Observational Follow up of Prior HPV Vaccinees

NCT02811068 | Completed

• 1 other identifier: HPVfollowup
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 2

Brief Summary

HPV vaccines have been included in the national immunisation schedule since 2008, firstly as the Cervarix vaccine which protects against two HPV types and in 2012 as the Gardasil vaccine which offers protection against a further two HPV types. This study will assess whether booster doses are indicated to protect females throughout their lifetime or if the vaccinations offered in early adolescence provide this by following up a cohort from a previous study where female adolescents were vaccinated 5-7 years ago.

Conditions

Human Papillomavirus Virus

Keywords

HPV; vaccine; Human Papillomavirus Virus Vaccine

Outcome Measures

Primary Outcomes (1)

• HPV immunogenicity

  antibody titres elicited to HPV vaccine and non-vaccine types following vaccination with either Cervarix(R) or Gardasil(R) at 5-7 years post first immunisation and comparison between vaccines and over time

  single timepoint per participant, over the duration of the study which is anticipated to be 12 months

Study Arms (1)

Venepuncture

Collection of single blood sample to assess antibody persistence over time

Other: venepuncture

Interventions

venepuncture OTHER

single venepuncture

Venepuncture

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers who previously took part in a study of HPV vaccines

You may qualify if:

• Participant is willing and able to give written informed consent for participation.
• Females originally enrolled in the randomised parallel group study

You may not qualify if:

• Known bleeding diathesis (or any condition that may be associated with a prolonged bleeding time).
• Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Sponsors & Collaborators

• Public Health England: lead

Study Sites (2)

Gloucestershire primary care

Gloucestershire, Gloucestershire, United Kingdom

Location

Hertfordshire primary care

Hertfordshire, Hertfordshire, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serology samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Elizabeth Coates

  Public Health England

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 23, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 26, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)