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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00717834
First received: July 17, 2008
Last updated: October 20, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Ross River Virus Disease (RRVD)
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
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Blinded Phase 1/2 Dose Escalation Study to Assess Safety and Immunogenicity and Investigate the Optimal Dose Level of a Formalin-Treated, UV-Inactivated, Vero Cell-Derived Ross River Virus (RRV) Vaccine in Healthy Volunteers Aged 18 to 40 Years

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Rates of subjects with fever with onset within 7 days after the first and 7 days after the second vaccination [ Time Frame: Within 7 days after the first and second vaccinations ] [ Designated as safety issue: Yes ]
  • Immune response measured by RRV-specific IgG titer 21 days after the second vaccination [ Time Frame: 21 days after the second vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2008
Study Completion Date: October 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1, Treatment Arm 1
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.
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
Two intramuscular injections of either 1.25 µg, 2.5 µg, 5 µg or 10 µg on Days 0 and 21, with a booster vaccination to follow 180 days after the first.
Experimental: Cohort 1, Treatment Arm 2
Same as Cohort 1, Treatment Arm 1
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
Two intramuscular injections of either 1.25 µg, 2.5 µg, 5 µg or 10 µg on Days 0 and 21, with a booster vaccination to follow 180 days after the first.
Experimental: Cohort 1, Treatment Arm 3
Same as Cohort 1, Treatment Arm 1
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
Two intramuscular injections of either 1.25 µg, 2.5 µg, 5 µg or 10 µg on Days 0 and 21, with a booster vaccination to follow 180 days after the first.
Experimental: Cohort 1, Treatment Arm 4
Same as Cohort 1, Treatment Arm 1
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
Two intramuscular injections of either 1.25 µg, 2.5 µg, 5 µg or 10 µg on Days 0 and 21, with a booster vaccination to follow 180 days after the first.
Experimental: Cohort 2, Treatment Arm 1
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.
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
Two intramuscular injections of either 1.25 µg, 2.5 µg, 5 µg or 10 µg on Days 0 and 21, with a booster vaccination to follow 180 days after the first.
Experimental: Cohort 2, Treatment Arm 2
Same as Cohort 2, Treatment Arm 1
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
Two intramuscular injections of either 1.25 µg, 2.5 µg, 5 µg or 10 µg on Days 0 and 21, with a booster vaccination to follow 180 days after the first.
Experimental: Cohort 3, Treatment Arm 1
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.
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
Two intramuscular injections of either 1.25 µg, 2.5 µg, 5 µg or 10 µg on Days 0 and 21, with a booster vaccination to follow 180 days after the first.
Experimental: Cohort 3, Treatment Arm 2
Same as Cohort 3, Treatment Arm 1
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
Two intramuscular injections of either 1.25 µg, 2.5 µg, 5 µg or 10 µg on Days 0 and 21, with a booster vaccination to follow 180 days after the first.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717834

Locations
Austria
Privatklinik Leech
Graz, Austria, 8010
General Hospital Vienna, Department for Clinical Pharmacology
Vienna, Austria, 1090
Belgium
Universiteit Antwerpen VAXINFECTIO
Antwerp, Belgium, 2610
Unité d´Investigation Clinique BioVallée
La Louvière, Belgium, 7100
Netherlands
Andromed Breda
Breda, Netherlands, 4811 VL
Andromed Eindhoven
Eindhoven, Netherlands, 5611 NJ
Andromed Leiden
Leiden, Netherlands, 2311 GZ
Andromed Nijmegen
Nijmegen, Netherlands, 6533 HL
Andromed Oost
Velp, Netherlands, 6883 ES
Andromed Zoetermeer
Zoetermeer, Netherlands, 2724 EK
Sponsors and Collaborators
Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Christiane Thomasser, Clinical Project Manager, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00717834     History of Changes
Other Study ID Numbers: 880701
Study First Received: July 17, 2008
Last Updated: October 20, 2009
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicinal Products and Health Products
The Netherlands: Medicines Evaluation Board (MEB)

Additional relevant MeSH terms:
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014