Phase 1/2a,Ad26 or MVA-vectored Vaccine in HPV16 or18 Cervix Infection

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled First-in-Human, Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Otherwise Healthy Women with HPV16 or 18 Infection of the Cervix

• IRAS ID

  275098

• Contact name

  Hanneke Schuitemaker

• Contact email

  hschuite@its.jnj.com

• Sponsor organisation

  Janssen Vaccines and Prevention B.V.

• Eudract number

  2018-000200-41

• Clinicaltrials.gov Identifier

  NCT03610581

• Duration of Study in the UK

  1 years, 8 months, 30 days

• Research summary

  Human Papilloma Virus (HPV) causes a common cervical infection in women that is spread through intimate sexual contact. Most of it goes away on its own. If it does not go away, may cause cervical precancerous lesions, known as cervical intraepitheial neoplasia (CIN) and some women with CIN may develop cervical cancer.HPV types 16 and 18 are responsible for approximately 70% of cervical cancers.
  This study will evaluate a combination of experimental HPV vaccines: Adenovirus 26 HPV16 , Adenovirus 26 HPV18 (both in 2 different doses) and MVA-mBN411B.
  The purpose is to find out if the HPV vaccine can cause side effects. Another purpose is to find out how long the HPV vaccine stays in and acts on the body and how the body responds. Potentially if the vaccines help to get rid of the HPV infection, the woman will be at very low risk of developing cervical cancer in the future.

  The participant will be in the study for a maximum of 13.5 months and will receive 2 study vaccinations, given 2 months apart. She will receive the active study vaccines or placebo.
  During the study, neither the subject nor the study staff will know which vaccination group the subject is in (unless they must find it out due to a medical emergency).
  Once the patient is eligible to participate, there will be six visits and 2 additional telephone contact visits (or 4 contacts for a small subgroup) over a 16 weeks period. No more visits are required until study week 26. If the participant stops the participation early, she will be asked to complete an early exit visit.
  There will be three follow-up visits to the clinic at about 6, 8 and 12 months after the first vaccination (starting on study week 26). The participant will not receive any study vaccine during this time.

• REC name

  North East - York Research Ethics Committee

• REC reference

  19/NE/0356

• Date of REC Opinion

  9 Jan 2020

• REC opinion

  Further Information Favourable Opinion