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Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ESCUDDO Study (ESCUDDO)

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: NCT03180034
Recruitment Status : Active, not recruiting
First Posted : June 8, 2017
Last Update Posted : December 14, 2020
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase IV trial investigates whether one dose of a human papillomavirus vaccine works as well as two doses in preventing human papillomavirus (HPV) infection. Certain types of HPV cause almost all cases of cervical cancer. Vaccines that protect against infection with these types of human papillomavirus may reduce the risk of cervical cancer. Both Gardasil-9 and Cervarix protect against HPV 16 and 18, which cause 70% of all cervical cancers. However, HPV vaccination rates are too low, especially in countries with very high rates of cervical cancer. HPV vaccines are expensive-many countries cannot afford them-more than one dose is needed, and giving multiple doses is difficult. Researchers want to find out if one dose prevents HPV infection. If it does, more people might get the vaccine.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Infection Human Papillomavirus-Related Cervical Carcinoma Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed Other: Questionnaire Administration Biological: Recombinant Human Papillomavirus Bivalent Vaccine Biological: Recombinant Human Papillomavirus Nonavalent Vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Scientific Evaluation of One or Two Doses of Vaccine Against Human Papillomavirus: the ESCUDDO Study ("Estudio de Comparacion de Una y Dos Dosis de Vacunas Contra el Virus de Papiloma Humano (VPH)")
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (Gardasil, DTaP)
Participants receive Gardasil IM at month 0 and DTaP IM at month 6.
Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed
Given IM
Other Names:
  • Adacel
  • Daptacel
  • Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
  • Diphtheria Toxoid Tetanus Toxoid Acellular Pertussis Vaccine Adsorbed
  • Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine
  • DTaP
  • Infanrix
  • Tripedia

Other: Questionnaire Administration
Ancillary studies

Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
Given IM
Other Names:
  • Gardasil 9
  • Nonavalent HPV VLP Vaccine
  • Recombinant HPV Nonavalent Vaccine
  • Recombinant Human Papillomavirus 9-valent Vaccine

Experimental: Arm II (Cervarix, DTaP)
Participants receive Cervarix IM at month 0 and DTaP IM at month 6.
Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed
Given IM
Other Names:
  • Adacel
  • Daptacel
  • Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
  • Diphtheria Toxoid Tetanus Toxoid Acellular Pertussis Vaccine Adsorbed
  • Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine
  • DTaP
  • Infanrix
  • Tripedia

Other: Questionnaire Administration
Ancillary studies

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: Arm III (Gardasil)
Participants receive Gardasil IM at month 0 and 6.
Other: Questionnaire Administration
Ancillary studies

Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
Given IM
Other Names:
  • Gardasil 9
  • Nonavalent HPV VLP Vaccine
  • Recombinant HPV Nonavalent Vaccine
  • Recombinant Human Papillomavirus 9-valent Vaccine

Active Comparator: Arm IV (Cervarix)
Participants receive Cervarix IM at month 0 and 6.
Other: Questionnaire Administration
Ancillary studies

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

No Intervention: Arm V (epidemiologic survey)
A concurrent epidemiologic survey for HPV status among unvaccinated women. Survey participants are followed for two study visits six months apart to determine their HPV DNA status, with no further follow-up. These women will be offered HPV vaccination (Cervarix) at the two study visits.



Primary Outcome Measures :
  1. Incidence of persistent human papillomavirus (HPV)-16 and/or HPV-18 cervical infections [ Time Frame: Months 42 and 48 ]
    To be considered incident and persistent, an HPV-16 and/or HPV-18 infection must fulfill the following criteria: Two same-type HPV positive (by polymerase chain reaction [PCR]) test results 3+ months apart at consecutive study visits reported after the 6-month visit (i.e. 12-month visit or later); type-specific HPV negative (by urine or, if available, PCR) test results from baseline and 6 month visits.

  2. Incidence of persistent HPV-16 and/or HPV-18 cervical infections [ Time Frame: Baseline, 6 months ]
    To be considered incident and persistent, an HPV-16 and/or HPV-18 infection must fulfill the following criteria: Two same-type HPV positive (by PCR) test results 3+ months apart at consecutive study visits reported after the 6-month visit (i.e. 12-month visit or later); type-specific HPV negative (by urine or, if available, PCR) test results from baseline and 6 month visits.


Secondary Outcome Measures :
  1. Immunogenicity of one or two doses of Cervarix [ Time Frame: Up to 4 years ]
    Will be compared between girls who received one or two doses of recombinant human papillomavirus bivalent vaccine (Cervarix). Measured via measurement of serum antibodies.

  2. Immunogenicity of one or two doses of Gardasil 9 [ Time Frame: Up to 4 years ]
    Will be compared between girls who received one or two doses of recombinant human papillomavirus nonavalent vaccine (Gardasil 9). Measured via measurement of serum antibodies.

  3. Incidence of any new HPV infection (after Gardasil 9) [ Time Frame: Up to 4 years ]
    Demonstrate non-inferiority of one versus two doses of Gardasil 9 in the prevention of any new vaccine type HPV infection.

  4. Incidence of any new carcinogenic HPV cervical infection (after Cervarix) [ Time Frame: Up to 4 years ]
    Demonstrate non-inferiority of one versus two doses of Cervarix in the prevention of any new carcinogenic HPV cervical infection.

  5. Cost and cost-effectiveness evaluation of HPV vaccination in Costa Rica [ Time Frame: Up to 4 years ]


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:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Living in the study area without plans to move outside the country in the next six months
  • Able to communicate with study personnel
  • Willing to participate in the study and sign the informed assent
  • Supported in study participation by at least one of their parents (or guardians), who is willing to sign the informed consent document
  • 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, yeast, or latex
  • The clinician determining the eligibility in agreement with principal investigator considers that there is a reason that precludes participation
  • They have been vaccinated against HPV
  • The girl or her parent/legal guardian does not have an identification document

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): NCT03180034


Locations
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Costa Rica
Agencia Costarricense de Investigaciones Biomédicas (ACIB)
Liberia, Guanacaste, Costa Rica
Sponsors and Collaborators
National Cancer Institute (NCI)
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Aimee R Kreimer National Cancer Institute (NCI)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03180034    
Other Study ID Numbers: NCI-2020-08550
NCI-2020-08550 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
999917108
17-C-N108 ( Other Identifier: National Cancer Institute )
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: November 2020

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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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Infection
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs