Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine (NCT05005247) | Clinical Trial Compass
CompletedPhase 1
Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine
United Kingdom27 participantsStarted 2021-08-17
Plain-language summary
This is an open label booster vaccine follow-up study. Participants who had received a primary course of GBS-NN/NN2 or placebo in Study MVX0002 will be invited to return to receive a booster dose (or first dose in the case of placebo or vaccine naïve participants) 1 to 5 years after the completion of the primary course of vaccination. All participants will receive a single dose of GBS-NN/NN2 containing 50μg of each fusion protein.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. Women who have participated in study MVX0002, with GBS-NN/NN2 vaccine and received active vaccine or placebo (unless it is necessary to recruit vaccine naïve participants to bolster the number of participants who received placebo in MVX0002).
✓. Able to voluntarily provide written informed consent to participate in the study.
✓. Female participant of childbearing potential willing to use a highly effective method of contraception (in addition to a condom for male partners), if applicable (unless of non-childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from the first dose until completion of the Day 85 visit. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. For the purposes of this study, this definition of a female of childbearing potential applies to all females in the study i.e., those who participated in the MVX0002 study and those who are considered vaccine naïve.
✓. Female participant of non-childbearing potential. For the purposes of this study, this is defined as the participant being at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy).
✓. Female participant with a negative pregnancy test at Screening and prior to dose.
✓. Female participant of menopausal status confirmed by demonstrating at Screening that the serum level of the follicle stimulating hormone (FSH) falls within the respective pathology reference range. In the event a participant's menopausal status has been clearly established (for example, the participant indicates she has been amenorrhoeic for 10 years, confirmed by medical history, etc), but serum FSH levels are not consistent with a postmenopausal status, determination of the participant's eligibility to be included in the study will be at the Investigator's discretion following consultation with the Sponsor.
✓. Body mass index (BMI) ≥18 and ≤30 kg/m2 (vaccine naïve participants only).
Exclusion criteria
✕. Participants who have an autoimmune disease.
✕. Participants who have a current infection or any significant illness at Screening (such participants can be rescreened once the active infection or significant illness has resolved).
✕. Participants with history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease or current infection.
✕. Laboratory values at Screening which are deemed by the Investigator to be clinically significantly abnormal.
✕. Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
✕. Participation in a clinical drug study during the 90 days or 5 half-lives, whichever is longer, preceding the initial dose in this study (such participants can be rescreened once the 90-day or 5 half-lives period has elapsed).
✕. Participants with a history of severe allergic reactions after previous vaccination.
✕. Participants with a history of hypersensitivity to the Investigational Medicinal Product (IMP) or any of the excipients within the IMP or documented allergy to aminoglycosides.