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

NCT02968420 | Completed Phase 4 Results

• 1 other identifier: H16-00700
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus

Outcome Measures

Primary Outcomes (2)

• B Memory Cell Response (% of Memory B Cells That Are Antigen-specific)

  To compare the B memory cell populations between girls that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose after 120 months

  At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine

• Plasmablast Response (% of All B Cells That Are Plasmablasts)

  To compare the plasmablast populations between girls that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose after 120 months

  At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine

Secondary Outcomes (5)

• Variable Gene Usage (Comparison of the Nucleotide Sequences of Antigen-specific Antibody Heavy and Light Chain Variable Region Sequences)

  At Day 7 and Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine

• Serum Antibody Response (cLIA) - Geometric Mean Titer

  At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine

• Serum Antibody Response (cLIA) - Geometric Mean Titer

  At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine

• Serum Antibody Response (Total IgG) - Geometric Mean Titer

  At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine

• Serum Antibody Response (Total IgG) - Geometric Mean Titer

  At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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.

Biological: Human Papillomavirus 9-valent Vaccine, Recombinant

Group 2

ACTIVE COMPARATOR

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.

Biological: Human Papillomavirus 9-valent Vaccine, Recombinant

Group 3

ACTIVE COMPARATOR

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.

Biological: Human Papillomavirus 9-valent Vaccine, Recombinant

Interventions

Human Papillomavirus 9-valent Vaccine, Recombinant BIOLOGICAL

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

Also known as: Gardasil9

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 17 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Merck Canada Inc.: collaborator

Study Sites (1)

Vaccine Evaluation Center, BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Related Publications (2)

• 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.

  PMID: 17499406 BACKGROUND

• 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.

  PMID: 39914257 DERIVED

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Results Point of Contact

• Title: Dr. Manish Sadarangani
• Organization: Vaccine Evaluation Center

msadarangani@bcchr.ubc.ca

604-875-2422

Study Officials

• Tobi Kollmann, MD PhD

  Vaccine Evaluation Center, University of British Columbia

  PRINCIPAL INVESTIGATOR

• Manish Sadarangani, BM BCh DPhil

  Vaccine Evaluation Center, University of British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: November 18, 2016
• Study Start: September 11, 2017
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: June 25, 2021
• Results First Posted: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)