Ross River Virus Disease (RRVD)Phase 1/2NCT00717834
Safety and Immunogenicity Study of a Ross River Virus (RRV) Vaccine
A Phase 1/2 study testing Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant in people with Ross River Virus Disease (RRVD), run by Alachua Government Services, Inc. at 10 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Ross River Virus Disease (RRVD)
- What is being tested?
- Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jun 2008to Oct 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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 locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Netherlands6 sites
Andromed Breda
Breda, 4811 VL
Andromed Eindhoven
Eindhoven, 5611 NJ
Andromed Leiden
Leiden, 2311 GZ
Andromed Nijmegen
Nijmegen, 6533 HL
Andromed Oost
Velp, 6883 ES
Andromed Zoetermeer
Zoetermeer, 2724 EK
Austria2 sites
Privatklinik Leech
Graz, 8010
General Hospital Vienna, Department for Clinical Pharmacology
Vienna, 1090
Belgium2 sites
Universiteit Antwerpen VAXINFECTIO
Antwerp, 2610
Unité d´Investigation Clinique BioVallée
La Louvière, 7100
About this study
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
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.
- Conditions
- Ross River Virus Disease (RRVD)
- Being tested
- Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant
- Medical subject headings
- Ross River Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: 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 Receives: 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. Receives: 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 Receives: 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. Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of subjects with fever with onset within 7 days after the first and 7 days after the second vaccination
Measured: Within 7 days after the first and second vaccinations
Immune response measured by RRV-specific IgG titer 21 days after the second vaccination
Measured: 21 days after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ross River Virus Disease (RRVD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717834
- Sponsor's protocol ID
- 880701
- Status last verified
- Oct 2009
- First submitted
- 17 Jul 2008
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00717834
- Acronym / sponsor ID
- 880701
- Conditions
- Ross River Virus Disease (RRVD)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 18 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Treatment Arm 1 | Experimental | Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvantRandomization 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. |
| Cohort 1, Treatment Arm 2 | Experimental | Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvantSame as Cohort 1, Treatment Arm 1 |
| Cohort 1, Treatment Arm 3 | Experimental | Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvantSame as Cohort 1, Treatment Arm 1 |
| Cohort 1, Treatment Arm 4 | Experimental | Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvantSame as Cohort 1, Treatment Arm 1 |
| Cohort 2, Treatment Arm 1 | Experimental | Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvantRandomization 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. |
| Cohort 2, Treatment Arm 2 | Experimental | Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvantSame as Cohort 2, Treatment Arm 1 |
| Cohort 3, Treatment Arm 1 | Experimental | Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvantRandomization 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. |
| Cohort 3, Treatment Arm 2 | Experimental | Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvantSame as Cohort 3, Treatment Arm 1 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvantTwo 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. | Biological | Cohort 1, Treatment Arm 1, Cohort 1, Treatment Arm 2, Cohort 1, Treatment Arm 3, Cohort 1, Treatment Arm 4, Cohort 2, Treatment Arm 1, Cohort 2, Treatment Arm 2, Cohort 3, Treatment Arm 1, Cohort 3, Treatment Arm 2 |
Primary outcome
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
Immune response measured by RRV-specific IgG titer 21 days after the second vaccination
Time frame: 21 days after the second vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant in people with Ross River Virus Disease (RRVD), run by Alachua Government Services, Inc. at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands, Austria, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.