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Completed

NCT Number: NCT02603952

A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza

The purpose of this study is to evaluate safety and tolerability of a single dose of MEDI8852 when given with oseltamivir, the safety and tolerability of oseltamivir alone, and the safety and tolerability of a single dose of MEDI8852 alone in adult participants with acute, uncomplicated influenza caused by Type A strains.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site, Durban, South Africa

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About this study

The MEDI8852 phase 2a study will evaluate the safety and tolerability of a single intravenous (IV) dose of MEDI8852 administered in conjunction with oseltamivir, the safety and tolerability of oseltamivir alone and the safety and tolerability of a single IV dose of MEDI8852 alone in adult participants with confirmed acute, uncomplicated influenza caused by Type A strains. Enrollment is planned in the United States, South Africa, and Australia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 through 65 years at the time of screening.
  • Symptomatic presumptive Influenza A infection with onset of symptoms less than or equal to (≤) 5 days prior to MEDI8852 administration and defined as the presence of:
  • Fever of greater than or equal to (≥) 38.0 degrees Celsius (100.4 degrees Fahrenheit) at screening AND
  • ≥ 1 moderate systemic symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) AND
  • ≥ 1 moderate respiratory symptom (cough, sore throat, or nasal symptoms)
  • Influenza A infection confirmed with positive rapid antigen test
  • Able to complete the follow-up period through Day 101 as required by protocol (including telephone follow-up for Days 11 to 101)
  • Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for at least 2 days prior to the first dose of investigational product and must agree to continue using such precautions through Day 101 of the study

Exclusion criteria

  • Hospitalized subjects.
  • Receipt of influenza antiviral therapy within the preceding 14 days.
  • Receipt of immunoglobulin or blood products within 6 months prior to screening.
  • Known immunodeficiency due to illness, including human immunodeficiency virus (HIV), or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.
  • Current clinical evidence of pneumonia.
  • Active bacterial infection requiring treatment with oral or parenteral antibiotics.
  • History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 3 years.
  • Any planned surgical procedure before completion of Day 101.

Treatment and study plan

oseltamivir

Drug

75 mg capsules orally BID from Day 1 to Day 5.

MEDI8852

Drug

MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1.

Placebo

Drug

Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1.

Primary outcomes

  1. Number of Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10

    Time frame: Day 1 (post-dose) through Day 10

    Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).

  2. Number of Participants With Any Solicited Influenza Symptoms From Day 10 Through Day 13

    Time frame: Day 10 through Day 13

    Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).

  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Day 1 (post-dose) through Day 28

    An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 28 that were absent before treatment or that worsened relative to pre-treatment state.

  4. Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)

    Time frame: Day 1 (post-dose) through Day 101

    A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre-treatment state.

  5. Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESIs)

    Time frame: Day 1 (post-dose) through Day 101

    An AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. An AESI was one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre treatment state.

Secondary outcomes

  1. Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)

    Time frame: Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13

    Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure influenza viral shedding from the nasopharyngeal swabs. Percentage of participants who shed influenza virus are reported.

  2. Quantitation of Influenza Viral Shedding as Measured by qRT-PCR

    Time frame: Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13

    qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.

  3. Number of Days of Influenza Viral Shedding as Measured by qRT-PCR

    Time frame: From Baseline (Day 1) to Day 7; and Day 9 to Day 13

    Number of days of viral shedding for participants who shed influenza virus is reported. qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.

  4. Percentage of Participants With Amino Acid Changes in MEDI8852 Binding Site

    Time frame: From Baseline (Day 1) to Day 13

    Genotypic analysis was performed to identify all amino acid changes in MEDI8852 binding site between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with changes in the amino acid corresponding to MEDI8852 binding site is reported. Due to the fact that the percentage of participants with amino acid changes in MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.

  5. Number of Participants With Viral Susceptibility to MEDI8852 as Determined by a Cell Based Microneutralization Assay

    Time frame: From Baseline (Day 1) to Day 13

    Viral susceptibility to MEDI8852 was measured by a Madin-Darby canine kidney (MDCK) cell-based microneutralization assay (Virospot) for viruses recovered from baseline samples and viruses recovered from samples following treatment that contain amino acid changes within the MEDI8852 binding site. Participants with detectable levels (50% tissue culture infectious dose [TCID50]) of virus were considered susceptible and were reported. Due to the fact that the number of participants with viral susceptibility to MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.

  6. Percentage of Participants With Virus Containing Known Oseltamivir Resistance-Associated Mutations

    Time frame: From Baseline (Day 1) to Day 13

    Genotypic analysis was performed to identify all amino acid changes in neuraminidase (NA) gene between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with virus containing known oseltamivir resistance-associated mutations (change in the NA genes) is reported. Due to the fact that the percentage of participants with virus containing known oseltamivir resistance-associated mutation was zero across all participant samples analyzed, no additional per arm analyses were performed.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase 2a, Randomized, Partial Double-blind, Single Dose, Active-controlled, Dose Ranging Study to Evaluate the Safety of MEDI8852 in Adults With Acute, Uncomplicated Influenza

Acronym: MEDI8852

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 13, 2015
Registry last updated
Jun 8, 2018

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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