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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728881
Recruitment Status : Active, not recruiting
First Posted : November 2, 2018
Last Update Posted : April 26, 2023
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus-Related Cervical Carcinoma Biological: Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine Biological: Recombinant Human Papillomavirus Bivalent Vaccine Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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")
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : September 30, 2022
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HPV Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group I (Cervarix)
Participants 9-14 years old receive Cervarix IM at baseline.
 Biological: Recombinant Human Papillomavirus Bivalent Vaccine
Given IM
Other Names:
  • Cervarix
  • GSK-580299
  • HPV 16/18 L1 VLP/AS04 VAC
  • HPV-16/18 VLP/AS04 Vaccine
  • Human Papillomavirus 16/18 L1 Virus-Like Particle/AS04 Vaccine
  • Human Papillomavirus Bivalent Types 16 and 18 Vaccine, Recombinant
  • Human Papillomavirus Vaccine L1 16,18
  • Human Papillomavirus Vaccine, L1 Type 16, 18
  • Recombinant HPV Bivalent Vaccine
Active Comparator: Group II (Gardasil)
Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity.
 Biological: Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine
Given IM
Other Names:
  • Gardasil
  • Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine
  • quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccine
  • Recombinant Human Papillomavirus (HPV) Quadrivalent Vaccine
  • V501


Outcome Measures
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Primary Outcome Measures :
  1. Human papillomavirus (HPV) 16 antibody level [ Time Frame: At 24 months after initial vaccination ]
    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.

  2. HPV-16 antibody level [ Time Frame: At 36 months after initial vaccination ]
    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.

  3. HPV-18 antibody level [ Time Frame: At 24 months after initial vaccination ]
    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.

  4. HPV-18 antibody level [ Time Frame: At 36 months after initial vaccination ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged between:

    • 9 and 14 years inclusive for Cervarix group
    • 18 and 25 years inclusive for Gardasil group
  • Living in the study area without plans to move outside the country in the next six months
  • Able to communicate with study personnel
  • Able and willing to provide a blood sample
  • Willing to permit export of blood samples to the United States

  • Willing to participate in the study and:

    • If Cervarix group and less than 12 years old, receive study information and be supported in study participation by at least one of parent (or guardian), who is willing to sign the informed consent document
    • If Cervarix group and 12 years old or older, sign the informed assent and be supported in study participation by at least one parent (or guardian), who is willing to sign the informed consent document
    • If Gardasil group, sign the informed consent
  • In good health as determined by a medical history (physical exam will be conducted if necessary per the doctor's criterion)

Exclusion Criteria:

  • They have a diagnosis of an autoimmune, degenerative, or neurological disease without treatment or adequate control; a progressive or severe neurological disease; a genetic immunodeficiency; or any other serious chronic disease without treatment and / or adequate control that, according to the principal investigator or designee, for which vaccination is contraindicated (NOTE: Potential participants with these conditions can be included after consultation with the external medical advisor of the study or with an appropriate specialist)
  • They are allergic to one of the vaccine components, including yeast (if Gardasil group)
  • They have received immunoglobulins within 90 days preceding enrollment/vaccination visit
  • They are unwilling to provide a blood sample
  • Unwilling to permit export of blood samples to the United States
  • They have a positive urine pregnancy test result
  • They are pregnant
  • They are planning to become pregnant
  • The clinician determining eligibility in agreement with the principal investigator considers that there is a reason that precludes participation
  • They have been vaccinated against HPV
  • The participant or her parent/legal guardian, as applicable, does not have an identification document
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728881


Locations
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Costa Rica
Agencia Costarricense de Investigaciones Biomédicas (ACIB)
Liberia, Guanacaste, Costa Rica, 50101
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Aimee R Kreimer National Cancer Institute (NCI)
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03728881    
Other Study ID Numbers: NCI-2020-07432
NCI-2020-07432 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
999919009
19-C-N009 ( Other Identifier: National Cancer Institute )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: April 26, 2023
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs