RabiesPhase 1NCT02238756
Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults
A Phase 1 study testing CV8102, Rabipur and CV8102 + Rabipur in people with Rabies, run by CureVac at 1 site in Germany.
Trial summary
The purpose of this clinical trial is to investigate the safety and tolerability of IM administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in humans. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- CV8102, Rabipur and CV8102 + Rabipur
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Nov 2016
- Phase
- Phase 1
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Compliant with protocol procedures and available for clinical F/U until the protocol-defined end of the trial
- Physical examination and laboratory results without clinically significant findings
- Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
- Subjects must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during treatment and the 4-week F/U period after the last treatment.
Who cannot join
- Use of any investigational or non-registered product (adjuvant, drug) other than CV8102 within 4 weeks preceding the administration of the CV8102, or planned use of any such agent during the trial period
- Subject has received any licensed or non-licensed vaccines within 4 weeks prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine or planned vaccinations during the trial period
- Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted
- Any medically diagnosed or suspected immune deficient condition based on medical history and physical examination
- History of autoimmune disease or suspected autoimmune disease based on medical history and physical examination that cannot be ruled out based on further examinations
- Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of CV8102 or licensed rabies vaccine
Show all 21Show fewer
- Acute disease at the time of enrolment. Acute disease is defined as the presence of any acute condition including but not limited to non-febrile or febrile common colds, urinary tract infections, inflammatory, allergic or traumatic conditions that may interfere with safety assessment of the investigational products
- Presence or evidence of significant acute or chronic disease, in particular heart disease including coronary artery disease and chronic pulmonary diseases (e.g., chronic obstructive pulmonary disease [COPD]); uncontrolled medical or psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated for ≥ 3 months e.g., mild hypertension well-controlled with medication, may be enrolled - provided the condition and its therapy are known not to be associated with an immunocompromised state or an autoimmune disease)
- Major congenital defects
- Known allergy to any component (or closely related substance) of the licensed rabies vaccine product
- Known type I allergy to beta-lactam antibiotics
- Evidence of current alcohol or drug abuse
- History of any neurological disorders or seizures
- Known seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (except in subjects previously vaccinated against HBV) or hepatitis C virus (HCV)
- Foreseeable non-compliance with protocol as judged by the Investigator
- History of any life-threatening anaphylactic reactions
- Subjects with impaired coagulation in whom an IM injection is contraindicated.
- Additional exclusion criteria for subjects participating in the (adjuvanted) rabies vaccination part:
- Subject has previously received any investigational or licensed rabies vaccine
- Intending to travel to regions/countries for which rabies vaccinations are recommended or where high risk of infection exists according to travel recommendations by the German Society of Tropical Medicine and International Health (DTG) during the trial and F/U period
- Subject is taking chloroquine for malaria treatment or prophylaxis.
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRS Clinical Research Services Mönchengladbach GmbH
Mönchengladbach
About this study
Official title: Phase I Safety and Tolerability Trial of Single and Repeat Doses of the RNA-based Adjuvant CV8102 Alone and in Combination With a Licensed Rabies Virus Vaccine in Healthy Adults
The purpose of this clinical trial is to investigate the safety and tolerability of IM administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in humans.
- Conditions
- Rabies
- Being tested
- CV8102, Rabipur, CV8102 + Rabipur
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CV8102Biological
Subjects will receive 2 intramuscular doses of CV8102 given 21 days apart
RabipurBiological
Subjects will receive 2 intramuscular doses of Rabipur given 21 days apart
CV8102 + RabipurBiological
Subjects will receive 2 intramuscular doses of CV8102+Rabipur given 21 days apart
| Study group | Role | What they receive |
|---|---|---|
| CV8102 | Experimental | Not described Receives: Biological: CV8102 |
| Rabipur | Active comparator | Not described Receives: Biological: Rabipur |
| CV8102 + Rabipur | Experimental | Not described Receives: Biological: CV8102 + Rabipur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with serious and non serious adverse events
Measured: Up to 12 months
Secondary outcomes (4)
Maximum tolerated dose (MTD) of CV8102 within the dose range of 25 µg to 250 µg.
Measured: Up to day 49
MTD of CV8102 in combination with rabies vaccine
Measured: Up to Day 49
Vaccination-elicited serum rabies VNTs among the dose groups
Measured: Up to day 35
Vaccination-elicited innate and adaptive immune responses
Evaluation of corresponding serum and blood parameters (e.g. relevant cytokines, chemokines, immune effector molecules and lymphocyte phenotyping)
Measured: Up to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RabiesStudies 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CureVac
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ingo Meyer, MD, Principal investigator, CRS Clinical Research Services Mönchengladbach GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238756
- Sponsor's protocol ID
- CV-8102-201
- Other IDs
- 2013-004514-18
- Status last verified
- Jun 2018
- First submitted
- 4 Sep 2014
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety and Tolerability Trial of Single and Repeat Doses of the RNA-based Adjuvant CV8102 Alone and in Combination With a Licensed Rabies Virus Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT02238756
- Acronym / sponsor ID
- CV-8102-201
- Conditions
- Rabies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- CureVacIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 12 Sep 2014 (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 purpose of this clinical trial is to investigate the safety and tolerability of IM administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CV8102 | Experimental | Biological: CV8102 |
| Rabipur | Active comparator | Biological: Rabipur |
| CV8102 + Rabipur | Experimental | Biological: CV8102 + Rabipur |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Compliant with protocol procedures and available for clinical F/U until the protocol-defined end of the trial
- Physical examination and laboratory results without clinically significant findings
- Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
- Subjects must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during treatment and the 4-week F/U period after the last treatment.
Key exclusion criteria (21 listed)
- Use of any investigational or non-registered product (adjuvant, drug) other than CV8102 within 4 weeks preceding the administration of the CV8102, or planned use of any such agent during the trial period
- Subject has received any licensed or non-licensed vaccines within 4 weeks prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine or planned vaccinations during the trial period
- Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted
- Any medically diagnosed or suspected immune deficient condition based on medical history and physical examination
- History of autoimmune disease or suspected autoimmune disease based on medical history and physical examination that cannot be ruled out based on further examinations
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 |
|---|---|---|
| CV8102Subjects will receive 2 intramuscular doses of CV8102 given 21 days apart | Biological | CV8102 |
| RabipurSubjects will receive 2 intramuscular doses of Rabipur given 21 days apart | Biological | Rabipur |
| CV8102 + RabipurSubjects will receive 2 intramuscular doses of CV8102+Rabipur given 21 days apart | Biological | CV8102 + Rabipur |
Primary outcome
Number of subjects with serious and non serious adverse events
Time frame: Up to 12 months
4 secondary outcomes
Maximum tolerated dose (MTD) of CV8102 within the dose range of 25 µg to 250 µg.
Time frame: Up to day 49
MTD of CV8102 in combination with rabies vaccine
Time frame: Up to Day 49
Vaccination-elicited serum rabies VNTs among the dose groups
Time frame: Up to day 35
Vaccination-elicited innate and adaptive immune responses
Time frame: Up to Day 35
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 6 Jun 2018.
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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.
Ingo Meyer, MD principal investigator
CRS Clinical Research Services Mönchengladbach GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CV8102, Rabipur and CV8102 + Rabipur in people with Rabies, run by CureVac at 1 site in Germany.
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 4 inclusion and 21 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 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.
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?
Number of subjects with serious and non serious adverse events (time frame: Up to 12 months). 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 6 Jun 2018.