drugset / Trial / NCT02103023

Intradermal Influenza Vaccine in the Young

NCT02103023 ↗

Phase 3 Completed 160 enrolled The University of Hong Kong
RandomizedParallel-groupTriple-blindPrevention

Summary

Influenza poses a heavy burden to our health service. The WHO estimates that seasonal influenza causes 250,000-500,000 deaths worldwide each year. Various strategies including intradermal vaccination and new vaccine adjuvants have been shown to improve immunogenicity. Recently, imiquimod, a synthetic Toll-like receptor 7 (TLR7) agonist useful for the treatment of DNA virus infection, have been shown to improve vaccine immunogenicity against influenza virus in mouse model. The objective of this prospective double-blind randomized controlled trial is to evaluate the effect and safety of topical treatment with imiquimod immediately before intradermal influenza vaccination in healthy young adults.

Timeline

Start
2014-03
Primary completion
2014-11
Completion
2014-11

Outcome

Met primary endpoint

paper seroconversion at day 7 occurred in 39 participants (98%) in the INF-Q-ID group, 25 (63%) in the INF-C-ID group PMID 26559482 ↗

paper p<0·0001 for all three vaccine strains PMID 26559482 ↗

paper the seroconversion rate against the four non-vaccine strains was better in the INF-Q-ID group than in the control groups on days 7 and 21 (p<0·0001). PMID 26559482 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Imiquimod Other / unclassified 5 % Topical
Subject Imiquimod Other / unclassified 250 mg Topical
Subject Intradermal influenza vaccine Vaccine — Intramuscular
Comparator Intramuscular influenza vaccine Vaccine — Intramuscular

Indications