- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05782179
Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants
A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of Group B Streptococcus Vaccine (GBS NN/NN2 With Alhydrogel®) in Elderly Participants Aged 55 to 75
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sixty (60) healthy older adult participants aged 55 to 75 years will be randomised in two cohorts; 30 obese and/or diabetic participants aged 55 to 75 years will be randomised in two cohorts.
Participants will be involved in the study for approximately one year including screening and safety follow-up.
Eligible participants will be administered a dose of GBS-NN/NN2 or placebo on three occasions: the first dose will be administered on Day 1, followed by the second and third doses 4 and 24 weeks later, respectively.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Cornelia (Lidia) Oostvogels
- Phone Number: +4915150925821
- Email: lio@minervax.com
Study Contact Backup
- Name: Karina Nymark
- Phone Number: +4530167906
- Email: kan@minervax.com
Study Locations
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Ghent, Belgium, 9000
- University Hospital Ghent - Centrum voor Vaccinologie (CEVAC) department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants aged 55 to 75 years.
- Body mass index (BMI) ≥18 and ≤30 kg/m2 for healthy participants, ≥ 30 to ≤45 kg/m2 for obese participants and ≥18 to ≤45 kg/m2 for type 2 diabetic participants.
- Able to voluntarily provide written informed consent to participate in the study.
- Female participants must be post-menopausal.
- Participants capable and willing to follow trial schedule and procedures.
Exclusion Criteria:
- Participants who have received a GBS vaccine previously.
Participants with history or presence of significant (as evaluated by the investigator) cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease or current infection.
NOTE: Patients with type 2 diabetes are to be recruited for Cohort 3 and Cohort 4.
- Laboratory values at screening which are deemed by the investigator to be clinically significantly abnormal.
- Current or history of drug or alcohol abuse per investigator judgement.
- Positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Participants currently participating in a clinical trial.
- Participants receiving an investigational drug, vaccine or device during the 90 days preceding the initial dose in this study.
- Any significant illness during the 4 weeks preceding the vaccination visit, per investigator judgement.
- Participants with a history of severe allergic reactions after previous vaccination.
Participants who have received any vaccine within 30 days of first IMP administration, or who are planning to receive any vaccine (eg, travel vaccines) up to 30 days after each vaccination.
NOTE: Exceptions could be made for emergency vaccinations (eg, tetanus) or vaccination campaigns (eg, SARS, CoV-2 or influenza) which will be permitted not less than 7 days before or after study vaccination.
- Participants receiving immunosuppressive therapy or immunoglobulins in the 6 months prior to screening.
- Participants within a 7-day period after an acute infection in the 7 days preceding vaccination, as per investigator judgement, or with fever (oral temperature >37.9°C) in the 72 hours preceding vaccination.
- Participants who have received antipyretics/analgesics treatment within 72 hours prior to dosing.
Participants on chronic medications that are likely to affect the assessments specified in the protocol (eg, anticoagulant therapy, systemic steroids).
NOTE: Chronic medications such as antihypertensives, bronchodilators, statins that do not affect the immune system, will be permitted and allowed to continue during the study at the discretion of the investigator. Treatment for diabetes will be continued as required for the diabetic participants recruited. Non-steroidal anti-inflammatory drugs or paracetamol will be permitted for the treatment of headache or other symptoms during the study. Use of over the counter (OTC) vitamins and dietary supplements is allowed.
- Participants with skin defects and/or tattoos at the proposed site of vaccine administration.
- Donation of blood or blood products within 90 days prior to first study vaccination.
- Participants who, in the opinion of the Investigator, are unsuitable for participation in the study.
- Involvement in the planning and/or conduct of the study (applies to both Sponsor personnel and/or personnel at the study centre or Clinical Research Organisation [CRO]).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1 - Active
Cohort 1 (30 healthy older adult) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
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GBS-NN/NN2 bound to alhydrogel as an adjuvant
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Placebo Comparator: Cohort 1 - Placebo
Cohort 1 (30 healthy older adult) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
|
Normal Saline 0.9 %
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Experimental: Cohort 2 - Active
Cohort 2 (30 healthy older adult) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
|
GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Placebo Comparator: Cohort 2 - Placebo
Cohort 2 (30 healthy older adult) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
|
Normal Saline 0.9 %
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Experimental: Cohort 3 - Active
Cohort 3 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
|
GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Placebo Comparator: Cohort 3 - Placebo
Cohort 3 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
|
Normal Saline 0.9 %
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Experimental: Cohort 4 - Active
Cohort 4 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
|
GBS-NN/NN2 bound to alhydrogel as an adjuvant
|
Placebo Comparator: Cohort 4 - Placebo
Cohort 4 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
|
Normal Saline 0.9 %
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of GBS-NN/NN2 vaccine
Time Frame: Up to 28 days after each vaccination
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Up to 28 days after each vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate IgG antibody response to the GBS-NN/NN2 vaccine at Day 197
Time Frame: Day 197
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Geometric mean antibody concentration in μg/mL for antibodies to the four individual Alps
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Day 197
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To evaluate IgG antibody responses induced by the three vaccine doses, on a 0-, 1- and 6-month regimen, in older adult participants 4 weeks after each vaccination.
Time Frame: 4 weeks after each vaccination
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Geometric mean fold increase in antibody concentration for antibodies to the four individual Alps
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4 weeks after each vaccination
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To assess whether pre existing antibody levels affect the vaccine-induced antibody response.
Time Frame: Up to 6 months after last vaccination
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Seroconversion rate (proportion of participants with a 4-fold increase above baseline - pre dose concentration) at any time post vaccination.
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Up to 6 months after last vaccination
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To evaluate the immune response up to 6 months following the third dose
Time Frame: Up to day 197
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Proportion of participants achieving antibody concentrations for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) above specific thresholds at Days 29, 57, 169, and 197
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Up to day 197
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To evaluate the long-term safety profile of the GBS-NN/NN2 vaccine between Day 57 (28 days post second injection) to Day 168 and 6 months following the third dose (safety endpoint)
Time Frame: Up to day 365
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Up to day 365
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Geoff Kitson, gkitson@propharmapartners.uk.com
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
- MVX0006
- 2022-003681-20 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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