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Immunogenicity of Influenza Vaccines in HIV-infected Persons in Thailand

Primary Purpose

Influenza

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Intradermal vaccine

Intramuscular vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccine, Thailand

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Silom Community ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Other

Arm Label

HIV+, CD4<200, ID vaccine

HIV+, CD4<200, IM vaccine

HIV+, CD4>=200, ID vaccine

HIV+, CD4 >=200, IM vaccine

HIV-, ID vaccine

HIV-, IM vaccine

Arm Description

Outcomes

Primary Outcome Measures

Antibody titers

Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine

Secondary Outcome Measures

Antibody titers

Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine

Antibody titers

Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine

Full Information

NCT ID

NCT01538940

First Posted

February 21, 2012

Last Updated

September 10, 2012

Sponsor

Centers for Disease Control and Prevention

Collaborators

Ministry of Health, Thailand

1. Study Identification

Unique Protocol Identification Number

NCT01538940

Brief Title

Immunogenicity of Influenza Vaccines in HIV-infected Persons in Thailand

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Unknown status

Study Start Date

November 2011 (undefined)

Primary Completion Date

July 2013 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centers for Disease Control and Prevention

Collaborators

Ministry of Health, Thailand

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, Vaccine, Thailand

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HIV+, CD4<200, ID vaccine

Arm Type

Active Comparator

Arm Title

HIV+, CD4<200, IM vaccine

Arm Type

Active Comparator

Arm Title

HIV+, CD4>=200, ID vaccine

Arm Type

Active Comparator

Arm Title

HIV+, CD4 >=200, IM vaccine

Arm Type

Active Comparator

Arm Title

HIV-, ID vaccine

Arm Type

Other

Arm Title

HIV-, IM vaccine

Arm Type

Other

Intervention Type

Biological

Intervention Name(s)

Intradermal vaccine

Intervention Description

15ug

Intervention Type

Biological

Intervention Name(s)

Intramuscular vaccine

Intervention Description

15ug

Primary Outcome Measure Information:

Title

Antibody titers

Description

Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Antibody titers

Description

Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine

Time Frame

6 months

Title

Antibody titers

Description

Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine

Time Frame

12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charung Muangchana, MD

Organizational Affiliation

Ministry of Health, Thailand

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Prasert Thongcharoen, MD

Organizational Affiliation

Influenza Foundation of Thailand

Official's Role

Principal Investigator

Facility Information:

Facility Name

Silom Community Clinic

City

Bangkok

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pornchai Sornsathapornkul, RN

Phone

+66-2-634-2917

fnpst@diamond.mahidol.ac.th

12. IPD Sharing Statement

Citations:

PubMed Identifier

31045222

Citation

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.

Results Reference

derived

PubMed Identifier

26486702

Citation

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.

Results Reference

derived

Links:

URL

http://www.silomclinic.in.th/

Description

Website for clinic where the study is being conducted.

Learn more about this trial

Immunogenicity of Influenza Vaccines in HIV-infected Persons in Thailand

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