Safety and immunogenicity of Ad26 and MVA vaccines in acutely treated HIV and effect on viral rebound after antiretroviral therapy interruption

Donn J Colby; Michal Sarnecki; Dan H Barouch; Somporn Tipsuk; Daniel J Stieh; Eugène Kroon; Alexandra Schuetz; Jintana Intasan; Carlo Sacdalan; Suteeraporn Pinyakorn; Pornsuk Grandin; Hongshuo Song; Sodsai Tovanabutra; Zhanna Shubin; Dohoon Kim; Dominic Paquin-Proulx; Michael A Eller; Rasmi Thomas; Mark de Souza; Lindsay Wieczorek; Victoria R Polonis; Amélie Pagliuzza; Nicolas Chomont; Lauren Peter; Joseph P Nkolola; Johan Vingerhoets; Carla Truyers; Maria G Pau; Hanneke Schuitemaker; Nittaya Phanuphak; Nelson Michael; Merlin L Robb; Frank L Tomaka; Jintanat Ananworanich

doi:10.1038/s41591-020-0774-y

Safety and immunogenicity of Ad26 and MVA vaccines in acutely treated HIV and effect on viral rebound after antiretroviral therapy interruption

Nat Med. 2020 Apr;26(4):498-501. doi: 10.1038/s41591-020-0774-y. Epub 2020 Mar 23.

Authors

Donn J Colby¹, Michal Sarnecki², Dan H Barouch³, Somporn Tipsuk¹, Daniel J Stieh⁴, Eugène Kroon¹, Alexandra Schuetz^{5

6

7}, Jintana Intasan¹, Carlo Sacdalan¹, Suteeraporn Pinyakorn^{6

7}, Pornsuk Grandin⁵, Hongshuo Song^{6

7

8}, Sodsai Tovanabutra^{6

7}, Zhanna Shubin^{6

7}, Dohoon Kim^{6

7}, Dominic Paquin-Proulx^{6

7}, Michael A Eller^{6

7}, Rasmi Thomas^{6

7}, Mark de Souza^{1

7}, Lindsay Wieczorek⁷, Victoria R Polonis⁷, Amélie Pagliuzza⁹, Nicolas Chomont⁹, Lauren Peter³, Joseph P Nkolola³, Johan Vingerhoets¹⁰, Carla Truyers¹⁰, Maria G Pau⁴, Hanneke Schuitemaker⁴, Nittaya Phanuphak¹, Nelson Michael^{6

7}, Merlin L Robb^{11

12}, Frank L Tomaka¹³, Jintanat Ananworanich^{1

6

7

14}

Affiliations

¹ SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
² Janssen Vaccines, Bern, Switzerland.
³ Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.
⁴ Janssen Vaccines & Prevention BV, Leiden, the Netherlands.
⁵ Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.
⁶ Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
⁷ US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.
⁸ Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA.
⁹ Centre de Recherche du CHUM and Department of Microbiology, Infectiology and Immunology, Montréal, Canada.
¹⁰ Janssen Pharmaceutica NV, Beerse, Belgium.
¹¹ Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA. [email protected].
¹² US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA. [email protected].
¹³ Janssen Research & Development, Titusville, NJ, USA.
¹⁴ Department of Global Health, the University of Amsterdam, Amsterdam, the Netherlands.

PMID: 32235883
DOI: 10.1038/s41591-020-0774-y

Abstract

We administered Ad26, modified vaccinia Ankara vectors containing mosaic HIV-1 antigens or placebo in 26 individuals who initiated antiretroviral therapy during acute human immunodeficiency virus infection as an exploratory study to determine the safety and duration of viremic control after treatment interruption. The vaccine was safe and generated robust immune responses, but delayed time to viral rebound compared to that in placebo recipients by only several days and did not lead to viremic control after treatment interruption (clinical trial NCT02919306).

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

AIDS Vaccines* / administration & dosage
AIDS Vaccines* / adverse effects
AIDS Vaccines* / immunology
Acute Disease
Adolescent
Adult
Anti-Retroviral Agents / therapeutic use*
Double-Blind Method
Drug Substitution / adverse effects
Female
HIV Infections / immunology
HIV Infections / therapy*
HIV Infections / virology
HIV-1 / drug effects
HIV-1 / immunology*
Humans
Immunogenicity, Vaccine* / drug effects
Male
Middle Aged
Placebos
Thailand
Treatment Outcome
Vaccines, DNA
Viral Load* / drug effects
Viral Vaccines* / administration & dosage
Viral Vaccines* / adverse effects
Viral Vaccines* / immunology
Withholding Treatment
Young Adult

Substances

AIDS Vaccines
Anti-Retroviral Agents
MVA vaccine
Placebos
Vaccines, DNA
Viral Vaccines

Associated data

ClinicalTrials.gov/NCT02919306