Immunogenicity and Safety of a Tetravalent Recombinant Subunit Dengue Vaccine in Adults Previously Vaccinated with a Live Attenuated Tetravalent Dengue Vaccine: Results of a Phase-I Randomized Clinical Trial
| Autor: | Beth D. Kirkpatrick, Melissa Cook, Michele Sausser, Beulah P. Sabundayo, Liman Wang, Stephen S. Whitehead, Helen He, Anna P. Durbin, Donna Hyatt, Kristen K. Pierce, Jeffrey R. Sachs, Beth Ann Coller, Amy Falk Russell, Andrew W. Lee, Jason C. Martin, Palmtama L. Grier |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male 030231 tropical medicine Immunization Secondary Aluminum Hydroxide Dengue Vaccines Dengue virus medicine.disease_cause Vaccines Attenuated Dengue fever Dengue 03 medical and health sciences Young Adult 0302 clinical medicine Plaque reduction neutralization test Immunogenicity Vaccine Adjuvants Immunologic Double-Blind Method Viral Envelope Proteins Neutralization Tests Virology medicine Humans Adverse effect Neutralizing antibody Dengue vaccine Vaccines Synthetic biology business.industry Immunogenicity Articles Dengue Virus Middle Aged medicine.disease Antibodies Neutralizing Injection Site Reaction Vaccination Infectious Diseases Vaccines Subunit biology.protein Parasitology Female business |
| Zdroj: | Am J Trop Med Hyg |
| ISSN: | 1476-1645 |
| Popis: | New dengue vaccines are needed to prevent this globally expanding vector-borne disease. The V180 vaccine candidate consists of four recombinant, soluble, dengue virus envelope glycoproteins and has been previously evaluated in two clinical trials for safety and immunogenicity in Flavivirus-naive participants (NCT01477580 and NCT0093642). Here, we report on a randomized, placebo-controlled, double-blind study of the safety and immunogenicity of the V180 vaccine in subjects who have previously received the live attenuated tetravalent vaccine (LATV) developed by the National Institute of Allergy and Infectious Diseases (protocol #V180-002 [CIR-301]). The study was designed to evaluate whether this recombinant subunit vaccine could boost the neutralizing antibody responses induced by dengue LATV. Twenty participants who had previously received one or two doses of dengue LATV were randomized and received a single dose of V180 nonadjuvanted (N = 8), V180 adjuvanted with Alhydrogel™ (aluminum hydroxide gel, Brenntag Biosector, Frederikssund, Denmark) (N = 8), or placebo (N = 4). Immunogenicity was measured using a plaque reduction neutralization test at days 1, 15, 28, and 180 after vaccination. In addition, vaccine safety (solicited and unsolicited adverse events) was assessed using a vaccination report card for 28 days following vaccination, and serious adverse events were captured from the time of informed consent through the final study visit at 6 months after vaccination. The results of the study demonstrate that the V180 vaccine is generally well tolerated and immunogenic in these dengue-seropositive volunteers. |
| Databáze: | OpenAIRE |
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