| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Two doses HIV vaccination in adults aged 18 to 40 years, in good general health and HIV seronegative. |
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| MedDRA Classification |
| 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 |
•To evaluate the reactogenicity and safety of the candidate vaccine F4co (p24-RT-Nef-p17) with or without AS01B adjuvant at three different doses (10-30-90 mcg).
•To evaluate the CD4+ T-cell response to the candidate vaccine F4co (p24-RT-Nef-p17) with or without AS01B at three different doses (10-30-90 mcg) in terms of proportion of responders to at least 1, 2, 3 antigens and to all 4 antigens determined two weeks after the second vaccination.
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| E.2.2 | Secondary objectives of the trial |
•To evaluate the CD4+ T-cell immune response to the candidate vaccine F4co (p24-RT-Nef-p17) with or without AS01B at three different doses (10-30-90 mcg) after two vaccinations.
•To evaluate the serological response to the candidate vaccine F4co (p24-RT-Nef-p17) with or without AS01B at three different doses (10-30-90 mcg) after two vaccinations.
•To evaluate the persistence of cell-mediated and serological responses to the candidate vaccine F4co (p24-RT-Nef-p17) with or without AS01B at three different doses (10-30-90 mcg).
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•A male or female between and including 18–40 years at the time of first vaccination.
•Written informed consent obtained from the subject prior to any study procedure.
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards and return for follow-up visits).
•Good general health without significant medical history, physical examination findings, or clinically significant abnormal laboratory results.
•If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
•Negative for antibodies against HIV-1, HIV-2 and negative for HIV p24 antigen, using Abbott AxSYM autoanalyser within 56 days (8 weeks) prior to enrolment.
Note: Subjects must be willing to accept HIV test results. Individuals who elect not to receive test results will not be enrolled.
•Negative for anti-HBc Ab, HBsAg and anti-HCV Ab.
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| E.4 | Principal exclusion criteria |
•Women who are pregnant or breast-feeding.
•Subjects with a history of, or current, alcohol or substance abuse.
•The subject is at high risk of acquiring HIV according to the behavioural risk assessment questionnaire.
•Morbid obesity
•Previous inclusion in a HIV vaccines trial.
•Receipt of live attenuated vaccines within 30 days of enrolment.
•Receipt of medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) or allergy treatment with antigen injections (including a tuberculin skin test) within 14 days of study vaccine administration.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Prior receipt of HIV-1 vaccines or placebo in a previous HIV vaccine trial.
•Receipt of blood products 120 days prior to HIV screening.
•Receipt of immunoglobulin 120 days prior to HIV screening.
•History of serious adverse reactions including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain to vaccines.
•History of serious allergic reaction to any substance requiring hospitalization or emergency medical care (e.g., Steven-Johnson syndrome, bronchospasm, or hypotension).
•History of immunodeficiency or autoimmune disease.
•History of malignancy (unless there has been surgical excision followed by a sufficient observation period, of at least 5 years, to give a reasonable assurance of sustained cure and which, in the estimate of the investigator, is not likely to recur during the study period).
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•History of type I or type II diabetes mellitus including cases controlled with diet alone.
Note: A subject with past gestational diabetes is eligible.
•Thyroid disease including history of thyroidectomy and diagnoses requiring medication.
Note: A subject not requiring thyroid medicine within the past 12 months is eligible.
•Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever.
•Asthma requiring daily steroid or long acting beta agonist prevention.
•Unstable asthma defined as:
Sudden acute attacks occurring in less than three hours without an obvious trigger.
Hospitalization for asthma in the last two years.
•Food- or wine-induced asthma
•Known sensitivity to sulfites or aspirin
•Bleeding disorder that was diagnosed by a physician; e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions.
Note: A subject who states that he or she has easy bruising or bleeding, but does not carry a formal diagnosis and has intramuscular (IM) injections and blood draws without any adverse experience is eligible.
•History of any serious neurologic disorder or seizure
•History of major congenital defect
•History of chronic fatigue syndrome or fibromyalgia
•Splenectomy
•Hypertension.
Note: A subject with hypertension is eligible if he or she is controlled on medication and the documented blood pressure is less than 150/100.
•Any medical, psychiatric or social condition, or occupational or other responsibility that, in the judgement of the investigator, would interfere with or serve as a contradiction to adherence to the study protocol or ability to give informed consent.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Reactogenicity and safety
•Occurrence, intensity and relationship to vaccination of solicited local and general symptoms during a 7-day (Day 0 to Day 6) follow-up period after each vaccination.
•Occurrence, intensity and relationship to vaccination of unsolicited symptoms during a 30-day (Day 0 to Day 29) follow-up period after each vaccination.
•Occurrence and relationship to vaccination of serious adverse events during the whole study period.
•Haematological and biochemical levels at months 0, 1, 2, 6, 9, 12 and at Day 44 (two weeks after the second vaccination) in all subjects.
Immunogenicity
•Frequency of CD4+ T cells expressing at least two cytokines including IL-2 equal or above the cut-off to at least 1, 2, 3 antigens and to all 4 antigens at Day 44 (two weeks after the second vaccination).
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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 | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| 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 |
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| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Yes |
| E.7.1.1 | First administration to humans | Yes |
| 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 | Yes |
| E.8.1.1 | Randomised | Yes |
| 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 | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
| partially-blinded, dose-escalating, staggered |
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| 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 | Yes |
| E.8.2.3.1 | Comparator description |
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| 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 | Information not present in EudraCT |
| 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
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| 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 | 2 |
| E.8.9.1 | In the Member State concerned days | |
| 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 | 2 |
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