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Completed

NCT Number: NCT02229357

Evaluation of Priming Effects by PLAI Vaccine on the Subsequent Response to Inactivated H5N1 Vaccine

This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose between subjects previously vaccinated with LAIV H5N2 and naïve subjects

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Key information

Conditions

Avian Influenza Animal Diseases Bird Diseases Infections Influenza in Birds Orthomyxoviridae Infections RNA Virus Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, 10400, Thailand

About this study

It is a non-randomized, open label study to evaluate a licensed OrniFlu® inactivated vaccine (produced by Microgen Russia) which will be given to healthy adult volunteers who participated in a double blind placebo-controlled study Protocol No.: GPO AVIAN FLU Vaccine-V02-2 at Vaccine Trial Centre and Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University in February to May 2013.

A total of 60 subjects, of whom 40 received two doses of LAIV H5N2 (prime-boost group), and 20 received placebo (control group) in the previous study will be asked to return to the clinic to receive a single dose of an inactivated H5 influenza vaccine.

Total foloww up is 90 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participated in the Phase II study Protocol No.: GPO AVIAN FLU Vaccine-V02-2
  • Healthy
  • Age 18-49 years old
  • Having Thai ID card or equivalent
  • Anti HIV - Negative
  • All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not higher than 1.5 time of normal value without any clinical finding from history and physical examination)
  • Able to read and write and sign written informed consent.

Exclusion criteria

  • Known history of egg allergy
  • Having had recently influenza infection confirmed as H5
  • Receiving other vaccination against H5N1
  • History of bronchial asthma
  • History of chronic lung diseases
  • History of chronic rhinitis
  • History of immunodeficiency state
  • History of immunosuppression< 6 months prior to immunization
  • History of heavy smoking (more than 5 packs per day)
  • History of alcoholic (pure drink 200 ml per day)
  • Acute infectious and noninfectious diseases (within 2 weeks)
  • HIV positives
  • The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment
  • Participation in other research study or stop participant less than 1 month
  • Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
  • Poultry workers

Treatment and study plan

OrniFlu® inactivated vaccine

Biological

All subjects will receive a single dose of an H5 inactivated influenza vaccine after blood collection for immunology assays

Primary outcomes

  1. Proportion of subjects exhibiting sero-responses in each of the assays (HAI, microneutralization) in the prime-boost and the control groups.

    Time frame: 12 Months

Secondary outcomes

  1. Post-vaccination injection site and systemic reactogenicity and adverse events to the H5 inactivated influenza vaccine in subjects previously primed with LAIV H5N2 and in naïve subjects.

    Time frame: 12 Month

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • The Government Pharmaceutical Organization
  • World Health Organization

Registry information

Official study title

Evaluation of Priming Effects by Pandemic Live Attenuated Influenza Vaccine (LAIV Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2)) on the Subsequent Response to Inactivated H5N1 Vaccine in Healthy Thai Volunteers: A Non-Randomized, Open Label Study

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 1, 2014
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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