Safety and Immunogenicity of a Live-attenuated Universal Flu Vaccine Followed by an Inactivated Universal Flu Vaccine

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.

Conditions

• Influenza
• Vaccine

Interventions

BIOLOGICAL

cH8/1N1 LAIV

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).

BIOLOGICAL

AS03-adjuvanted cH5/1N1 IIV

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).

BIOLOGICAL

cH5/1N1 IIV

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).

BIOLOGICAL

AS03-adjuvanted cH8/1N1 IIV

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).

BIOLOGICAL

Normal saline

Administered intranasally as 0.25 mL nasal drops per nostril

BIOLOGICAL

Phosphate buffered saline (PBS)

Administered intramuscularly as 0.5 mL injection

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Duke University

  collaborator OTHER

• The Emmes Company, LLC

  collaborator INDUSTRY

• GlaxoSmithKline

  collaborator INDUSTRY

• PATH

  lead OTHER

Principal Investigators

• David Bernstein, MD · Children's Hospital Medical Center, Cincinnati

• Jeffrey Guptill, MD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

39 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-10-10

Primary Completion

2018-04-24

Completion

2019-08-09

FDA Drug

Yes

Countries

• United States

Study Locations