Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| VAC18192RSV1001 | Other Identifier | Crucell Holland BV |
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
The purpose of this study is to assess the safety and tolerability of intramuscular homologous and heterologous prime-boost regimens of Ad35.RSV.FA2 (human adenovirus-vectored vaccine candidate) and Ad26.RSV.FA2 in healthy participants.
This is a single-center, randomized (study medication assigned to participants by chance), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), double-blind (neither the researchers nor the participants know what treatment the participant is receiving) and Phase 1 study in healthy participants. The study comprises a 4-week screening period; vaccination for each participant on Days 1, 85, and, 169; a 28-day follow-up period performed after each vaccination and a final visit at Day 323 or 351. Participants will be randomly assigned to one of the 4 treatment groups (Group 1/2/3/4) to receive either Ad35.RSV.FA2 or Ad26.RSV.FA2 or placebo. The study duration will be approximately 52 weeks. Blood samples for immunogenicity will be collected. Participant's safety will be evaluated throughout the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Two subsequent Intramuscular injections of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on Day 1, Day 85 and an intramuscular injection of Ad26.RSV.FA2 (5x10^10 vp) on Day 169. |
|
| Group 2 | Experimental | Intramuscular injection of Ad35.RSV.FA2 (1x10^11 vp) on Day 1, an intramuscular injection of placebo control on Day 85 and an injection of Ad35.RSV.FA2 (1x10^11 vp) on Day 169. |
|
| Group 3 | Experimental | One intramuscular injection of Ad35.RSV.FA2 (1x10^11 vp) on Day 1 and an intramuscular injection of placebo control on Day 85 and an intramuscular injection of Ad26.RSV.FA2 (5x10^10 vp) on Day 169. |
|
| Group 4 | Experimental | Two subsequent intramuscular injections of placebo control on Day 1, Day 85 and an intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on Day 169. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad35.RSV.FA2 | Biological | Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10^11) virus particles on Day 1 and 85 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10^11) virus particles on Day 1 and 169 in Group 2. Intramuscular injection of Ad35.RSV.FA2 (1x10^11) virus particles on Day 1 in Group 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs are precisely defined events that participants are specifically asked about and which are noted by participants through the participant diary. | Up to 8 days after each vaccination |
| Unsolicited AEs | Unsolicited AEs will be reported by the participant from when the informed consent form (ICF) is signed until 28 days after each vaccination, or early discontinuation. | From Signing of informed consent up to 28 days after each vaccination |
| Serious Adverse Events (SAEs) | A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly | Up to Day 337 |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Respiratory Syncytial Virus (RSV)-Specific Humoral Immune Response | Determine induction and persistence of humoral immune response against RSV F-protein. | Day 1 (predose) up to day 337 |
| To Assess RSV-specific Cellular Immune Response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Crucell Holland BV Clinical Trial | Crucell Holland BV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Ad26.RSV.FA2 | Biological | Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on Day 169 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10^10) virus particles on Day 169 in Group 3. Intramuscular injection of Ad26.RSV.FA2 (5x10^10) virus particles on Day 169 in Group 4. |
|
|
| Placebo | Drug | Participants will receive intramuscular injection of placebo (sterile formulation buffer) on Day 85 in Group 2. One intramuscular injections of placebo on Day 85 in Group 3. Two intramuscular injections of placebo on Day 1, and Day 85 in Group 4. |
|
Assess the quantity and quality of the elicited cellular immune response.
| Day 1 (predose) up to day 337 |