Testing RG1-VLP Vaccine to Prevent HPV-related Cancers

Inclusion Criteria:

• Women, age 18 - 60 years. Because no dosing or adverse event (AE) data is currentlyavailable for the use of RG1-VLP in humans, children and adolescents are excludedfrom this study

• White blood cell (WBC) between 3000/mm^3 - institutional upper limit of normal

• Hemoglobin (Hgb) between 10 g/dl - institutional upper limit of normal

• Platelets >= 100,000/mm^3

• Serum creatinine within institutional normal limits

• Bilirubin =< 2x institutional upper limit of normal

• Alanine aminotransferase (ALT) =< 2x institutional upper limit of normal

• Aspartate aminotransferase (AST) =< 2x institutional upper limit of normal

• Human immunodeficiency virus (HIV)-1/HIV-2 negative

• Hepatitis B and hepatitis C negative

• The effects of RG1-VLP vaccination on the developing human fetus at the proposeddoses are unknown. For this reason, all women of childbearing potential will have apregnancy test and all heterosexually active women must agree to use adequatecontraception (hormonal or barrier method of birth control; abstinence) prior tostudy entry and for the duration of study participation. Should a woman becomepregnant or suspect she is pregnant while participating in this study, she shouldinform her study physician immediately

• The following persons are not considered to be able to bear children and aretherefore eligible to participate without the use of concurrent birth control:

• Female with bilateral oophorectomy and/or hysterectomy

• Female with fallopian tubes cut, tied or sealed

• Female with sterilization implant (e.g. Adiana, Essure) placed > 3 months priorto randomization

• Female post-menopausal (> 1 year since last menses or prior laboratory folliclestimulating hormone [FSH] value per institutional range indicatingpost-menopausal)

• Eastern Cooperative Oncology Group (ECOG) performance status of =< 1

• Ability to understand and the willingness to sign a written informed consentdocument

Exclusion Criteria:

• History of any of the following:

• Prior or current genital warts

• Treatment for anogenital intraepithelial neoplasia (cervical intraepithelialneoplasia [CIN], anal intraepithelial neoplasia [AIN], vaginal intraepithelialneoplasia [VAIN], vulvar intraepithelial neoplasia [VIN])

• Systemic cancer treatment within the prior year

• History of anaphylaxis to vaccines

• Any prior vaccination with Gardasil, Gardasil-9, or Cervarix or other HPV vaccine

• Receipt of blood products within 3 months of enrollment, or continuing plasmadonation

• Participants receiving any other investigational agents

• History of allergic reactions attributed to compounds of similar chemical orbiologic composition to the adjuvant or to RG1-VLP

• Uncontrolled intercurrent illness or psychiatric illness/social situations thatwould limit compliance with study requirements or preclude protocol vaccination

• Pregnant women or actively lactating women are excluded from this study becauseRG1-VLP is a vaccine with the potential for teratogenic or abortifacient effects

• Planned receipt of any inactivated vaccine in the 2 weeks preceding and the 2 weeksfollowing any trial vaccination

• Planned receipt of any live attenuated vaccine in the 4 weeks preceding and the 4weeks following any trial vaccination

• Women with a history of bleeding disorders or use of anticoagulants (aspirin isacceptable)

• Had prior medical diagnoses:

• Rheumatoid arthritis or other auto-immune disease

• Congenital or acquired immunodeficiency

• Collagen vascular disease

• Following medical treatments:

• Current use of immunosuppressive drugs including corticosteroid use (inhaled ortopical steroids are permitted)

• Unrecovered major infections and/or surgical procedures