Yellow Fever Immune Response at Single Cell Resolution

NCT03458780 | Completed FDA Drug

• 2 other identifiers: BRO-09055U19AI111825
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

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

Outcome Measures

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.

  up to 42 days post baseline visit

Secondary Outcomes (1)

• Utility of inDrop RNA-Seq

  Days 0, 3, 7, 14, 42

Study Arms (1)

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

Yellow Fever Vaccine DRUG

Yellow Fever Vaccine .5 ml

Also known as: YF-Vax

Yellow Fever Vaccine Participant

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

• 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

You may not qualify if:

• 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 investigational 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
• Immunosuppressed individuals as a result of cancer, transplantation, and or primary immunodeficiency
• Immunosuppressed individuals as a result of medications (such as high-dose systemic corticosteroids, 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 HIV

Sponsors & Collaborators

• Rockefeller University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

Related Publications (8)

• 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.

  PMID: 19029902 BACKGROUND

• 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.

  PMID: 23601689 BACKGROUND

• 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.

  PMID: 24725414 BACKGROUND

• 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.

  PMID: 24336226 BACKGROUND

• 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.

  PMID: 19047440 BACKGROUND

• 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.

  PMID: 26742691 BACKGROUND

• 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.

  PMID: 24981333 BACKGROUND

• 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.

  PMID: 24851811 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Research Bloods

MeSH Terms

Interventions

Yellow Fever Vaccine

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Brad R Rosenberg, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 8, 2018
• Study Start: August 22, 2016
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

US (1)