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Vaccines

Gardasil® 0.5 mL administered intramuscularly in the deltoid or anterolateral area of the thigh

Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

Nelly Mugo, MD

The risk for Human Papillomavirus (HPV) infection persists through an individual sexual life and duration of protection is critical to vaccine effectiveness in protection from oncogenic hrHPV infection. HIV-infected individuals have an increased risk for HPV infection, and persistent infection.

Most vaccine efficacy data among HIV-infected adolescents is represented by immunogenicity data, and there is little published literature on vaccine effectiveness as assessed by persistent incident genital HPV infection.

Investigators shall re-enroll a cohort of previously vaccinated HIV-infected girls and boys for assessment of genital HPV infection 9-years post initial 3 doses of vaccination with quadrivalent HPV vaccine at ages 9 to 14 years.

Background: Genital Human Papilloma Virus (HPV) infections occur rapidly after sexual debut, and immunosuppressed individuals are at greater risk for incident and persistent infection. HPV vaccine contains virus-like particles (VLP), which are highly immunogenic and induce a robust humoral response that has been demonstrated to confer long term protection from HPV infection and associated disease among HIV-uninfected individuals. The magnitude of type-specific vaccine induced neutralizing HPV antibody responses are diminished among HIV-infected compared to uninfected individuals.

There is no established minimum level of antibody that predicts protection against HPV infection or associated disease, the impact of lower antibody titers among HIV infected individuals on vaccine efficacy is unknown. The risk of HPV exposure persists throughout a person's sexual life and the duration of protection, especially when the vaccine is given in the early adolescent period is critical to vaccine effectiveness. Long lasting memory is characterized by memory B cells and long-lived plasma cells and a QHPV booster dose has demonstrated an anamnestic response among HIV-infected adolescents.

HPV efficacy and effectiveness data for HIV-uninfected individuals has informed the current World Health Organization (WHO) two-dose vaccine schedule. The field lacks data on effectiveness of three dose or two-dose for the HIV-infected adolescents. The current on-going research for single dose schedules gives urgency to the determination of long-term efficacy of three HPV vaccine 231 doses for the HIV-infected adolescent.

Investigators shall recall HIV-infected girls and boys who were previously vaccinated at ages 9-14 years with three doses of the quadrivalent vaccine (QHPV) in 2014 and evaluated for vaccine immunogenicity.

Method: The participants will be assessed for genital warts and genital HPV infection. Type specific HPV DNA will be assessed using genital swabs and genital warts assessed through physical examination among sexually active participants at enrollment, month 6 \&12.

Among those that have not become sexually active, or that decline a genital exam, a self-collected swab will be requested. A sub-set of approximately 30 participants, will receive a booster dose of QHPV, from this subset, Peripheral Blood Mononuclear Cells (PBMC) and plasma samples will be collected at enrollment, at month 1 and month 12 to evaluate for memory B and T cell responses.

The total duration of study follow up will be 12 months.

Effectiveness of the Q-HPV Vaccine 9-years Post Vaccination Among HIV Positive Adolescents

A Longitudinal Cohort Study to Assess Effectiveness and B-memory Response to the Quadrivalent HPV Vaccine 9 Years Post-vaccination Among HIV-Infected Boys and Girls Ages 9-14 Years in Kenya

Number of participants with incident persistent genital infection with the QHPV specific serotypes: -6, -11, -16 and -18 and additional 13 oncogenic HPV serotypes (31,33,35,39,45,51,52,56,58,59,66, 68,73)

Concentration of QHPV specific antibody titers (HPV -6, -11, -16 \& -18) nine years after primary vaccination

B cell marker concentration following a booster 4th dose of QHPV

Merck Sharp & Dohme LLC

University of Washington

Associate Professor, School of Medicine: Global Health

Neoplasms

Skin and Connective Tissue Diseases

Papilloma

Warts

Skin Diseases

Skin Diseases, Viral

Skin Diseases, Infectious

Immunologic Factors

Patient receive 0.1 ml of quadrivalent HPV vaccine intralesional every two weeks

Patient received 0.1 ml of bivalent HPV vaccine intralesional once every two weeks

Patient received 0.1 ml of intralesional saline once every two weeks

Bivalent Human Papilloma Virus Vaccine

intralesional into the largest warts every two weeks

Saline

Warts are common, benign, epidermal proliferations caused by HPV infecting skin and mucous membranes. Treatment of warts poses a true challenge despite existing variable therapeutic modalities, whether destructive or immunotherapeutic. Human papilloma virus (HPV) vaccines are FDA approved for the prevention of genital warts and wart related precancerous and cancerous lesions but they are not indicated for treatment of preexisting warts yet

Approximately 35% of viral warts tend to be recalcitrant either showing no response to treatment or having prompt recurrences after treatment, causing frustration for both patients and physicians. Success rates vary significantly across patients and across different therapeutic interventions ranging from 7% to 90%.

Immunotherapy is proposed to enhance virus recognition by the cell mediated immunity, which allows the clearance of both treated and untreated warts and helps to prevent recurrences through induction of a long-term acquired immunity to HPV.

Few reports suggest the possibility of using quadrivalent or bivalent HPV vaccines as therapeutic modality rather than only preventive modality. This is a randomized controlled study to assess the efficacy and safety of quadrivalent and bivalent HPV vaccines in the treatment of warts

Gardasil Versus Cervarix in the Treatment of Warts

Quadrivalent and Bivalent Human Papilloma Virus Vaccines in the Treatment of Common Recalcitrant Warts

The percentage of patients in each group achieving complete, partial or no response at the end of the treatment sessions

Immediate adverse events recorded by the treating physician within 1 hour post injection

Delayed adverse events reported by the patients in between sessions

Percentage of patients experiencing recurrences in each group

Zagazig University

Clinical Professor

Recurrence

Condylomata Acuminata

Blood-Borne Infections

Lentivirus Infections

Retroviridae Infections

RNA Virus Infections

Syndrome

Immunologic Deficiency Syndromes

Patients who are in the control group received a placebo of saline in the upper extremity at initial visit, 2 months and 6 months after enrollment.

The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity at initial visit, and again at two months and six months after enrollment.

0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.

Steven R Hunt, MD

The primary objective of this pilot study is to evaluate the effect of the HPV vaccine Gardasil on anal condylomata recurrence and persistence rates in HIV positive patients.

A quadrivalent human papilloma virus (HPV) vaccine called Gardasil had recently (at start of study) been developed and approved by the FDA for the prevention of cervical HPV infection and cervical cancer, which is associated with infection from this virus. It is unknown whether the same vaccine could also be of benefit in treating anogenital warts, which are caused by the same virus. This is an important and clinically relevant question which needs to be answered. Anal warts have a high prevalence and recurrence and usually require extended lengths of treatment and follow-up, especially in the HIV population. At times, treatment of anal warts requires multiple surgeries to excise them if the burden of disease is high. Therefore, this disease represents a significant expense to patients and the health care system.

Further, the HPV virus that causes anal warts has been associated with anal cancer and with its preliminary lesion known as anal intraepithelial neoplasia (AIN). This study touches on two important, relevant and costly healthcare issues: finding a better treatment for the most common sexually transmitted disease in our country, and helping to prevent anal cancer, which is often a fatal disease.

The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata

The Effect of Human Papillomavirus Vaccination on Recurrence Rates in HIV Positive Patients Treated for Anal Condylomata

No outcomes data were collected or analyzed due to lack of participant follow-up.

Persistence of anal warts will be measured by the presence of any lesions at one month follow-up after surgery. Recurrence of anal warts will be measured by the development of new lesions after one month of follow-up.

Washington University School of Medicine

Serious and/or other non-serious adverse events were not collected or assessed.

Patients who are in the control group received a placebo of saline at initial date, 2 months and 6 months.

Placebo

The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.

Treatment Group

Patients in this group received placebo of saline at initial date, 2 months and 6 months after enrollment.

Patients in this group received Gardasil injection at initial date, 2 months and 6 months after enrollment.

Gardasil

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Baseline characteristics were reported (age, gender, region of enrollment). Five of 17 patients in the placebo group completed study follow-up through at least 6 months and received all three study injections. Seven of 15 patients in the Gardasil group completed study follow-up through at least 6 months and received all three study injections.

Compliance with follow up was an ongoing issue.

Steven Hunt, MD

Patients who received placebo of saline at initial visit, 2 months and 6 months after enrollment.

Placebo Group

Patients who received Gardasil injection at initial visit, 2 months, and 6 months after enrollment.

Gardasil Group

Five patients from the placebo group and seven patients from the gardasil group completed all three injections per the protocol. The remaining patients did not complete study-required follow-up and therefore could not be analyzed. One patient from the Gardasil Group and one patient from the placebo group met the outcome measure of recurrence.

The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.

Patients who are in the control group will receive a placebo of saline at initial date, 2 months and 6 months.

The treatment group will receive a 0.5 mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness of the Q-HPV Vaccine 9-years Post Vaccination Among HIV Positive Adolescents	NCT05435209	HPV Infection HPV Vaccination	Quadrivalent Hu...	16 Years - 25 Years	University of Washington
Gardasil Versus Cervarix in the Treatment of Warts	NCT05383625	Verruca Viral	Quadrivalent Hu... Bivalent Human ... Saline	18 Years -	Zagazig University
The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata	NCT00941889	HIV Positive Anal Condylomat... Anal Warts HIV Infections	Saline Quadrivalent Hu...	18 Years -	Washington University School of Medicine
The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata	NCT00941889	HIV Positive Anal Condylomat... Anal Warts HIV Infections	Saline Quadrivalent Hu...	18 Years -	Washington University School of Medicine
Gardasil Versus Cervarix in the Treatment of Warts	NCT05383625	Verruca Viral	Quadrivalent Hu... Bivalent Human ... Saline	18 Years -	Zagazig University

Spots Global Cancer Trial Database for quadrivalent human papillomavirus (types 6,11,16,18) recombinant vaccine