E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vaccination against Ross River Virus Infection in healthy subjects between 18-40 years of age. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050931 |
E.1.2 | Term | Ross river virus infection |
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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 |
Assess the safety and tolerability of the RRV vaccine in a healthy young adult population.
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E.2.2 | Secondary objectives of the trial |
- Assess the immunogenicity of the RRV vaccine in a healthy young adult population;
- Identify the optimal dose level of the RRV vaccine in a healthy young adult population.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female subjects will be eligible for participation in this study if they:
·Are 18 to 40 years of age, inclusive, on the day of screening;
·Have an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry;
·Are generally healthy
·Are physically and mentally capable of participating in the study and following study procedures;
·Agree to keep a daily record of symptoms for the duration of the study;
·If female of childbearing potential – have a negative urine pregnancy test result within 24 hours of the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study.
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E.4 | Principal exclusion criteria |
Subjects will be excluded from participation in this study if they:
·Have a history of RRV exposure or a history of travel to a RRV endemic area: Australia, West Papua, Papua New Guinea, Solomon Islands, New Caledonia, Fiji Islands, Samoa Islands and Cook Island;
·Have a Body Mass Index > 35;
·Have an elevated blood pressure at screening of >159 mmHg systolic and/or >99 mmHg diastolic while seated and at rest and confirmed by two additional measurements taken at least 30 minutes apart (while seated and at rest)
·Have clinically significant abnormal clinical laboratory values at screening;
·Have clinically significant electrocardiographic abnormalities at screening;
·Test positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV);
·Have a history of cardiovascular disease;
·Have a history of immunodeficiency or autoimmune diseases;
·Have a history of arthritis (joint swelling, tenderness, warmth or erythema) on more than one occasion, not related to trauma (including running) or any episode of non-trauma related arthritis within the previous 6 months;
·Have an active neoplastic disease or have a history of hematological malignancy;
·Have a disease or are undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800 mg/day of beclomethasone dipropionate or equivalent), corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs;
·Have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
·Have received any vaccination within 2 weeks prior to vaccination in this study;
·Have received a blood transfusion or immunoglobulins within 30 days prior to vaccination in this study;
·Have donated blood or plasma within 30 days prior to vaccination in this study;
·Have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the test vaccine, other known contraindications);
·Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;
·Have a positive urine drug screen, (unless the detected drug is currently prescribed by a licensed health care provider and the continued administration of the drug would not otherwise exclude the subject from participation);
·Were administered an investigational drug within 6 weeks prior to study entry;
·Are concurrently participating in a clinical study that includes the administration of an investigational product;
·Are a member of the team conducting this study;
·Are in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study;
·If female, are pregnant or lactating.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Safety Endpoint ·Rates of subjects with fever with onset within 7 days after the first and second vaccination.
Primary Immunogenicity Endpoint ·Immune response measured by RRV-specific IgG titer 21 days 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 | Yes |
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 | Yes |
E.7.1.3.1 | Other trial type description |
safety, Immunogenicity, tolerability, dose finding |
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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 | Yes |
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) | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 | Yes |
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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The study is terminated when the last subject completes Day 201. The study may be prematurely terminated if SAE or other significant vaccine related side effect occur. In addition the sponsor may stop the entire study for any medical reason at any time. |
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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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |