Evaluation of a SARS-CoV-2 Vaccine NVX-CoV2373 in Younger and Older Adults
Open accessPreprint — published as 10.1371/journal.pmed.1003769
Abstract
Background: NVX-CoV2373 is a recombinant severe acute respiratory coronavirus 2 (rSARS-CoV-2) nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins and Matrix-M1 adjuvant. Methods: The phase 2 component of our randomized, placebo-controlled, phase 1-2 trial was designed to identify which dosing regimen of NVX-CoV2373 should move forward into late phase studies in younger (18-59 years) and older (60-84 years) participants and was based on immunogenicity and safety data through day 35 (14 days after the second dose). Participants were randomly assigned to receive either one or two intramuscular doses of 5-µg or 25-µg NVX-CoV2373 or placebo, 21 days apart. Primary endpoints were immunoglobulin G (IgG) anti-spike protein response, 7-day solicited reactogenicity, and unsolicited adverse events. A key secondary endpoint was wild-type virus neutralizing antibody response. Results: After randomization, approximately 250 participants each were assigned to one of four vaccine groups or placebo. Of these, approximately 45% were older participants. Reactogenicity was predominantly mild to moderate in severity and of short duration (median <3 days) after first and second vaccination with NVX-CoV2373, with higher frequencies and intensity after second vaccination and with the higher dose, and occurred less frequently and was of lower intensity in older participants. The two-dose regimen of 5-µg NVX-CoV2373 induced robust geometric mean titer (GMT) IgG anti-spike protein (65,019 and 28,137 EU/mL) and wild-type virus neutralizing antibody (2201 and 981 titers) responses in younger and older participants, respectively, with seroconversion rates of 100% in both age groups. Neutralizing antibody responses exceeded those seen in convalescent sera for both age groups. Conclusions: The study confirmed that the two-dose regimen of 5-µg NVX-CoV2373 is highly immunogenic and well tolerated in both younger and older participants. (Funded by the Coalition for Epidemic Preparedness Innovations; ClinicalTrials.gov number: NCT04368988 ).
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Early clinical studies showed that NVX-CoV2373 was safe and produced a robust immune response in healthy adults.
“Early clinical data from studies of the NVX-CoV2373 vaccine (Novavax), which consists of 5 μg of a recombinant nanoparticle spike protein plus 50 μg of Matrix-M adjuvant, have shown that a two-dose regimen administered 21 days apart was safe and associated with a robust immune response in healthy adult participants.10,11”
From Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine (2021) · cites this paper as [11]
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Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine
Heath, P. T., Galiza, E. P., Baxter, D. N., Boffito, M., Browne, D., Burns, F., Chadwick, D. R., Clark, R., Cosgrove, C., Galloway, J., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2107659 · Cited by 1,085 · see citing works
Self-citation
- Authors
- Formica, N., Mallory, R., Albert, G., Robinson, M., Plested, J. S., Cho, I., Robertson, A., Dubovsky, F., Glenn, G. M., & for the 2019nCoV-101 Study Group
- Affiliations
- Novavax (United States) (US)
- Corresponding author
- Formica, Neil
- Mallory, Raburn
- Albert, Gary
- Robinson, Michelle
- Plested, Joyce S.
- Cho, Iksung
- Robertson, Andreana
- Dubovsky, Filip
- Glenn, Gregory M.
- ORCID
- Venue
- PLoS Medicine
- Publisher
- openRxiv
- Published
- 2021-03-01
- Volume
- 18
- Issue
- 10
- Pages
- e1003769-e1003769
- ISSN
- 1549-1277 (ISSN-L)
- PMC
- PMC8486115
- OpenAlex
- W3203630421
- Cited by
- 111
- References
- 2
- Citations by year
- 2026: 2 · 2025: 10 · 2024: 9 · 2023: 25 · 2022: 47 · 2021: 18
- FWCI
- 7.83
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- PLoS Medicine (publishedVersion, cc-by)
- medRxiv (acceptedVersion)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- U.S. Department of Defense
- Bill and Melinda Gates Foundation
- AstraZeneca
- Novavax
- Coalition for Epidemic Preparedness Innovations
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Life Sciences › Agricultural and Biological Sciences › Animal Science and Zoology › Animal Virus Infections Studies
- Keywords
- NVX-CoV2373, nanoparticle vaccine, dosing regimen, vaccine dose, older adults, immunogenicity, neutralizing antibodies, anti-spike IgG, reactogenicity, adverse events, COVID-19 vaccination, age differences in immune response, vaccine safety
- MeSH terms
- Immunogenicity, Vaccine, COVID-19, SARS-CoV-2, COVID-19 Vaccines, Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Viral, Dose-Response Relationship, Immunologic, Female, Humans, Immunoglobulin G, Male, Middle Aged, Young Adult, Antibodies, Neutralizing, Spike Glycoprotein, Coronavirus
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