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Cancer Vaccine

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

Q: Is this investigation taking on new candidates?

<p>It appears that this medical trial is not currently enrolling patients. Although the study was initially posted on September 15th, 2022 and last edited on September 2nd, 2022, there are numerous other clinical trials actively sourcing participants at present.</p>

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

AGO-Gard 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.Check my eligibility

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.See study design

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.

AGO-Gard Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have never received the Gardasil-9 vaccine.

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My HIV is under control with less than 1,000 copies/mL.

Select...

I am HIV positive.

AGO-Gard Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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

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

Primary outcome measures

change in serological response to Gardasil-9

Secondary outcome measures

change in HPV infection status: protection against incident HPV infection

change in HPV infection status: resolution of prevalent HPV infection

Other outcome measures

change in mucosal antibody response to Gardasil-9

AGO-Gard Trial Design

1Treatment groups

Experimental Treatment

Group I: Gardasil-9 recipientsExperimental Treatment1 Intervention

Participants receive 3-dose Gardasil-9 vaccine series.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansLead Sponsor

114 Previous Clinical Trials

44,051 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,054,933 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

Frequently Asked Questions

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

Does this research program have an upper age limit for participants?

"According to the inclusion criteria, prospective candidates for this trial must be between 18 and 45 years old. 696 trials are available for minors while 3311 can be found for seniors."

Answered by AI

What evidence indicates that the Human papillomavirus 9-valent vaccine, recombinant is safe for human use?

"Our internal evaluation rated Human papillomavirus 9-valent vaccine, recombinant as a 3 due to its Phase 4 status and thus approval for general use."

Answered by AI

Am I eligible to take part in this scientific evaluation?

"This clinical trial seeks 150 participants aged 18-45 with cervical intraepithelial neoplasia. To be eligible, prospective patients must have an intact immune system (CD4+ T cell count >200 cells/mL), a stable antiretroviral regimen for at least three months and undetectable HIV viral load (<1,000 genome copies/ml). Moreover, the participant should not yet have received Gardasil-9."

Answered by AI

Is this investigation taking on new candidates?

"It appears that this medical trial is not currently enrolling patients. Although the study was initially posted on September 15th, 2022 and last edited on September 2nd, 2022, there are numerous other clinical trials actively sourcing participants at present."

Answered by AI