Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rabipur · 2 trials · 3 indications
A SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death, is life-threatening, required/prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the participants or may require intervention to prevent one of the other outcomes listed. Safety is assessed as the number of participants reporting SAEs after a booster dose of PCEC rabies vaccine administered in this extension study, if RNVA concentrations were \<0.5 IU/mL, following a primary series of accelerated or conventional rabies pre-exposure (PrEP) intramuscular (IM) regimen in the parent study.
RVNA antibody concentrations were measured in terms of Geometric Mean Concentrations (GMCs) and expressed in IU/mL. The booster dose was administered in this Extension study (conducted from Year 3 to Year 9 after the primary schedule study) only when participants had RVNA concentrations \<0.5 IU/mL at the yearly immunogenicity check (i.e., at "Scheduled Clinic Visit"). Booster dose administration occurred at an approximate timepoint between 6 and 9 months from the previous "Scheduled Clinic Visit" during the Years 3 to 9.
GMR was calculated as ratio of post booster dose RVNA GMCs (7-day post booster dose) to the baseline RVNA GMCs (7 days before booster dose). The booster dose was administered in this Extension study (conducted from Year 3 to Year 9 after the primary schedule study) only when participants had RVNA concentrations \<0.5 IU/mL at the yearly immunogenicity check (i.e., at "Scheduled Clinic Visit"). Booster dose administration occurred at an approximate timepoint between 6 and 9 months from the previous "Scheduled Clinic Visit" during the Years 3 to 9.
The booster dose was administered in this Extension study (conducted from Year 3 to Year 9 after the primary schedule study) only when participants had RVNA concentrations \<0.5 IU/mL at the yearly immunogenicity check (i.e., at "Scheduled Clinic Visit"). Booster dose administration occurred at an approximate timepoint between 6 and 9 months from the previous "Scheduled Clinic Visit" during the Years 3 to 9.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Arm | Type | Description |
|---|---|---|
| Conv-R/JE Group | EXPERIMENTAL | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29, and Japanese Encephalitis (JE) primary series regimen on days 1 and 29 in the parent study (V49\_23) and who received at least one booster dose of purified chick embryo cell culture (PCEC) rabies vaccine in this extension study, if Rabies Virus Neutralizing Antibody (RNVA) concentrations were less than (\<)0.5 IU/mL at scheduled visits. |
| Acc-R/JE Group | EXPERIMENTAL | Participants who completed the Rabies PrEP regimen on days 1, 4 and 8 and JE primary series regimen on days 1 and 8 in the parent study (V49\_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were \<0.5 IU/mL at scheduled visits. |
| Conv-R Group | EXPERIMENTAL | Participants who completed the Rabies PrEP regimen on days 1, 8 and 29 in the parent study (V49\_23) and who received at least one booster dose of PCEC rabies vaccine in this extension study, if RNVA concentrations were \<0.5 IU/mL at scheduled visits. |
| SB257049 F2 0-1 M Group | EXPERIMENTAL | Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F1 0-1 M Group | EXPERIMENTAL | Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F2 0-1-2 M Group | EXPERIMENTAL | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F1 0-1-2 M Group | EXPERIMENTAL | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F2 0-1-7 M Group | EXPERIMENTAL | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F1 0-1-7 M Group | ACTIVE_COMPARATOR | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| Rabipur 0-1-2 M Group | ACTIVE_COMPARATOR | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| Name | Type | Description |
|---|---|---|
| Rabipur | BIOLOGICAL | Participants in all the groups received Rabipur vaccine booster dose, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Blood sampling | PROCEDURE | Blood samples were drawn from all participants at Day 1 and then at subsequent year intervals from extension study Day 1 onwards. |
| Purified Chick-Embryo Cell Rabies Vaccine | BIOLOGICAL | 1 booster dose of 1.0 mL of Purified Chick-Embryo Cell Rabies Vaccine intramuscular (IM). |
| GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 | BIOLOGICAL | 2 different formulations are tested. For each formulation, 3 different dosing schedules are tested |
Inclusion Criteria: * All individuals who were randomized to a Rabies primary series vaccination for pre-exposure prophylaxis (PrEP), received the full PrEP regimen and completed the parent trial following study protocol. Exclusion Criteria: * Completed the parent study without receiving the full...
Rabipur is a purified chick-embryo cell rabies vaccine used for pre-exposure prophylaxis against rabies, a virus disease. It is also being studied in the context of malaria, though its primary use is rabies prevention. The vaccine is administered to adults and children to generate immunity against the rabies virus.
Rabipur is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is responsible for the research, development, and manufacturing of the vaccine.
Rabipur is in Phase 2 clinical development. One Phase 2 trial has been completed, and a Phase 3 trial has also been completed to evaluate long-term immunogenicity and boostability of the vaccine in adults. It is an investigational vaccine and not yet approved for general use.
Rabipur has been studied in two completed clinical trials. NCT00360230 is a Phase 2, partially-blind, observer-blind study of safety and immunogenicity of two malaria vaccines in Ghanaian children, with 540 participants. NCT02545517 is a Phase 3 trial evaluating long-term immunogenicity and boostability of the rabies vaccine in adults, with 459 participants.
Rabipur is primarily a rabies vaccine, but it has been studied in a clinical trial for malaria. In the Phase 2 trial NCT00360230, Rabipur was used as a comparator or component in a study of malaria vaccines in Ghanaian children. It is not itself a malaria vaccine, but its immunogenicity was evaluated in that context.