Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GBS-NN/NN2 · 1 trial · 1 indication
* 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.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 - Active | EXPERIMENTAL | 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 - Placebo | PLACEBO_COMPARATOR | 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 - Active | EXPERIMENTAL | 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 - Placebo | PLACEBO_COMPARATOR | 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 - Active | EXPERIMENTAL | 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 - Placebo | PLACEBO_COMPARATOR | 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 - Active | EXPERIMENTAL | 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 - Placebo | PLACEBO_COMPARATOR | 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). |
| Name | Type | Description |
|---|---|---|
| GBS-NN/NN2 | BIOLOGICAL | GBS-NN/NN2 bound to alhydrogel as an adjuvant |
| Placebo | BIOLOGICAL | Normal Saline 0.9 % |
Inclusion Criteria: 1. Participants aged 55 to 75 years. 2. 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. 3. Able to voluntarily provide written informed consent to participate in the...
GBS-NN/NN2 is an investigational monoclonal antibody being developed for Group B Streptococcal Infections. It is being studied in elderly participants aged 55 years and older. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
GBS-NN/NN2 is being developed by IQVIA Holdings, Inc., a company traded on the New York Stock Exchange under the ticker symbol IQV. The company is conducting clinical research on this investigational monoclonal antibody for Group B Streptococcal Infections.
GBS-NN/NN2 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, and the drug remains in early-stage clinical development.
GBS-NN/NN2 has one completed clinical trial registered as NCT05782179. This Phase 1 study evaluated the safety, tolerability, and immunogenicity of three doses of the vaccine in elderly participants. The trial enrolled 90 healthy volunteers in Belgium and was randomized, double-blind, and placebo-controlled.
GBS-NN/NN2 is a monoclonal antibody designed to target Group B Streptococcus bacteria. As an antibody, it is intended to bind to the bacteria and help the immune system neutralize the infection. The drug is being studied for its ability to prevent or treat Group B Streptococcal Infections.