Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase 1/2 study will evaluate the safety, reactogenicity and immunogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Parts 1 and 2) or Placebo (Part 3).
In Part 1 and Part 2, the study will descriptively evaluate three dose levels of SCB-1022 and SCB-1033. Part 3 will descriptively compare SCB-1022 and SCB-1033 against placebo.
The sample size of this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1/2 study. The study will be overseen by a safety monitoring committee.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (SCB-1022 dose level 1) | Experimental | 24 adults to receive dose level 1 of SCB-1022 at Day 1 |
|
| Group 2 (SCB-1022 dose level 2) | Experimental | 24 adults to receive dose level 2 of SCB-1022 at Day 1 |
|
| Group 3 (SCB-1033 dose level 1) | Experimental | 24 adults to receive dose level 1 of SCB-1033 at Day 1 |
|
| Group 4 (SCB-1019T) | Active Comparator | 24 adults to receive SCB-1019T at Day 1 |
|
| Group 5 (SCB-1022 dose level 3) | Experimental | 24 adults to receive dose level 3 of SCB-1022 at Day 1 |
|
| Group 6 (SCB-1033 dose level 2) | Experimental | 24 adults to receive dose level 2 of SCB-1033 at Day 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCB-1019T | Biological | SCB-1019T (bivalent recombinant RSV vaccine candidate) consists of two recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)) and RSV B strain (SCB-1019T(B)). |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T (Part 1 and Part 2) or Placebo (Part 3). | Proportion of participants with local and systemic solicited AEs | Within 7 days after vaccination |
| To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2) or Placebo (Part 3). | Proportion of participants with unsolicited AEs | Within 28 days after vaccination |
| To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2) or placebo (Part 3). | Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study | Throughout the study period, from enrollment up to 2 years follow-up |
| To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2). | Mean change and shift from baseline in hematology, biochemistry and coagulation parameters; by safety set. | Screening and day 8 |
Not provided
Not provided
Inclusion Criteria:
Please refer to Protocol for full list of Inclusion and Exclusion criteria.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher D Rook, MD | Fusion Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fusion Clinical Research | Adelaide | Southern Australia | 5067 | Australia | ||
| Paratus Clinical Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| D018184 | Paramyxoviridae Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Group 7 (SCB-1033 dose level 3) | Experimental | 24 adults to receive dose level 3 of SCB-1033 at Day 1 |
|
| Group 8 (SCB-1019T) | Active Comparator | 24 adults to receive SCB-1019T at Day 1 |
|
| Group 9 (SCB-1022 Formulation 1) | Experimental | 105 adults to receive formulation 1 of SCB-1022 at Day 1 |
|
| Group 10 (SCB-1022 Formulation 2) | Experimental | 105 adults to receive formulation 2 of SCB-1022 at Day 1 |
|
| Group 11 (SCB-1033) | Experimental | 105 adults to receive SCB-1033 at Day 1 |
|
| Group 12 Placebo (saline) | Experimental | 105 adults to receive placebo at Day 1 |
|
| SCB-1022 | Biological | SCB-1022 (combination recombinant RSV-hMPV vaccine candidate) consists of three recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), and hMPV (SCB-1021). |
|
| SCB-1033 | Biological | SCB-1033 (combination recombinant RSV-hMPV-PIV3 vaccine candidate) consists of four recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), hMPV (SCB-1021) and PIV3 (SCB-1020). |
|
| Placebo (saline) | Biological | 0.9% saline |
|
| Melbourne |
| Victoria |
| 3070 |
| Australia |
| Linear Clinical Research | Perth | Western Australia | 6009 | Australia |
| D007239 |
| Infections |
| D017670 |
| Sodium Compounds |