E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV (effect of HIV on the response to live attenuated intranasal influenza vaccine) |
|
E.1.1.1 | Medical condition in easily understood language |
HIV (effect of HIV on the response to live attenuated intranasal influenza vaccine) |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020160 |
E.1.2 | Term | HIV disease |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Do HIVinfected individuals have distinct differential early gene expression profiles following intranasal live attenuated influenza vaccine, when compared to age and sexmatched HIVnegative subjects, thus providing insights into the aberrant immunological response to live vaccines modulated by HIV infection? |
|
E.2.2 | Secondary objectives of the trial |
Are blood and pulmonary influenza specific Tcells detectable in HIV infected and HIV negative subjects following administration of live attenuated influenza vaccine? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18 – 49 HIV1 infected On antiretroviral therapy CD4 count of >200/mm3 (for at least 6 months, last available measurement within 3 months) Viral load undetectable (for at least 6 months, last available measurement within 3 months) History of having received at least one dose of trivalent inactivated influenza vaccine in the past Nonsmoker |
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E.4 | Principal exclusion criteria |
Severe egg allergy Hypersensitivity to gentamicin Pregnant or breastfeeding Chronic lung disease (e.g. bronchiectasis) A history of severe asthma or current active wheezing Other cause for immunosuppression (e.g. malignancy) or immunosuppressive medication Hepatitis B or C coinfection (as defined by a detectable HBSAg or HCV RNA) Planned close contact with severely immunocompromised individuals in 2 weeks following LAIV (e.g bone marrow transplant recipients) Recipient of any other vaccination within the last 4 weeks Individuals who have had a febrile illness or other symptoms of acute infectious illness (respiratory, enteric or soft tissue) within the last 2 weeks. Individuals with a known and current history of anaemia or any symptoms (shortness of breath, chronic fatigue, chest pain or pallor) suggestive of possible anaemia or haemoglobin below the lower limit of sex adjusted normal range on a full blood count taken within the last 3 months. Current (active) participation in any clinical trial Inability to communicate in English or convey willingness to participate |
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E.5 End points |
E.5.1 | Primary end point(s) |
Differential gene expression profiles after LAIV in HIV infected and HIV uninfected individuals |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 3 following administration of the live attenuated influenza vaccination (LAIV). |
|
E.5.2 | Secondary end point(s) |
Influenza specific Tcell responses in blood (and in a subset of patients in lung). Antiinfluenza antibody titres in serum |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Identify how HIV modulates innate and adaptive immunological responses to LAIV |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The End of the Trial will be when all study specific laboratory procedures have been completed. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 30 |