Phase 4
N=18
Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine
Human Papillomavirus
Bottom Line
View on ClinicalTrials.gov: NCT02968420 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: B Memory Cell Response (% of Memory B Cells That Are Antigen-specific) — 0.61; 0.94; 0.36; 0.08 % of memory B cells that are Ag-specific
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Human Papillomavirus 9-valent Vaccine, Recombinant (Biological)
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- Female
- Sponsor
- University of British Columbia
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY B Memory Cell Response (% of Memory B Cells That Are Antigen-specific) |
0.61; 0.94; 0.36; 0.08; 0.11; 0.03 | — |
| PRIMARY Plasmablast Response (% of All B Cells That Are Plasmablasts) |
2.37; 3.14; 5.37 | — |
| SECONDARY Variable Gene Usage (Comparison of the Nucleotide Sequences of Antigen-specific Antibody Heavy and Light Chain Variable Region Sequences) |
— | — |
| SECONDARY Serum Antibody Response (cLIA) - Geometric Mean Titer |
1313; 2722; 815; 3430; 6042; 5778 | — |
| SECONDARY Serum Antibody Response (cLIA) - Geometric Mean Titer |
1313; 2722; 815; 3430; 6042; 5778 | — |
| SECONDARY Serum Antibody Response (Total IgG) - Geometric Mean Titer |
4579; 7308; 7371; 3234; 6637; 6271 | — |
| SECONDARY Serum Antibody Response (Total IgG) - Geometric Mean Titer |
4579; 7308; 7371; 3234; 6637; 6271 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02968420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.