An interventional study of Infectious titre 1 (H3N2) and Infectious titre 2 (H3N2) in Influenza, sponsored by Hvivo. Completed. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-27.
Sponsored by Hvivo · Not applicable, Interventional, and Basic science
The study will characterise Influenza A/Perth/16/2009(H3N2) virus in healthy participants using the viral challenge model. The study includes two cohorts.
Cohort 1: A randomised, double-blind study of 4 titres of Challenge Virus to determine the optimum titre.
Cohort 2: An open-label extension arm in which all participants will receive the 'optimum' titre as identified from Cohort 1.
Influenza and its associated diseases are a major cause of morbidity and mortality. The United States Advisory Committee on Immunization Practices recommends influenza vaccination for everyone over 6 months of age. The failure of the flu vaccine in 2014-2015 demonstrates the need for a model that allows the rapid development of novel antivirals, universal/intra-seasonal vaccines, immunomodulators, monoclonal antibodies and other novel treatments. Studies using experimental influenza virus infection in human participants have demonstrated that adult volunteers can be infected by nasal inoculation, and experimental infection is safe and not associated with transmission to contacts. The experimental virus is manufactured in compliance with Good Manufacturing Practice for use in the Human Viral Challenge Model.
The investigators chose an H3N2 influenza subtype given that this strain has the most substantial impact in terms of morbidity or mortality annually as described by the Centre for Disease Control . The investigators first subjected the virus batch to rigorous adventitious agent testing, then confirmed the virus to be wild-type by Sanger sequencing and finally determined the virus titres appropriate for human use via the established ferret model. hVIVO team built on its previous experience with other H3N2 and H1N1 viruses to develop this unique model.
The first part of study (Cohort 1) was to determine the safety and optimal virus titre in healthy adult volunteers using our unique clinical quarantine facility in London, UK. After the first part of the study was completed, the study was amended to add an older population group (45-64 years old) in order to characterise the course of infection in an age group better representing the at-risk population.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's enrollment of 46 is below the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Hvivo is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6 participants aged 18 to 45 were inoculated with 1mL containing 2.8 x 10\*3 TCID50 of virus
Other: Infectious titre 1 (H3N2)
6 participants aged 18 to 45 were inoculated with 1mL containing 2.5 x 10\*4 TCID50 of virus
Other: Infectious titre 2 (H3N2)
6 participants aged 18 to 45 were inoculated with 1mL containing 3.6 x 10\*5 TCID50 of virus
Other: Infectious titre 3 (H3N2)
6 participants aged 18 to 45 were inoculated with 1mL containing 4.7 x 10\*6 TCID50 of virus
Other: Infectious titre 4 (H3N2)
6 participants aged 18 to 45 were inoculated with 1mL containing 3.5 x 10\*5 TCID50 of virus.
Other: Infectious titre 5 (H3N2) (Subjects aged 18 to 45 years old)
16 participants aged 46 to 64 were inoculated with 1mL containing 3.5 x 10\*5 TCID50 of virus.
Other: Infectious titre 5 (H3N2) (Subjects aged 46 to 64 years old)
Infectious titre 1: 2.8 x 10\*3 TCID50/mL
Infectious titre 2: 2.5 x 10\*4 TCID50/mL
Infectious titre 3: 3.6 x 10\*5 TCID50/mL
Infectious titre 4: 4.7 x 10\*6 TCID50/mL
Infectious titre 5: 3.5 x 10\*5 TCID50/mL
Infectious titre 5: 3.5 x 10\*5 TCID50/mL
Area Under the Curve of Virus Load
Area under the curve (AUC) of the Challenge Viral load, measured by nasopharyngeal swab quantitative polymerase chain reaction \[qPCR\], from Day 1 to Day 8 post-Viral Challenge. Nasopharyngeal swabs are collected up to 3 times per day ( every 8 hours +/- 30mins)
Time frame: 8 days
Incidence (Number and Percentage [%]) of Viral Challenge Emergent Adverse Events
Time frame: 8 days
| Milestone | Infectious Titre 1 | Infectious Titre 2 | Infectious Titre 3 | Infectious Titre 4 | Infectious Titre 5 (18 to 45 Years Old) | Infectious Titre 5 (46 to 64 Years Old) |
|---|---|---|---|---|---|---|
| Started | 6 | 6 | 6 | 6 | 6 | 16 |
| Completed | 6 | 6 | 6 | 6 | 6 | 16 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Area under the curve (AUC) of the Challenge Viral load, measured by nasopharyngeal swab quantitative polymerase chain reaction \[qPCR\], from Day 1 to Day 8 post-Viral Challenge. Nasopharyngeal swabs are collected up to 3 times per day ( every 8 hours +/- 30mins)
| mins*Eq log10 TCID50/mL | Infectious Titre 1 | Infectious Titre 2 | Infectious Titre 3 | Infectious Titre 4 | Infectious Titre 5 (18 to 45 Years Old) | Infectious Titre 5 (46 to 64 Years Old) |
|---|---|---|---|---|---|---|
| Area Under the Curve of Virus Load | -2081.98 ± 869.61 | 18,973.90 ± 1048.23 | 15,944.09 ± 13751.39 | 12,201.14 ± 8877.43 | 9563.26 ± 10,536.96 | 11,710.28 ± 11833.87 |
Results for this outcome have not been posted.
Collected over Adverse events are collected throughout the study from screening to last study visit (108 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Infectious Titre 1 | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Infectious Titre 2 | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Infectious Titre 3 | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Infectious Titre 4 | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Infectious Titre 5 (Aged 18 to 45) | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Infectious Titre 5 (Aged 45 to 64) | 0/16 (0%) | 0/16 (0%) | 10/16 (62.5%) |
| Event | Infectious Titre 1 | Infectious Titre 2 | Infectious Titre 3 | Infectious Titre 4 | Infectious Titre 5 (Aged 18 to 45) | Infectious Titre 5 (Aged 45 to 64) |
|---|---|---|---|---|---|---|
| Procedural haemorrhageInjury, poisoning and procedural complications | 1/6 | 1/6 | 3/6 | 1/6 | 0/6 | 2/16 |
| C-reactive protein increasedInvestigations | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 3/16 |
| ToothacheGastrointestinal disorders | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 0/16 |
| Seasonal allergyImmune system disorders | 0/6 | 0/6 | 0/6 | 0/6 | 1/6 | 0/16 |
| Rash pustularInfections and infestations | 0/6 | 1/6 | 0/6 | 0/6 | 0/6 | 0/16 |
| Spirometry abnormalInvestigations | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 | 0/16 |
| ALT increasedInvestigations | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 | 0/16 |
| HeadacheNervous system disorders | 0/6 | 0/6 | 0/6 | 0/6 | 1/6 | 2/16 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 0/16 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 0/16 |
| Age, Categorical(Participants) | Infectious Titre 1 | Infectious Titre 2 | Infectious Titre 3 | Infectious Titre 4 | Infectious Titre 5 (18 to 45 Years Old) | Infectious Titre 5 (46 to 64 Years Old) | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 6 | 6 | 6 | 6 | 16 | 46 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Infectious Titre 1 | Infectious Titre 2 | Infectious Titre 3 | Infectious Titre 4 | Infectious Titre 5 (18 to 45 Years Old) | Infectious Titre 5 (46 to 64 Years Old) | Total |
|---|---|---|---|---|---|---|---|
| Female | 4 | 1 | 2 | 3 | 2 | 5 | 17 |
| Male | 2 | 5 | 4 | 3 | 4 | 11 | 29 |
| Region of Enrollment(participants) | Infectious Titre 1 | Infectious Titre 2 | Infectious Titre 3 | Infectious Titre 4 | Infectious Titre 5 (18 to 45 Years Old) | Infectious Titre 5 (46 to 64 Years Old) | Total |
|---|---|---|---|---|---|---|---|
| United Kingdom | 6 | 6 | 6 | 6 | 6 | 16 | 46 |
No study locations are listed for this record.
The record gives a start of Jan 2014, a primary completion of Aug 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2020, 5 years 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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