Ad26.ZEBOV Booster in Children Previously Vaccinated With Ad26.ZEBOV and MVA-BN-Filo (EBOVAC Booster Study)

NCT04711356 | Completed Phase 2 Results

• 1 other identifier: VAC52150EBL2011
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label study evaluating the safety and immunogenicity of a booster dose of Ad26.ZEBOV administered to children who were previously vaccinated with Ad26.ZEBOV followed by MVA-BN-Filo 56 days later.

Conditions

Ebola Virus Disease

Keywords

Ad26.ZEBOV; booster vaccination; children

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Solicited Local (at the Administration Site) Adverse Events

  Number and percentage of participants with at least one solicited local adverse event (i.e. pain, erythema, pruritus and swelling)

  From the booster vaccination to 7 days post booster

• Number of Participants With Solicited Systemic Adverse Events

  Number and percentage of participants with at least one solicited systemic adverse event (i.e. arthralgia, chills, fatigue, headache, myalgia, nausea and pyrexia)

  From the booster vaccination to 7 days post booster

• Number of Participants With Unsolicited Adverse Events

  Number and percentage of participants with at least one unsolicited adverse event

  From the booster vaccination to 28 days post booster

• Number of Participants With Serious Adverse Events

  Number and percentage of participants with serious adverse events

  From the booster vaccination to 28 days post booster

• Pre-booster Baseline Humoral Immune Responses to the Ebola Virus Glycoprotein (EBOV GP)

  EBOV GP antibody geometric mean concentration measured by FANG ELISA in Elisa Units (EU) per millilitre

  day 1 before booster administration

• Vaccine-induced Humoral Immune Responses to the Ebola Virus Glycoprotein (EBOV GP)

  EBOV GP antibody geometric mean concentration measured by FANG ELISA in Elisa Units (EU) per millilitre

  At 7 days post booster

• Vaccine-induced Humoral Immune Responses to the Ebola Virus Glycoprotein (EBOV GP)

  EBOV GP antibody geometric mean concentration measured by FANG ELISA in Elisa Units (EU) per millilitre

  At 21 days post booster

Study Arms (1)

Study Intervention

EXPERIMENTAL

All study participants will receive an Ad26.ZEBOV vaccine at a dose of 5x10\^10 vp given via IM injection

Drug: Ad26.ZEBOV booster vaccination, given at a dose of 5x10^10 vp, via IM injection

Interventions

Ad26.ZEBOV booster vaccination, given at a dose of 5x10^10 vp, via IM injection DRUG

Ad26.ZEBOV is a monovalent, replication-incompetent adenovirus serotype 26-based vector that expresses the full-length Ebola virus Mayinga glycoprotein

Study Intervention

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child must be enrolled in the VAC52150EBL3005 (EBOVAC-Salone Extension) study but not in the immunogenicity subset of EBOVAC-Salone Extension study.
• Child must be a former participant in the VAC52150EBL3001 (EBOVAC-Salone) trial, and have received Ad26.ZEBOV (dose 1) vaccination followed by the MVA-BN-Filo (dose 2) vaccination within the EBOVAC- Salone trial window for dose 2 vaccination.
• Child must have been aged 1 to 11 years old at the time of dose 1 vaccination in the EBOVAC-Salone trial.
• The parent/guardian must consent for their child to participate in the VAC52150EBL2011 study. Children aged 7 years and older will be asked to give positive assent for their participation in the study.
• The parent/guardian is willing/able to ensure that their child adheres to the prohibitions and restrictions specified in this protocol.
• Child must be healthy in the investigator's clinical judgement (and the parent/guardian's judgement) on the basis of medical history, physical examination, vital signs, and a haematological assessment (i.e. full blood count) performed at screening. Subjects must meet the following haematology parameters within 28 days before Day 1:
• Haemoglobin ≥8.0 g/dL for children aged 1 to \<5 years, ≥9g/dL for children aged 5 or older
• Platelet count ≥100 x 10\^9/L
• White blood cell count ≥5.0 x 10\^9/L
• Adolescent girls who have started their menstrual periods and/or are ≥12 years of age at the time of screening, must have a negative urine β-hCG pregnancy test at screening and immediately prior to the booster vaccination on Day 1.
• The parent/guardian is available and willing to have their infant participate for the duration of the study visits.
• The parent/guardian must have a means to be contacted.
• The parent/guardian must pass the Test of Understanding (TOU)

You may not qualify if:

• Participants in the EBOVAC-Salone trial who were allocated to the control arm receiving the WHO- prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.
• Participants in the EBOVAC-Salone trial who were age 12 years and older at the time of dose 1 vaccination.
• Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccine, e.g., polysorbate 80, ethylenediaminetetraacetic acid or L-histidine for Ad26.ZEBOV vaccine), including known allergy to chicken or egg proteins and aminoglycosides (gentamicin).
• Presence of acute illness (this does not include minor illnesses such as mild diarrhoea or mild upper respiratory tract infection) or axillary temperature ≥38C on Day 1. Participants with such symptoms will be excluded from enrolment at that time but may be rescheduled for enrolment at a later date within the screening window.
• Clinically significant history of skin disorder (e.g., psoriasis, contact dermatitis), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the investigator or other delegated individual.
• Adolescent girls who are known to be pregnant or breastfeeding at screening.
• Received a blood transfusion or other blood products within 8 weeks of vaccination day.
• Children who have been vaccinated with live-attenuated vaccines within 30 days before the study vaccination, and with inactivated vaccine within 15 days before the study vaccination.
• Children who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study or are unlikely to complete the vaccination and observation.
• Any other finding which in the opinion of the investigator or other delegated individual would increase the risk of an adverse outcome from participation in the study.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Innovative Medicines Initiative: collaborator
• University of Sierra Leone: collaborator

Study Sites (1)

EBOVAC Kambia 1 clinic

Kambia, Sierra Leone

Location

Related Publications (1)

• Manno D, Bangura A, Baiden F, Kamara AB, Ayieko P, Kallon J, Foster J, Conteh M, Connor NE, Koroma B, Njie Y, Borboh P, Keshinro B, Lawal BJ, Kroma MT, Otieno GT, Deen AT, Choi EM, Balami AD, Gaddah A, McLean C, Luhn K, Adetola HH, Deen GF, Samai M, Lowe B, Robinson C, Leigh B, Greenwood B, Watson-Jones D. Safety and immunogenicity of an Ad26.ZEBOV booster dose in children previously vaccinated with the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen: an open-label, non-randomised, phase 2 trial. Lancet Infect Dis. 2023 Mar;23(3):352-360. doi: 10.1016/S1473-3099(22)00594-1. Epub 2022 Oct 20.

  PMID: 36273490 DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Limitations and Caveats

In the study protocol, the follow-up was only 28 days due to the end of the grant that funded the study. Neutralising antibodies and cellular immune responses post booster could not be assessed within the timeframe of the grant and were not included in the protocol. We do not know if the concentrations of binding antibodies achieved after booster vaccination indicate protection against Ebola virus disease because an antibody threshold correlating with protection has not yet been established.

Results Point of Contact

• Title: Dr Daniela Manno, clinical trial coordinator and responsible physician
• Organization: London School of Hygiene & Tropical Medicine

daniela.manno@lshtm.ac.uk

+44 20 7927

Study Officials

• Deborah Watson-Jones, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Bailah Leigh, MD

  University of Sierra Leone

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive a single dose of Ad26.ZEBOV at a dose of 5x10\^10 viral particles (vp) administered intramuscularly.

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: January 15, 2021
• Study Start: July 8, 2021
• Primary Completion: September 17, 2021
• Study Completion: March 31, 2022
• Last Updated: December 13, 2023
• Results First Posted: December 13, 2023

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: within 12 months of the study completion date
• Access Criteria: open

Locations

SI (1)