HPV Vaccination Immune Response Study

Not currently recruiting at 1 trial location

Overseen By Lauren Johnson

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Emory University

Must not be taking: Anticoagulants, Antiplatelets, NSAIDs, Immunosuppressants

Disqualifiers: HPV vaccine, Genital warts, Autoimmune, 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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the body's response to the 9-valent HPV vaccine (Gardasil 9). Researchers will study the immune response in the blood, saliva, bone marrow, and lymph nodes after participants receive the vaccine. Participants will receive three doses over six months. Suitable candidates have not previously received an HPV vaccine, have no history of genital warts or abnormal pap smears, and are willing to undergo specific medical tests, such as lymph node and bone marrow sampling. As a Phase 4 trial, this research helps determine how the already FDA-approved and effective vaccine benefits more patients.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking anti-coagulant products, anti-platelet products, NSAIDs, or immunosuppressive therapies, you may be excluded from participation. It's best to discuss your specific medications with the trial investigator.

What is the safety track record for these treatments?

Research has shown that Gardasil 9, the HPV vaccine, is safe for people. Studies have found its safety comparable to Gardasil, an earlier version of the vaccine. Over 15 years of research and monitoring provide strong evidence of the safety and effectiveness of HPV vaccination. Recent studies tracking the vaccine for several years found no new safety issues. This indicates that Gardasil 9 is safe for individuals aged 9 to 45, helping protect against diseases caused by HPV. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the HPV Vaccination Immune Response Study because it aims to uncover how the immune system responds over time to the Gardasil 9 vaccine, which targets nine different HPV strains. Unlike standard HPV vaccines that focus primarily on preventing infection, this trial investigates the body's immune response by using fine-needle aspiration (FNA) to sample lymph nodes at different times after vaccination. This approach could provide a deeper understanding of how long-lasting and robust the immune protection is. Additionally, the study includes bone marrow sampling, which might reveal insights into how immune memory is formed and maintained, potentially leading to more effective vaccination strategies in the future.

What is the effectiveness track record for the HPV vaccine?

Research shows that the 9-valent HPV vaccine, Gardasil 9, is highly effective. More than 98% of individuals who receive all doses develop antibodies, proteins that help fight infections, against the virus types the vaccine targets. Studies have found that this robust protection lasts for years, with over 80% of individuals still protected against all nine HPV types after three years. This vaccine targets HPV types linked to various cancers and genital warts, offering broad protection. Even a single dose has proven to be 95.4% effective, making it a powerful tool in preventing HPV-related diseases. Participants in this trial will receive three doses of Gardasil 9, with lymph node and bone marrow sampling conducted at various intervals to assess immune response. ^{6 7 8 9 10}

Who Is on the Research Team?

Erin Scherer, Ph.D.

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

Adults aged 18-45 with a BMI ≤ 32, in good health, and able to give informed consent can join this HPV vaccine study. They must be willing to undergo lymph node and bone marrow sampling and not have any history of genital warts, abnormal pap smears, positive HPV tests, or certain cancers. Participants should not have received blood products recently or plan major surgery during the study.

Inclusion Criteria

BMI ≤ 32

Must be willing to consent to the future use of remaining (residual) samples/specimens

Must be available and willing to participate for the duration of this study

Exclusion Criteria

I have had cancer other than skin cancer, but it was surgically removed and considered cured.

I haven't had, nor plan to have, major surgery within 4 weeks of joining this study.

Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

1 visit (in-person)

Vaccination and Initial Immune Response Assessment

Participants receive the 9-valent HPV vaccine at D0, D60, and D180. Immune responses are assessed through blood, saliva, and lymph node sampling.

6 months

Multiple visits for vaccination and sampling

Extended Immune Monitoring

Participants are monitored for long-term immune responses through blood, saliva, and bone marrow sampling.

5 years

Periodic visits for sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Gardasil
• HPV vaccine
• Lidocaine injections

Trial Overview

The trial is testing immune responses to the Gardasil HPV vaccine through blood, saliva, bone marrow, and lymph node samples over two years. Participants will receive three doses of the vaccine at specific intervals followed by multiple assessments.

How Is the Trial Designed?

Group I: Group 3: Lymph node sampling at D180, D194 and D210 Experimental Treatment 2 Interventions

Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180. Group 3 will undergo an FNA on the same day, but prior to, the third vaccine dose (D180±5; Visit 13) or up to 5 days before. Participants will repeat the procedure at Visit 13 + 14±5 days and Visit 13 + 30±5 days. Bone marrow sampling will be done for all groups at D730 and D1825.

Group II: Group 2: Lymph node sampling at D60, D74 and D90 Experimental Treatment 2 Interventions

Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180. Participants will undergo an FNA on the same day, but prior to, the second vaccine dose (D60±5; Visit 8) or up to 5 days before. Participants will repeat the procedure at Visit 8 + 14±5 days and Visit 8 + 30±5 days. Bone marrow sampling will be done for all groups at D730 and D1825.

Group III: Group 1: Lymph node sampling at D-30 to D0, D14 and D30 Experimental Treatment 2 Interventions

Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180. Group 1 will undergo an FNA at D-30 to D0. Participants will repeat the procedure at D14±5 and D30±5. Bone marrow sampling will be done for all groups at D730 and D1825.

Gardasil is already approved in United States, European Union, Canada, Switzerland 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 (condyloma acuminata) 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 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 (condyloma acuminata) 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 Canada 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 (condyloma acuminata) 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 Switzerland 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 (condyloma acuminata) 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

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

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]

Cervarix® induced higher antibody levels and stronger T cell responses compared to Gardasil® after three doses, suggesting it may provide a more robust immune response against HPV-16 and HPV-18.

Both vaccines are highly immunogenic, but the differences in immune responses, such as elevated cytokine levels in Cervarix® recipients, could have clinical implications that require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of adaptive and innate immune responses induced by licensed vaccines for Human Papillomavirus. Herrin, DM., Coates, EE., Costner, PJ., et al.[2018]

The two-dose HPV vaccine series for pre-adolescent girls (ages 9-15) is effective in providing protection against HPV 16 and other types, with the World Health Organization recommending this schedule since 2015, while older women still require a three-dose series.

Gardasil9 and Cervarix both show strong efficacy in preventing HPV infections, with Cervarix offering a potentially more cost-effective option due to its sustained high antibody levels and the possibility of effective protection with just one dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV vaccines - A review of the first decade. Harper, DM., DeMars, LR.[2022]

The post-licensure safety profile of HPV vaccines Gardasil and Cervarix was evaluated using data from three sources, including VigiBase and VAERS, confirming that the reported adverse events align with existing safety data.

The analysis showed that the safety profiles of both vaccines are consistent with the information provided in their Summary of Product Characteristics (SPC), indicating that they are safe for public use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. Labadie, J.[2015]

In a study involving 198 girls aged 12-15, the tetravalent HPV vaccine Gardasil® demonstrated a comparable safety profile to the bivalent HPV vaccine Cervarix®, with most local and systemic reactions being mild and infrequent.

Severe tenderness at the injection site was reported more frequently in the Cervarix® group (24%) compared to the Gardasil® group (7%), indicating that Gardasil® may be associated with fewer injection site reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reactogenicity of Cervarix and Gardasil human papillomavirus (HPV) vaccines in a randomized single blind trial in healthy UK adolescent females. Haskins-Coulter, T., Southern, J., Andrews, N., et al.[2021]

A comprehensive analysis of adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) identified 3,112 AEs for Cervarix, 31,606 for Gardasil, and 6,872 for Gardasil 9, highlighting the need for ongoing monitoring of vaccine safety.

The study found 46 unique serious adverse events (SAEs) associated with the HPV vaccines, clustered around behavioral, neurological, immune, nervous, and reproductive systems, indicating that while the vaccines are effective, further research is needed to understand the cause-and-effect relationships of these AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. Zi, W., Yang, Q., Su, J., et al.[2022]

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]

Cervarix, an HPV vaccine, has shown a 70.2% reduction in cervical precancerous lesions in HPV-naïve young girls, indicating its strong efficacy in preventing cervical cancer caused by HPV types 16, 18, 31, 33, and 45.

Cervarix induces significantly higher levels of neutralizing antibodies and memory immune cells compared to Gardasil, with sustained protection lasting over 7 years, demonstrating its long-term effectiveness and safety in preventing HPV-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical update of the AS04-adjuvanted human papillomavirus-16/18 cervical cancer vaccine, Cervarix. Schwarz, TF.[2020]

Over 4 years of post-licensure safety surveillance of the HPV-16/18 vaccine (Cervarix) showed that the most commonly reported adverse events were consistent with those expected in the general population, indicating a favorable safety profile.

No significant patterns of serious immune-mediated diseases were found, and the incidences of conditions like Bell's palsy and Guillain-Barré syndrome were within expected ranges, reinforcing the vaccine's acceptable benefit-risk profile for adolescent girls and women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. Angelo, MG., Zima, J., Tavares Da Silva, F., et al.[2021]

Both Gardasil and Cervarix HPV vaccines have shown outstanding efficacy in preventing infections and related conditions in young women, with excellent safety profiles and only mild to moderate side effects reported.

Neither vaccine is effective in treating existing HPV infections or lesions, but they provide strong protection against specific HPV types for at least four years, with Gardasil also preventing genital warts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update of prophylactic human papillomavirus L1 virus-like particle vaccine clinical trial results. Schiller, JT., Castellsagué, X., Villa, LL., et al.[2022]

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]

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HPV Vaccine Efficacy

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three-year follow-up data from a randomised clinical trial

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cdc.gov/vaccine-safety/vaccines/hpv.html

Human Papillomavirus (HPV) Vaccine Safety

The safety findings from these pre-licensure studies show that Gardasil 9 has a similar safety profile to Gardasil, an earlier version of the vaccine. The main ...

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Parent Concerns About HPV Vaccine Safety Increasing - NCI

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