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Cancer Vaccine

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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month (+ 1 month) after vaccination #3.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ICL and Healthy VolunteersExperimental Treatment1 Intervention
Biological/Vaccine

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,369 Total Patients Enrolled
Andrea Lisco, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
2 Previous Clinical Trials
910 Total Patients Enrolled

Media Library

Gardasil 9 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03519464 — Phase 2
CD4 T Cell Lymphocytopenia Research Study Groups: ICL and Healthy Volunteers
CD4 T Cell Lymphocytopenia Clinical Trial 2023: Gardasil 9 Highlights & Side Effects. Trial Name: NCT03519464 — Phase 2
Gardasil 9 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03519464 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you inform me of any related research that has been conducted regarding this treatment?

"To date, 16 Phase 3 trials are exploring this treatment, and 32 separate studies have been initiated. In Bangkok and Chang Wat Nonthaburi alone there are 244 clinical trial sites where research is taking place."

Answered by AI

Who are the ideal candidates for enrollment in this research endeavor?

"This clinical trial is looking to enrol 100 individuals aged 18-70 with cd4 antigens. Participants must also be regularly using a hormonal method of contraception such as the pill, implant or injection (which needs to have been started at least 1 month before receiving their first dose) and are encouraged to use additional methods including diaphragms/cervical caps and condoms with spermicide."

Answered by AI

Are there vacancies in this clinical trial for participants?

"According to the clinicaltrials.gov database, this medical trial is open for recruitment and has been since February 4th 2019 (last updated on July 6th 2022)."

Answered by AI

Does this research offer inclusion to those younger than 35?

"Participants of this medical trial must be between 18 and 70 years old."

Answered by AI

What conditions typically respond positively to this treatment regimen?

"This treatment is capable of targeting and treating infections stemming from Human Papillomavirus type 58, Human Papillomavirus type 31, and general HPV infection."

Answered by AI

What is the total census of participants in this clinical investigation?

"Affirmative. According to data published on clinicaltrials.gov, this medical study was initially advertised in February of 2019 and has been actively recruiting since then. The trial is hoping to enroll a total of 100 participants at one location."

Answered by AI

To what extent could this treatment option be detrimental to patient health?

"At Power, the safety of this therapy has been assigned a score of 2. This is because while there are some findings that suggest it may be safe to use, no evidence points towards its efficacy at present."

Answered by AI

Is this experiment unprecedented in its field?

"Investigations into this medication have been ongoing since 2002, when Merck Sharp & Dohme Corp. sponsored the first study which included 12167 participants. Thanks to its successful conclusion in Phase 3 trials, it has achieved drug approval and is now being trialled at 32 sites spanning 129 cities and 32 countries worldwide."

Answered by AI
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~24 spots leftby Dec 2025