Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial
Abstract
Background Vaccines based on mRNA coding for antigens have been shown to be safe and immunogenic in preclinical models. We aimed to report results of the first-in-human proof-of-concept clinical trial in healthy adults of a prophylactic mRNA-based vaccine encoding rabies virus glycoprotein (CV7201).Methods We did an open-label, uncontrolled, prospective, phase 1 clinical trial at one centre in Munich, Germany. Healthy male and female volunteers (aged 18-40 years) with no history of rabies vaccination were sequentially enrolled. They received three doses of CV7201 intradermally or intramuscularly by needle-syringe or one of three needle-free devices. Escalating doses were given to subsequent cohorts, and one cohort received a booster dose after 1 year. The primary endpoint was safety and tolerability. The secondary endpoint was to determine the lowest dose of CV7201 to elicit rabies virus neutralising titres equal to or greater than the WHO-specified protective antibody titre of 0·5 IU/mL. The study is continuing for long-term safety and immunogenicity follow-up. This trial is registered with ClinicalTrials.gov, number NCT02241135.Findings Between Oct 21, 2013, and Jan 11, 2016, we enrolled and vaccinated 101 participants with 306 doses of mRNA (80-640 μg) by needle-syringe (18 intradermally and 24 intramuscularly) or needle-free devices (46 intradermally and 13 intramuscularly). In the 7 days post vaccination, 60 (94%) of 64 intradermally vaccinated participants and 36 (97%) of 37 intramuscularly vaccinated participants reported solicited injection site reactions, and 50 (78%) of 64 intradermally vaccinated participants and 29 (78%) of 37 intramuscularly vaccinated participants reported solicited systemic adverse events, including ten grade 3 events. One unexpected, possibly related, serious adverse reaction that occurred 7 days after a 640 μg intramuscular dose resolved without sequelae. mRNA vaccination by needle-free intradermal or intramuscular device injection induced virus neutralising antibody titres of 0·5 IU/mL or more across dose levels and schedules in 32 (71%) of 45 participants given 80 μg or 160 μg CV7201 doses intradermally and six (46%) of 13 participants given 200 μg or 400 μg CV7201 doses intramuscularly. 1 year later, eight (57%) of 14 participants boosted with an 80 μg needle-free intradermal dose of CV7201 achieved titres of 0·5 IU/mL or more. Conversely, intradermal or intramuscular needle-syringe injection was ineffective, with only one participant (who received 320 μg intradermally) showing a detectable immune response.Interpretation This first-ever demonstration in human beings shows that a prophylactic mRNA-based candidate vaccine can induce boostable functional antibodies against a viral antigen when administered with a needle-free device, although not when injected by a needle-syringe. The vaccine was generally safe with a reasonable tolerability profile.Funding CureVac AG.
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In a first-in-human study, immune responses to a rabies virus glycoprotein (RABV-G)-mRNA vaccine were dependent on the route of administration, necessitating specialized devices.
“In a first-in-human study immune responses to rabies virus glycoprotein (RABV-G)-mRNA vaccine were dependent on the route of administration, necessitating specialized devices.”
From Proof-of-concept of a low-dose unmodified mRNA-based rabies vaccine formulated with lipid nanoparticles in human volunteers: A phase 1 trial (2021) · cites this paper as [8]
Initial studies of the mRNA technology using rabies mRNA, CV7201, found that there was potential for a human mRNA rabies vaccine, but the mode of delivery of the molecule was critical to elicit an adequate immune response due to its known instability in physiological conditions.
“Our initial studies of the mRNA technology using rabies mRNA, CV7201, found that there was potential for a human mRNA rabies vaccine, but the mode of delivery of the molecule was critical to elicit an adequate immune response due to its known instability in physiological conditions [8].”
From Proof-of-concept of a low-dose unmodified mRNA-based rabies vaccine formulated with lipid nanoparticles in human volunteers: A phase 1 trial (2021) · cites this paper as [8]
Another 20 years later, mRNA vaccines against infectious disease were investigated in phase I proof-of-concept clinical trials.
“Another 20 years later, mRNA vaccines against infectious disease were investigated in phase I, proof-of-concept, clinical trials.23,24”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [23]
Although the delivery route did not affect the immune response, the delivery device did, with only the intradermal injector producing a short-lived humoral response.
“Interestingly, although the delivery route did not affect the immune response, the delivery device did, with only the intradermal injector producing a short-lived humoral response188.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [188]
CureVac's protamine-based rabies candidate CV7201 elicited severe adverse events in 78% of participants.
“CureVac’s protamine-based rabies candidate CV7201 elicited severe adverse events in 78% of participants188”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [188]
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- Authors
- Alberer, M., Gnad-Vogt, U., Hong, H. S., Mehr, K. T., Backert, L., Finak, G., Gottardo, R., Bica, M. A., Garofano, A., Koch, S. D., Fotin-Mleczek, M., Hoerr, I., Clemens, R., & von Sonnenburg, F.
- Affiliations
- Ludwig-Maximilians-Universität München (DE)
- CureVac (Germany) (DE)
- Quantitative Biology Center (DE)
- Fred Hutch Cancer Center (US)
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2017-09
- Volume
- 390
- Issue
- 10101
- Pages
- 1511-1520
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2738515079
- Cited by
- 530
- References
- 25
- Citations by year
- 2026: 44 · 2025: 68 · 2024: 58 · 2023: 76 · 2022: 85 · 2021: 94 · 2020: 51 · 2019: 29 · 2018: 22 · 2017: 3
- FWCI
- 15.58
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Immunology and Microbiology › Virology › Rabies epidemiology and control
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
- Keywords
- rabies vaccine, mRNA vaccines, rabies virus glycoprotein, prophylactic vaccination, vaccine safety, immunogenicity, neutralizing antibodies, intradermal injection, booster vaccination, dose escalation, healthy adults, adverse events, injection site reactions, rabies prevention
- MeSH terms
- Immunogenicity, Vaccine, Adolescent, Adult, Antibodies, Viral, Double-Blind Method, Drug Administration Routes, Drug Administration Schedule, Female, Germany, Humans, Male, Prospective Studies, Rabies, Rabies Vaccines, RNA, Messenger, Young Adult, Antibodies, Neutralizing, Drug-Related Side Effects and Adverse Reactions
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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