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

Human Papillomavirus Clinical Trial

— Merck08  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02968420
• Other study ID #: H16-00700
• Status: Completed
• Phase: Phase 4
• Start date: September 11, 2017
• Est. completion date: May 15, 2019

Study information

• Verified date: June 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Canada	Vaccine Evaluation Center, BC Children's Hospital Research Institute	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Merck Canada Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Olsson SE, Villa LL, Costa RL, Petta CA, Andrade RP, Malm C, Iversen OE, Høye 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. Epub 2007 Apr 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Variable Gene Usage (Comparison of the Nucleotide Sequences of Antigen-specific Antibody Heavy and Light Chain Variable Region Sequences)	To compare the extent of somatic hypermutation and the variable gene usage between girls that received either a primary 2 or 3 dose series	At Day 7 and Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
Secondary	Serum Antibody Response (cLIA) - Geometric Mean Titer	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	At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine
Secondary	Serum Antibody Response (cLIA) - Geometric Mean Titer	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	At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
Secondary	Serum Antibody Response (Total IgG) - Geometric Mean Titer	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	At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine
Secondary	Serum Antibody Response (Total IgG) - Geometric Mean Titer	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	At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine