Safety, Tolerability, and Lack of Antibody Responses After Administration of aPfCSP DNA Malaria Vaccine via Needle or Needle-Free Jet Injection, and Comparison of Intramuscular and Combination Intramuscular/Intradermal Routes
| Autor: | Suezanne E. Parker, Yupin Charoenvit, Jon Norman, Judith E. Epstein, John Nerges, Ruobing Wang, Lucy M. L. Goh, Sanjai Kumar, Richard Stout, Stephen L. Hoffman, Jennifer Ng, Edward J. Gorak, Richard C. Hedstrom, Nicole Freydberg, Esteban Abot, Fernando Trespalacios, Thomas L. Richie, Oluwatoyin Osinowo, Victoria Fallarme-Majam, Erin L. Stoltz |
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| Rok vydání: | 2002 |
| Předmět: |
Injections
Intradermal biology Malaria vaccine business.industry Immunogenicity Plasmodium falciparum Genetic transfer Injections Intramuscular Malaria DNA vaccination Tolerability Immunization Immunology Vaccines DNA Genetics biology.protein Animals Humans Molecular Medicine Medicine Antibody Adverse effect business Molecular Biology |
| Zdroj: | Human Gene Therapy. 13:1551-1560 |
| ISSN: | 1557-7422 1043-0342 |
| DOI: | 10.1089/10430340260201644 |
| Popis: | Introduction of a new vaccine requires choosing a delivery system that provides safe administration and the desired level of immunogenicity. The safety, tolerability, and immunogenicity of three monthly 2.5-mg doses of a PfCSP DNA vaccine were evaluated in healthy volunteers as administered intramuscularly (IM) by needle, IM by jet injection (Biojector or IM/intradermally (ID) by jet injection. Vaccine administration was well-tolerated. Adverse events were primarily mild and limited to the site of injection (98%). Jet injections (either IM or ID) were associated with approximately twice as many adverse events per immunization as needle IM, but nevertheless were strongly and consistently preferred in opinion polls taken during the study. No volunteers had clinically significant biochemical or hematologic changes or detectable anti-dsDNA antibodies. In conclusion, the injection of Plasmodium falciparum circumsporozoite (PfCSP) DNA vaccine appeared to be safe and well-tolerated when administered by any of the three modes of delivery. However, despite improved antibody responses following both jet injection and ID delivery in animal models, no antibodies could be detected in volunteers by immunofluorescence antibody test (IFAT) or enzyme-linked immunosorbent assay (ELISA) after DNA vaccination. |
| Databáze: | OpenAIRE |
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