HPV Vaccine for Low Lymphocyte Count

Phase 2

Recruiting

Led By Andrea Lisco, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female study participants engaging in sexual activities that can result in pregnancy must agree to use one of the listed contraceptive methods at every potentially reproductive sexual encounter.

Aged 18 to 70 years.

Must not have

HIV infection or any other recognized congenital or acquired immunodeficiency.

Current use of systemic glucocorticosteroids or immunomodulants, except corticosteroid nasal spray or inhaler and topical steroids.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month (+ 1 month) after vaccination #3.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether the HPV vaccine can help people with a rare disease who get more HPV-related diseases than other people do.

Who is the study for?

Adults aged 18-70 with idiopathic CD4 T cell lymphocytopenia (ICL) or healthy volunteers meeting specific CD4 count criteria. Participants must not be pregnant, breastfeeding, have had GARDASIL 9 before, severe allergies to vaccine components, HIV, certain acute illnesses or immunodeficiencies, recent cancer treatments or immunomodulants.

What is being tested?

The trial is testing the effectiveness of the HPV vaccine GARDASIL 9 in people with ICL compared to healthy individuals. It involves three doses over six months and follow-up visits for up to 18 months after the last dose to monitor immune response and side effects.

What are the potential side effects?

Possible side effects include reactions at the injection site like pain and swelling, fever, headache, nausea. Rarely there may be allergic reactions. Side effects are generally mild but will be closely monitored post-vaccination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use birth control if there's a chance I could get pregnant.

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV or another type of immune system problem.

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I am not taking any steroids or immune system medications, except for nasal sprays, inhalers, or creams.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month (+ 1 month) after vaccination no3.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month (+ 1 month) after vaccination no3.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month (+ 1 month) after vaccination no3. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients with ICL who become seropositive to at least 1 homologous HPV vaccine genotype at 1 month after completion of the vaccination schedule.

Secondary study objectives

Humoral responses, expressed as geometric mean titer (GMT), will be compared between patients with ICL and healthy subjects, within the subgroup of subjects who seroconvert for any specific homologous HPV genotype.

Number of adverse events (AEs) and serious adverse events (SAEs) following administration of 9-valent HPV recombinant vaccine.