Safety and Efficacy of Intradermal Trivalent Influenza Vaccination in Institutionalized Older Adults

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Influenza is associated with significant morbidity and mortality. Institutionalized older adults (age>65) is the group associated with highest risk of complications. Influenza vaccines are the cornerstone of influenza prevention but one systematic review has found that there is no statistically significant difference against laboratory confirmed influenza. A major reason is immune senescence in older adults which result in weaker response towards vaccines when compared with young adults. Intradermal administration of vaccine has been suggested to improve immune response due to the abundance of immunostimulatory cells, such as dendritic cells in the dermis. Intradermal administration of influenza vaccine has been shown to have comparable or superior efficacy compared with intramuscular administration in the >60-year old population and the rates of adverse events post-vaccination were also comparable between them. The immunogenicity of intradermal administration has also been shown to be better in immunocompromised patients, including community dwelling older adults. In addition, intradermal vaccination has good acceptability and safety profile in different countries, so it has been licensed in Hong Kong and worldwide. However, there is little study regarding the efficacy of intradermal vaccination of influenza in institutionalized older adults, investigators therefore would like to perform a prospective, randomized study to compare the safety and immunogenicity between conventional full dose intramuscular immunization and full dose intradermal immunization of the trivalent influenza vaccine in institutionalized older adults.

The hypothesis is that full dose intradermal trivalent influenza vaccination is as effective as full-dose standard intramuscular injection in terms of seroconversion and seroprotection rate in institutionalized older adults. Finding of this study will be important in the vaccination of institutionalized older adults and immunocompromised patients as intradermal vaccine may induce a better immune response against influenza infection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• Institutionalized older adult patients at the age of 65 or above

Exclusion Criteria:

• Clinically significant immune-related diseases and significant recent co-morbidities