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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Minervax ApS
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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]).
研究组 & 干预措施
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).
干预措施: GBS-NN/NN2 (Biological)
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).
干预措施: Placebo (Biological)
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).
干预措施: GBS-NN/NN2 (Biological)
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).
干预措施: Placebo (Biological)
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).
干预措施: GBS-NN/NN2 (Biological)
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).
干预措施: Placebo (Biological)
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).
干预措施: GBS-NN/NN2 (Biological)
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).
干预措施: Placebo (Biological)
结局指标
主要结局
Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine
时间窗: Up to 28 days after each vaccination
* Safety and tolerability as determined by the occurrence of Adverse Events (AEs) consisting of local and systemic reactogenicity within 7 days after vaccination * Unsolicited AEs, including adverse events of special interest (AESIs), Medically attended adverse events (MAAEs) and Serious adverse events (SAEs) within 28 days after each vaccination * AESIs, MAAEs, ARs/SARs leading to withdrawal from the study.
次要结局
- Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps(Day 197)
- Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps(4 weeks after each vaccination (Days 29, 57 and 197))
- Seroconversion Rate at Any Time Post Vaccination(Up to 6 months after last vaccination)
- Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps(Up to day 197)
- 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)(Up to day 365)