Details:

Alternative Title:
Vaccine
Personal Author:
Diallo, Aldiouma ; Victor, John C. ; Feser, Jodi ; Ortiz, Justin R. ; Kanesa-thasan, Niranjan ; ... More +
Diallo, Aldiouma ; Victor, John C. ; Feser, Jodi ; Ortiz, Justin R. ; Kanesa-thasan, Niranjan ; Ndiaye, Moussa ; Diarra, Bou ; Cheikh, Sathie ; Diene, Djibril ; Ndiaye, Tofene ; Ndiaye, Assane ; Lafond, Kathryn E. ; Widdowson, Marc-Alain ; Neuzil, Kathleen M. ; Less -
Description:
Introduction: Effective, programmatically suitable influenza vaccines are needed for low-resource countries. Materials and methods: This phase II, placebo-controlled, randomized safety and immunogenicity trial (NCT01819155) was conducted in Senegal using the 2012–2013 Northern Hemisphere trivalent influenza vaccine (TIV) formulation. Participants were allocated in a 2:2:1 ratio to receive TIV (full-dose for all age groups), adjuvanted TIV (aTIV), or placebo. Participants were stratified into age groups: 6–11,12–35, and 36–71 months. All participants were vaccine-naïve and received two doses of study vaccine 4weeks apart. The two independent primary objectives were to estimate the immunogenicity of TIV and of aTIV as the proportion of children with a hemagglutination inhibition (HI) antibody titer of ≥1:40 to each vaccine strain at 28 days post-dose two. Safety was evaluated by solicited local and systemic reactions, unsolicited adverse events, and serious adverse events. Results: 296 children received TIV, aTIV, or placebo, and 235 were included in the final analysis. After two doses, children aged 6–11, 12–35, and 36–71 months receiving TIV had HI titers >1:40 against A/H1N1 (73.1%, 94.1%, and 97.0%), A/H3N2 (96.2%, 100.0%, and 100.0%), and B (80.8%, 97.1%, and 97.0%), respectively. After two doses, 100% children aged 6–11, 12–35, and 36–71 months receiving aTIV had ≥1:40 titers against A/H1N1, A/H3N2, and B. After a single dose, the aTIV response was comparable to or greater than the TIV response for all vaccine strains. TIV and aTIV reactogenicity were similar, except for mild elevation in temperature (37.5–38.4 °C) which occurred more frequently in aTIV than TIV after each vaccine dose. TIV and aTIV had similarly increased pain/tenderness at the injection site compared to placebo. Conclusions: Both aTIV and full-dose TIV were well-tolerated and immunogenic in children aged 6–71 months. These vaccines may play a role in programmatically suitable strategies to prevent influenza in low-resource settings.
Subject:
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Adjuvants, Immunologic
Antibodies, Viral
Article
Child, Preschool
Female
Hemagglutination Inhibition Tests
Humans
Immunogenicity, Vaccine
Infant
Influenza, Human
Influenza A Virus, H1N1 Subtype
Influenza A Virus, H3N2 Subtype
Influenza Vaccines
Male
Polysorbates
Squalene
Vaccines, Inactivated

Source:
Vaccine. 36(43):6424-6432
Pubmed ID:
30224199
Pubmed Central ID:
PMC6327321
Document Type:
Journal Article ;
Funding:
U01 IP000476/IP/NCIRD CDC HHS/United States ;
Place as Subject:
Senegal ;
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:0217b50c109d68e1a64a770003f23214ff4e74360ece1c2dd578c367237ad7e5
File Type:

Supporting Files

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