Safety and Immunogenicity of a Novel Staphylococcus aureus Vaccine: Results from the First Study of the Vaccine Dose Range in Humans
Open accessAbstract
Merck V710 is a novel vaccine containing the conserved Staphylococcus aureus iron surface determinant B shown to be protective in animal models. A phase I, multicenter, double-blind study of the dose range was conducted to assess the immunogenicity and safety of an adjuvanted liquid formulation of V710. A total of 124 adults (18 to 55 years of age) were randomized 1:1:1:1 to receive one 0.5-ml intramuscular injection of V710 (5 μg, 30 μg, or 90 μg) or saline placebo. A positive immune response was defined as at least a 2-fold increase in IsdB-specific IgG levels from baseline levels. Local and systemic adverse events were assessed for 5 and 14 days, respectively, following vaccination. Positive immune responses were detected in 12 (67%) of the 18 subjects in the groups receiving 30 and 90 μg V710 tested at day 10. At day 14, a significantly greater proportion of subjects manifested a positive immune response with higher geometric mean concentrations in the V710 30-μg (86%; geometric mean concentration of 116 μg/ml) and 90-μg (87%; geometric mean concentration of 131 μg/ml) dose groups than in the V710 5-μg (29%; geometric mean concentration of 51 μg/ml) or placebo (4%; geometric mean concentration of 23 μg/ml) groups. Immune responses were durable through day 84. Subjects <40 and ≥40 years of age had comparable immune responses. The most common adverse events were injection-site pain, nausea, fatigue, and headache, usually of mild intensity. No immediate reactions or serious adverse events were reported. In this first study of V710 in humans, a single 30-μg or 90-μg dose was more immunogenic than the 5-μg dose or placebo. Immune responses were evident by 10 to 14 days after vaccination in most responders.
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In a phase I double-blind dose-range study, antibody titers in subjects given higher V710 doses were similar to those in preclinical primate studies.
“Antibody titers in subjects receiving the higher doses of vaccine were similar to those achieved in the preclinical primate studies [68, 70].”
From A battle for iron: host sequestration and Staphylococcus aureus acquisition (2012) · cites this paper as [70]
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- Authors
- Harro, C., Betts, R., Orenstein, W., Kwak, E.-J., Greenberg, H. E., Onorato, M. T., Hartzel, J., Lipka, J., DiNubile, M. J., & Kartsonis, N.
- Affiliations
- Johns Hopkins University (US)
- University of Rochester Medicine (US)
- Emory University (US)
- University of Pittsburgh Medical Center (US)
- Thomas Jefferson University (US)
- Merck Research Laboratories, West Point, Pennsylvania
- Corresponding author
- Harro, Clayton
- Venue
- Clinical and Vaccine Immunology
- Publisher
- American Society for Microbiology
- Published
- 2010-12
- Volume
- 17
- Issue
- 12
- Pages
- 1868-1874
- ISSN
- 1556-679X (ISSN-L)
- 1556-6811
- PMC
- PMC3008200
- OpenAlex
- W2099223466
- Cited by
- 57
- References
- 48
- Citations by year
- 2026: 2 · 2025: 2 · 2023: 3 · 2020: 3 · 2019: 1 · 2018: 1 · 2017: 2 · 2016: 3 · 2015: 2 · 2014: 4 · 2013: 7 · 2012: 13
- FWCI
- 7.02
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Locations
- Clinical and Vaccine Immunology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Antimicrobial Resistance in Staphylococcus
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › vaccines and immunoinformatics approaches
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Keywords
- Staphylococcus aureus vaccine, ISDB, dose range, immunogenicity, vaccine safety, immune response durability, adverse events, injection site pain
- MeSH terms
- Adjuvants, Immunologic, Adolescent, Adult, Antibodies, Bacterial, Double-Blind Method, Fatigue, Female, Headache, Humans, Immunoglobulin G, Injections, Intramuscular, Male, Middle Aged, Nausea, Pain, Placebos, Staphylococcal Vaccines, Staphylococcus aureus, Cation Transport Proteins, Young Adult
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