First-in-human safety and immunogenicity investigations of three adjuvanted reduced dose inactivated poliovirus vaccines (IPV-Al SSI) compared to full dose IPV Vaccine SSI when given as a booster vaccination to adolescents with a history of IPV vaccination at 3, 5, 12months and 5years of age
| Autor: | Lindgren, Line M., Tingskov, Pernille N., Justesen, Annette H., Nedergaard, Bettina S., Olsen, Klaus J., Andreasen, Lars V., Kromann, Ingrid, Sørensen, Charlotte, Dietrich, Jes, Thierry-Carstensen, Birgit |
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| Rok vydání: | 2016 |
| Předmět: |
Male
Adolescent Drug-Related Side Effects and Adverse Reactions Affordable IPV Denmark education Dose investigation Immunization Secondary Aluminum Hydroxide Antibodies Viral behavioral disciplines and activities Article Adjuvants Immunologic Immunology and Microbiology(all) mental disorders Humans Child IPV dose sparing Public Health Environmental and Occupational Health Infant social sciences veterinary(all) Poliovirus Vaccine Inactivated Infectious Diseases Child Preschool Aluminium hydroxide adjuvant population characteristics Molecular Medicine Female Poliomyelitis |
| Zdroj: | Vaccine |
| ISSN: | 0264-410X |
| DOI: | 10.1016/j.vaccine.2016.12.027 |
| Popis: | Highlights • Three adjuvanted reduced dose IPV-Al SSI were safe and immunogenic in adolescents. • The three IPV-Al SSI were highly immunogenic, but inferior to IPV Vaccine SSI as a booster. • Reduced dose IPV-Al SSI is intended for markets in need of affordable IPV. Background There is a demand of affordable IPV in the World. Statens Serum Institut (SSI) has developed three reduced dose IPV formulations adsorbed to aluminium hydroxide; 1/3 IPV-Al, 1/5 IPV-Al and 1/10 IPV-Al SSI, and now report the results of the first investigations in humans. Methods 240 Danish adolescents, aged 10–15 years, and childhood vaccinated with IPV were booster vaccinated with 1/3 IPV-Al, 1/5 IPV-Al, 1/10 IPV-Al or IPV Vaccine SSI. The booster effects (GMTRs) of the three IPV-Al SSI were compared to IPV Vaccine SSI, and evaluated for non-inferiority. Immunogenicity results The pre-vaccination GMTs were similar across the groups; 926 (type 1), 969 (type 2) and 846 (type 3) in the total trial population. The GMTRs by poliovirus type and IPV formulation were: Type 1: 17.0 (1/3 IPV-Al), 13.0 (1/5 IPV-Al), 7.1 (1/10 IPV-Al) and 42.2 (IPV Vaccine SSI). Type 2: 12.5 (1/3 IPV-Al), 13.1 (1/5 IPV-Al), 7.6 (1/10 IPV-Al) and 47.8 (IPV Vaccine SSI). Type 3: 14.5 (1/3 IPV-Al), 16.2 (1/5 IPV-Al), 8.9 (1/10 IPV-Al) and 62.4 (IPV Vaccine SSI) Thus, the three IPV-Al formulations were highly immunogenic, but inferior to IPV Vaccine SSI, in this booster vaccination trial. Safety results No SAE and no AE of severe intensity occurred. 59.2% of the subjects reported at least one AE. Injection site pain was the most frequent AE in all groups; from 24.6% to 43.3%. Injection site redness and swelling frequencies were |
| Databáze: | OpenAIRE |
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