Booster Vaccine for Yellow Fever

NCT05332197 | Unknown Phase 3 DMC

• 1 other identifier: LEO 26467
• Study Type: interventional
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase III trial on Children. The investigators will enroll a total of 750 participants in Fajikunda Health Center (Gambia) The aims of the study are

• To describe the safety and immunogenicity of a booster dose of a licensed yellow fever vaccine administered to 3 different age cohorts of children, following a documented primary dose of a yellow fever vaccine administered at nine-months of age.
• To characterise the rate of yellow-fever PRNT sero-reversion (seropositive to seronegative) over a period of 9 months to 8 years following a single primary dose of yellow fever vaccine administered to Gambian infants at nine months age.
• To profile the immune response to the booster dose of YF vaccine in order to explore underlying mechanisms for longevity of vaccine-induced antibody.

Conditions

Yellow Fever

Keywords

immunogenicity; Yellow fever vaccine

Outcome Measures

Primary Outcomes (2)

• Number of participants with a PRNT (Plague Reduction Neutralization Testing) sero-conversion after receiving booster Yellow Fever vaccination.

  Children will receive Yellow fever booster vaccination and different intervals of the primary dose and their blood will be collected 28days after the booster and tested for seroconversion to PRNT.

  28 days post booster

• Number of children who develop adverse events from Day 0 to D28 after receiving the booster Yellow fever vaccination

  After receiving the booster, children will be reviewed for adverse events 30 minutes to 1hour after the vaccination and followed up through home visits daily for 3days. Then they will be advised to come to the site for assessment if they develop an adverse event up to 28days after vaccination

  from Day 0 to Day 28 post booster

Study Arms (1)

17D Yellow fever vaccine

EXPERIMENTAL

All children will receive a single shot of the 17D Yellow fever vaccine. This vaccine contains the Rockefeller17D-substrain 204 strain of Yellow fever virus. This vaccine is presented as a 10 dose vial with freeze-dried content which is reconstituted with a diluent, provided with the vaccine by the manufacturer. Reconstituted vaccines have to be kept in a vaccine carrier at 2-8°C as per WHO and manufacturer requirements. Any remaining reconstituted vaccine not used has to be discarded after 6 h. The standard dose is 0·5 ml and is administered subcutaneously in the deltoid region using standard vaccination syringes (needle size 25G × 3/4") with a 45° injection angle

Biological: 17D Yellow fever vaccine

Interventions

17D Yellow fever vaccine BIOLOGICAL

This vaccine contains the Rockefeller17D-substrain 204 strain of Yellow fever virus. The exact potency of each batch is released with the certificate of analysis that accompanies each batch and the potency confirmed at time of release closest to internal minimum specification. This vaccine is the same vaccine used by the national EPI program

17D Yellow fever vaccine

Eligibility Criteria

• Age: 1 Year - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Any child fitting the required age cohorts who has a documented record of having received a primary dose of the Institut Pasteur YF 17D vaccine between 9 and 12 months of age.
• Documented evidence can be either a previous record of YF vaccination with dates in our own trial registers if the child was a previous participant or documented evidence on the Infant Welfare card.

You may not qualify if:

• Any child with a height/length for weight z-score of -3 or below.
• Any child known to be immunocompromised including any child with know vertical exposure to HIV infection.
• Any child with a history of serious adverse event or other contraindication to previous yellow fever vaccination.
• Participants who have an acute illness including abnormal vital signs or a fever of \> 37.5°C will not be vaccinated on the day but may be invited back for rescreening when they have recovered.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Related Publications (14)

• Rezende IM, Sacchetto L, Munhoz de Mello E, Alves PA, Iani FCM, Adelino TER, Duarte MM, Cury ALF, Bernardes AFL, Santos TA, Pereira LS, Dutra MRT, Ramalho DB, de Thoisy B, Kroon EG, Trindade GS, Drumond BP. Persistence of Yellow fever virus outside the Amazon Basin, causing epidemics in Southeast Brazil, from 2016 to 2018. PLoS Negl Trop Dis. 2018 Jun 4;12(6):e0006538. doi: 10.1371/journal.pntd.0006538. eCollection 2018 Jun.

  PMID: 29864115 BACKGROUND

• Domingo C, Fraissinet J, Ansah PO, Kelly C, Bhat N, Sow SO, Mejia JE. Long-term immunity against yellow fever in children vaccinated during infancy: a longitudinal cohort study. Lancet Infect Dis. 2019 Dec;19(12):1363-1370. doi: 10.1016/S1473-3099(19)30323-8. Epub 2019 Sep 19.

  PMID: 31543249 BACKGROUND

• Idoko OT, Domingo C, Tapia MD, Sow SO, Geldmacher C, Saathoff E, Kampmann B. Serological Protection 5-6 Years Post Vaccination Against Yellow Fever in African Infants Vaccinated in Routine Programmes. Front Immunol. 2020 Oct 8;11:577751. doi: 10.3389/fimmu.2020.577751. eCollection 2020.

  PMID: 33133096 BACKGROUND

• Campi-Azevedo AC, Reis LR, Peruhype-Magalhaes V, Coelho-Dos-Reis JG, Antonelli LR, Fonseca CT, Costa-Pereira C, Souza-Fagundes EM, da Costa-Rocha IA, Mambrini JVM, Lemos JAC, Ribeiro JGL, Caldas IR, Camacho LAB, Maia MLS, de Noronha TG, de Lima SMB, Simoes M, Freire MDS, Martins RM, Homma A, Tauil PL, Vasconcelos PFC, Romano APM, Domingues CM, Teixeira-Carvalho A, Martins-Filho OA. Short-Lived Immunity After 17DD Yellow Fever Single Dose Indicates That Booster Vaccination May Be Required to Guarantee Protective Immunity in Children. Front Immunol. 2019 Sep 26;10:2192. doi: 10.3389/fimmu.2019.02192. eCollection 2019.

  PMID: 31616412 BACKGROUND

• de Noronha TG, de Lourdes de Sousa Maia M, Geraldo Leite Ribeiro J, Campos Lemos JA, Maria Barbosa de Lima S, Martins-Filho OA, Campi-Azevedo AC, da Silva Freire M, de Menezes Martins R, Bastos Camacho LA; Collaborative Group for Studies of Yellow Fever Vaccine. Duration of post-vaccination humoral immunity against yellow fever in children. Vaccine. 2019 Nov 15;37(48):7147-7154. doi: 10.1016/j.vaccine.2019.09.051. Epub 2019 Oct 4.

  PMID: 31590934 BACKGROUND

• Vaccines and vaccination against yellow fever. WHO position paper -- June 2013. Wkly Epidemiol Rec. 2013 Jul 5;88(27):269-83. No abstract available. English, French.

  PMID: 23909008 BACKGROUND

• Staples JE, Barrett ADT, Wilder-Smith A, Hombach J. Review of data and knowledge gaps regarding yellow fever vaccine-induced immunity and duration of protection. NPJ Vaccines. 2020 Jul 6;5(1):54. doi: 10.1038/s41541-020-0205-6. eCollection 2020.

  PMID: 32655896 BACKGROUND

• Grobusch MP, Goorhuis A, Wieten RW, Verberk JD, Jonker EF, van Genderen PJ, Visser LG. Yellow fever revaccination guidelines change - a decision too feverish? Clin Microbiol Infect. 2013 Oct;19(10):885-6. doi: 10.1111/1469-0691.12332. Epub 2013 Aug 8. No abstract available.

  PMID: 23927031 BACKGROUND

• Bovay A, Nassiri S, Maby-El Hajjami H, Marcos Mondejar P, Akondy RS, Ahmed R, Lawson B, Speiser DE, Fuertes Marraco SA. Minimal immune response to booster vaccination against Yellow Fever associated with pre-existing antibodies. Vaccine. 2020 Feb 24;38(9):2172-2182. doi: 10.1016/j.vaccine.2020.01.045. Epub 2020 Jan 31.

  PMID: 32008879 BACKGROUND

• Kongsgaard M, Bassi MR, Rasmussen M, Skjodt K, Thybo S, Gabriel M, Hansen MB, Christensen JP, Thomsen AR, Buus S, Stryhn A. Adaptive immune responses to booster vaccination against yellow fever virus are much reduced compared to those after primary vaccination. Sci Rep. 2017 Apr 6;7(1):662. doi: 10.1038/s41598-017-00798-1.

  PMID: 28386132 BACKGROUND

• Lee AH, Shannon CP, Amenyogbe N, Bennike TB, Diray-Arce J, Idoko OT, Gill EE, Ben-Othman R, Pomat WS, van Haren SD, Cao KL, Cox M, Darboe A, Falsafi R, Ferrari D, Harbeson DJ, He D, Bing C, Hinshaw SJ, Ndure J, Njie-Jobe J, Pettengill MA, Richmond PC, Ford R, Saleu G, Masiria G, Matlam JP, Kirarock W, Roberts E, Malek M, Sanchez-Schmitz G, Singh A, Angelidou A, Smolen KK; EPIC Consortium; Brinkman RR, Ozonoff A, Hancock REW, van den Biggelaar AHJ, Steen H, Tebbutt SJ, Kampmann B, Levy O, Kollmann TR. Dynamic molecular changes during the first week of human life follow a robust developmental trajectory. Nat Commun. 2019 Mar 12;10(1):1092. doi: 10.1038/s41467-019-08794-x.

  PMID: 30862783 BACKGROUND

• 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

• Co MD, Terajima M, Cruz J, Ennis FA, Rothman AL. Human cytotoxic T lymphocyte responses to live attenuated 17D yellow fever vaccine: identification of HLA-B35-restricted CTL epitopes on nonstructural proteins NS1, NS2b, NS3, and the structural protein E. Virology. 2002 Feb 1;293(1):151-63. doi: 10.1006/viro.2001.1255.

  PMID: 11853408 BACKGROUND

• Kampmann B, Pley C, Strandmark J, Leigh MN, Ndow P, Clarke E, Roberts E, Faal A, Jeffries D, Kanteh E. Booster Vaccination against Yellow Fever in Gambian children-(BoVY) -a Phase 3 clinical trial to establish safety and immunogenicity of repeated YF vaccination in healthy Gambian children of different ages. Wellcome Open Res. 2024 Dec 24;9:733. doi: 10.12688/wellcomeopenres.23138.1. eCollection 2024.

  PMID: 39935766 DERIVED

MeSH Terms

Conditions

Yellow Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Central Study Contacts

Ebrima K Kanteh, MD, MSc

CONTACT

+2207714481; ekanteh@mrc.gm

Beate Kampmann, MD, PhD,DTM&H

CONTACT

+447833170145; beate.kampmann@lshtm.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 18, 2022
• Study Start: May 16, 2022
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 18, 2022

Record last verified: 2022-04