HPVPhase 4NCT06799494
HPV Vaccine Reduced Dose
A Phase 4 study testing Gardasil-9, Lidocaine injection and Lorazepam in people with HPV, run by Emory University at 1 site in United States.
Trial summary
This study aims to answer the question: does 1-dose HPV vaccination generate the same immune responses compared to 2- or 3-dose HPV vaccination? This will be done by studying the immune response in blood, lymph nodes, and bone marrow. 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, Lidocaine injection and Lorazepam
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2025to Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 (inclusive), as the HPV vaccine is approved for this age range in adults
- BMI < 35
- Able to understand and give informed consent (in American English).
- In good health based on physical examination, vital signs, medical history, and the investigator's clinical judgment.
- Available and willing to participate for the duration of this study
- Willing to undergo lymph node fine-needle aspiration and bone marrow aspiration
- Willing to consent to the future use of remaining (residual) samples/specimens with IRB review
- Willing to defer completion of the recommended 9vHPV series
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 a positive HPV DNA test
- Known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products
- Known allergy or history of anaphylaxis to yeast or products containing yeast.
- Any allergy to lidocaine.
Show all 26Show fewer
- Pregnancy or breastfeeding.
- Participants who believe they cannot tolerate the lymph node fine needle aspirate or bone marrow aspirate procedures without general 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 the targeted area.
- Received any vaccine from 14 days before the vaccine dose until 30 days after each vaccine dose* (*An individual 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 participant continues to meet all other entry criteria)
- Volunteers with fever (≥100.4 F or 38°C regardless of the route) within 3 days before vaccination*. (*An individual 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 participant 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 anticoagulant 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 participant continues to meet all other entry criteria)
- History of active malignancy other than squamous cell or basal cell skin cancer, unless there was a surgical excision considered to have achieved a cure.
- Current and/or expected immunosuppression due to cancer, receipt of chemotherapy, radiation therapy, and other immunosuppressive therapies (including anti-TNF therapy).
- 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) is allowed)
- Known chronic infections including, but not limited to, 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 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 the first vaccine dose or plans to receive any experimental therapeutic agents 12 months after the first vaccine dose that, at the investigator's discretion, 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 this study.
- Is currently participating or plans to participate in another clinical study that would involve the receipt of an investigational product or undergo a procedure that, in the investigator's opinion, would interfere with the 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 investigator's discretion, might interfere with compliance with the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, 30030
About this study
Official title: Comparing the Antibody and B Cell Responses Induced by 1- or 2-dose 9-valent HPV (9vHPV) Vaccination in Healthy Adults
This study aims to answer the question: does 1-dose HPV vaccination generate the same immune responses compared to 2- or 3-dose HPV vaccination? This will be done by studying the immune response in blood, lymph nodes, and bone marrow.
Human papillomaviruses (HPV) cause cancers (cervical, anal, oropharyngeal, vulvar, vaginal, and penile), and the current HPV vaccine is highly effective at preventing disease by HPV types that cause 90% of cancer cases. While this vaccine generates high levels of antibodies that last for > 10 years, understanding of how this occurs is limited, and studying this immune response will help design new and better vaccines.
The study population consists of healthy adult (age 18-45) participants who have not previously received an HPV vaccine, do not have antibodies against certain types of HPV, do not have a history of HPV infection or disease (such as genital warts, abnormal pap test, or HPV DNA test), and do not have contraindications to study procedures. Populations of increased concern are not being enrolled.
Read the detailed description
This study aims to determine whether a single-dose HPV vaccination produces the same immune response as a two- or three-dose HPV vaccination.
The 1-dose HPV vaccination was recently recommended by the World Health Organization (WHO) for people with healthy immune systems aged 9-20 years. To learn whether 1-dose HPV vaccination makes the same immune responses as 2- or 3-dose HPV vaccination in humans, there is a need to study the immune response to the HPV vaccine in the blood (where antibodies are), in the lymph nodes (where immune cells that make antibodies get activated), and in the bone marrow (where long-lived cells that produce antibodies are found). After informed consent, participants will have blood drawn for screening tests. If they are eligible, they will receive the FDA-approved HPV vaccine. The vaccine will be given in 1 or 2 doses, but participants will have the opportunity to receive the full vaccine series at the end of the study. Participants will have additional blood draws and undergo fine needle aspiration (FNA) of a lymph node in the axilla (armpit) at 3 different times. Later, they will have bone marrow aspiration procedures during which marrow is sampled from the hip bone through a needle. Researchers will use this knowledge to inform public health decisions about the broader use of 1-dose HPV vaccination.
- Conditions
- HPV
- Being tested
- Gardasil-9, Lidocaine injection, Lorazepam
- Keywords
- HPV Prevention, HPV Vaccine, Immune responses
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, 9-valent HPV vaccine (9vHPV)
The 9-valent HPV VLP vaccine is a sterile liquid suspension prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant and the final purification buffer. The 9-valent HPV vaccine, or Gardasil-9, is a sterile suspension for intramuscular administration. Each 0.5-mL dose of the vaccine also contains approximately 500 mcg of aluminum (provided as AAHS), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, <7 mcg yeast protein, and water for injection. The product does not contain a preservative or antibiotics.
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. After thorough agitation, GARDASIL 9 is a white, cloudy liquid.
Lidocaine injectionDrug
Also called Lidocaine 1% Injectable Solution
Lidocaine 1% will be injected intradermally and subcutaneously into the margin of the lymph node to be sampled to numb the area. To confer local anesthesia, 1-2% will be injected into the tissue surrounding the area where the bone marrow will be removed.
LorazepamDrug
Lorazepam, an FDA-approved benzodiazepine, will be administered as an anxiolytic before the bone marrow aspirate procedure per the clinician who will perform the procedure. If needed, lorazepam will be administered sublingually per manufacturer dosing recommendations.
| Study group | Role | What they receive |
|---|---|---|
| One dose of the 9-valent HPV vaccine | Experimental | Participants will receive one dose of the 9-valent HPV (9vHPV) vaccine by intramuscular injection on Day 0.
Participants will be asked to donate blood samples for immunologic testing at screening (from Day -60 to -1), on Day 0 (before vaccination), 7±1, 30±5, 180±5 (before vaccination; Visit 5), Visit 5 + 7±1 days, Visit 5 + 30±5 days, 365±14, 730±14 (Visit 10), ≥84 days from Visit 10 (Optional Visit 12), 1095±14 (Optional Visit 13), 1460±14 (Optional Visit 14), 1825±30 (Optional Visit 16), and ≥84 days from Visit 16 (Optional Visit 18).
Axillary lymph node sampling by fine-needle aspiration (FNA) will be done 3 times per group on Day 30±5, 180±5 (Visit 5), and Visit 5 + 30±5 days.
Bone marrow sampling will be done for all groups at Days 730±14 and 1825±30. Receives: Biological: Gardasil-9; Drug: Lidocaine injection; Drug: Lorazepam |
| Two doses of the 9-valent HPV vaccine | Active comparator | Participants will receive two doses of the 9vHPV vaccine on Day 0 and a second dose 6 months later.
Participants will be asked to donate blood samples for immunologic testing at screening (from Day -60 to -1), on Day 0 (before vaccination), 7±1, 30±5, 180±5 (before vaccination; Visit 5), Visit 5 + 7±1 days, Visit 5 + 30±5 days, 365±14, 730±14 (Visit 10), ≥84 days from Visit 10 (Optional Visit 12), 1095±14 (Optional Visit 13), 1460±14 (Optional Visit 14), 1825±30 (Optional Visit 16), and ≥84 days from Visit 16 (Optional Visit 18).
Axillary lymph node sampling by fine-needle aspiration (FNA) will be done 3 times per group on Day 30±5, 180±5 (Visit 5), and Visit 5 + 30±5 days.
Bone marrow sampling will be done for all groups at Days 730±14 and 1825±30. Receives: Biological: Gardasil-9; Drug: Lidocaine injection; Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of plasma cells specific for HPV16/18 virus like particles (VLPs)
Frequency of plasma cells specific for HPV16/18 virus-like particles (VLPs) per total IgG-secreting plasma cells in bone marrow in per-protocol participants of the 1- and 2-dose 9vHPV arms
Measured: 730 days after receiving the first vaccine dose
Secondary outcomes (1)
Frequency of memory B cells specific for HPV16/18 VLPs
Frequency of memory B cells specific for HPV16/18 VLPs per total memory B cells in PBMC in per protocol participants of the 1- and 2-dose 9vHPV arms.
Measured: Baseline (Day 0), Day 30, Day 180, Day 210, Day 365, and 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 posted29 Jan 2025
- Study start6 Aug 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Erin Scherer, PhD, Emory University
- Investigators
- Erin Scherer, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799494
- Sponsor's protocol ID
- STUDY00008623
- Other IDs
- 2025P011496
- Status last verified
- Aug 2026
- First submitted
- 23 Jan 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share de-identified demographic, ELISPOT, pseudovirus neutralization, ELISA, flow cytometry, sc-RNA-seq, paired immunoglobulin repertoire sequencing, monoclonal antibody neutralization, and the monoclonal antibody heavy and light chain sequence data utilized in our publications. Data will be made publicly available in relevant repositories and easy to find in their publications.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Antibody and B Cell Responses Induced by 1- or 2-dose 9-valent HPV (9vHPV) Vaccination in Healthy Adults
- ClinicalTrials.gov ID
- NCT06799494
- Acronym / sponsor ID
- STUDY00008623
- Conditions
- HPV
- Keywords
- HPV Prevention, HPV Vaccine, Immune responses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to answer the question: does 1-dose HPV vaccination generate the same immune responses compared to 2- or 3-dose HPV vaccination? This will be done by studying the immune response in blood, lymph nodes, and bone marrow.
Human papillomaviruses (HPV) cause cancers (cervical, anal, oropharyngeal, vulvar, vaginal, and penile), and the current HPV vaccine is highly effective at preventing disease by HPV types that cause 90% of cancer cases. While this vaccine generates high levels of antibodies that last for > 10 years, understanding of how this occurs is limited, and studying this immune response will help design new and better vaccines.
The study population consists of healthy adult (age 18-45) participants who have not previously received an HPV vaccine, do not have antibodies against certain types of HPV, do not have a history of HPV infection or disease (such as genital warts, abnormal pap test, or HPV DNA test), and do not have contraindications to study procedures. Populations of increased concern are not being enrolled.
Detailed description
This study aims to determine whether a single-dose HPV vaccination produces the same immune response as a two- or three-dose HPV vaccination.
The 1-dose HPV vaccination was recently recommended by the World Health Organization (WHO) for people with healthy immune systems aged 9-20 years. To learn whether 1-dose HPV vaccination makes the same immune responses as 2- or 3-dose HPV vaccination in humans, there is a need to study the immune response to the HPV vaccine in the blood (where antibodies are), in the lymph nodes (where immune cells that make antibodies get activated), and in the bone marrow (where long-lived cells that produce antibodies are found). After informed consent, participants will have blood drawn for screening tests. If they are eligible, they will receive the FDA-approved HPV vaccine. The vaccine will be given in 1 or 2 doses, but participants will have the opportunity to receive the full vaccine series at the end of the study. Participants will have additional blood draws and undergo fine needle aspiration (FNA) of a lymph node in the axilla (armpit) at 3 different times. Later, they will have bone marrow aspiration procedures during which marrow is sampled from the hip bone through a needle. Researchers will use this knowledge to inform public health decisions about the broader use of 1-dose HPV vaccination.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One dose of the 9-valent HPV vaccine | Experimental | Biological: Gardasil-9, Drug: Lidocaine injection, Drug: LorazepamParticipants will receive one dose of the 9-valent HPV (9vHPV) vaccine by intramuscular injection on Day 0. Participants will be asked to donate blood samples for immunologic testing at screening (from Day -60 to -1), on Day 0 (before vaccination), 7±1, 30±5, 180±5 (before vaccination; Visit 5), Visit 5 + 7±1 days, Visit 5 + 30±5 days, 365±14, 730±14 (Visit 10), ≥84 days from Visit 10 (Optional Visit 12), 1095±14 (Optional Visit 13), 1460±14 (Optional Visit 14), 1825±30 (Optional Visit 16), and ≥84 days from Visit 16 (Optional Visit 18). Axillary lymph node sampling by fine-needle aspiration (FNA) will be done 3 times per group on Day 30±5, 180±5 (Visit 5), and Visit 5 + 30±5 days. Bone marrow sampling will be done for all groups at Days 730±14 and 1825±30. |
| Two doses of the 9-valent HPV vaccine | Active comparator | Biological: Gardasil-9, Drug: Lidocaine injection, Drug: LorazepamParticipants will receive two doses of the 9vHPV vaccine on Day 0 and a second dose 6 months later. Participants will be asked to donate blood samples for immunologic testing at screening (from Day -60 to -1), on Day 0 (before vaccination), 7±1, 30±5, 180±5 (before vaccination; Visit 5), Visit 5 + 7±1 days, Visit 5 + 30±5 days, 365±14, 730±14 (Visit 10), ≥84 days from Visit 10 (Optional Visit 12), 1095±14 (Optional Visit 13), 1460±14 (Optional Visit 14), 1825±30 (Optional Visit 16), and ≥84 days from Visit 16 (Optional Visit 18). Axillary lymph node sampling by fine-needle aspiration (FNA) will be done 3 times per group on Day 30±5, 180±5 (Visit 5), and Visit 5 + 30±5 days. Bone marrow sampling will be done for all groups at Days 730±14 and 1825±30. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Individuals aged 18-45 years (inclusive), as the HPV vaccine is approved for this age range in adults
- BMI < 35
- Able to understand and give informed consent (in American English).
- In good health based on physical examination, vital signs, medical history, and the investigator's clinical judgment.
- Available and willing to participate for the duration of this study
Key exclusion criteria (26 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 a positive HPV DNA test
- Known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products
- 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 Vaccine, 9-valent HPV vaccine (9vHPV)The 9-valent HPV VLP vaccine is a sterile liquid suspension prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant and the final purification buffer. The 9-valent HPV vaccine, or Gardasil-9, is a sterile suspension for intramuscular administration. Each 0.5-mL dose of the vaccine also contains approximately 500 mcg of aluminum (provided as AAHS), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, <7 mcg yeast protein, and water for injection. The product does not contain a preservative or antibiotics. 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. After thorough agitation, GARDASIL 9 is a white, cloudy liquid. | Biological | One dose of the 9-valent HPV vaccine, Two doses of the 9-valent HPV vaccine |
| Lidocaine injectionAlso: Lidocaine 1% Injectable SolutionLidocaine 1% will be injected intradermally and subcutaneously into the margin of the lymph node to be sampled to numb the area. To confer local anesthesia, 1-2% will be injected into the tissue surrounding the area where the bone marrow will be removed. | Drug | One dose of the 9-valent HPV vaccine, Two doses of the 9-valent HPV vaccine |
| LorazepamLorazepam, an FDA-approved benzodiazepine, will be administered as an anxiolytic before the bone marrow aspirate procedure per the clinician who will perform the procedure. If needed, lorazepam will be administered sublingually per manufacturer dosing recommendations. | Drug | One dose of the 9-valent HPV vaccine, Two doses of the 9-valent HPV vaccine |
Primary outcome
Frequency of plasma cells specific for HPV16/18 virus like particles (VLPs)
Time frame: 730 days after receiving the first vaccine dose
Frequency of plasma cells specific for HPV16/18 virus-like particles (VLPs) per total IgG-secreting plasma cells in bone marrow in per-protocol participants of the 1- and 2-dose 9vHPV arms
1 secondary outcome
Frequency of memory B cells specific for HPV16/18 VLPs
Time frame: Baseline (Day 0), Day 30, Day 180, Day 210, Day 365, and Day 730 post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. The research team will share de-identified demographic, ELISPOT, pseudovirus neutralization, ELISA, flow cytometry, sc-RNA-seq, paired immunoglobulin repertoire sequencing, monoclonal antibody neutralization, and the monoclonal antibody heavy and light chain sequence data utilized in our publications. Data will be made publicly available in relevant repositories and easy to find in their publications.
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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.
Erin Scherer, PhD principal investigator
Emory University
1 site 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, Lidocaine injection and Lorazepam in people with HPV, run by Emory University at 1 site 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 8 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 31 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Scherer, PhD (404-712-6904, emscher@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of plasma cells specific for HPV16/18 virus like particles (VLPs) (time frame: 730 days after receiving the 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 31 Aug 2026.