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Ad26.ZEBOV Booster in HIV+ Adults Previously Vaccinated With Ad26.ZEBOV/MVA-BN-Filo (EBOVAC HIV+ Booster Study)

NCT05064956 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-02-21

No results posted yet for this study

Summary

This is an open label study to evaluate the safety and immune response to a booster dose of Ad26.ZEBOV Ebola vaccine in HIV+ adults from Kenya and Uganda. Only participants who have received the 2-dose Ebola vaccine regimen "Ad26.ZEBOV/MVA-BN-Filo " in the VAC52150EBL2002 vaccine trial about 4 years ago are eligible to take part.

Approximately 50 healthy HIV+ adults, aged 18 - 50 years at the time of the parent trial, will be invited. Participants will first be asked to provide consent to participate in this study. Upon receiving the booster vaccination, participants will be followed up for approximately 28 days (+/- 3 days) to collect information on side effects and provide blood samples for antibody measurement.

This study is designed to provide descriptive information regarding vaccine safety and immunogenicity. There is no formal treatment comparisons and no formal testing of statistical hypothesis.

Conditions

  • Ebola Virus Disease
  • Ebola
  • Hiv

Interventions

BIOLOGICAL

Ad26.ZEBOV

Ad26.ZEBOV is a non-replicating, monovalent vaccine expressing the full-length Mayinga glycoprotein (GP) of the Ebola virus (formerly known as Zaire ebolavirus), and is produced in human cell line. Participants will receive a 0.5mL intramuscular injection of Ad26.ZEBOV, at a concentration of 1x10\^11 vp/mL, into the anterolateral deltoid muscle.

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Pontiano Kaleebu, PhD · MRC/UVRI and LSHTM Uganda Research Unit

  • Omu Anzala, PhD · KAVI - Institute of Clinical Research

  • Deborah L Watson-Jones, PhD · London School of Hygiene and Tropical Medicine

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2021-11-17
Completion
2022-10-24

Countries

  • Kenya
  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064956 on ClinicalTrials.gov