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Cancer Vaccine

HPV Vaccine for HIV/AIDS (AGO-Gard Trial)

Phase 4
Recruiting
Led By Jennifer E Cameron, PhD
Research Sponsored by Louisiana State University Health Sciences Center in New Orleans
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gardasil-9 naive
HIV controlled (peripheral blood HIV viral load <1,000 genome copies/mL)
Must not have
Taking immune modulating medications
Women who are pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will study the nonavalent HPV vaccine in adults with HIV to see if it produces a similar antibody response to the vaccine as people without HIV, and to observe short-term clinical outcomes of HPV infections.

Who is the study for?
This trial is for adults with well-controlled HIV (viral load <1,000 copies/mL and CD4+ count >200 cells/ml) who have not previously received the Gardasil-9 vaccine. They must be stable on antiretroviral therapy for at least 3 months. Pregnant women, those acutely ill, on chronic steroids or immune-modulating meds, recent recipients of blood products or vaccines are excluded.
What is being tested?
The study tests how effective the Gardasil-9 HPV vaccine is in adults with controlled HIV by measuring their antibody response compared to people without HIV. It also looks at short-term effects on existing HPV-related infections after completing the three-dose vaccine series.
What are the potential side effects?
While specific side effects aren't listed here, common reactions to vaccines like Gardasil-9 may include pain at injection site, fatigue, headache, muscle or joint pain, fever and chills.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never received the Gardasil-9 vaccine.
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My HIV is under control with less than 1,000 copies/mL.
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I am HIV positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication that affects my immune system.
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I am currently pregnant.
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I am currently experiencing a sudden illness.
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I am on long-term steroids, more than half a milligram per kilogram of my body weight.
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I am unable to sign a consent form.
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I have received a blood transfusion in the last 6 months.
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I cannot receive vaccines due to medical reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in serological response to Gardasil-9
Secondary study objectives
change in HPV infection status: protection against incident HPV infection
change in HPV infection status: resolution of prevalent HPV infection
Other study objectives
change in mucosal antibody response to Gardasil-9

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gardasil-9 recipientsExperimental Treatment1 Intervention
Participants receive 3-dose Gardasil-9 vaccine series.

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansLead Sponsor
120 Previous Clinical Trials
42,717 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,015 Previous Clinical Trials
5,186,183 Total Patients Enrolled
Jennifer E Cameron, PhDPrincipal InvestigatorLouisiana State University Health Sciences Center

Media Library

Human papillomavirus 9-valent vaccine, recombinant (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05266898 — Phase 4
Human Papillomavirus Research Study Groups: Gardasil-9 recipients
Human Papillomavirus Clinical Trial 2023: Human papillomavirus 9-valent vaccine, recombinant Highlights & Side Effects. Trial Name: NCT05266898 — Phase 4
Human papillomavirus 9-valent vaccine, recombinant (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05266898 — Phase 4
~51 spots leftby Nov 2025
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