as the sum of all 10 individual composite symptoms).

    The minimum value, for subjects who had no symptoms, would be 0. The maximum value would be 30.

    Higher scores indicate worse outcome than lower scores.

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

    Time frame: 8 days

    The number of subjects with viral shedding. Viral shedding was measured by PCR, testing the nasopharyngeal swab samples.

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

    Time frame: 8 days

    The number of subjects with seroconversion. Seroconversion was measured by the ratio of Influenza A/Perth/16/2009 (H3N2) virus antibodies at follow-up versus pre-dose.

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

    Time frame: 8 days

    Viral load data was supplied in Log10 Copies/mL. These values were used to calculate the Area Under the Curve (AUC) of Viral Load for each subject.

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

    Time frame: 8 days

    Total weight of nasal discharge (in grams) was calculated as the sum of mucus weights taken from Day 1 (Post viral challenge) to Day 8 (Quarantine Discharge).

Sponsors and collaborators

Lead sponsor

Hvivo

Industry

Collaborators

  • Prep Biopharm Limited

Registry information

Official study title

A Phase II, Repeated Dose, Double-Blinded, Randomised, Controlled Study to Examine the Prophylactic Efficacy, Safety and Tolerability of PrEP-001 in Healthy Subjects Subsequently Challenged With Influenza A/Perth/16/2009 (H3N2) Virus

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 18, 2017
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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