- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03807245
Group B Streptococcus Vaccine in Healthy Females (MVX0002)
A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Group B Streptococcus Vaccine (GBS-NN/NN2 With Alhydrogel®) in Healthy Female Subjects Aged 18 to 40
Study Overview
Status
Conditions
Detailed Description
There will be 4 arms in 2 cohorts of 30 subjects. Cohort 1 will receive two 0.5 mL injections, 4 weeks apart, each consisting of 25 μg of GBS-NN and 25 μg of GBS-NN2 (24 subjects) or placebo (6 subjects). Cohort 2 (30 subjects) will receive two 0.5 mL injections, 4 weeks apart, each consisting of 50 μg of GBS-NN and 50 μg of GBS-NN2 (24 subjects) or placebo (6 Subjects). All vaccines will be adsorbed to 500 μg Al3+ as Alhydrogel®.
Safety will be assessed after all subjects have completed Visit 4 (Day 8) for Cohort 1, at which point the decision will be made as to whether proceeding with administration of the doses in cohort 2 is appropriate.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Wales
-
Merthyr Tydfil, Wales, United Kingdom, CF48 4DR
- Simbec Research Limited
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Established use of oral, injected or implanted hormonal methods of contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). [For female subjects, the vasectomised male partner should be the sole partner for that subject].
- True abstinence, when this is in line with the preferred and usual lifestyle of the subject.
[Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
• The chosen contraception method(s) must be followed from the first dose until at least Day 85 of the study.
- 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).
- Subjects with a history of allergic reactions after previous vaccination.
- Subjects who have received any vaccine within 30 days of screening, or who are planning to receive a vaccine up to Day 85 of the study.
- Subjects receiving immunosuppressive therapy in the 6 months prior to screening, taking any short-term medications including over-the-counter (OTC) preparations, within 7 days of the first dose. Chronic medications such as antihypertensives, bronchodilators, oral contraceptives or statins that do not affect the immune system, will be permitted and allowed to continue during the study at the discretion of the Investigator. Paracetamol will be permitted for the treatment of headache or other symptoms. Use of OTC vitamins and dietary supplements is allowed
- Subjects with tattoos at the proposed site of vaccine administration.
- Donation of blood or blood products within 90 days prior to vaccine administration or intending to donate blood or blood products within 90 days of the last visit.
- Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: GBS-NN/NN2 with Alhydrogel® 25
GBS-NN/NN2 with Alhydrogel® 25 mcg intramuscular 2 times with 4 weeks apart
|
GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
|
PLACEBO_COMPARATOR: Placebo GBS-NN/NN2 with Alhydrogel® 25
Intramuscular injection with Alhydrogel® 2 times with 4 weeks apart
|
GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
|
EXPERIMENTAL: GBS-NN/NN2 with Alhydrogel® 50
Intramuscular GBS-NN/NN2 with Alhydrogel® injection 50 mcg 2 times with 4 weeks apart
|
GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
|
PLACEBO_COMPARATOR: Placebo GBS-NN/NN2 with Alhydrogel® 50
Intramuscular injection with Alhydrogel® 2 times with 4 weeks apart
|
GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment Emergent Adverse Events
Time Frame: 85 days
|
Number of Participants with Treatment Emergent Adverse Events
|
85 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunoglobulin(Ig)G Antibody Concentration
Time Frame: Day 85
|
Adjusted geometric mean concentration (GMC)
|
Day 85
|
Fold Change in Antibody Concentration
Time Frame: Day 1 to Day 85
|
Geometric mean fold change in antibody concentration from Day 1 to Day 85 for each group.
|
Day 1 to Day 85
|
Seroconversion Rate
Time Frame: Day 85
|
4-fold increase in Immunoglobulin(Ig)G antibody concentration
|
Day 85
|
Number of Participants With an Immune Response to First and Second Doses
Time Frame: Day 29 and Day 85
|
Number of participants with Immunoglobulin(Ig)G antibody concentration above thresholds
|
Day 29 and Day 85
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-003871-27
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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