NCT00717834

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2008

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 9, 2015

Status Verified

October 1, 2009

Enrollment Period

4 months

First QC Date

July 17, 2008

Last Update Submit

October 7, 2015

Conditions

Ross River Virus Disease (RRVD)

Outcome Measures

Primary Outcomes (2)

  • Rates of subjects with fever with onset within 7 days after the first and 7 days after the second vaccination

    Within 7 days after the first and second vaccinations

  • Immune response measured by RRV-specific IgG titer 21 days after the second vaccination

    21 days after the second vaccination

Study Arms (8)

Cohort 1, Treatment Arm 1

EXPERIMENTAL

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

Cohort 1, Treatment Arm 2

EXPERIMENTAL

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

Cohort 1, Treatment Arm 3

EXPERIMENTAL

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

Cohort 1, Treatment Arm 4

EXPERIMENTAL

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

Cohort 2, Treatment Arm 1

EXPERIMENTAL

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

Cohort 2, Treatment Arm 2

EXPERIMENTAL

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

Cohort 3, Treatment Arm 1

EXPERIMENTAL

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

Cohort 3, Treatment Arm 2

EXPERIMENTAL

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

Interventions

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

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.

Cohort 1, Treatment Arm 1Cohort 1, Treatment Arm 2Cohort 1, Treatment Arm 3Cohort 1, Treatment Arm 4Cohort 2, Treatment Arm 1Cohort 2, Treatment Arm 2Cohort 3, Treatment Arm 1Cohort 3, Treatment Arm 2

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Privatklinik Leech

Graz, 8010, Austria

Location

General Hospital Vienna, Department for Clinical Pharmacology

Vienna, 1090, Austria

Location

Universiteit Antwerpen VAXINFECTIO

Antwerp, 2610, Belgium

Location

Unité d´Investigation Clinique BioVallée

La Louvière, 7100, Belgium

Location

Andromed Breda

Breda, 4811 VL, Netherlands

Location

Andromed Eindhoven

Eindhoven, 5611 NJ, Netherlands

Location

Andromed Leiden

Leiden, 2311 GZ, Netherlands

Location

Andromed Nijmegen

Nijmegen, 6533 HL, Netherlands

Location

Andromed Oost

Velp, 6883 ES, Netherlands

Location

Andromed Zoetermeer

Zoetermeer, 2724 EK, Netherlands

Location

MeSH Terms

Conditions

Ross River Virus Infection

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Alphavirus InfectionsArbovirus InfectionsVector Borne DiseasesInfectionsMosquito-Borne DiseasesVirus DiseasesTogaviridae InfectionsRNA Virus Infections

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 18, 2008

Study Start

June 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2009

Last Updated

October 9, 2015

Record last verified: 2009-10

Locations

BE(2)NL(6)AU(2)