The Effect of Live Attenuated Inactivated Influenza Vaccine on Experimental Human Pneumococcal Carriage Study

Summary

The investigators are interested in examining the effect of the Live Attenuated Influenza (flu) Vaccine (LAIV) upon nasal carriage of bacteria called Streptococcus pneumoniae (also known as pneumococcus). The nasal spray is a live attenuated vaccine which means that it has weakened virus that does not cause disease. This vaccine is licenced in the United Kingdom for children and adolescents from 2 to 18 years of age.

Pneumococcus can commonly be found harmlessly inhabiting the nose where it does not cause any problem (pneumococcal colonisation). About 10% of adults carry pneumococcus at any one time, and almost all adults experience an episode of carriage at least once per year. Carriage acts as a natural vaccine, boosting immunity against pneumococcal infection in adults and children.

During influenza there is an increase in the burden of pneumococcal pneumonia. We have studied the effects of pneumococcus for many years and have developed a programme in which we can nasally inoculate healthy participants with a dose of pneumococcus and achieve a reproducible carriage rate. The investigators would now like to use this model to investigate the effects of the nasal influenza vaccine upon pneumococcal carriage and to better understand how influenza infections lead to increased susceptibility to pneumonia.

Pneumococcal disease in young adults is rare - less than 10 cases per 100,000 people per year. When pneumococcus does cause problems, usually in young children or elderly people, it can be very serious as it is responsible for diseases such as pneumonia, sepsis and meningitis, which kill millions of children around the world each year.

Conditions

• Pneumonia
• Influenza, Human

Interventions

BIOLOGICAL

Study one: LAIV + Inoculation

Pneumococci bacteria nasal inoculation following vaccination with LAIV and intramuscular placebo

BIOLOGICAL

Study one: Placebo + Inoculation

Pneumococci bacteria nasal inoculation following vaccination QIV with nasal placebo spray

BIOLOGICAL

Study two: Inoculation + LAIV

Pneumococci bacteria nasal inoculation prior to vaccination with LAIV and intramuscular placebo

BIOLOGICAL

Study two: Inoculation + placebo

Pneumococci bacteria nasal inoculation prior to vaccination QIV with nasal placebo

Sponsors & Collaborators

• Sponsor GmbH

  collaborator OTHER

• Liverpool School of Tropical Medicine

  collaborator OTHER

• Liverpool University Hospitals NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Jamie Rylance · Liverpool School of Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2017-05-31

Completion

2017-05-31

Countries

• United Kingdom

Study Locations