Immunogenicity of Influenza Vaccines in HIV-infected Persons in Thailand

Influenza Clinical Trial

Official title:

Randomized Controlled Trial to Compare the Immunogenicity of Intramuscular Versus Intradermal Trivalent Inactivated Split Virion Influenza Vaccine in HIV-infected Men Who Have Sex With Men in Bangkok, Thailand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538940
• Other study ID #: CDC-NCIRD-6181
• Secondary ID: 1U01GH000152
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2011
• Est. completion date: October 2015

Study information

• Verified date: June 2024
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy of a new intradermal formulation of the trivalent inactivated influenza vaccine compared to the standard intramuscular vaccine in HIV-infected men who have sex with men in Bangkok, Thailand. Relative efficacy of the two different formulations of influenza vaccine will be assessed by comparing immunologic responses to vaccine between the two study arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: October 2015
• Est. primary completion date: September 9, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Thai men by nationality who have sex with men

• HIV-infected or HIV-uninfected men

• At least 18 years of age

• Willing and able to provide written informed consent

• Availability and commitment for 12 months of study follow-up (3 study visits)

Exclusion Criteria:

• Men with severe allergies to chicken eggs (they will specifically be asked about severe egg allergies during the screening visit; appendix C1)

• Men > 60 years of age

• Men who have had a severe reaction to influenza vaccine in the past

• Men with a history of Guillain-Barré Syndrome

• Men who received influenza vaccine within 12 months prior to enrollment

• Men who are on steroid therapy or other immunosuppressant medications

• Men who received any vaccine in the 4 weeks prior to the first study visit or who plan to receive a vaccine (other than influenza vaccine provided through the study protocol) in the 4 weeks following the first study visit

• Men who received an experimental agent (vaccine, drug, biologic, device, blood product, medication) within 1 month prior to enrollment in this study, or expect to receive an experimental agent during the 12 month study period

• Men who have any condition, in the opinion of the investigator, that would place them at an unacceptable risk of injury or render them unable to meet requirements of the protocol. (e.g., severe reaction to another vaccine, blood clotting disorder, inflammatory skin condition).

• Foreign (non-Thai) nationality

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Intradermal vaccine
15ug
• Intramuscular vaccine
15ug

Locations

Country	Name	City	State
Thailand	Silom Community Clinic	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody titers	Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine	30 days
Secondary	Antibody titers	Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine	6 months
Secondary	Antibody titers	Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine	12 months

External Links

•   Website for clinic where the study is being conducted.