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

NCT05064956 | Completed Phase 2

• 1 other identifier: VAC52150EBL2010
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Ebola; Vaccine; HIV; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (5)

• Incidence of solicited adverse events

  Number and percentage of participants with solicited adverse events at the local injection site and systemically

  From the day of the booster to 7 days post-booster vaccination

• Incidence of unsolicited adverse events

  Number and percentage of participants with any untoward medical event

  From the day of the booster to 28 days post-booster vaccination

• Vaccine-induced humoral immune responses to the Ebola virus glycoprotein (EBOV GP)

  EBOV GP antibody concentration measured by FANG ELISA in ELISA Units (EU) per mL.

  At Day 1 (vaccination)

• Vaccine-induced humoral immune responses to the Ebola virus glycoprotein (EBOV GP)

  EBOV GP antibody concentration measured by FANG ELISA in ELISA Units (EU) per mL.

  At Day 8

• Vaccine-induced humoral immune responses to the Ebola virus glycoprotein (EBOV GP)

  EBOV GP antibody concentration measured by FANG ELISA in ELISA Units (EU) per mL.

  At Day 22

Study Arms (1)

Ad26.ZEBOV

EXPERIMENTAL

Ad26.ZEBOV will be given as a booster dose to all participants approximately 4 years after administration of the 2-dose Ebola regimen, Ad26.ZEBOV/MVA-BN-Filo, as part of the parent trial VAC52150EBL2002.

Biological: Ad26.ZEBOV

Interventions

Ad26.ZEBOV BIOLOGICAL

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.

Also known as: Zabdeno®

Ad26.ZEBOV

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must have previously received the 2-dose Ebola vaccine regimen in Kenya or Uganda in Cohort 2a of the VAC52150EBL2002 study.
• Must be aged 18 - 50 years at time of randomisation in the VAC52150EBL2002 study.
• Must consent to participate in the study by signing or thumbprinting an informed consent form (ICF), indicating that the participant understands the purpose and procedures of the study, as well as the potential risks and benefits of participation.
• Must be willing/able to ensure that participants adhere to the prohibitions and restrictions specified in this protocol
• Must be available and willing to participate for the duration of the study visits.
• Must be in reasonably good medical condition (absence of acquired immunodeficiency syndrome \[AIDS\]-defining illnesses or clinically significant disease)
• Must be on a stable regimen of HAART, with a HIV viral load of \<50 copies/mL and a CD4+ T-cell count of \>350 cells/µL at screening. Must be willing to continue HAART throughout the study.
• Potential participants must be healthy on the basis of clinical laboratory tests performed at screening.
• Female subjects of childbearing potential must use adequate birth control measures consistent with local regulations, from at least 14 days before vaccination until the end of the study. Must have a negative pregnancy test at screening and immediately prior to vaccination.
• Must have a means to be contacted

You may not qualify if:

• Participants in the VAC52150EBL2002 trial who were not in the Cohort 2a, or were allocated to the placebo arm.
• Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products, chicken or egg proteins and aminoglycosides (e.g. gentamicin).
• Presence of acute illness or axillary temperature ≥38ºC on the day of vaccination. Participants with such symptoms will be deferred.
• Women who are breast-feeding or known to be pregnant or planning to become pregnant during the study.
• Clinically significant history of skin disorder, allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
• Received a blood transfusion or other blood products within 8 weeks of enrolment.
• Potential participants who have been vaccinated with live-attenuated vaccines within 30 days before and after the study vaccination, and with inactive vaccine within 15 days before and after the study vaccination.
• Receipt of any disallowed therapies before the planned administration of the study vaccine.
• Subjects who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study or are unlikely to complete the study.
• Any other finding which, in the opinion of the investigator, would increase the risk of an adverse outcome.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (2)

KAVI - Institute of Clinical Research

Nairobi, Kenya

Location

MRC/UVRI and LSHTM Uganda Research Unit

Masaka, Buganda, Uganda

Location

Related Publications (1)

• Man-Lik Choi E, Abu-Baker Mustapher G, Omosa-Manyonyi G, Foster J, Anywaine Z, Musila Mutua M, Ayieko P, Vudriko T, Ann Mwangi I, Njie Y, Ayoub K, Mundia Muriuki M, Kasonia K, Edward Connor N, Florence N, Manno D, Katwere M, McLean C, Gaddah A, Luhn K, Lowe B, Greenwood B, Robinson C, Anzala O, Kaleebu P, Watson-Jones D; EBL2010 Study Team. Safety and immunogenicity of an Ad26.ZEBOV booster vaccine in Human Immunodeficiency Virus positive (HIV+) adults previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen against Ebola: A single-arm, open-label Phase II clinical trial in Kenya and Uganda. Vaccine. 2023 Dec 7;41(50):7573-7580. doi: 10.1016/j.vaccine.2023.10.055. Epub 2023 Nov 18.

  PMID: 37981473 DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Pontiano Kaleebu, PhD

  MRC/UVRI and LSHTM Uganda Research Unit

  PRINCIPAL INVESTIGATOR

• Omu Anzala, PhD

  KAVI - Institute of Clinical Research

  PRINCIPAL INVESTIGATOR

• Deborah L Watson-Jones, PhD

  London School of Hygiene and Tropical Medicine

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 1, 2021
• Study Start: October 6, 2021
• Primary Completion: November 17, 2021
• Study Completion: October 24, 2022
• Last Updated: February 21, 2023

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Start date: within 12 months of the study completion date End date: 60 months after the sharing start date Sharing period: 5 years
• Access Criteria: Study documents, such as the full protocol, statistical codes, Statistical Analytical Plan, Analytic Code, Independent Medical Reviewer's Terms of Reference, will be available upon request by email to Deborah Watson-Jones (Chief Investigator, Deborah.watson-jones@lshtm.ac.uk), Philip Ayieko (Study Statistician, philip.ayieko@lshtm.ac.uk) or Edward Choi (Study Coordinator, edward.choi@lshtm.ac.uk).

Locations

KE (1); UG (1)