Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 Dec 7;41(50):7573-7580.
doi: 10.1016/j.vaccine.2023.10.055. Epub 2023 Nov 18.

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

Edward Man-Lik Choi  1 , Ggayi Abu-Baker Mustapher  2 , Gloria Omosa-Manyonyi  3 , Julie Foster  4 , Zacchaeus Anywaine  5 , Michael Musila Mutua  6 , Philip Ayieko  7 , Tobias Vudriko  8 , Irene Ann Mwangi  9 , Yusupha Njie  10 , Kakande Ayoub  11 , Moses Mundia Muriuki  12 , Kambale Kasonia  13 , Nicholas Edward Connor  14 , Nambaziira Florence  15 , Daniela Manno  16 , Michael Katwere  17 , Chelsea McLean  18 , Auguste Gaddah  19 , Kerstin Luhn  20 , Brett Lowe  21 , Brian Greenwood  22 , Cynthia Robinson  23 , Omu Anzala  24 , Pontiano Kaleebu  25 , Deborah Watson-Jones  26 ; EBL2010 Study Team
Affiliations
Free article
Clinical Trial

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

Edward Man-Lik Choi et al. Vaccine. .
Free article

Abstract

Background: People living with HIV constitute an important part of the population in regions at risk of Ebola virus disease outbreaks. The two-dose Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen induces strong immune responses in HIV-positive (HIV+) adults but the durability of this response is unknown. It is also unclear whether this regimen can establish immune memory to enable an anamnestic response upon re-exposure to antigen.

Methods: This paper describes an open-label, phase 2 trial, conducted in Kenya and Uganda, of Ad26.ZEBOV booster vaccination in HIV+ participants who had previously received the Ad26.ZEBOV, MVA-BN-Filo primary regimen. HIV+ adults with well-controlled infection and on highly active antiretroviral therapy were enrolled, vaccinated with booster, and followed for 28 days. The primary objectives were to assess Ad26.ZEBOV booster safety and antibody responses against the Ebola virus glycoprotein using the Filovirus Animal Non-Clinical Group ELISA.

Results: The Ad26.ZEBOV booster was well-tolerated in HIV+ adults with mostly mild to moderate symptoms. No major safety concerns or serious adverse events were reported. Four and a half years after the primary regimen, 24/26 (92 %) participants were still classified as responders, with a pre-booster antibody geometric mean concentration (GMC) of 726 ELISA units (EU)/mL (95 %CI 447-1179). Seven days after the booster, the GMC increased 54-fold to 38,965 EU/mL (95 %CI 23532-64522). Twenty-one days after the booster, the GMC increased 176-fold to 127,959 EU/mL (95 %CI 93872-174422). The responder rate at both post-booster time points was 100 %.

Conclusions: The Ad26.ZEBOV booster is safe and highly immunogenic in HIV+ adults with well-controlled infection. The Ad26.ZEBOV, MVA-BN-Filo regimen can generate long-term immune memory persisting for at least 4·5 years, resulting in a robust anamnestic response.

Trial registration: Pan African Clinical Trial Registry (PACTR202102747294430).

Clinicaltrials: gov (NCT05064956).

Keywords: Ad26.ZEBOV; Booster; Clinical trial; Ebola vaccine; HIV; MVA-BN-Filo.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Janssen Vaccines & Prevention B.V. was the vaccine manufacturer and donated the vaccine for this study. BKe, AG, CM, KL, and CR were full-time employees of Janssen, Pharmaceutical Companies of Johnson & Johnson at the time of the study. AG, CM, KL, and CR, declared ownership of shares in Janssen, Pharmaceutical Companies of Johnson & Johnson. All other authors declare funding from the Innovative Medicines Initiative 2 Joint Undertaking. GAM reports having received travel grant from the vaccine manufacturer to attend scientific meetings and present, after the study has completed.

References

Publication types

Substances

Associated data