HPVPhase 4NCT05031078
Assessing Durable Antibody Response to HPV Vaccination
A Phase 4 study testing Gardasil-9 and Lidocaine injections in people with HPV, run by Emory University at 2 sites in United States.
Trial summary
This is a single center, longitudinal cohort study in which subjects will receive 9-valent HPV vaccine according to package insert (i.e., one dose of 9-valent HPV vaccine on day (D) 0 followed by a second dose 2 months later and a third dose 6 months later). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV
- What is being tested?
- Gardasil-9 and Lidocaine injections
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Dec 2021to 26 Mar 2026
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals aged 18-45 years old (inclusive), as the HPV vaccine is approved for this age range in adults
- BMI ≤ 32.
- Able to understand and give informed consent (provided in American English).
- Must be in good health based on physical examination, vital signs, medical history, and the investigator's clinical judgment.
- Must be available and willing to participate for the duration of this study
- Must be willing to undergo lymph node fine needle aspiration and bone marrow aspiration
- Must be willing to consent to the future use of remaining (residual) samples/specimens.
Who cannot join
- Ever received a dose of an HPV vaccine
- HPV 6, 11, 16, 18, 31, 33, 45, 52 or 58 seropositivity
- Any history of genital warts, an abnormal pap smear, or positive HPV DNA test
- Has known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products
- Has known allergy or history of anaphylaxis to yeast or products containing yeast
- Any allergy to lidocaine.
Show all 32Show fewer
- Pregnancy or breast feeding.
- Subjects who believe they cannot tolerate the lymph node fine needle aspirate or bone marrow aspirate procedures without sedation
- Any history of lymphoma involving axillary nodes, any history of breast cancer, bilateral inflammatory process of upper arms in the past 2 weeks, prior breast or axillary biopsy and/or surgery that in the opinion of the investigator would affect the immune response results.
- Local infection, lymphadenitis, or rash in targeted area.
- Received any vaccine from 14 days before vaccine dose until 30 days after each vaccine dose.*
- An individual who is initially excluded from study participation based on one or more of the time-limited exclusion criteria (fever, receipt of other vaccines) may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria.
- Volunteers with fever (≥100.4 F or 38°C regardless of the route) within 3 days prior to vaccination.*
- An individual who is initially excluded from study participation based on one or more of the time-limited exclusion criteria (fever, receipt of other vaccines) may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria.
- History of or presence of severe co-morbidities as determined by the investigator, including autoimmune disease, or clinically significant cardiac, pulmonary, gastrointestinal, hepatic, rheumatologic, renal disease, thrombocytopenia, and grade 4 hypertension*.
- Grade 4 hypertension per CTCAE criteria is defined as Life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive)
- History of a bleeding disorder or currently taking anti-coagulant products* (e.g. warfarin, direct thrombin inhibitors, heparin products, etc.), anti-platelet products, and/or NSAIDs including aspirin.
- including in the past week; however, an individual who is initially excluded from study participation based on one or more of the time-limited exclusion criteria may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria
- Has history of active malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure.
- Current and/or expected immunosuppression due to cancer, receipt of chemotherapy, radiation therapy, and any other immunosuppressive therapies (including anti-TNF therapy).
- Has known or suspected congenital or acquired immunodeficiency, including functional or anatomic asplenia, or recent history or current use of immunosuppressive therapy*.
- Anti-cancer chemotherapy or radiation therapy within the preceding 3 years, or long-term (≥2 weeks within the previous 3 months) systemic corticosteroid therapy (e.g., prednisone at a dosage of ≥20 mg per day or on alternative days). Intranasal or topical prednisone (or equivalent) are allowed.
- Known chronic infections including, but not limited to, known HIV, tuberculosis, hepatitis B or C.
- Is post-organ, bone marrow, and/or stem cell transplant, whether or not on chronic immunosuppressive therapy.
- Received blood products or immunoglobulin in the 3 months before study entry or planned use during this study.
- Had major surgery (per the investigator's judgment) within 4 weeks before study entry or planned major surgery during this study.
- Insulin-dependent diabetes* mellitus type 1 or type 2 requiring therapy
- History of isolated gestational diabetes is not an exclusion criterion.
- Received experimental therapeutic agents within 12 months before first vaccine dose or plans to receive any experimental therapeutic agents 12 months after first vaccine dose that, in the opinion of the investigator, would interfere with the safety or objectives of the study. COVID-19 vaccines that fall under FDA EUA will be treated as approved vaccines for the purposes of this study.
- Is currently participating or plans to participate in another clinical study which would involve receipt of an investigational product or undergo a procedure that, in the opinion of the investigator, would interfere with safety or objectives of the study.
- Current diagnosed or self-reported alcohol abuse, drug abuse, or psychiatric conditions that in the opinion of the investigator would preclude compliance with the study.
- Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Hope Clinic of Emory University
Atlanta, Georgia, 30030
Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Assessing Immunological Basis of Durable Antibody Responses to 9-valent HPV Vaccination
This is a single center, longitudinal cohort study in which subjects will receive 9-valent HPV vaccine according to package insert (i.e., one dose of 9-valent HPV vaccine on day (D) 0 followed by a second dose 2 months later and a third dose 6 months later).
Immune responses in the blood, saliva, bone marrow, and lymph nodes will be assessed in subjects receiving the HPV vaccine.
Read more
Blood samples for immunologic testing will be collected at screening (from D-60 to D-45), on D0 (before vaccination), D1 (optional visit), D7±1, D14±5, D30±5, D60±5 (Visit 8, before vaccination), Visit 8 +1 day (optional visit), Visit 8 + 7±1 days, Visit 8 + 14±5 days, Visit 8 + 30±5 days, D180±5 (Visit 13, before vaccination), Visit 13 + 7±1 days, Visit 13 + 14±5 days, Visit 13 + 30±5 days, D365±14, D730±14, D1095±14, D1460±14, D1825±30. Saliva samples for antibody testing will be collected on D0 (before vaccination), D30, D60 (before vaccination), Visit 8 + 30±5 days, D180 (before vaccination), Visit 13 + 30±5 days, D365, and D730.
Axillary lymph node sampling by fine needle aspiration will be done 3 times per group. Group 1 will have lymph node sampling done D-30 to D0, D14, and D30. Group 2 will have lymph node sampling done D60, Visit 8 + 14±5 days, and Visit 8 + 30±5 days. Group 3 will have lymph node sampling D180, Visit 13 + 14±5 days, and Visit 13 + 30±5 days. Bone marrow sampling will be done for all groups at D730±14 and D1825±30.
Read the detailed description
Human papillomaviruses (HPV) cause cervical, anal, oropharyngeal, vulvar, vaginal, and penile cancers. There are over 200 types of HPV; 12 are known to cause cancer. The current HPV vaccine is a subunit vaccine, meaning it is made of only part of the virus (a protein) and cannot infect humans. The HPV vaccine is highly effective at preventing disease by HPV types that cause 90% of cancer cases and 90% of genital warts cases in women and men who do not have ongoing or prior HPV infection.
Most vaccines protect by generating antibodies. Importantly, the HPV vaccine, first approved in 2006, has been shown to make high levels of antibodies against HPV that last for >10 years. The durability of HPV vaccine antibody levels is exceptional compared to other approved and experimental subunit vaccines whose antibody levels drop more rapidly. However, how the HPV vaccine - let alone any vaccine - generates long-lasting antibodies is not understood. Understanding how vaccines make high levels of long-lasting antibodies will help the efforts to successfully and reliably design new vaccines that make these highly desired responses (like vaccines against new pandemics).
The investigators designed this study to better understand how the HPV vaccine generates such high levels of long-lasting antibodies in humans. To do this, the investigators need to study early immune responses in lymph nodes, which is where cells that make antibodies (B cells) are activated by the vaccine. The investigators will also need to study immune responses in blood. For example, to measure the levels of antibodies in blood and also the levels of cells that help B cells (helper T cells). As the HPV vaccine can protect against oropharyngeal cancer, the study team aim to understand the level of antibodies in the saliva and how the antibodies compare to blood. Finally, antibodies themselves are not long-lived as proteins, but the cells that make these antibodies are (specialized B cells called plasma cells). Plasma cells are found in the bone marrow. It is important that the research team finds and study these cells making antibodies against HPV, so the investigators can better understand how they contribute to long-lasting antibody levels.
- Conditions
- HPV
- Being tested
- Gardasil-9, Lidocaine injections
- Keywords
- HPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardasil-9Biological
Also called HPV vaccine
Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180 The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.
Lidocaine injectionsDrug
1-2% lidocaine injections.
1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Lymph node sampling at D-30 to D0, D14 and D30 | Experimental | 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. Receives: Biological: Gardasil-9; Drug: Lidocaine injections |
| Group 2: Lymph node sampling at D60, D74 and D90 | Experimental | 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. Receives: Biological: Gardasil-9; Drug: Lidocaine injections |
| Group 3: Lymph node sampling at D180, D194 and D210 | Experimental | 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. Receives: Biological: Gardasil-9; Drug: Lidocaine injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Minimum Four-fold Rise in Post-vaccination HPV-16 and HPV-18 Neutralizing Antibody Titers
Determining the number of participants with a minimum four-fold rise in post-vaccination HPV-16 and HPV-18 neutralizing antibody titers determined using an HPV pseudovirus neutralization assay
Measured: 30 days after receiving the third and final vaccine dose (approximately Day 210 after first vaccine dose)
Secondary outcomes (1)
Change in Number of HPV-specific Memory B Cell (Bmem) Response From Baseline
Magnitude of HPV specific Bmem responses will be assessed at baseline and following 9-valent HPV vaccination
Baseline (Day 0), Day 30, Day 180, Day 210, Day 365, Day 730
Measured: Baseline (Day 0), Day 30, Day 180, Day 210, Day 365, Day 730 post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start21 Dec 2021
- Primary completion23 Oct 2024
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Scherer, PhD, Emory University
- Investigators
- Erin Scherer, Ph.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031078
- Sponsor's protocol ID
- STUDY00002830
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2021
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data, after deidentification, and RNA sequencing data
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Immunological Basis of Durable Antibody Responses to 9-valent HPV Vaccination
- ClinicalTrials.gov ID
- NCT05031078
- Acronym / sponsor ID
- STUDY00002830
- Conditions
- HPV
- Keywords
- HPV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 26 Mar 2026 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Posted 23 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, longitudinal cohort study in which subjects will receive 9-valent HPV vaccine according to package insert (i.e., one dose of 9-valent HPV vaccine on day (D) 0 followed by a second dose 2 months later and a third dose 6 months later).
Immune responses in the blood, saliva, bone marrow, and lymph nodes will be assessed in subjects receiving the HPV vaccine.
Blood samples for immunologic testing will be collected at screening (from D-60 to D-45), on D0 (before vaccination), D1 (optional visit), D7±1, D14±5, D30±5, D60±5 (Visit 8, before vaccination), Visit 8 +1 day (optional visit), Visit 8 + 7±1 days, Visit 8 + 14±5 days, Visit 8 + 30±5 days, D180±5 (Visit 13, before vaccination), Visit 13 + 7±1 days, Visit 13 + 14±5 days, Visit 13 + 30±5 days, D365±14, D730±14, D1095±14, D1460±14, D1825±30. Saliva samples for antibody testing will be collected on D0 (before vaccination), D30, D60 (before vaccination), Visit 8 + 30±5 days, D180 (before vaccination), Visit 13 + 30±5 days, D365, and D730.
Axillary lymph node sampling by fine needle aspiration will be done 3 times per group. Group 1 will have lymph node sampling done D-30 to D0, D14, and D30. Group 2 will have lymph node sampling done D60, Visit 8 + 14±5 days, and Visit 8 + 30±5 days. Group 3 will have lymph node sampling D180, Visit 13 + 14±5 days, and Visit 13 + 30±5 days. Bone marrow sampling will be done for all groups at D730±14 and D1825±30.
Detailed description
Human papillomaviruses (HPV) cause cervical, anal, oropharyngeal, vulvar, vaginal, and penile cancers. There are over 200 types of HPV; 12 are known to cause cancer. The current HPV vaccine is a subunit vaccine, meaning it is made of only part of the virus (a protein) and cannot infect humans. The HPV vaccine is highly effective at preventing disease by HPV types that cause 90% of cancer cases and 90% of genital warts cases in women and men who do not have ongoing or prior HPV infection.
Most vaccines protect by generating antibodies. Importantly, the HPV vaccine, first approved in 2006, has been shown to make high levels of antibodies against HPV that last for >10 years. The durability of HPV vaccine antibody levels is exceptional compared to other approved and experimental subunit vaccines whose antibody levels drop more rapidly. However, how the HPV vaccine - let alone any vaccine - generates long-lasting antibodies is not understood. Understanding how vaccines make high levels of long-lasting antibodies will help the efforts to successfully and reliably design new vaccines that make these highly desired responses (like vaccines against new pandemics).
The investigators designed this study to better understand how the HPV vaccine generates such high levels of long-lasting antibodies in humans. To do this, the investigators need to study early immune responses in lymph nodes, which is where cells that make antibodies (B cells) are activated by the vaccine. The investigators will also need to study immune responses in blood. For example, to measure the levels of antibodies in blood and also the levels of cells that help B cells (helper T cells). As the HPV vaccine can protect against oropharyngeal cancer, the study team aim to understand the level of antibodies in the saliva and how the antibodies compare to blood. Finally, antibodies themselves are not long-lived as proteins, but the cells that make these antibodies are (specialized B cells called plasma cells). Plasma cells are found in the bone marrow. It is important that the research team finds and study these cells making antibodies against HPV, so the investigators can better understand how they contribute to long-lasting antibody levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Lymph node sampling at D-30 to D0, D14 and D30 | Experimental | Biological: Gardasil-9, Drug: Lidocaine injectionsParticipants 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. |
| Group 2: Lymph node sampling at D60, D74 and D90 | Experimental | Biological: Gardasil-9, Drug: Lidocaine injectionsParticipants 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 3: Lymph node sampling at D180, D194 and D210 | Experimental | Biological: Gardasil-9, Drug: Lidocaine injectionsParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Individuals aged 18-45 years old (inclusive), as the HPV vaccine is approved for this age range in adults
- BMI ≤ 32.
- Able to understand and give informed consent (provided in American English).
- Must be in good health based on physical examination, vital signs, medical history, and the investigator's clinical judgment.
- Must be available and willing to participate for the duration of this study
Key exclusion criteria (32 listed)
- Ever received a dose of an HPV vaccine
- HPV 6, 11, 16, 18, 31, 33, 45, 52 or 58 seropositivity
- Any history of genital warts, an abnormal pap smear, or positive HPV DNA test
- Has known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products
- Has known allergy or history of anaphylaxis to yeast or products containing yeast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gardasil-9Also: HPV vaccineParticipants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180 The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap. | Biological | Group 1: Lymph node sampling at D-30 to D0, D14 and D30, Group 2: Lymph node sampling at D60, D74 and D90, Group 3: Lymph node sampling at D180, D194 and D210 |
| Lidocaine injections1-2% lidocaine injections. 1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg. | Drug | Group 1: Lymph node sampling at D-30 to D0, D14 and D30, Group 2: Lymph node sampling at D60, D74 and D90, Group 3: Lymph node sampling at D180, D194 and D210 |
Primary outcome
Number of Participants With a Minimum Four-fold Rise in Post-vaccination HPV-16 and HPV-18 Neutralizing Antibody Titers
Time frame: 30 days after receiving the third and final vaccine dose (approximately Day 210 after first vaccine dose)
Determining the number of participants with a minimum four-fold rise in post-vaccination HPV-16 and HPV-18 neutralizing antibody titers determined using an HPV pseudovirus neutralization assay
1 secondary outcome
Change in Number of HPV-specific Memory B Cell (Bmem) Response From Baseline
Time frame: Baseline (Day 0), Day 30, Day 180, Day 210, Day 365, Day 730 post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data, after deidentification, and RNA sequencing data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Scherer, Ph.D. principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gardasil-9 and Lidocaine injections in people with HPV, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Minimum Four-fold Rise in Post-vaccination HPV-16 and HPV-18 Neutralizing Antibody Titers (time frame: 30 days after receiving the third and final vaccine dose (approximately Day 210 after first vaccine dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.