NCT01538940

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2013

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.9 years

First QC Date

February 21, 2012

Last Update Submit

September 3, 2024

Conditions

Influenza

Keywords

InfluenzaVaccineThailand

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Antibody titers

    6 months

  • Antibody titers

    12 months

Study Arms (6)

HIV+, CD4<200, ID vaccine

ACTIVE COMPARATOR

Humoral and cell-mediated immune responses among HIV-infected individuals with CD4 cell counts less than 200 per microliter will be compared to immune responses in HIV-infected individuals with CD4 cell counts of 200 per microliter or greater.

Biological: Intradermal vaccine

HIV+, CD4<200, IM vaccine

ACTIVE COMPARATOR

Humoral and cell-mediated immune responses among HIV-infected individuals with CD4 cell counts less than 200 per microliter will be compared to immune responses in HIV-infected individuals with CD4 cell counts of 200 per microliter or greater.

Biological: Intramuscular vaccine

HIV+, CD4>=200, ID vaccine

ACTIVE COMPARATOR

Humoral and cell-mediated immune responses among HIV-infected individuals with CD4 cell counts less than 200 per microliter will be compared to immune responses in HIV-infected individuals with CD4 cell counts of 200 per microliter or greater.

Biological: Intradermal vaccine

HIV+, CD4 >=200, IM vaccine

ACTIVE COMPARATOR

Humoral and cell-mediated immune responses among HIV-infected individuals with CD4 cell counts less than 200 per microliter will be compared to immune responses in HIV-infected individuals with CD4 cell counts of 200 per microliter or greater.

Biological: Intramuscular vaccine

HIV-, ID vaccine

OTHER

A small HIV-uninfected MSM control group will be enrolled (with persons randomized into either an intramuscular or intradermal TIV arm) to serve as a comparator group for the cell-mediated immunity studies.

Biological: Intradermal vaccine

HIV-, IM vaccine

OTHER

A small HIV-uninfected MSM control group will be enrolled (with persons randomized into either an intramuscular or intradermal TIV arm) to serve as a comparator group for the cell-mediated immunity studies.

Biological: Intramuscular vaccine

Interventions

Intradermal vaccineBIOLOGICAL

15ug

HIV+, CD4<200, ID vaccineHIV+, CD4>=200, ID vaccineHIV-, ID vaccine
Intramuscular vaccineBIOLOGICAL

15ug

HIV+, CD4 >=200, IM vaccineHIV+, CD4<200, IM vaccineHIV-, IM vaccine

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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-BarrĂ© 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silom Community Clinic

Bangkok, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 31045222DERIVED

  • 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.

    PMID: 26486702DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Charung Muangchana, MD

    Ministry of Health, Thailand

    PRINCIPAL INVESTIGATOR

  • Prasert Thongcharoen, MD

    Influenza Foundation of Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2012

First Posted

February 27, 2012

Study Start

November 1, 2011

Primary Completion

September 9, 2013

Study Completion

October 1, 2015

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

TH(1)