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Comparing different methods of trivalent influenza vaccination on the post-vaccination immunogenicity in patients on maintenance hemodialysis

Comparing intramuscular and intradermal injection of trivalent influenza vaccine, and topical imiquimod use before intradermal vaccination, on the post-vaccination immunogenicity, in patients on maintenance hemodialysis: A randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015101724575N1
Enrollment
120
Registered
2017-06-04
Start date
2016-02-04
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Need for immunization against influenza. Need for immunization against influenza

Interventions

Intervention 1: The first group (Intervention): 250mg Imiquimod 5% cream (Aldara) was rubbed on deltoid region of right arm, and after 15 minutes, 0.25cc of trivalent influenza vaccine was injected in
Treatment - Drugs
Placebo
Prevention
The first group (Intervention): 250mg Imiquimod 5% cream (Aldara) was rubbed on deltoid region of right arm, and after 15 minutes, 0.25cc of trivalent influenza vaccine was injected intradermal.
The second group (Intervention/Control): received 0.25cc trivalent influenza vaccine via intradermal route after rubbing 250 mg aqueous cream in the same region with the same prior interval. The a
The third group (control): 0.5 cc trivalent influenza vaccine was injected intramuscular after using 250 mg aqueous topical cream on the same area. The applied inactivated trivalent influenza

Sponsors

Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Individuals more than 18 years old who are known to have end stage renal disease and need routine dialysis (i.e. at least 2 times a week for more than one month). Exclusion criteria: History of influenza or other viral diseases and also live viral vaccination in recent 4 weeks; History of influenza vaccination in prior 6 months; Prior history of hypersensitivity to egg, components of influenza vaccine; Documented primary or secondary immunosuppression especially impaired cellular and humoral immunity.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Comparing the immunogenicity against influenza vaccine via intradermal and intramuscular routes. Timepoint: Obtaining blood samples for antibody titration, before and 14 to 21 days after vaccination. Method of measurement: Antibody titration within the sera obtained before and after vaccination, by hemagglutination inhibition assay test.

Secondary

MeasureTime frame
The effect of imiquimod pretreatment before intradermal influenza vaccination on immunogenicity of vaccine. Timepoint: Antibody titration within blood samples obtained before and 14 to 21 days after vaccination. Method of measurement: Antibody titration within the sera obtained before and after vaccination, by hemagglutination inhibition assay test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Doosti

Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sci

z.doosti@sbmu.ac.ir; sayeroshan1383@gmail.com+98 21 4481 2171

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026