Dose, Safety, and Pathogenicity of a New Influenza H1N1 Challenge Strain (NCT05572450) | Clinical Trial Compass
CompletedNot Applicable
Dose, Safety, and Pathogenicity of a New Influenza H1N1 Challenge Strain
United Kingdom70 participantsStarted 2022-09-07
Plain-language summary
A total of up to 90 participants may be given H1N1 influenza challenge virus.
In Part A, 40 participants will be randomly allocated to one of two groups to be given one of two virus doses (Virus Dose 1 or Virus Dose 2).
Based on the outcome of Part A, participants in Part B, may be given Virus Dose 1, Virus Dose 2, or another virus dose (e.g., Virus Dose 3)
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Written informed consent
* Adult male or female aged between 18 and 55 years
* A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2
* In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety.
* Documented medical history
* Adherence to contraception requirements
* Serosuitable for the challenge virus.
Exclusion Criteria:
* History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (LRT) infection within 4 weeks prior to the first study visit.
* Any history or evidence of any clinically significant or currently active disease.
* Any participants who have smoked ≥10 pack years at any time.
* Female participants who are breastfeeding, or have been pregnant within 6 months prior to the study, or have a positive pregnancy test at any point during screening or prior to inoculation.
* Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction.
* Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
* Significant abnormality of the nose, epistaxis, nasal or sinus surgery.
* Recent vaccinations or intention to receive vaccination before the final follow up visit.
* Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to the planned ino…
What they're measuring
1
To determine the safe and optimal titre of the influenza challenge virus