Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine

NCT ID: NCT02968420

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2019-05-15

Brief Summary

The overall aim of this study is to further understand the memory response to HPV vaccination in subjects who have received 2 versus 3 doses of quadrivalent HPV vaccine. Although memory responses can be detected shortly after immunization, the best approach to measure the long-lasting anamnestic response is to challenge with a booster dose years (> 5) after the original exposure.

Detailed Description

This is a single center, interventional study to evaluate long term memory response to Q-HPV vaccination and to natural infection. Memory response will be assessed by measuring seroprotection 8-10 years post Q-HPV vaccination and to challenge with a booster dose years after the original exposure to measure the long-lasting anamnestic response.

Conditions

Human Papillomavirus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.

Group Type: ACTIVE_COMPARATOR

Human Papillomavirus 9-valent Vaccine, Recombinant

Intervention Type: BIOLOGICAL

All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.

Group 2

Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.

Group Type: ACTIVE_COMPARATOR

Human Papillomavirus 9-valent Vaccine, Recombinant

Intervention Type: BIOLOGICAL

All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.

Group 3

Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.

Group Type: ACTIVE_COMPARATOR

Human Papillomavirus 9-valent Vaccine, Recombinant

Intervention Type: BIOLOGICAL

All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.

Interventions

Human Papillomavirus 9-valent Vaccine, Recombinant

All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.

Intervention Type: BIOLOGICAL

Other Intervention Names

Gardasil9

Eligibility Criteria

Inclusion Criteria

• Written informed consent provided by the participant.
• Participant whom the investigator believes can and will comply with the requirements of the protocol.
• General good health.
• Immunized with Q-HPV vaccine between the ages of 9-13 or 16 to 26 years on the BCGov01 study or the BC provincial program.
• Participant who is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study. Examples of effective methods of birth control include:

• Abstinence (no sexual activity)
• Hormonal contraceptives including oral, injectable, implants & skin patches
• Intrauterine device (IUD)
• Male partner sterilization
• Male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository)
• Male condom combined with a female diaphragm, whether with or without a vaginal spermicide (foam, gel, cream, or suppository)
• Adequate contraception does not apply to participants with same sex partners, when this is their preferred and usual lifestyle

Exclusion Criteria

• Received more than 3 doses of Q-HPV vaccine
• Received any doses of HPV9 vaccine
• Systemic hypersensitivity to Q-HPV vaccine or HPV9 vaccine or severe reaction to any previous dose of Q-HPV vaccine.
• Receipt of blood or blood product within 3 months prior to Visit 1.
• Receipt of a live vaccine within 28 days or an inactive vaccine within 14 days of Visit 1
• Immune compromise resulting from disease or immunosuppressive systemic medication use within 3 months prior to Visit 1.
• Inadequate participant fluency in English to provide fully informed consent.
• Participant who is currently pregnant or planning a pregnancy during the course of the trial

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Canada Inc.

INDUSTRY

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Manish Sadarangani

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobi Kollmann, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Vaccine Evaluation Center, University of British Columbia

Manish Sadarangani, BM BCh DPhil

Role: PRINCIPAL_INVESTIGATOR

Vaccine Evaluation Center, University of British Columbia

Locations

Vaccine Evaluation Center, BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

Countries

Canada

References

Olsson SE, Villa LL, Costa RL, Petta CA, Andrade RP, Malm C, Iversen OE, Hoye J, Steinwall M, Riis-Johannessen G, Andersson-Ellstrom A, Elfgren K, von Krogh G, Lehtinen M, Paavonen J, Tamms GM, Giacoletti K, Lupinacci L, Esser MT, Vuocolo SC, Saah AJ, Barr E. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine. 2007 Jun 21;25(26):4931-9. doi: 10.1016/j.vaccine.2007.03.049. Epub 2007 Apr 20.

Reference Type: BACKGROUND

PMID: 17499406 (View on PubMed)

Carter JJ, Smith RA, Scherer EM, Skibinski DAG, Sankaranarayanan S, Luxembourg A, Kollmann T, Marty KD, Sadarangani M, Dobson S, Galloway DA. Term immune memory responses to human papillomavirus (HPV) vaccination following 2 versus 3 doses of HPV vaccine. Vaccine. 2025 Mar 19;50:126817. doi: 10.1016/j.vaccine.2025.126817. Epub 2025 Feb 5.

Reference Type: DERIVED

PMID: 39914257 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

H16-00700

Identifier Type: -

Identifier Source: org_study_id