RabiesPhase 1NCT02241135
RNActive® Rabies Vaccine (CV7201) in Healthy Adults
A Phase 1 study testing CV7201 mRNA in people with Rabies, run by CureVac at 1 site in Germany.
Trial summary
The purpose of this trial is to assess the safety and immunogenicity of an investigational RNActive® rabies vaccine (CV7201) in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- CV7201 mRNA
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to 8 Feb 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers aged 18 to 40 years inclusive
- Compliant with protocol procedures and available for clinical follow-up through the last planned visit (V9)
- Physical examination and laboratory results without clinically significant findings
- Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
- Females: Negative human chorionic gonadotropin (HCG) pregnancy test (serum) for women presumed to be of reproductive potential on the day of enrolment
- Females of childbearing potential must use acceptable methods of birth control during the trial and Follow-up period (from 6 weeks before the first administration of the test vaccine for the duration of the trial i.e., until the last planned visit (V9)). The following methods of birth control are acceptable when used consistently and correctly: established use of oral, injected or implanted hormonal methods of contraception; intrauterine devices (IUDs) or intrauterine systems (IUSs) with the exception of steel or copper wire; barrier methods of contraception (condom or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository); true abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and postovulation methods] and withdrawal are not acceptable).
- Males must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during the trial and Follow-up period i.e., until the last planned visit (V9).
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the trial vaccine within 4 weeks preceding the administration of the trial vaccine, or planned use during the trial period
- Subject has received any other licensed vaccines within 4 weeks prior to the administration of the trial vaccine
- Subject has received any investigational or licensed rabies vaccine previously
- Intending to travel to regions/countries for which rabies vaccinations are recommended or where high risk of infections exists according to travel recommendations by the German Society of Tropical Medicine and International Health (DTG) during the trial and up to V9 (Day 91/120) Follow-up
- Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial 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 immunodeficient condition based on medical history and physical examination
Show all 21Show fewer
- History of autoimmune disease
- Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of the trial vaccine
- Subject is taking chloroquine for malaria treatment or prophylaxis
- Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness or fever ≥ 38 °C measured orally
- Presence or evidence of significant acute or chronic, 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 of the trial product i.e., protamine. This includes subjects with allergy to fish protein, diabetics with allergy to protamine-containing insulin, or post-vasectomy males
- Known type I allergy to beta lactam antibiotics
- Evidence of current alcohol or drug abuse
- History of any neurological disorders or seizures, with the exception of febrile seizures during childhood
- 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
- For females: Pregnancy or lactation
- History of any life-threatening anaphylactic reactions.
- Subjects with impaired coagulation in whom an IM injection is contraindicated.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Abteilung für Infektions- und Tropenmedizin der Ludwig-Maximilians-Universität
Munich, 80802
About this study
Official title: Phase I Safety and Immunogenicity Trial of an Investigational RNActive® Rabies Vaccine (CV7201) in Healthy Adults
The purpose of this trial is to assess the safety and immunogenicity of an investigational RNActive® rabies vaccine (CV7201) in healthy adults.
- Conditions
- Rabies
- Being tested
- CV7201 mRNA
- Keywords
- Rav G protein, rabies, VNT, immunogenicity, PrEP vaccination, mRNA, CV7201
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CV7201 mRNABiological
Also called CV7201 messenger RNA, CV7201 RNActive®
CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
| Study group | Role | What they receive |
|---|---|---|
| 80 µg CV7201 mRNA short | Experimental | Vaccination by injection on days 0, 7, 28. Receives: Biological: CV7201 mRNA |
| 160µg CV7201 mRNA short | Experimental | Vaccination by injection on days 0, 7, 28. Receives: Biological: CV7201 mRNA |
| 80 µg CV7201 mRNA long | Experimental | Vaccination by injection on days 0, 28, 56. Receives: Biological: CV7201 mRNA |
| 160 µg CV7201 mRNA long | Experimental | Vaccination by injection on days 0, 28, 56. Receives: Biological: CV7201 mRNA |
| 320 µg CV7201 mRNA long | Experimental | Vaccination by injection on days 0, 28, 56. Receives: Biological: CV7201 mRNA |
| 640 µg CV7201 mRNA long | Experimental | Vaccination by injection on days 0, 28. Receives: Biological: CV7201 mRNA |
| 200 µg CV7201 mRNA long | Experimental | Vaccination by injection on days 0, 28, 56. Receives: Biological: CV7201 mRNA |
| 400 µg CV7201 mRNA long | Experimental | Vaccination by injection on days 0, 28, 56. Receives: Biological: CV7201 mRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of serious adverse events (SAEs)/adverse events (AEs) and local tolerability assessment of the vaccination site
The occurrence of AEs will be assessed by non-directive questioning of the subject at each visit. Further, AEs volunteered by the subject during or between visits - as subject diary card entries - or detected through observation, physical examination, laboratory test, or other assessments during the entire observation period, will be documented. Subjects will be instructed that they must immediately report any AEs, subjective complaints or objective changes in their well-being to the Investigator or the clinic personnel, regardless of the perceived relationship between the event and the test product. The Investigator is responsible for reporting all AEs in the eCRF that are observed or described by the subject, regardless of their relationship to the trial vaccine or their clinical significance.
Measured: up to 64 days after the last vaccination
Secondary outcomes (2)
The lowest CV7201 dose to elicit rabies VNTs ≥ 0.5 IE/ml
Rabies virus neutralizing titers (VNTs) measured in serum blood samples taken 14 days after the the last vaccination (Visit 8).
Measured: Rabies VNTs measured 14 days after the 3rd vaccination (Visit 8)
Number of treatment discontinuation due to IMP-related AEs/SAEs
Number of subjects discontinued from treatment after the first or second vaccination due to vaccination-related reactions or AEs/SAEs.
Period for observation in order to decide on withdrawal of subjects from next vaccination starts with Visit 1 (day 0, first vaccination) and lasts until the day of the third scheduled vaccination (pre-vaccination examination).
Measured: up to 64 days after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startOct 2013
- Primary completion8 Feb 2018
- Study completion8 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- CureVac
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Franz-Josef Falkner von Sonnenburg, MD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241135
- Sponsor's protocol ID
- CV-7201-102
- Other IDs
- 2013-002171-17
- Status last verified
- May 2018
- First submitted
- 22 Aug 2014
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alberer M, Gnad-Vogt U, Hong HS, Mehr KT, Backert L, Finak G, Gottardo R, Bica MA, Garofano A, Koch SD, Fotin-Mleczek M, Hoerr I, Clemens R, von Sonnenburg F. Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial. Lancet. 2017 Sep 23;390(10101):1511-1520. doi: 10.1016/S0140-6736(17)31665-3. Epub 2017 Jul 25.
PubMed 28754494
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety and Immunogenicity Trial of an Investigational RNActive® Rabies Vaccine (CV7201) in Healthy Adults
- ClinicalTrials.gov ID
- NCT02241135
- Acronym / sponsor ID
- CV-7201-102
- Conditions
- Rabies
- Keywords
- Rav G protein, rabies, VNT, immunogenicity, PrEP vaccination, mRNA, CV7201
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- CureVacIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 16 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 trial is to assess the safety and immunogenicity of an investigational RNActive® rabies vaccine (CV7201) in healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 80 µg CV7201 mRNA short | Experimental | Biological: CV7201 mRNAVaccination by injection on days 0, 7, 28. |
| 160µg CV7201 mRNA short | Experimental | Biological: CV7201 mRNAVaccination by injection on days 0, 7, 28. |
| 80 µg CV7201 mRNA long | Experimental | Biological: CV7201 mRNAVaccination by injection on days 0, 28, 56. |
| 160 µg CV7201 mRNA long | Experimental | Biological: CV7201 mRNAVaccination by injection on days 0, 28, 56. |
| 320 µg CV7201 mRNA long | Experimental | Biological: CV7201 mRNAVaccination by injection on days 0, 28, 56. |
| 640 µg CV7201 mRNA long | Experimental | Biological: CV7201 mRNAVaccination by injection on days 0, 28. |
| 200 µg CV7201 mRNA long | Experimental | Biological: CV7201 mRNAVaccination by injection on days 0, 28, 56. |
| 400 µg CV7201 mRNA long | Experimental | Biological: CV7201 mRNAVaccination by injection on days 0, 28, 56. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male and female volunteers aged 18 to 40 years inclusive
- Compliant with protocol procedures and available for clinical follow-up through the last planned visit (V9)
- Physical examination and laboratory results without clinically significant findings
- Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
- Females: Negative human chorionic gonadotropin (HCG) pregnancy test (serum) for women presumed to be of reproductive potential on the day of enrolment
Key exclusion criteria (21 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the trial vaccine within 4 weeks preceding the administration of the trial vaccine, or planned use during the trial period
- Subject has received any other licensed vaccines within 4 weeks prior to the administration of the trial vaccine
- Subject has received any investigational or licensed rabies vaccine previously
- Intending to travel to regions/countries for which rabies vaccinations are recommended or where high risk of infections exists according to travel recommendations by the German Society of Tropical Medicine and International Health (DTG) during the trial and up to V9 (Day 91/120) Follow-up
- Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted
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 |
|---|---|---|
| CV7201 mRNAAlso: CV7201 messenger RNA, CV7201 RNActive®CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein. | Biological | 160 µg CV7201 mRNA long, 160µg CV7201 mRNA short, 200 µg CV7201 mRNA long, 320 µg CV7201 mRNA long, 400 µg CV7201 mRNA long, 640 µg CV7201 mRNA long, 80 µg CV7201 mRNA long, 80 µg CV7201 mRNA short |
Primary outcome
Incidence and severity of serious adverse events (SAEs)/adverse events (AEs) and local tolerability assessment of the vaccination site
Time frame: up to 64 days after the last vaccination
The occurrence of AEs will be assessed by non-directive questioning of the subject at each visit. Further, AEs volunteered by the subject during or between visits - as subject diary card entries - or detected through observation, physical examination, laboratory test, or other assessments during the entire observation period, will be documented. Subjects will be instructed that they must immediately report any AEs, subjective complaints or objective changes in their well-being to the Investigator or the clinic personnel, regardless of the perceived relationship between the event and the test product. The Investigator is responsible for reporting all AEs in the eCRF that are observed or described by the subject, regardless of their relationship to the trial vaccine or their clinical significance.
2 secondary outcomes
The lowest CV7201 dose to elicit rabies VNTs ≥ 0.5 IE/ml
Time frame: Rabies VNTs measured 14 days after the 3rd vaccination (Visit 8)
Number of treatment discontinuation due to IMP-related AEs/SAEs
Time frame: up to 64 days after the last 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 29 Oct 2018.
- Derived from this study: PubMed 28754494Alberer M, Gnad-Vogt U, Hong HS, Mehr KT, Backert L, Finak G, Gottardo R, Bica MA, Garofano A, Koch SD, Fotin-Mleczek M, Hoerr I, Clemens R, von Sonnenburg F. Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial. Lancet. 2017 Sep 23;390(10101):1511-1520. doi: 10.1016/S0140-6736(17)31665-3. Epub 2017 Jul 25.
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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.
Franz-Josef Falkner von Sonnenburg, MD principal investigator
Ludwig-Maximilians - University of Munich
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 CV7201 mRNA 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 7 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 29 Oct 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?
Incidence and severity of serious adverse events (SAEs)/adverse events (AEs) and local tolerability assessment of the vaccination site (time frame: up to 64 days after the last vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02241135, which also lists 1 linked publication.
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 29 Oct 2018.