Randomized, double-blind, placebo-controlled, safety and immunogenicity study of 4 formulations of Anthrax Vaccine Adsorbed plus CPG 7909 (AV7909) in healthy adult volunteers
Open accessAbstract
A new anthrax vaccine that could accelerate the immune response and possibly reduce the number of injections needed for protection would be desirable in a post-exposure setting. This Phase 1 study compared the safety and immunogenicity of 2 IM doses (Days 0 and 14) of 4 formulations of AV7909 (AVA plus CPG 7909) with 2 IM doses of BioThrax(®) (Anthrax Vaccine Adsorbed) and 2 IM doses of saline placebo administered on Days 0 and 14. A total of 105 healthy adults 18-50 years of age were randomized to 1 of 6 study groups: BioThrax (0.5 mL), AV7909 Formulation 1 (0.5 mL AVA+0.5mg CPG 7909), AV7909 Formulation 2 (0.5 mL AVA+0.25mg CPG 7909), AV7909 Formulation 3 (0.25 mL AVA+0.5mg CPG 7909), AV7909 Formulation 4 (0.25 mL AVA+0.25mg CPG 7909), or saline placebo (0.5 mL). All randomized subjects received at least 1 vaccination, and 100 subjects completed the trial. After 2 doses, mean peak normalized toxin neutralizing antibody responses (TNA NF50) in the AV7909 groups were higher than in the BioThrax group. Differences among the 4 AV7909 groups were not statistically significant. Subjects who received AV7909 reached peak titers on Day 28 vs. Day 35 in the BioThrax group. The most common adverse events (AEs) in the BioThrax and AV7909 groups assessed as related to vaccination were injection site reactions. Transient lymphopenia was observed after the first dose in each AV7909 group. Frequencies of injection site and systemic reactions recorded by subjects in diaries for 7 days after each injection were highest with AV7909 Formulation 1. No AEs of special interest (autoimmune events) were observed in the study. Further studies of doses and dosing regimens are planned to assess the immunogenicity and reactogenicity of AV7909.
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The transient lymphopenia changes were not considered to represent toxicity but rather redistribution of lymphocytes due to the vaccine's mode of action, as has been observed for other vaccines.
“These transient changes were not considered to represent toxicity but rather redistribution of lymphocytes due to the vaccine’s mode of action as has been observed for other vaccines [12], [13].”
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 [12]
The Discussion reports transient lymphopenia after AV7909 and says it may result from altered lymphocyte trafficking; it also notes similar findings in other trials using CPG 7909 as a vaccine adjuvant. It does not establish redistribution as the cause or say the changes were not toxicity. The Results > Safety section classifies lymphopenia as a vaccination-related adverse event, including one severe case. (LLM, conf=0.87)
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Cites
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CpG Oligodeoxynucleotides Alter Lymphocyte and Dendritic Cell Trafficking in Humans
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“These transient changes were not considered to represent toxicity but rather redistribution of lymphocytes due to the vaccine’s mode of action as has been observed for other vaccines [12,13].”
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- Authors
- Hopkins, R. J., Daczkowski, N. F., Kaptur, P. E., Muse, D., Sheldon, E., LaForce, C., Sari, S., Rudge, T. L., & Bernton, E.
- Affiliations
- Emergent BioSolutions (United States) (US)
- Jean Brown Research (US)
- North Carolina Clinical Research (US)
- Battelle (US)
- Corresponding author
- Kaptur, Paulina E.
- Venue
- Vaccine
- Publisher
- Elsevier BV
- Published
- 2013-06
- Volume
- 31
- Issue
- 30
- Pages
- 3051-3058
- ISSN
- 0264-410X (ISSN-L)
- PMC
- PMC3687017
- OpenAlex
- W2043697982
- Cited by
- 70
- References
- 13
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 3 · 2023: 4 · 2022: 4 · 2021: 9 · 2020: 13 · 2019: 7 · 2018: 2 · 2017: 5 · 2016: 9 · 2015: 3 · 2014: 3 · 2013: 3
- FWCI
- 2.69
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Vaccine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Biomedical Advanced Research and Development Authority
- National Institute of Allergy and Infectious Diseases (HHSN272200800051C)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Bacillus and Francisella bacterial research
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Neurology › Botulinum Toxin and Related Neurological Disorders
- Keywords
- anthrax vaccine adsorbed, CpG 7909, vaccine formulation, toxin-neutralizing antibodies, immunogenicity, vaccine safety, reactogenicity, injection site reactions, lymphopenia, post-exposure prophylaxis, healthy adults, dose comparison, adjuvants, vaccination schedule, adverse events
- MeSH terms
- Adolescent, Adult, Anthrax, Antigens, Bacterial, Double-Blind Method, Female, Humans, Male, Middle Aged, Oligodeoxyribonucleotides, Volunteers, Anthrax Vaccines, Young Adult, Antibodies, Neutralizing
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