| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Immunisation against Hepatitis B and HIV in healthy adults aged between 18-52 years old, inclusive. |
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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 effect of chloroquine on a specific CD8+ T cell response to the F4co/AS01B candidate vaccine at Day 14.
• To evaluate the reactogenicity and safety of a booster dose of the investigational vaccines.
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| E.2.2 | Secondary objectives of the trial |
• To evaluate the effect of chloroquine on a specific CD8+ T cell response to Engerix™-B at Day 14.
• To evaluate the CD8+ T cell immune response to the study vaccines with or without chloroquine, determined at Day 0, 7, 14, 30 and 180.
• To evaluate the CD4+ T cell immune response to the study vaccines with or without chloroquine, determined at Day 0, 7, 14, 30 and 180.
• To evaluate the serological response to the study vaccines with or without chloroquine, determined at Day 0, 7, 14, 30 and 180.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
ALL subjects must satisfy ALL the following criteria at study entry:
• A male or female between, and including, 18 to 52 years of age at the time of vaccination.
• Written informed consent prior to any study related procedure on the subject.
• 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 or physical examination findings.
• Negative for anti-HBc and anti-Hepatitis C Virus (HCV) antibodies.
• Female subjects of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception until study completion.
In addition, subjects from the TH-ADJ-005 (287615) study willing to participate in this study must satisfy ALL the following criteria at study entry:
• Previous participation and completion of the TH-ADJ-005 (287615) study.
• CD4+-responder to HBsAg from the AS01B, AS02B or AS02V groups of the TH-ADJ-005 (287615) study.
In addition, subjects from the PRO-HIV-005 (108706) study willing to participate in this study must satisfy ALL the following criteria at study entry:
• Previous participation and completion of the PRO-HIV-005 (108706) study.
• CD4+-responder from the 10µg or the 30µg groups of the PRO-HIV-005 (108706) study.
• Subjects must be willing to accept HIV test results. Individuals who elect not to receive test results will not be enrolled.
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| E.4 | Principal exclusion criteria |
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
For ALL subjects:
• Clinically significant laboratory value above normal range for Blood Urea Nitrogen, Creatinine, Alanine aminotransferase and Aspartate aminotransferase, or clinically significant laboratory value above or below normal range for Hemoglobin, as per investigator judgment.
• Women who are pregnant or breast-feeding.
• Receipt of live attenuated vaccines within 30 days of vaccination.
• Receipt of medically indicated subunit or killed vaccines or allergy treatment with antigen injections within 14 days of study vaccine administration.
• Receipt of blood products 120 days prior to vaccination.
• Receipt of immunoglobulin 120 days prior to vaccination.
• Subject has donated blood in the last 3 months.
• Bleeding disorder that was diagnosed by a physician; e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions (a subject who states that he or she has easy bruising or bleeding, but does not carry a formal diagnosis and has intramuscular injections and blood drawn without any adverse experience is eligible).
• 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 from 10 milligram/day, or equivalent). Inhaled and topical steroids are allowed.
• History of serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product.
• History of serious allergic reaction to any substance requiring hospitalization or emergency medical care (e.g., Steven-Johnson syndrome, bronchospasm, or hypotension).
• History of hypersensitivity against chloroquine or any components of the drug.
• History of hypersensitivity against aminoglycosides.
• Ophthalmologic findings at screening (namely maculopathy, retinopathy, corneal opacities and cataracts).
• Previous administration of 4-aminoquinoline in the previous year or for a duration of more than 1 year.
• History of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
• History of hematopoietic disease.
• History of Myasthenia gravis.
• History of any serious neurological disorder or seizure.
• History of immunodeficiency or immune-mediated disorders, including active psoriasis.
• History of type I or type II diabetes mellitus including cases controlled with diet alone (a subject with past gestational diabetes is eligible).
• Thyroid disease including history of thyroidectomy and diagnoses requiring medication (a subject not requiring thyroid medicine within the past 12 months is eligible).
• 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.
• History of major congenital defect.
• History of chronic fatigue syndrome or fibromyalgia.
• 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).
• Splenectomy.
• Morbid obesity.
• Hypertension (a subject with hypertension is eligible if she/he is controlled on medication and the documented blood pressure is less than 150/100).
• Subjects with a history of, or current, alcohol or substance abuse.
• 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 vaccines, or planned use during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
In addition, for subjects from the TH-ADJ-005 (287615) study willing to participate in this study, if ANY exclusion criterion applies, the subject must not be included in the study:
• Previous hepatitis B vaccination after completion of TH-ADJ-005 (287615) study.
• History of HIV infection.
In addition, for subjects from the PRO-HIV-005 (108706) study willing to participate in this study, if ANY exclusion criterion applies, the subject must not be included in the study:
• Previous inclusion in a HIV vaccines trial other than PRO-HIV-005 (108706).
• Subject is seropositive for HIV, as determined by the test results (including confirmation test) performed.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
• Immunogenicity :
Cellular immune response to components of the study vaccine at Day 14.
• 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 vaccination.
Occurrence, intensity and relationship to vaccination of unsolicited symptoms until Day 29 Post-Vaccination.
Occurrence and relationship to vaccination of serious adverse event during the whole study period.
Occurrence and relationship to vaccination of adverse event of specific interest, including Immune-Mediated Disorders (IMD) during the whole study period.
Haematological and biochemical levels at Days 0, 7, 30 and 180 (visits 1, 2, 4 and 5) in all subjects.
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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) | 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 | Yes |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| 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 | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| 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 | 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 | 0 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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