Ross River Virus (RRV) Vaccine Study

Ology Bioservices

Status and phase: Completed; Phase 3

Conditions: Prophylaxis of Ross River Virus Infection

Treatments: Biological: Ross River Virus Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01242670

880801

Details and patient eligibility

About

The purpose of the study is to verify the safety and adequacy of the immune response produced by a 2.5 µg, adjuvanted (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine and to demonstrate the consistency of manufacture of 3 separate lots of RRV vaccine.

Enrollment: 1,968 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is 16 to 59 years of age on the day of screening (for Stratum A only)
• Subject is 60 years of age or older on the day of screening (for Stratum B only)
• Subject and, if applicable, subject's parent(s)/legal guardian(s) has (/have) an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry
• Subject provides written assent according to his/her age, if applicable
• Subject is generally healthy as determined by the investigator's clinical judgment based upon medical history and physical examination
• Subject is physically and mentally capable of participating in the study and following study procedures
• Subject agrees to keep a daily record of symptoms for the duration of the study
• If female of childbearing potential - subject has 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

• Subject has a Body Mass Index > 35.0
• Subject has an elevated blood pressure at screening of > 159 mmHg systolic and/or > 99 mmHg diastolic while seated and at rest and confirmed by 2 additional measurements taken at least 30 minutes apart (while seated and at rest)
• Subject has any inherited or acquired immune deficiency
• Subject has or has a recent history of significant neurological, cardiovascular, respiratory (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
• Subject has a history of arthritis (including RRV disease, 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
• Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (> 800 μg/day of beclomethasone dipropionate or equivalent), corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
• Subjects has received any vaccination within 30 days prior to study entry
• Subject has received a blood transfusion or immunoglobulins within 90 days prior to study entry
• Subject has donated blood or plasma within 30 days prior to study entry
• Subject has a history of any vaccine related contraindicating event (eg, anaphylaxis, allergy to components of the test vaccine, other known contraindications)
• Subject has a dermatologic condition or tattoos which may interfere with injection site reaction rating
• Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to enrollment in this study or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study
• Subject has functional or surgical asplenia
• Subject has a known or suspected problem with alcohol or drug abuse
• Subject is a member of the team conducting this study or is 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 this study
• Subject is pregnant or lactating

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,968 participants in 1 patient group

Ross River Virus Vaccine

Experimental group

Description:

Subjects will be randomized in equal numbers (1:1:1) to receive one of three different lots of the vaccine on Day 1, Day 22 and Day 181. (The study is blinded with regard to which vaccine lot is administered to a subject but all subjects will receive 3 injections with a 2.5 µg aluminum hydroxide adjuvanted dose of RRV vaccine.)

Treatment:

Biological: Ross River Virus Vaccine