HPV Vaccine Reduced Dose

PHASE4RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 6, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions
HPV
Interventions
BIOLOGICAL

Gardasil-9

"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."

DRUG

Lidocaine injection

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.

DRUG

Lorazepam

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.

Trial Locations (1)

30030

RECRUITING

Hope Clinic of the Emory Vaccine Center, Decatur

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Emory University

OTHER

NCT06799494 - HPV Vaccine Reduced Dose | Biotech Hunter | Biotech Hunter