Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine
Open accessPublished version of a preprint
Abstract
BACKGROUND: NVX-CoV2373 is a recombinant severe acute respiratory syndrome coronavirus 2 (rSARS-CoV-2) nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins and Matrix-M1 adjuvant. METHODS: We initiated a randomized, placebo-controlled, phase 1-2 trial to evaluate the safety and immunogenicity of the rSARS-CoV-2 vaccine (in 5-μg and 25-μg doses, with or without Matrix-M1 adjuvant, and with observers unaware of trial-group assignments) in 131 healthy adults. In phase 1, vaccination comprised two intramuscular injections, 21 days apart. The primary outcomes were reactogenicity; laboratory values (serum chemistry and hematology), according to Food and Drug Administration toxicity scoring, to assess safety; and IgG anti-spike protein response (in enzyme-linked immunosorbent assay [ELISA] units). Secondary outcomes included unsolicited adverse events, wild-type virus neutralization (microneutralization assay), and T-cell responses (cytokine staining). IgG and microneutralization assay results were compared with 32 (IgG) and 29 (neutralization) convalescent serum samples from patients with Covid-19, most of whom were symptomatic. We performed a primary analysis at day 35. RESULTS: After randomization, 83 participants were assigned to receive the vaccine with adjuvant and 25 without adjuvant, and 23 participants were assigned to receive placebo. No serious adverse events were noted. Reactogenicity was absent or mild in the majority of participants, more common with adjuvant, and of short duration (mean, ≤2 days). One participant had mild fever that lasted 1 day. Unsolicited adverse events were mild in most participants; there were no severe adverse events. The addition of adjuvant resulted in enhanced immune responses, was antigen dose-sparing, and induced a T helper 1 (Th1) response. The two-dose 5-μg adjuvanted regimen induced geometric mean anti-spike IgG (63,160 ELISA units) and neutralization (3906) responses that exceeded geometric mean responses in convalescent serum from mostly symptomatic Covid-19 patients (8344 and 983, respectively). CONCLUSIONS: At 35 days, NVX-CoV2373 appeared to be safe, and it elicited immune responses that exceeded levels in Covid-19 convalescent serum. The Matrix-M1 adjuvant induced CD4+ T-cell responses that were biased toward a Th1 phenotype. (Funded by the Coalition for Epidemic Preparedness Innovations; ClinicalTrials.gov number, NCT04368988).
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Robust CD4+ and CD8+ T cell memory is induced after COVID-19, and multiple COVID-19 vaccines elicit CD4+ and CD8+ T cell responses.
“Robust CD4+ and CD8+ T cell memory is induced after COVID-19,22,39, 40, 41 and multiple COVID-19 vaccines elicit CD4+ and CD8+ T cell responses.26,42, 43, 44, 45”
From Impact of SARS-CoV-2 variants on the total CD4+ and CD8+ T cell reactivity in infected or vaccinated individuals (2021) · cites this paper as [45]
The NVX-CoV2373 vaccine had an acceptable safety and reactogenicity profile.
“Preliminary safety data continued to indicate an acceptable safety and reactogenicity profile.11”
From Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant (2021) · cites this paper as [11]
Multiple candidate vaccines had similar immunogenicity profiles to the COVID-19 RNA vaccines in humans, with equivalent or better neutralizing antibody titers or CD4+ T cell responses.
“Multiple candidate vaccines had similar immunogenicity profiles to the COVID-19 RNA vaccines in humans, with equivalent or better neutralizing antibody titers or CD4+ T cell responses”
From Adaptive immunity to SARS-CoV-2 and COVID-19 (2021) · cites this paper as Keech et al., 2020
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 [10]
Only 1 out of the 82 participants who received NVX-CoV2373 in a prime-boost schedule developed a mild fever.
“only 1 out of the 82 participants who received the vaccine in a prime-boost schedule, developed a mild fever [84].”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [84]
AEs occurred more frequently when NVX-CoV2373 was combined with the adjuvant, and slightly more AEs were reported after the boost dose.
“AEs occurred more frequent when NVX-CoV2373 was combined with the adjuvant, and slightly more AEs were reported after the boost dose.”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [84]
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- Authors
- Keech, C., Albert, G., Cho, I., Robertson, A., Reed, P., Neal, S., Plested, J. S., Zhu, M., Cloney-Clark, S., Zhou, H., Smith, G., Patel, N., Frieman, M. B., Haupt, R. E., Logue, J., McGrath, M., Weston, S., Piedra, P. A., Desai, C., Callahan, K., Lewis, M., Price-Abbott, P., Formica, N., Shinde, V., Fries, L., Lickliter, J. D., Griffin, P., Wilkinson, B., & Glenn, G. M.
- Affiliations
- University of Maryland, Baltimore (US)
- Corresponding author
- Keech, Cheryl
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-12-10
- Volume
- 383
- Issue
- 24
- Pages
- 2320-2332
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC7494251
- OpenAlex
- W3081892744
- Cited by
- 1,156
- References
- 19
- Citations by year
- 2026: 22 · 2025: 64 · 2024: 80 · 2023: 155 · 2022: 275 · 2021: 481 · 2020: 77
- FWCI
- 32.41
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- medRxiv (acceptedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Coalition for Epidemic Preparedness Innovation (ClinicalTrials.gov number, NCT04368988)
- 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
- nanoparticle vaccine, SARS-CoV-2 spike protein, NVX-CoV2373, COVID-19 vaccines, vaccine safety, immunogenicity, anti-spike IgG, neutralizing antibodies, T cell response, Th1 response, reactogenicity, dose sparing, convalescent serum
- MeSH terms
- Immunogenicity, Vaccine, COVID-19, COVID-19 Vaccines, Adjuvants, Immunologic, Adolescent, Adult, Antibodies, Viral, Enzyme-Linked Immunosorbent Assay, Female, Humans, Immunoglobulin G, Immunization Schedule, Male, Middle Aged, Saponins, Vaccines, Synthetic, Th1 Cells, Nanoparticles, Young Adult, Antibodies, Neutralizing, Pandemics, Spike Glycoprotein, Coronavirus
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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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