Evaluation of Correlates of Protective Efficacy of Seasonal Live Attenuated Influenza Vaccine (LAIV) by Utilization of a Human Challenge Model of Infection With Wild-type (wt) Influenza A/California/2009 (H1N1)-Like Virus

NCT02950688 Phase 1 WITHDRAWN

The purpose of this study is to evaluate the immune response produced by a seasonal live attenuated influenza vaccine (LAIV) when compared to placebo. The initial vaccination will be followed 2 months later by an inpatient trial evaluating safety, infectivity, clinical response, and viral shedding after exposure to the wild-type A/California/2009-like influenza challenge virus.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	WITHDRAWN

Conditions

• Influenza, Human

Interventions

• Seasonal LAIV
• Placebo
• Wild-type A/California/2009-like Influenza Virus

Primary outcomes

• Frequency of any reactogenicity events after administration of seasonal LAIV — Measured through Day 180
• Frequency of significant increases in nasal secretion hemagglutination (HA)-specific antibody assessed by enzyme-linked immunosorbent assay (ELISA) — Measured through Day 84
• Frequency of instances of greater than 200 influenza-specific interferon-gamma-secreting cells per million lymphocytes as assessed by enzyme-linked immuno spot assay (ELISPOT) — Measured on Day 28 after immunization
• Frequency of detection of influenza-specific immunoglobulin G (IgG) or immunoglobulin A (IgA) secreting B cells assessed by antibody secreting cells (ASC) assay — Measured on Day 7 following vaccination
• Frequency of challenge virus shedding on one or more days on Days 56-63 as assessed by culture or real-time reverse transcriptase polymerase chain reaction (rRT-PCR) — Measured through Day 63
• A 4-fold or greater increase in either hemagglutination-inhibition (HAI) or microneutralization (MN) antibody when compared to pre-challenge samples, as assessed by HAI assays — Measured through Day 56

Countries

United States