Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study
Open accessAbstract
This phase 1, open-label, dose-escalation, multi-center study (NCT05477186) assessed the safety and immunogenicity of a booster dose of an mRNA COVID-19 vaccine (CV0501) encoding the SARS-CoV-2 Omicron BA.1 spike protein. Participants aged ≥ 18 years previously vaccinated with ≥ 2 doses of an mRNA COVID-19 vaccine received CV0501 doses ranging from 12 to 200 μg. After assessment of safety and immunogenicity of the 12 μg dose in 30 adults, 30 adults ≤ 64 years were randomized to receive either a 3 or 6 μg dose. Solicited adverse events (AEs) were collected for 7 days, unsolicited AEs for 28 days, and serious AEs (SAEs), medically attended AEs (MAAEs), and AEs of special interest (AESIs) until day (D) 181 post-vaccination. Serum neutralizing titers specific to SARS-CoV-2 BA.1, wild-type, Delta, and additional Omicron subvariants were assessed at D1, D15, D29, D91, and D181. Of 180 vaccinated participants (mean age: 49.3 years; 57.8% women), 70.6% had prior SARS-CoV-2 infection. Most solicited local (98.1%) and systemic (96.7%) AEs were of mild-to-moderate severity; the most common were injection site pain (57.5%; 33.3-73.3% across groups) and myalgia (36.9%; 13.3-56.7%). Unsolicited AEs were reported by 14.4% (6.7-26.7%) of participants (mild-to-moderate severity in 88.5% of the participants). Three participants (1.7%) reported SAEs, 16.7% (6.7-30.0%) reported MAAEs, and 8.3% (0.0-13.3%) reported AESIs (15 COVID-19 cases), none related to vaccination. Geometric means of serum neutralizing titers increased from baseline to D15 and D29 (dose-dependent), and then decreased over time. The safety and immunogenicity results supported advancement to a phase 2 trial.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Polack, F. P., Thomas, S. J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L., Pérez Marc, G., Moreira, E. D., Zerbini, C., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2034577 · Cited by 14,592 · cited 1× · see citing works
“19 22 In addition, this vaccine platform could be easily adapted to express different antigens or antigen combinations, thus allowing the potential development of multivalent or universal vaccines against different pathogens.”
BackgroundEfficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine
Baden, L. R., El Sahly, H. M., Essink, B., Kotloff, K., Frey, S., Novak, R., Diemert, D., Spector, S. A., Rouphael, N., Creech, C. B., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2035389 · Cited by 10,119 · see citing works
Self-citationMarkov, P. V., Ghafari, M., Beer, M., Lythgoe, K., Simmonds, P., Stilianakis, N. I., & Katzourakis, A. (2023) · Nature Reviews Microbiology · doi:10.1038/s41579-023-00878-2 · Cited by 1,179 · see citing works
Munro, A. P. S., Feng, S., Janani, L., Cornelius, V., Aley, P. K., Babbage, G., Baxter, D., Bula, M., Cathie, K., Chatterjee, K., et al. (2022) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(22)00271-7 · Cited by 175 · see citing works
Kremsner, P. G., Ahuad Guerrero, R. A., Arana-Arri, E., Aroca Martinez, G. J., Bonten, M., Chandler, R., Corral, G., De Block, E. J. L., Ecker, L., Gabor, J. J., et al. (2022) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(21)00677-0 · Cited by 172 · see citing works
Self-citationOptimization of non-coding regions for a non-modified mRNA COVID-19 vaccine
Gebre, M. S., Rauch, S., Roth, N., Yu, J., Chandrashekar, A., Mercado, N. B., He, X., Liu, J., McMahan, K., Martinot, A., et al. (2022) · Nature · doi:10.1038/s41586-021-04231-6 · Cited by 127 · see citing works
Self-citationTseng, H. F., Ackerson, B. K., Bruxvoort, K. J., Sy, L. S., Tubert, J. E., Lee, G. S., Ku, J. H., Florea, A., Luo, Y., Qiu, S., et al. (2023) · Nature Communications · doi:10.1038/s41467-023-35815-7 · Cited by 105 · see citing works
Flagged first, then by citations
- Authors
- Essink, B. J., Shapiro, C., Isidro, M. G. D., Bradley, P., Pragalos, A., Bloch, M., Santiaguel, J., Frias, M. V., Miyakis, S., Alves de Mesquita, M., Berrè, S., Servais, C., Waugh, N., Hoffmann, C., Baba, E., Schönborn-Kellenberger, O., Wolz, O.-O., Koch, S. D., Ganyani, T., Boutet, P., Mann, P., Mueller, S. O., Ramanathan, R., Gaudinski, M. R., & Vanhoutte, N.
- Affiliations
- Velocity Clinical Research (United States) (US)
- RCA (United States) (US)
- West Visayas State University (PH)
- Clinical Trial and Consulting (US)
- Holdsworth House Medical Practice (AU)
- University of the Philippines System (PH)
- De La Salle Medical and Health Sciences Institute (PH)
- University of Wollongong (AU)
- CureVac SE
- GlaxoSmithKline (United Kingdom) (GB)
- CureVac (Germany) (DE)
- Corresponding author
- Vanhoutte, Nicolas
- ORCID
- Venue
- Human Vaccines & Immunotherapeutics
- Publisher
- Informa UK Limited
- Published
- 2024-10-18
- Volume
- 20
- Issue
- 1
- Pages
- 2408863-2408863
- ISSN
- 2164-5515 (ISSN-L)
- 2164-554X
- PMC
- PMC11492660
- OpenAlex
- W4403545203
- Cited by
- 8
- References
- 7
- Citations by year
- 2026: 5 · 2025: 3
- FWCI
- 2.77
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Human Vaccines & Immunotherapeutics (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- GlaxoSmithKline Biologicals
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- mRNA vaccines, COVID-19 vaccines, booster vaccination, lipid nanoparticles, vaccine safety, immunogenicity, neutralizing antibodies, prior SARS-CoV-2 infection, dose escalation, adverse events, Omicron subvariants, Delta variant, SARS-CoV-2
- MeSH terms
- Immunogenicity, Vaccine, COVID-19, SARS-CoV-2, COVID-19 Vaccines, mRNA Vaccines, Nanovaccines, Adult, Aged, Antibodies, Viral, Female, Humans, Immunization, Secondary, Lipids, Liposomes, Male, Middle Aged, Vaccines, Synthetic, Nanoparticles, Young Adult, Antibodies, Neutralizing, Spike Glycoprotein, Coronavirus
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 ›
Are you an author, or do you see a problem with this page? Request a review
