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Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants

Primary Purpose

Group B Streptococcal Infections

Status
Active
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
GBS-NN/NN2
Placebo
Sponsored by
Minervax ApS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Group B Streptococcal Infections

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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]).

Sites / Locations

  • University Hospital Ghent - Centrum voor Vaccinologie (CEVAC) department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Cohort 1 - Active

Cohort 1 - Placebo

Cohort 2 - Active

Cohort 2 - Placebo

Cohort 3 - Active

Cohort 3 - Placebo

Cohort 4 - Active

Cohort 4 - Placebo

Arm Description

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).

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).

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).

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).

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Safety and tolerability of GBS-NN/NN2 vaccine
Safety and tolerability as determined by the occurrence of AEs consisting of local and systemic reactogenicity within 7 days after vaccination Unsolicited AEs, including AESIs, MAAEs and SAEs within 28 days after each vaccination AESIs, MAAEs, ARs/SARs leading to withdrawal from the study.

Secondary Outcome Measures

To evaluate IgG antibody response to the GBS-NN/NN2 vaccine at Day 197
Geometric mean antibody concentration in μg/mL for antibodies to the four individual Alps
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.
Geometric mean fold increase in antibody concentration for antibodies to the four individual Alps
To assess whether pre existing antibody levels affect the vaccine-induced antibody response.
Seroconversion rate (proportion of participants with a 4-fold increase above baseline - pre dose concentration) at any time post vaccination.
To evaluate the immune response up to 6 months following the third dose
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
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)
Proportion of participants with any SAE from between Day 57 (28 days post second injection) to Day 168 and 28 days after third vaccination (Day 197) up to Day 365. Proportion of participants with MAAEs, AESIs, ARs/SARs requiring a medical consultation, and or leading to withdrawal from the study from 28 days after third vaccination (Day 197) up to Day 365.

Full Information

First Posted
February 23, 2023
Last Updated
June 8, 2023
Sponsor
Minervax ApS
Collaborators
Iqvia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05782179
Brief Title
Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 16, 2023 (Anticipated)
Study Completion Date
May 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minervax ApS
Collaborators
Iqvia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of three doses of GBS NN/NN2 with Alhydrogel® (Recombinant protein vaccine against Group B Streptococcus) in elderly participants aged 55 to 75.Participants will be followed up to 6 months after last vaccination.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Group B Streptococcal Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 - Active
Arm Type
Experimental
Arm Description
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).
Arm Title
Cohort 1 - Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Cohort 2 - Active
Arm Type
Experimental
Arm Description
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).
Arm Title
Cohort 2 - Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Cohort 3 - Active
Arm Type
Experimental
Arm Description
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).
Arm Title
Cohort 3 - Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Cohort 4 - Active
Arm Type
Experimental
Arm Description
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).
Arm Title
Cohort 4 - Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
GBS-NN/NN2
Intervention Description
GBS-NN/NN2 bound to alhydrogel as an adjuvant
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Normal Saline 0.9 %
Primary Outcome Measure Information:
Title
Safety and tolerability of GBS-NN/NN2 vaccine
Description
Safety and tolerability as determined by the occurrence of AEs consisting of local and systemic reactogenicity within 7 days after vaccination Unsolicited AEs, including AESIs, MAAEs and SAEs within 28 days after each vaccination AESIs, MAAEs, ARs/SARs leading to withdrawal from the study.
Time Frame
Up to 28 days after each vaccination
Secondary Outcome Measure Information:
Title
To evaluate IgG antibody response to the GBS-NN/NN2 vaccine at Day 197
Description
Geometric mean antibody concentration in μg/mL for antibodies to the four individual Alps
Time Frame
Day 197
Title
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.
Description
Geometric mean fold increase in antibody concentration for antibodies to the four individual Alps
Time Frame
4 weeks after each vaccination
Title
To assess whether pre existing antibody levels affect the vaccine-induced antibody response.
Description
Seroconversion rate (proportion of participants with a 4-fold increase above baseline - pre dose concentration) at any time post vaccination.
Time Frame
Up to 6 months after last vaccination
Title
To evaluate the immune response up to 6 months following the third dose
Description
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
Time Frame
Up to day 197
Title
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)
Description
Proportion of participants with any SAE from between Day 57 (28 days post second injection) to Day 168 and 28 days after third vaccination (Day 197) up to Day 365. Proportion of participants with MAAEs, AESIs, ARs/SARs requiring a medical consultation, and or leading to withdrawal from the study from 28 days after third vaccination (Day 197) up to Day 365.
Time Frame
Up to day 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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]).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoff Kitson
Organizational Affiliation
gkitson@propharmapartners.uk.com
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Ghent - Centrum voor Vaccinologie (CEVAC) department
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants

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