CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 65 enrolled
Drug / intervention
cH8/1N1 LAIV +5 morebiological
Likely dose
cH8/1N1 LAIV 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03300050
NCT03300050Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Controlled, Observer-blind Study to Assess the Reactogenicity, Safety, and Immunogenicity of a Live Attenuated Universal Influenza Vaccine (cH8/1N1 LAIV) Administered as a Single Priming Dose Followed Three Months Later by a Single Booster Dose of an Inactivated Universal Influenza Vaccine (cH5/1N1 IIV) (Adjuvanted With AS03A or Unadjuvanted) in 18 Through 39 Year-old Healthy Subjects, Contrasted With a Two Dose Schedule of an Inactivated Universal Influenza Vaccine (cH8/1N1 IIV + AS03A Followed Three Months Later by cH5/1N1 IIV + AS03A)

PATH·interventional·Posted Oct 3, 2017·Updated Feb 21, 2021

In Brief

A Phase 1 clinical trial evaluating cH8/1N1 LAIV, AS03-adjuvanted cH5/1N1 IIV, and 4 other interventions for Influenza and Vaccine. Completed, enrolled 65 participants across 2 sites.

Detailed Summary

The clinical study will evaluate safety and the immune response of a prime- boost regimen with a live attenuated influenza vaccine (LAIV) prime and an inactivated split influenza vaccine (IIV) boost with or without adjuvant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Vaccine
CountriesUnited States
CollaboratorsIcahn School of Medicine at Mount Sinai, Children's Hospital Medical Center, Cincinnati, Duke University, The Emmes Company, LLC, GlaxoSmithKline

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 3, 2017
Enrollment StartOct 10, 2017
Primary CompletionApr 24, 2018
Study CompletionAug 9, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.7 years ago

Interventions

cH8/1N1 LAIVbiological

Live-attenuated influenza virus vaccine (LAIV) expressing chimeric hemagglutinin (HA) with the H8 head and H1 stalk and neuraminidase (NA) subtype 1 (N1) (cH8/1N1): HA head, A/mallard/Sweden/24/2002 (H8N4); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1) containing the backbone of the cold-adapted/temperature sensitive of the Russian LAIV A/Leningrad/134/17/1957 (Len17 IDCDCRG46D). Administered intranasally as drops at a dose of 10⁷·⁵ (plus or minus ⁰·⁵) 50% egg infectious dose (EID50), formulated in a total volume of 0.5 mL sterile saline (0.25 mL per nostril).

AS03-adjuvanted cH5/1N1 IIVbiological

Chimeric H5 head with H1 stalk plus N1 (cH5/1N1) split virion inactivated influenza virus vaccine (IIV) plus AS03 adjuvant: HA head, A/Vietnam/1203/2004 (H5N1); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1). Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS).

cH5/1N1 IIVbiological

Chimeric H5 head with H1 stalk plus N1 (cH5/1N1) split virion inactivated influenza virus vaccine (IIV): HA head, A/Vietnam/1203/2004 (H5N1); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1). Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS).

AS03-adjuvanted cH8/1N1 IIVbiological

Chimeric H8 head with H1 stalk plus N1 (cH8/1N1) inactivated influenza vaccine plus AS03 adjuvant: HA head, A/mallard/Sweden/24/2002 (H8N4); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1). Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS).

Normal salinebiological

Administered intranasally as 0.25 mL nasal drops per nostril

Phosphate buffered saline (PBS)biological

Administered intramuscularly as 0.5 mL injection