ClinicalTrials.gg
CompletedNCT03458780Updated Jul 14, 2026

Yellow Fever Immune Response at Single Cell Resolution

An observational study in Healthy, sponsored by Rockefeller University. Completed at 1 site in United States. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Rockefeller University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
6
Ages
18 Years to 59 Years
Sex
All
01

Study summary

The immune system is composed of diverse cell types with different functions that act together in order to defend against infection. This pilot study will test a new technology for studying these many different cell types at very large numbers at the level of individual cells. This method will then be used to identify the cell types and functions important for the immune response to the highly protective yellow fever vaccine, which will improve our understanding of effective vaccine features.

Read the detailed description

Vaccines have had monumental impact in reducing the mortality and morbidity of infectious disease. However, the underlying immune mechanisms that contribute to their effectiveness are incompletely understood. Transcriptomics (methods that measure the activity of thousands of genes) studies have identified key features of responses to vaccination(see references) and infection(see references). However, these experiments are typically performed on heterogeneous cell mixtures such as peripheral blood mononuclear cells (PBMC which include certain types of white blood cells) and therefore provide an aggregate measure of gene expression from the many different immune cells and their respective activities in the mixture. Such results can obscure important biological information, particularly in minor subsets of active cells. Establishing a method for immune transcriptomics at single cell resolution would be a highly significant advance and enable more informative and functionally relevant systems immunology studies with commonly used sample types (i.e. PBMC). Applying this high-resolution approach to Yellow Fever Vaccine (YFV), an exceptionally effective vaccine, is likely to identify unappreciated mechanisms that contribute to protective immunity.

02

Conditions studied

  • Healthy

Keywords

  • yellow fever vaccine
  • immune response
  • droplet microfluidics single cell ("inDrop") RNA-Seq
03

In context

Lead sponsor

Rockefeller University is the lead sponsor of 123 studies on the registry; 3 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy Volunteers

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female between the ages of 18 and 59 years old
  • Volunteers who have not received a vaccination within 30 days of the YFV and do not anticipate to receive a vaccination within 30 days
  • Volunteers who are seeking the YFV for either travel reasons or occupational risk
  • Volunteers willing to undergo one screening visit, one visit to receive the YFV, and four post-vaccination visits
  • Volunteers without medical conditions who are willing to give blood once for the development of the inDrop technique

Exclusion criteria

Exclusion Criteria:

  • Male or females under 18 or over 59 years of age
  • Volunteers who received other vaccination less than 30 days prior to receiving the YFV
  • Volunteers with acute or febrile disease
  • Volunteers unable to return for the post vaccination follow-up visits
  • Volunteers with an allergy to eggs, chicken proteins, gelatin, or other components of the Yellow Fever vaccine
  • Participation in another clinical study of an product currently or within the past 90 days, or expected participation during this study
  • Is pregnant or lactating
  • Volunteers with a history of yellow fever vaccination and/or infection
  • Volunteers with a history of viral hepatitis and/or non-viral liver disease
  • In the opinion of the investigators, the volunteer is unlikely to comply with the study protocol
  • individuals as a result of cancer, transplantation, and or primary immunodeficiency
  • Immunosuppressed individuals as a result of medications (such as high-dose systemic , alkylating drugs, antimetabolites, TNF-α inhibitors (e.g., etanercept), IL-1 blocking agents (e.g., anakinra), and other monoclonal antibodies targeting immune cells (e.g.,rituximab, alemtuzumab) and/or radiation
  • Volunteers with thymus disorders (including myasthenia gravis, Di George syndrome, or thymoma) and/or history of thymectomy
  • Individuals infected with
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
6 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Yellow Fever Vaccine Participant

    Healthy participants who receive the Yellow fever vaccine for travel and/or occupational risk will have peripheral blood samples collected longitudinally at time points selected for different immune events post-vaccination according to published studies (Day 0 baseline; Days: 3, 7, 14, and 42).

    Drug: Yellow Fever Vaccine

Interventions

06

What researchers measure

Primary outcomes

  1. Feasibility and accuracy of inDrop RNA-Seq

    The feasibility and accuracy of inDrop RNA-Seq for distinguishing different cell types will be assessed by comparing (for concordance) cell subset population frequency and distribution values determined by inDrop RNA-seq to cell subset population frequency and distribution values determined by flow cytometry immunophenotyping, the present "gold standard" technique.

    Time frame: up to 42 days post baseline visit

Secondary outcomes

  1. Utility of inDrop RNA-Seq

    The utility of inDrop RNA-Seq for characterizing an immune response will be determined by measuring cell subset frequencies and gene expression profiles at single cell resolution over time following YFV.

    Time frame: Days 0, 3, 7, 14, 42

07

Study locations

1 site
  • The Rockefeller University
    New York, New York 10065, United States
08

References and documents

Publications

  • Querec TD, Akondy RS, Lee EK, Cao W, Nakaya HI, Teuwen D, Pirani A, Gernert K, Deng J, Marzolf B, Kennedy K, Wu H, Bennouna S, Oluoch H, Miller J, Vencio RZ, Mulligan M, Aderem A, Ahmed R, Pulendran B. Systems biology approach predicts immunogenicity of the yellow fever vaccine in humans. Nat Immunol. 2009 Jan;10(1):116-125. doi: 10.1038/ni.1688. Epub 2008 Nov 23. PubMed 19029902 ↗
  • Obermoser G, Presnell S, Domico K, Xu H, Wang Y, Anguiano E, Thompson-Snipes L, Ranganathan R, Zeitner B, Bjork A, Anderson D, Speake C, Ruchaud E, Skinner J, Alsina L, Sharma M, Dutartre H, Cepika A, Israelsson E, Nguyen P, Nguyen QA, Harrod AC, Zurawski SM, Pascual V, Ueno H, Nepom GT, Quinn C, Blankenship D, Palucka K, Banchereau J, Chaussabel D. Systems scale interactive exploration reveals quantitative and qualitative differences in response to influenza and pneumococcal vaccines. Immunity. 2013 Apr 18;38(4):831-44. doi: 10.1016/j.immuni.2012.12.008. PubMed 23601689 ↗
  • Tsang JS, Schwartzberg PL, Kotliarov Y, Biancotto A, Xie Z, Germain RN, Wang E, Olnes MJ, Narayanan M, Golding H, Moir S, Dickler HB, Perl S, Cheung F; Baylor HIPC Center; CHI Consortium. Global analyses of human immune variation reveal baseline predictors of postvaccination responses. Cell. 2014 Apr 10;157(2):499-513. doi: 10.1016/j.cell.2014.03.031. PubMed 24725414 ↗
  • Li S, Rouphael N, Duraisingham S, Romero-Steiner S, Presnell S, Davis C, Schmidt DS, Johnson SE, Milton A, Rajam G, Kasturi S, Carlone GM, Quinn C, Chaussabel D, Palucka AK, Mulligan MJ, Ahmed R, Stephens DS, Nakaya HI, Pulendran B. Molecular signatures of antibody responses derived from a systems biology study of five human vaccines. Nat Immunol. 2014 Feb;15(2):195-204. doi: 10.1038/ni.2789. Epub 2013 Dec 15. PubMed 24336226 ↗
  • Gaucher D, Therrien R, Kettaf N, Angermann BR, Boucher G, Filali-Mouhim A, Moser JM, Mehta RS, Drake DR 3rd, Castro E, Akondy R, Rinfret A, Yassine-Diab B, Said EA, Chouikh Y, Cameron MJ, Clum R, Kelvin D, Somogyi R, Greller LD, Balderas RS, Wilkinson P, Pantaleo G, Tartaglia J, Haddad EK, Sekaly RP. Yellow fever vaccine induces integrated multilineage and polyfunctional immune responses. J Exp Med. 2008 Dec 22;205(13):3119-31. doi: 10.1084/jem.20082292. Epub 2008 Dec 1. PubMed 19047440 ↗
  • Fourati S, Cristescu R, Loboda A, Talla A, Filali A, Railkar R, Schaeffer AK, Favre D, Gagnon D, Peretz Y, Wang IM, Beals CR, Casimiro DR, Carayannopoulos LN, Sekaly RP. Pre-vaccination inflammation and B-cell signalling predict age-related hyporesponse to hepatitis B vaccination. Nat Commun. 2016 Jan 8;7:10369. doi: 10.1038/ncomms10369. PubMed 26742691 ↗
  • Kwissa M, Nakaya HI, Onlamoon N, Wrammert J, Villinger F, Perng GC, Yoksan S, Pattanapanyasat K, Chokephaibulkit K, Ahmed R, Pulendran B. Dengue virus infection induces expansion of a CD14(+)CD16(+) monocyte population that stimulates plasmablast differentiation. Cell Host Microbe. 2014 Jul 9;16(1):115-27. doi: 10.1016/j.chom.2014.06.001. Epub 2014 Jun 26. PubMed 24981333 ↗
  • Suthar MS, Pulendran B. Systems analysis of West Nile virus infection. Curr Opin Virol. 2014 Jun;6:70-5. doi: 10.1016/j.coviro.2014.04.010. Epub 2014 May 20. PubMed 24851811 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03458780
Responsible party
Brad Rosenberg (Assistant Professor, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Mar 8, 2018
Start date
Aug 22, 2016
Primary completion
Sep 5, 2018
Completion
Sep 5, 2018
Last update
Jul 14, 2026

Study contacts

Brad R Rosenberg, MD, PhD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion