Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Group B streptococcus (GBS) vaccine, Group B streptococcus (GBS) vaccine- low dose, Group B streptococcus vaccine- low dose
Group B streptococcus vaccine · 4 trials · 5 indications
GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.
The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women.
Serotype-specific (Ia, Ib \& III) group B streptococcus (GBS) IgG antibody levels in healthy subjects for potential use in pregnant woman was assessed in terms of Geometric Mean Concentrations (GMCs) at Day 61 in cohorts 1 and 2.
Geometric mean ratios (GMRs) relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels measured at Day 61 for subjects across cohorts 1 and 2.
The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL at day 361 across all the cohorts for potential use in non-pregnant women.
Serotype-specific (Ia, Ib \& III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant woman was assessed in terms of GMCs at Day 361 across all cohorts.
GMRs relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant women, measured at Day 361 across all cohorts.
| Arm | Type | Description |
|---|---|---|
| HIVneg | EXPERIMENTAL | HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of Group B streptococcus vaccine. |
| HIVposCD4HIGH | EXPERIMENTAL | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/µL received one dose of Group B streptococcus vaccine. |
| HIVposCD4LOW | EXPERIMENTAL | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but \> 50 cells/µL received one dose of Group B streptococcus vaccine |
| 5 µg_No Adj | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (5 µg) without any adjuvant |
| 20 µg_No Adj | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (20 µg) without any adjuvant. |
| 5 µg_Alum | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant. |
| 20 µg_Alum | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant. |
| 5 µg_MF59-H | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 4.87 mg of MF59 |
| 20 µg_MF59-H | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 4.87 mg of MF59 |
| 5 µg_MF59-F | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 9.75 mg of MF59 |
| 20 µg_MF59-F | EXPERIMENTAL | Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 9.75 mg of MF59 |
| Placebo | PLACEBO_COMPARATOR | Subjects received 2 injections of placebo administered 1 month apart |
| Arm 1 | NO_INTERVENTION | This is a phlebotomy study. |
| Name | Type | Description |
|---|---|---|
| Group B streptococcus vaccine | BIOLOGICAL | Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine. |
| Group B streptococcus (GBS) vaccine- low dose | BIOLOGICAL | - |
| Group B streptococcus (GBS) vaccine- High dose | BIOLOGICAL | - |
| Placebo- Saline | BIOLOGICAL | - |
| Group B streptococcus (GBS) vaccine | BIOLOGICAL | No vaccine will be administered in this study. Only one study visit is required. Subjects will return to the clinic for a single visit at 24 months (± 3 months) after the last injection administered in the V98P1 study. |
Inclusion Criteria: * Pregnant women 18-40 years of age between 24-35 weeks gestation * Women who were HIVneg or HIVpos with WHO stage I or II disease and with CD4+ counts \> 50 cells/µL Exclusion Criteria: * Women who had CD4+ count ≤ 50 cells/µL * Women who were HIVpos with WHO stage III or IV ...
The Group B streptococcus vaccine is an investigational vaccine developed by Novartis AG for the prevention of Group B Streptococcus (GBS) disease and related streptococcal infections. It is designed to be given to women, including pregnant women, to protect against GBS. It remains in clinical development and is not approved.
The Group B streptococcus vaccine is being studied for the prevention of Group B Streptococcus (GBS) disease and streptococcal infections. Clinical trials have enrolled pregnant and non-pregnant women, including HIV positive and HIV negative pregnant women, to evaluate antibody responses and safety.
Novartis AG, which trades under the ticker NVS, is the developer of the Group B streptococcus vaccine. The company has sponsored the clinical trials evaluating the vaccine in healthy women and in pregnant women.
The Group B streptococcus vaccine is in Phase 1 development. It is an investigational vaccine and has not been approved by the FDA. Completed studies include Phase 1 and Phase 2 trials, and no trials are currently active.
Completed trials include NCT01150123, a Phase 1 safety and immunogenicity study in healthy women in Belgium, and NCT01412801, a Phase 2 study in HIV positive and HIV negative pregnant women in Malawi and South Africa. NCT01053767 and NCT01052935 assessed antibody persistence in previously immunized women in Switzerland.
Yes. The Group B streptococcus vaccine is also known as the Group B streptococcus (GBS) vaccine and the Group B streptococcus (GBS) vaccine low dose. These names refer to the same investigational Novartis vaccine candidate for Group B Streptococcus.