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NCT03049488 · ClinicalTrials.gov registry record · Phase 1
Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults
A Phase 1 study of Respiratory Syncytial Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
- 1
- Study location
NCT03049488: Completed Phase 1 study of Respiratory Syncytial Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03049488 is a Phase 1 study of Respiratory Syncytial Virus that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 95 participants, below the 383-participant average among 7 other Respiratory Syncytial Virus trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03049488, a Phase 1 study of Respiratory Syncytial Virus, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Respiratory Syncytial Virus (RSV) is a virus that infects the lungs and breathing passages. Healthy adults who are infected generally have mild cold symptoms for a week or two. But it can also be serious, especially for infants and older adults. It can be spread by direct or indirect contact with respiratory secretions. Researchers want to study a new vaccine to prevent RSV. Objective: To see if a vaccine for RSV is safe and if it causes side effects. Eligibility: Healthy adults 18-50 years old Design: Volunteers were screened in a separate screening protocol. Subjects had 13 visits over 1 year. Some subjects received just vaccine. Some received vaccine mixed with alum adjuvant. All subjects received their dose by injection in the upper arm. They received up to two doses, one at the beginning of the study and another 12 weeks later. Subjects were monitored for 1 hour after injection and called to check on their safety 1 day after. Subjects recorded their temperature and side effects for 7 days after each vaccination. Subjects were provided with a thermometer to measure their temperature and a ruler to measure any changes if these occurred on their skin at the injection site. At all visits, subjects were checked for health changes or problems. They may have had blood drawn. At some visits, subjects had samples collected from their nose and mouth.
Primary Outcome
Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenic
Conditions Studied
Interventions
- BIOLOGICAL VRC-RSVRGP084-00-VP
- OTHER Aluminum Hydroxide Suspension
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2017-02-22 |
| Est. Completion | 2019-10-03 |
| Phase | Phase 1 |
What the finished NCT03049488 record still lists
NCT03049488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 383-participant average among 7 other Respiratory Syncytial Virus trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Respiratory Syncytial Virus appearing as the primary indexed condition, and to 2 interventions - of which VRC-RSVRGP084-00-VP is the first listed.
NCT03049488 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03049488 about?
NCT03049488 is a clinical study titled "Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults". Background: Respiratory Syncytial Virus (RSV) is a virus that infects the lungs and breathing passages. Healthy adults who are infected generally have mild cold symptoms for a week or two. But it can also be serious, especially for infants and older adults. It can be spread by direct or indirect co...
What is the current status of trial NCT03049488?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2017-02-22. Estimated completion is 2019-10-03.
What conditions does trial NCT03049488 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus.
What interventions are being tested in trial NCT03049488?
The interventions under investigation include: VRC-RSVRGP084-00-VP (BIOLOGICAL), Aluminum Hydroxide Suspension (OTHER).
Who is sponsoring clinical trial NCT03049488?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03049488 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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