A follow up study of GBS-NN/NN2 vaccine in healthy volunteers

• Research type

  Research Study

• Full title

  A long-term follow-up study to assess the persistence of IgG antibodies to the GBS-NN/NN2 vaccine after vaccination with the GBS-NN/NN2 vaccine in MVX0002 and/or in MVX0003.

• IRAS ID

  332126

• Contact name

  Lidia Oostvogels

• Contact email

  lio@minervax.com

• Sponsor organisation

  MinervaX Aps

• Duration of Study in the UK

  4 years, 9 months, 30 days

• Research summary

  The purpose of this study is to investigate ongoing effects of the GBS-NN2/NN2 vaccine.

  The main objective of this follow-on study is as follows:
  - To evaluate the overall immune response of the vaccine in participants who have previously received up to 3 doses of the vaccine (within the MVX0002 and/or MVX0003 studies respectively).

  GBS-NN/NN2 has been evaluated in two previous studies at Simbec-Orion in the UK (MVX0002 & MVX0003) and therefore, this study is considered a follow up to these studies in order to evaluate the long-term immune responses after the initial and booster doses of the vaccine (where applicable).

  The study will only include participants who previously completed the MVX0002 study and/or the MVX0003 study and have received at least one dose of the GBS-NN/NN2 vaccine.

  In this study, no vaccine will be administered, and participants will be asked to attend for a blood sample to be collected once a year for a period of 4 years (for a maximum of 5 blood samples). The samples will then be analysed in order to measure the levels of immune response of the vaccine in the body, how this changes over time and how this compares between participants who have received different numbers of doses within the MVX0002 and MVX0003 studies (up to a maximum of 3 doses based upon completing both the MVX0002 and MVX0003 studies).

  A minimum of 20 and a maximum of 55 female participants will be required for this study (recruited from participants from MVX0002 & MVX0003).

• REC name

  Wales REC 1

• REC reference

  23/WA/0307

• Date of REC Opinion

  8 Jan 2024

• REC opinion

  Further Information Favourable Opinion