Influenza Vaccination for HIV-Related Immune Response

Recruiting in Palo Alto (17 mi)

Overseen by Savita Pahwa, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Miami

Must be taking: Antiretrovirals

Must not be taking: Steroids, Immunosuppressives

Disqualifiers: Immunodeficiency, Active malignancies, Drug abuse, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this research is to evaluate blood samples from HIV infected and non-HIV infected people to understand how aging and HIV infection affect the immune responses (body defenses against infection) to the flu vaccine.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on steroids or other medications that suppress or modify the immune system.

How does the high-dose influenza vaccine differ from standard treatments for HIV-related immune response?

The high-dose influenza vaccine, such as Fluzone High-Dose, contains a higher amount of hemagglutinin, which can enhance the immune response in older adults and potentially in those with HIV. This higher dose aims to improve the vaccine's effectiveness in individuals with weakened immune systems, like those with HIV, compared to standard-dose vaccines. ^{1 2 3 4 5}

Research Team

Savita Pahwa, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for people aged ≤35 or ≥65 years, with or without HIV. HIV+ individuals must be on ART for at least a year, have a CD4 count >200/mm3, and an undetectable viral load. Participants should not have other immune disorders, be taking immunosuppressants, have active cancer, drug abuse history or received this season's flu shot.

Inclusion Criteria

For HIV negative participants: Documented negative HIV test at the time of study entry, either by any licensed ELISA. Individuals age: ≤35 years and ≥65 years. No history of other immunodeficiency disorders. Not on steroid or other immunosuppressive/immunomodulators medications. No active malignancies. Agreeable to receive both regular standard (STD-TIV) and high dose (HD-TIV) influenza vaccination. Agreeable to participate in study for a complete course of study full visits including 2 consecutive flu seasons. Able to provide informed consent.

I am HIV positive, on treatment for over a year, with a CD4 count over 200 and an undetectable viral load.

Exclusion Criteria

You can't get the flu shot, don't take your HIV medication regularly, can't understand what the study is about, already got the flu shot this year, or have a history of drug abuse, including cocaine.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Vaccination

Participants receive the standard dose flu vaccine

1 day

1 visit (in-person)

Follow-up Post Initial Vaccination

Participants are monitored for immune response to the standard dose flu vaccine

6 months

High Dose Vaccination

Participants who did not respond to the standard dose receive the high dose flu vaccine

1 day

1 visit (in-person)

Follow-up Post High Dose Vaccination

Participants are monitored for immune response to the high dose flu vaccine

6 months

Treatment Details

Interventions

• High dose influenza vaccination (Vaccine)
• Standard dose influenza vaccination (Vaccine)

Trial Overview The study aims to understand how aging and HIV affect the body's defense against flu by comparing immune responses to standard-dose (STD-TIV) and high-dose (HD-TIV) influenza vaccinations in both HIV infected and non-infected participants over two flu seasons.

Participant Groups

Group I: Young HIV positive group Experimental Treatment 2 Interventions

HIV infected viral suppressed participants, who are on anti-retroviral therapy (ART) aged 18-35 years of age, will receive the standard dose flu vaccine first followed by the high dose flu vaccine 1 year after initial standard dose.

Group II: Old HIV positive group Experimental Treatment 2 Interventions

HIV infected viral suppressed participants, who are on anti-retroviral therapy (ART) aged 65 years and older, will receive the standard dose flu vaccine first followed by the high dose flu vaccine 1 year after initial standard dose.

Group III: Old HIV negative group Experimental Treatment 2 Interventions

HIV uninfected participants that are 65 years and older will receive the standard dose flu vaccine first followed by the high dose flu vaccine 1 year after initial standard dose.

Group IV: Young HIV negative group Active Control 2 Interventions

HIV uninfected participants that are 18-35 years of age will receive the standard dose flu vaccine. Participants who did not respond to the standard dose flu vaccination, as defined by less than a four-fold increase in flu antibody titer from baseline, will then receive the high dose flu vaccination 1 year after initial standard dose flu vaccination. Participants who respond to the standard dose flu vaccination will not receive the high dose flu vaccination.

High dose influenza vaccination is already approved in Canada for the following indications:

Approved in Canada as Fluzone High-Dose for:

• Prevention of disease caused by influenza A subtype viruses and type B virus in individuals 65 years of age and older

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Miami Miami, FL

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Patients Recruited

423,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults ≥65 years of age: A phase 3 randomized clinical trial. Chang, LJ., Meng, Y., Janosczyk, H., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of two influenza virus subunit vaccines, with or without MF59 adjuvant, administered to human immunodeficiency virus type 1-seropositive and -seronegative adults. Durando, P., Fenoglio, D., Boschini, A., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influenza vaccination in HIV-positive subjects: latest evidence and future perspective. Ceravolo, A., Orsi, A., Parodi, V., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through Chang, LJ., Anderson, EJ., Jeanfreau, R., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the vaccination of the elderly against influenza: role of a high-dose vaccine. Sullivan, SJ., Jacobson, R., Poland, GA.[2010]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults ≥65 years of age: A phase 3 randomized clinical trial. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of two influenza virus subunit vaccines, with or without MF59 adjuvant, administered to human immunodeficiency virus type 1-seropositive and -seronegative adults. [2021]

3. Italy pubmed.ncbi.nlm.nih.gov

Influenza vaccination in HIV-positive subjects: latest evidence and future perspective. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through [2021]

5. England pubmed.ncbi.nlm.nih.gov

Advances in the vaccination of the elderly against influenza: role of a high-dose vaccine. [2010]