CompletedPhase 1

Group B Streptococcus Vaccine in Healthy Females

United Kingdom60 participantsStarted 2019-01-09

Plain-language summary

A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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Inclusion criteria

✓. Healthy female subjects aged 18 - 40 years.
✓. Body mass index (BMI) ≥18 and ≤30 kg/m2.
✓. Subjects weight ≥50kg and ≤100kg at screening.
✓. Able to voluntarily provide written informed consent to participate in the study.
✓. Subjects are pre-menopausal.
✓. Females of childbearing potential must have a negative pregnancy test at screening (β HCG) and prior to each dose. To prevent pregnancy female subjects of childbearing potential must take adequate contraceptive precautions for the entire duration of study participation (up to Day 85). Adequate and highly effective contraceptive precautions include:
✓. Non-smokers for at least 3 months prior to first study vaccine administration.

Exclusion criteria

✕. Subjects who have received GBS-NN vaccine previously.
✕. Subjects 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.
✕. Pregnant or lactating females.
✕. Laboratory values at screening which are deemed by the investigator to be clinically significantly abnormal.
✕. Positive drug screen for drugs of abuse or a positive alcohol urine test prior to first dosing unless there is a documented medical explanation for the positive result other than drugs of abuse (e.g., the subject has been prescribed opioids for pain).
✕. Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
✕. Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
✕. Any significant illness during the 4 weeks preceding check-in for this study (Day 1).

What they're measuring

Number of Participants With Treatment Emergent Adverse Events

Timeframe: 85 days

Trial details

NCT IDNCT03807245

SponsorMinervax ApS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-14

Results submitted2020-11-30

View on ClinicalTrials.gov More Group B Strep Infection trials