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Immunogenicity and Viral Shedding of Russian-Backbone, Seasonal, Trivalent, Live, Attenuated Influenza Vaccine in a Phase II, Randomized, Placebo-Controlled Trial Among Preschool-Aged Children in Urban Bangladesh.
Lewis, Kristen D C; Ortiz, Justin R; Rahman, Mohammed Z; Levine, Min Z; Rudenko, Larisa; Wright, Peter F; Katz, Jacqueline M; Dally, Len; Rahman, Mustafizur; Isakova-Sivak, Irina; Ilyushina, Natalia A; Matyushenko, Victoria; Fry, Alicia M; Lindstrom, Stephen E; Bresee, Joseph S; Brooks, W Abdullah; Neuzil, Kathleen M.
Affiliation
  • Lewis KDC; Pharmaceutical Product Development, San Diego, California.
  • Ortiz JR; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.
  • Rahman MZ; Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka.
  • Levine MZ; Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.
  • Rudenko L; Department of Virology, Institute of Experimental Medicine, St Petersburg, Russia.
  • Wright PF; Dartmouth College, Hanover, New Hampshire.
  • Katz JM; Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.
  • Dally L; The Emmes Corporation, Rockville.
  • Rahman M; Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka.
  • Isakova-Sivak I; Department of Virology, Institute of Experimental Medicine, St Petersburg, Russia.
  • Ilyushina NA; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring.
  • Matyushenko V; Department of Virology, Institute of Experimental Medicine, St Petersburg, Russia.
  • Fry AM; Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.
  • Lindstrom SE; Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.
  • Bresee JS; Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.
  • Brooks WA; International Health, Johns Hopkins University, Baltimore, Maryland.
  • Neuzil KM; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.
Clin Infect Dis ; 69(5): 777-785, 2019 08 16.
Article in En | MEDLINE | ID: mdl-30481272
ABSTRACT

BACKGROUND:

We evaluated a Russian-backbone, live, attenuated influenza vaccine (LAIV) for immunogenicity and viral shedding in a randomized, placebo-controlled trial among Bangladeshi children.

METHODS:

Healthy children received a single, intranasal dose of LAIV containing the 2011-2012 recommended formulation or placebo. Nasopharyngeal wash (NPW) specimens were collected on days 0, 2, 4, and 7. Reverse transcription polymerase chain reactions and sequencing identified the influenza virus (vaccine or wild-type). On days 0 and 21, blood specimens were collected to assess immunogenicity using hemagglutination inhibition, microneutralization, and immunoglobulin A (IgA) and G enzyme-linked immunosorbent assays (ELISAs); NPW specimens were also collected to assess mucosal immunogenicity using kinetic IgA ELISA.

RESULTS:

We enrolled 300 children aged 24 through 59 months in the immunogenicity and viral shedding analyses. Among children receiving LAIV, 45% and 67% shed A/H3N2 and B vaccine strains, respectively. No child shed A/H1N1 vaccine strain. There were significantly higher day 21 geometric mean titers (GMTs) for the LAIV, as compared to the placebo groups, in all immunoassays for A/H3N2 and B (log10 titer P < .0001; GMT Ratio >2.0). Among immunoassays for A/H1N1, only the mucosal IgA GMT was significantly higher than placebo at day 21 (log10 titer P = .0465).

CONCLUSIONS:

Children vaccinated with LAIV had serum and mucosal antibody responses to A/H3N2 and B, but only a mucosal IgA response to A/H1N1. Many children shed A/H3N2 and B vaccine strains, but none shed A/H1N1. More research is needed to determine the reason for decreased LAIV A/H1N1 immunogenicity and virus shedding. CLINICAL TRIALS REGISTRATION NCT01625689.
Subject(s)
Key words

Full text: 1 Database: MEDLINE Main subject: Influenza Vaccines / Virus Shedding / Immunogenicity, Vaccine / Antibodies, Viral Type of study: Clinical_trials Limits: Child, preschool / Female / Humans / Male Country/Region as subject: Asia Language: En Year: 2019 Type: Article

Full text: 1 Database: MEDLINE Main subject: Influenza Vaccines / Virus Shedding / Immunogenicity, Vaccine / Antibodies, Viral Type of study: Clinical_trials Limits: Child, preschool / Female / Humans / Male Country/Region as subject: Asia Language: En Year: 2019 Type: Article