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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
NCT03049488 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03049488
The ClinicalTrials.gov registry entry for NCT03049488 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03049488 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03049488?
The interventions under investigation include: VRC-RSVRGP084-00-VP (BIOLOGICAL), Aluminum Hydroxide Suspension (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03049488?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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