Neoplasms

All Conditions

Infections

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Communicable Diseases

Papillomavirus Infections

All Drugs and Chemicals

Vaccines

Immunologic Factors

Participants 9-14 years old receive Cervarix IM at baseline.

Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity.

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

Recombinant Human Papillomavirus Bivalent Vaccine

Aimee R Kreimer

This phase IIIb trial compares a single dose of the Cervarix vaccine in girls to 3 doses of the Gardasil vaccine in young women for the prevention of human papillomavirus (HPV) infection. Cervarix is a vaccine used to prevent cervical cancer caused by HPV types 16 and 18. Gardasil is vaccine used to prevent cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11. Giving only one dose of the Cervarix vaccine in girls may work the same as 3 doses of the Gardasil vaccine in young women in preventing HPV infection and ultimately, cervical and other HPV-related cancers. Currently, many women around the world cannot get HPV vaccines because they are too expensive. If this trial can show one dose given to young girls is enough to prevent cancer, more girls might be able to get the vaccine.

PRIMARY OBJECTIVE:

I. To demonstrate that the immunogenicity (as determined by enzyme-linked immunosorbent assay \[ELISA\]) of a single dose of recombinant human papillomavirus bivalent vaccine (Cervarix) in 9-14 year old girls is non-inferior to the immunogenicity of three doses of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Gardasil), administered at 0, 2, and 6 months, in 18-25 year old women 36 months after initial vaccination, with an interim analysis at 24 months after initial vaccination.

SECONDARY OBJECTIVES:

I. To compare the distribution of HPV -16 and HPV-18 antibodies levels, assessed at 24 and 36 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women.

II. To compare rates of seroconversion based on HPV-16 and HPV-18 antibody levels, assessed at 24 and 36 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women.

III. To compare geometric mean titers (GMTs), distributions, and seroconversion rates for HPV-16 and HPV-18 antibodies, assessed at 24 and 36 months after initial vaccination, following a single dose of Cervarix in 9-11 year old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women; to perform a similar comparison restricting to 12-14 year old girls.

IV. To compare GMTs, distributions, and seroconversion rates for HPV-16 and HPV-18 antibodies, assessed at 1-month after vaccination and 1-year after vaccination, following a single dose of Cervarix in 9-10 year old girls and a single dose of Cervarix in 11-14 year old girls.

V. To evaluate whether baseline variables (e.g. geographic district, initial antibody levels, date of vaccination) are associated with GMTs, distributions, and seroconversion rates for HPV16 and HPV-18 antibodies, assessed at 24 and 36 months after initial vaccination.

OUTLINE: Participants are assigned to 1 of 2 groups.

GROUP I: Participants 9-14 years old receive Cervarix intramuscularly (IM) at baseline.

GROUP II: Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity.

After completion of trial vaccine dose(s), participants are followed up at 1, 12, 24, and 36 months.

Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial

Non-Inferiority Trial Comparing Immunogenicity From 1-Dose of Bivalent HPV Vaccine in Girls to 3-Doses of Quadrivalent Vaccine in Women: The PRIMAVERA-ESCUDDO Trial ("Puente de Respuesta Inmunológica Para Mejorar el Acceso a Vacunas y ERrAdicar el Cancer")

Will measure HPV-16 specific serum antibody using the HPV type-specific enzyme-linked immunoassay (ELISA) on serum. Will estimate the two-sided 99% confidence interval of the geometric mean titer (GMT) ratios for HPV-16 and HPV-18 at 24 months and the two-sided 96% confidence intervals of the GMT ratios for HPV-16 and HPV-18 at 36 months.

Will measure HPV-16 specific serum antibody using the HPV type-specific ELISA on serum. Will estimate the two-sided 99% confidence interval of the GMT ratios for HPV-16 and HPV-18 at 24 months and the two-sided 96% confidence intervals of the GMT ratios for HPV-16 and HPV-18 at 36 months.

Will measure HPV-18 specific serum antibody using the HPV type-specific ELISA on serum. Will estimate the two-sided 99% confidence interval of the GMT ratios for HPV-16 and HPV-18 at 24 months and the two-sided 96% confidence intervals of the GMT ratios for HPV-16 and HPV-18 at 36 months.

National Cancer Institute (NCI)

Uterine Cervical Neoplasms

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

Patients receive one dose of Gardasil 9 IM.

Patients receive one dose of Cervarix IM.

Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed

Questionnaire Administration

Recombinant Human Papillomavirus Nonavalent Vaccine

This phase IV trial tests whether a single dose of the human papillomavirus (HPV) vaccine works in preventing cervical cancer in young women in Costa Rica. Human papilloma viruses, called HPV, are a group of viruses that very frequently cause infection in both men and women, mainly in the genital organs. There are many types of HPV, and some can cause cancer. The World Health Organization recommends a two-dose schedule for adolescents 9-14 and three doses for individuals 15 years old or older. This study examines whether a single dose of HPV vaccine can reduce the frequency with which women between ages 18-30 become infected with HPV.

PRIMARY OBJECTIVES:

I. To evaluate one dose of nonavalent human papillomavirus (HPV) vaccination compared to no vaccination in the protection against incident HPV16/18 cervical HPV infections that persist 6-months or more in women aged 18 to 30 years who are cervical HPV16/18 deoxyribonucleic acid (DNA) negative prior to and at the time of vaccination.

II. To evaluate one dose of bivalent HPV vaccination compared to no vaccination in the protection against incident HPV16/18 cervical HPV infections that persist 6-months or more in women aged 18 to 30 years who are cervical HPV16/18 DNA negative prior to and at the time of vaccination.

SECONDARY OBJECTIVES:

I. To quantitate the benefit of one dose of HPV vaccination compared to no vaccination in the protection against incident HPV16/18 cervical HPV infections that persist 6-months or more in women aged 18 to 30 years regardless of cervical HPV DNA status at the time of vaccination.

II. To estimate the health impact of older-age single-dose HPV vaccination by modeling the number of cervical cancer cases prevented as well as the cost-effectiveness of cervical cancer prevention strategies incorporating vaccination and screening in Costa Rica.

III. To evaluate the immunogenicity (absolute levels and stability of serum antibodies) of single dose HPV vaccination in women.

IV. For each vaccine separately, to evaluate one dose of HPV vaccination compared to no vaccination in the protection against:

IVa. Any new HPV16/18 anal infection that persists 6+ months. IVb. Any new HPV16/18 oral infection that persists 6+ months. IVc. Any new carcinogenic HPV cervical, anal or oral infection detected at a single timepoint and that persists 6+ months.

IVd. Any new cervical HPV6/11 infection that persists 6+ months.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive one dose of recombinant human papillomavirus nonavalent vaccine (Gardasil 9) intramuscularly (IM).

ARM II: Patients receive one dose of recombinant human papillomavirus bivalent vaccine (Cervarix) IM.

ARM III: Patients receive one dose of diphtheria toxoid/tetanus toxoid/acellular pertussis vaccine adsorbed vaccine (Adacel) IM.

After completion of study, patients are followed up at 6 and 12 months, and then every 6 months thereafter.

Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial

Single-Dose HPV Vaccination Among Young Adult Women in Costa Rica: the PRISMA-ESCUDDO Trial (PRevencIón Del Cáncer Cervical Con Una Sola Dosis de Vacuna Contra VPH en Mujeres Adultas Jóvenes)

Will estimate the rate of incident persistent infections (i.e. the primary endpoint defined above) in each of the three arms of an ATP cohort and then estimate the two Vaccine Efficacies (VE), comparing each HPV vaccine arm against the control arm. Will require a one-sided p-value of \< 0.0125 for statistical significance. The 97.5% confidence intervals for the VE will be calculated by inverting appropriate hypotheses tests.

Will require a one-sided p-value of \< 0.0125 for statistical significance. The 97.5% confidence intervals for the VE will be calculated by inverting appropriate hypotheses tests.

Will report the Geometric Mean Titer (GMT) of the antibodies for each HPV type at the five follow-up visits.

Will report the VE against any new carcinogenic HPV type and against HPV 6/11 in the according to protocol (ATP) cohort using an analysis plan similar to that described for the primary objectives.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial	NCT03728881	Human Papilloma...	Quadrivalent Hu... Recombinant Hum...	9 Years - 25 Years	National Cancer Institute (NCI)
Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial	NCT05237947	Cervical Carcin... Human Papilloma...	Diphtheria Toxo... Questionnaire A... Recombinant Hum... Recombinant Hum...	18 Years - 30 Years	National Cancer Institute (NCI)
Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial	NCT03728881	Human Papilloma...	Quadrivalent Hu... Recombinant Hum...	9 Years - 25 Years	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for recombinant human papillomavirus bivalent vaccine