HPV Vaccine for HIV/AIDS

(AGO-Gard Trial)

Overseen By Executive Director, Office of Research Services

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Louisiana State University Health Sciences Center in New Orleans

Must be taking: Antiretrovirals

Must not be taking: Chronic steroids, Immune modulators

Disqualifiers: Pregnancy, Acute illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

250 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to determine the magnitude and breadth of the serum antibody response to the nonavalent HPV vaccine (Gardasil-9) in adults with well-controlled HIV infection. The secondary objectives of the study are to observe short term clinical outcomes of prevalent HPV genotype-specific anogenital infections in adults living with HIV who complete the three-dose Gardasil-9 vaccine series, and to determine the protection afforded by Gardasil vaccine over time in previously vaccinated adults living with HIV. The clinical hypothesis is that adults with virologically controlled HIV mount a serum antibody response to the nonavalent HPV vaccine that is comparable to HIV negative counterparts. We also postulate that HPV vaccination will provide short-term clinical benefit against HPV infections and disease associated with vaccine genotypes and continuing protection against vaccine genotypes of HPV over time.

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

The trial does not specify if you need to stop your current medications. However, you cannot participate if you are taking chronic steroids or immune modulating medications.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking chronic steroids or immune-modulating medications.

What data supports the idea that the HPV Vaccine for HIV/AIDS is an effective treatment?

The available research shows that the 9-valent HPV vaccine, also known as Gardasil 9, is effective in preventing infections that can lead to cervical cancer and other HPV-related cancers. It covers more HPV types than earlier versions, increasing protection from about 70% to 90% for cervical cancer. Clinical trials demonstrated that the vaccine is safe and effective, with strong immune responses in both young women and younger boys and girls. This suggests that the vaccine is a powerful tool in reducing the risk of HPV-related diseases. ^{1 2 3 4 5}

What data supports the effectiveness of the HPV vaccine treatment for HIV/AIDS?

The 9-valent HPV vaccine, Gardasil 9, has been shown to increase protection against HPV-related cancers from 70% to 90% by covering more HPV types. It is effective in preventing cervical and other HPV-related cancers, which suggests it could be beneficial for people with HIV/AIDS who are at higher risk for these infections. ^{1 2 3 4 5}

What safety data is available for the HPV 9-valent vaccine?

The safety of the 9-valent HPV vaccine, also known as Gardasil 9, has been evaluated in multiple studies. A multiyear post-licensure study assessed its safety following routine administration. Additionally, a combined analysis of 7 Phase III clinical trials evaluated the safety profile in males and females aged 9 to 26 years. These studies demonstrated a comparable safety profile to the earlier 4-valent HPV vaccine. The vaccine's safety and immunogenicity were also assessed in females aged 12-26 who had previously received the quadrivalent HPV vaccine. ^{1 2 6 7 8}

Is the HPV vaccine safe for humans?

The 9-valent HPV vaccine, also known as Gardasil 9, has been shown to have a comparable safety profile to earlier versions of the vaccine in multiple studies involving males and females aged 9 to 26. It has been evaluated in several clinical trials and is considered safe for routine use. ^{1 2 6 7 8}

Is the HPV Vaccine for HIV/AIDS, specifically the Gardasil 9 drug, a promising treatment?

Yes, Gardasil 9 is a promising drug because it protects against more types of HPV, increasing protection from about 70% to 90% against cervical cancer. It has been shown to be safe and effective in both boys and girls, and it works well even with fewer doses in younger people. ^{1 2 3 7 9}

How is the HPV vaccine Gardasil 9 unique for treating HIV/AIDS patients?

Gardasil 9 is unique because it covers nine types of HPV, including five additional high-risk types not covered by earlier vaccines, potentially increasing protection from 70% to 90%. This expanded coverage is particularly important for HIV/AIDS patients who may be more susceptible to HPV-related complications. ^{1 2 3 7 9}

Research Team

Jennifer E Cameron, PhD

Principal Investigator

Louisiana State University Health Sciences Center

Michael Hagensee, MD

Principal Investigator

Louisiana State University Health Sciences Center

Eligibility Criteria

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.

Inclusion Criteria

I have never received the Gardasil-9 vaccine.

Immune intact (CD4+ T cell count in peripheral blood >200 cells/ml)

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

Exclusion Criteria

I am taking medication that affects my immune system.

Recipients of other vaccine products within the past month

I am currently pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive the 3-dose Gardasil-9 vaccine series at 0, 1, and 6 months

6 months

3 visits (in-person)

Follow-up

Participants are monitored for seroconversion and HPV infection status

18 months

4 visits (in-person)

Cross-sectional Study

Participants with prior Gardasil vaccination are evaluated for serum antibody titers

Treatment Details

Interventions

• Human papillomavirus 9-valent vaccine, recombinant

Trial Overview 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.

Participant Groups

Group I: Gardasil-9 recipients Experimental Treatment 1 Intervention

Participants receive 3-dose Gardasil-9 vaccine series.

Group II: Gardasil vaccine experienced cohort Experimental Treatment 1 Intervention

Observational cohort to determine Gardasil HPV serum antibody titers in relation to time since vaccine series completion.

Human papillomavirus 9-valent vaccine, recombinant is already approved in United States, European Union for the following indications:

Approved in United States as Gardasil 9 for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Prevention of genital warts caused by HPV types 6 and 11
• Prevention of precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58

Approved in European Union as Gardasil 9 for:

• Prevention of precancerous growths and cancer in the cervix and anus, and genital warts
• Protection against 9 types of HPV (types 6, 11, 16, 18, 31, 33, 45, 52, and 58)

Who Is Running the Clinical Trial?

Louisiana State University Health Sciences Center in New Orleans

Lead Sponsor

Trials

123

Recruited

42,400+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

The 9-valent HPV vaccine (Gardasil 9®) significantly increases protection against cervical cancer by covering 9 oncogenic HPV types, raising potential protection from about 70% to 90%, based on clinical trials involving young women.

Clinical trials demonstrated that the 9vHPV vaccine has a comparable safety profile and immunogenicity to the original 4-valent vaccine, with a 2-dose regimen showing similar effectiveness in younger boys and girls compared to the standard 3-dose regimen for older women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. Zhang, Z., Zhang, J., Xia, N., et al.[2019]

A study involving 215,965 individuals who received the nine-valent HPV vaccine (HPV9) found no new safety concerns, confirming its established safety profile from previous research.

While some elevated event categories were noted, such as skin disorders and ill-defined conditions, most were either previously known or had other causes, and no deaths were linked to the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. Hansen, J., Yee, A., Lewis, N., et al.[2023]

The 9-valent HPV vaccine demonstrated a high efficacy of 92.3% in preventing high-grade cervical, vulvar, and vaginal dysplasia related to HPV types 31, 33, 45, 52, and 58 in a study involving 5,312 participants aged 9-26 years.

The vaccine was well tolerated, with over 99% of recipients developing antibodies for all 9 HPV types, and most adverse events were mild to moderate, supporting its use in vaccination programs in Latin America.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. Ruiz-Sternberg, ÁM., Moreira, ED., Restrepo, JA., et al.[2021]

The 9-valent HPV vaccine (9vHPV) can potentially increase the prevention of cervical cancer from 70% to 90% by covering additional HPV types (31, 33, 45, 52, and 58) not included in earlier vaccines.

In addition to cervical cancer, the 9vHPV vaccine could prevent 85-95% of HPV-related vulvar, vaginal, and anal cancers, highlighting its broad efficacy in reducing the overall cancer burden associated with HPV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

9-Valent HPV vaccine for cancers, pre-cancers and genital warts related to HPV. Pitisuttithum, P., Velicer, C., Luxembourg, A.[2022]

In a study of 569 postpartum inpatients, 23.1% of vaccine-eligible patients received the nine-valent HPV (9vHPV) vaccine during their hospital stay, indicating that integrating vaccination into postpartum care can increase uptake.

The study found that certain demographics, particularly Hispanic, Spanish-speaking, and publicly insured patients, were more likely to receive the vaccine, suggesting that targeted approaches in postpartum care could help reduce vaccination disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Papillomavirus Inpatient Postpartum Vaccination: Clinical Guideline Implementation. Murphy, EC., Alimena, S., Pelletier, A., et al.[2023]

The 9-valent HPV vaccine (9vHPV) was well tolerated in over 15,000 participants aged 9 to 26, with a safety profile similar to the quadrivalent HPV vaccine, showing mostly mild-to-moderate adverse events like injection-site pain and headaches.

Serious adverse events were very rare (0.1%), and the vaccine did not show any significant safety concerns related to pregnancy outcomes, supporting its widespread use for HPV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Moreira, ED., Block, SL., Ferris, D., et al.[2019]

The nine-valent HPV vaccine, Gardasil9, significantly increases the efficacy against cervical cancer from 70% to 90% compared to the quadrivalent vaccine, covering a broader range of HPV types.

Gardasil9 also provides high efficacy (97%) against lesions associated with HPV types 31, 33, 45, 52, and 58, while maintaining similar effectiveness against HPV types 6, 11, 16, and 18 as the quadrivalent vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nine-valent HPV vaccine - new generation of HPV vaccine]. Fait, T., Dvořák, V., Pilka, R.[2018]

The 9-valent HPV vaccine (9vHPV) is highly immunogenic in females aged 12-26 who previously received the quadrivalent HPV vaccine (qHPV), with over 98% showing seropositivity for additional HPV types 31/33/45/52/58 after the third dose.

While injection-site adverse events were more common in the 9vHPV group (91.1%) compared to placebo (43.9%), systemic adverse events were similar between both groups, indicating that the 9vHPV vaccine is generally well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. Garland, SM., Cheung, TH., McNeill, S., et al.[2016]

In a study of 167 HIV-infected women, the prevalence of high-risk HPV types was found to be significantly higher in the anus (90%) compared to the cervix (83%), indicating a need for targeted screening and prevention in this population.

The nonavalent HPV vaccine, which targets both high-risk and low-risk HPV types, is supported by the findings as 9v HR-HPV types were prevalent (67% in the anus and 51% in the cervix), highlighting its potential effectiveness in reducing HPV-related disease in HIV-infected women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and Incidence of Anal and Cervical High-Risk Human Papillomavirus (HPV) Types Covered by Current HPV Vaccines Among HIV-Infected Women in the SUN Study. Kojic, EM., Conley, L., Bush, T., et al.[2019]

References

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

Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. [2021]

4. England pubmed.ncbi.nlm.nih.gov

9-Valent HPV vaccine for cancers, pre-cancers and genital warts related to HPV. [2022]

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

Human Papillomavirus Inpatient Postpartum Vaccination: Clinical Guideline Implementation. [2023]

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

Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. [2019]

7. Czech Republic pubmed.ncbi.nlm.nih.gov

[Nine-valent HPV vaccine - new generation of HPV vaccine]. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. [2016]

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

Prevalence and Incidence of Anal and Cervical High-Risk Human Papillomavirus (HPV) Types Covered by Current HPV Vaccines Among HIV-Infected Women in the SUN Study. [2019]