Safety and Immunogenicity Study of a Ross River Virus (RRV) Vaccine

Ology Bioservices

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ross River Virus Disease (RRVD)

Treatments: Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717834

880701

Details and patient eligibility

About

The primary objective of this study is to assess the safety and tolerability of the Ross River Virus (RRV) Vaccine in a healthy young adult population. Other objectives of this study are to assess the immunogenicity of the RRV Vaccine in a healthy young adult population and to identify the optimal dose level of the RRV Vaccine in a healthy young adult population.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 (eg 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 (eg, 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 (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study;
• If female, are pregnant or lactating.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 8 patient groups

Cohort 1, Treatment Arm 1

Experimental group

Description:

Randomization of a total of approx. 200 subjects to one of four treatment arms at 1:1:1:1 ratio to receive 1.25 µg of the RRV Vaccine with/without adjuvant (Al(OH)3), or 2.5 µg of the RRV Vaccine with/without adjuvant (Al(OH)3). Cohort 1 is subdivided into Cohort 1a (n = 60, i.e. 15 subjects per dose/adjuvantation combination) to receive the first vaccination on Day 0, with Day 7 safety data being reviewed by a Data Monitoring Committee and, following DMC recommendation, to receive the second vaccination at Day 21; Cohort 1b (n=140, i.e. 35 subjects per dose/adjuvantation combination) is to be vaccinated twice 21 days apart upon availability of DMC recommendation. Booster vaccination to follow 180 days after first vaccination.

Treatment:

Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant

Cohort 1, Treatment Arm 2

Experimental group

Description:

Same as Cohort 1, Treatment Arm 1

Treatment:

Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant

Cohort 1, Treatment Arm 3

Experimental group

Description:

Same as Cohort 1, Treatment Arm 1

Treatment:

Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant

Cohort 1, Treatment Arm 4

Experimental group

Description:

Same as Cohort 1, Treatment Arm 1

Treatment:

Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant

Cohort 2, Treatment Arm 1

Experimental group

Description:

Randomization of a total of approx. 100 subjects to one of two treatment arms at 1:1 ratio to receive 5 µg of the RRV Vaccine with/without adjuvant (Al(OH)3). Vaccinations take place upon review of Cohort 1a Day 7 safety data by DMC and recommendation to proceed. Booster vaccination to follow 180 days after first vaccination.

Treatment:

Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant

Cohort 2, Treatment Arm 2

Experimental group

Description:

Same as Cohort 2, Treatment Arm 1

Treatment:

Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant

Cohort 3, Treatment Arm 1

Experimental group

Description:

Randomization of a total of approx. 100 subjects to one of two treatment arms at 1:1 ratio to receive 10 µg of the RRV Vaccine with/without adjuvant (Al(OH)3). Vaccinations take place upon review of Cohort 1b and Cohort 2 Day 7 safety data by DMC and recommendation to proceed. Booster vaccination to follow 180 days after first vaccination.

Treatment:

Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant

Cohort 3, Treatment Arm 2

Experimental group

Description:

Same as Cohort 3, Treatment Arm 1

Treatment:

Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant