Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine (Merck08)

University of British Columbia

Status and phase: Completed; Phase 4

Conditions: Human Papillomavirus

Treatments: Biological: Human Papillomavirus 9-valent Vaccine, Recombinant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02968420

H16-00700

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 17 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Group 1

Active Comparator group

Description:

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.

Treatment:

Biological: Human Papillomavirus 9-valent Vaccine, Recombinant

Group 2

Active Comparator group

Description:

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.

Treatment:

Biological: Human Papillomavirus 9-valent Vaccine, Recombinant

Group 3

Active Comparator group

Description:

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.

Treatment:

Biological: Human Papillomavirus 9-valent Vaccine, Recombinant