HPV Vaccine Reduced Dose

ConditionHPV

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-45

SponsorEmory University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Gardasil-9
Biological/Vaccine
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 injection
Drug
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.
Lorazepam
Drug
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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: One dose of the 9-valent HPV vaccineExperimental treatment 3 interventions

Group B: Two doses of the 9-valent HPV vaccineActive comparator 3 interventions

Trial outcomes

Primary outcomes

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

Time frame

730 days after receiving the first vaccine dose

Secondary outcomes

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.

Time frame

Baseline (Day 0), Day 30, Day 180, Day 210, Day 365, and Day 730 post-intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov

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