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Completed

NCT Number: NCT02968420

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

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.

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Key information

Age range

17 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Vaccine Evaluation Center, BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Gardasil9

Primary outcomes

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

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

    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

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

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

    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

Secondary outcomes

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

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

    To compare the extent of somatic hypermutation and the variable gene usage between girls that received either a primary 2 or 3 dose series

  2. Serum Antibody Response (cLIA) - Geometric Mean Titer

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

    To compare the serum antibody responses (cLIA) to HPV 6, 11, 16 & 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose

  3. Serum Antibody Response (cLIA) - Geometric Mean Titer

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

    To compare the serum antibody responses (cLIA) to HPV 6, 11, 16 & 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose

  4. Serum Antibody Response (Total IgG) - Geometric Mean Titer

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

    To compare the serum antibody responses (total IgG) to HPV 6, 11, 16 & 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose

  5. Serum Antibody Response (Total IgG) - Geometric Mean Titer

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

    To compare the serum antibody responses (total IgG) to HPV 6, 11, 16 & 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Merck Canada Inc.

Registry information

Official study title

Long Term Immune Memory Responses to Human Papillomavirus (HPV) Vaccination Following 2 Verses 3 Doses of Quadrivalent HPV Vaccine

Acronym: Merck08

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 18, 2016
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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