Immunogenicity of Influenza Vaccines in HIV-infected Persons in Thailand

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Intradermal vaccine; Biological: Intramuscular vaccine

• Study Type: Interventional
• Enrollment (Actual): 415
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • Silom Community Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HIV+, CD4<200, ID vaccine	Biological: Intradermal vaccine; 15ug
Active Comparator: HIV+, CD4<200, IM vaccine	Biological: Intramuscular vaccine; 15ug
Active Comparator: HIV+, CD4>=200, ID vaccine	Biological: Intradermal vaccine; 15ug
Active Comparator: HIV+, CD4 >=200, IM vaccine	Biological: Intramuscular vaccine; 15ug
Other: HIV-, ID vaccine	Biological: Intradermal vaccine; 15ug
Other: HIV-, IM vaccine	Biological: Intramuscular vaccine; 15ug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody titers	Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine	6 months
Antibody titers	Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine	12 months

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention
• Collaborators: Ministry of Health, Thailand
• Investigators: Principal Investigator: Charung Muangchana, MD, Ministry of Health, Thailand; Principal Investigator: Prasert Thongcharoen, MD, Influenza Foundation of Thailand

Publications and helpful links

General Publications

• Amoah S, Mishina M, Praphasiri P, Cao W, Kim JH, Liepkalns JS, Guo Z, Carney PJ, Chang JC, Fernandez S, Garg S, Beacham L, Holtz TH, Curlin ME, Dawood F, Olsen SJ, Gangappa S, Stevens J, Sambhara S. Standard-Dose Intradermal Influenza Vaccine Elicits Cellular Immune Responses Similar to Those of Intramuscular Vaccine in Men With and Those Without HIV Infection. J Infect Dis. 2019 Jul 31;220(5):743-751. doi: 10.1093/infdis/jiz205.
• Garg S, Thongcharoen P, Praphasiri P, Chitwarakorn A, Sathirapanya P, Fernandez S, Rungrojcharoenkit K, Chonwattana W, Mock PA, Sukwicha W, Katz JM, Widdowson MA, Curlin ME, Gibbons RV, Holtz TH, Dawood FS, Olsen SJ. Randomized Controlled Trial to Compare Immunogenicity of Standard-Dose Intramuscular Versus Intradermal Trivalent Inactivated Influenza Vaccine in HIV-Infected Men Who Have Sex With Men in Bangkok, Thailand. Clin Infect Dis. 2016 Feb 1;62(3):383-391. doi: 10.1093/cid/civ884. Epub 2015 Oct 20.

Helpful Links

• Website for clinic where the study is being conducted.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): September 9, 2013
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (Estimated): February 27, 2012

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Influenza; Vaccine; Thailand
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CDC-NCIRD-6181; 1U01GH000152 (U.S. NIH Grant/Contract)