Safety, tolerability, and immunogenicity of the chimpanzee adenovirus type 3-vectored Marburg virus (cAd3-Marburg) vaccine in healthy adults in the USA: a first-in-human, phase 1, open-label, dose-escalation trial

Hamer, Melinda; Houser, Katherine V.; Hofstetter, Amelia R.; Ortega-Villa, Ana M; Lee, Christine; Preston, Anne; Augustine, Brooke; Andrews, Charla; Yamshchikov, Galina V.; Hickman, Somia P.; Schech, Steven; Hutter, Jack; Scott, Paul T.; Waterman, Paige; Amare, Mihret F.; Kioko, Victoria; Storme, Casey; Modjarrad, Kayvon; McCauley, Melanie; Robb, Merlin L.; Gaudinski, Martin R.; Gordon, Ingelise J.; Holman, LaSonji A.; Widge, Alicia T.; Strom, Larisa; Happe, Myra; Cox, Josephine H.; Vazquez, Sandra; Stanley, Daphne A.; Murray, Tamar; Dulan, Caitlyn N M; Hunegnaw, Ruth; Narpala, Sandeep; Swanson, Phillip A.; Basappa, Manjula; Thillainathan, Jagada; Padilla, Marcelino; Flach, Britta; O’Connell, Sarah; Trofymenko, Olga; Morgan, Patricia; Coates, Emily E.; Gall, Jason; McDermott, Adrian B.; Koup, Richard A.; Mascola, John R.; Ploquin, Aurélie; Sullivan, Nancy J.; Ake, Julie A; Ledgerwood, Julie E.; Lampley, Rebecca; Larkin, Brenda; Costner, Pamela; Wilson, Hope E.; Read, Mike

doi:10.1016/s0140-6736(22)02400-x

Cited by 27 publications

(19 citation statements)

References 35 publications

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“…Several vaccines to prevent MVD are at various stages of development, such as the candidate modified chimpanzee adenovirus vaccine by Sabin Vaccine Institute (Washington DC, USA); candidate human adenovirus vaccine by Janssen (Beerse, Belgium); and candidate vaccines being developed by the Public Health Vaccines (PHV) (Massachusetts, USA), the International Aids Vaccine Initiative (IAVI) (New York City, USA) and Auro Vaccines (Pearl River, New York), based on the weakened forms of vesicular stomatitis virus as vector [11][12][13] . The first-in-human trial of a cAd3-Marburg vaccine showed the candidate vaccine to be safe and immunogenic, with a safety profile like previously tested cAd3vectored filovirus vaccines [14] . The ongoing MVD outbreak in Equatorial Guinea has led WHO to convene a MVD expert group meeting in Geneva, Switzerland on February 14 th , 2023, which has discussed the logistics of testing the vaccines, although, like previous outbreaks, effective infection control measures such as quarantine are anticipated to end the outbreak before vaccines can be administered.…”

mentioning

confidence: 85%

The re-emergence of Marburg virus Disease in West Africa: how prepared is the sub-region for preventing recurrent zoonotic outbreaks?

Bockarie¹,

Hanson²,

Ansumana³

et al. 2023

International Journal of Infectious Diseases

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confidence: 85%

The re-emergence of Marburg virus Disease in West Africa: how prepared is the sub-region for preventing recurrent zoonotic outbreaks?

Bockarie¹,

Hanson²,

Ansumana³

et al. 2023

International Journal of Infectious Diseases

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“…The trial observed mild to moderate reactogenicity with commonly mild symptoms post-vaccination, including tenderness at the site of injection, headache, and myalgia [8] . Up to 95% of the sample produced a glycoprotein-specific antibody response against the administered antigen, demonstrating the favorable efficacy observed with the use of this vaccine [8] . However, comprehensive randomized controlled trials, with larger population groups, are required to arrive at a robust conclusion.…”

Section: Dear Editormentioning

confidence: 99%

“…However, a phase 1, open-label, clinical trial was performed on human participants, utilizing the cAd3-Marburg on healthy participants [8] . The trial observed mild to moderate reactogenicity with commonly mild symptoms post-vaccination, including tenderness at the site of injection, headache, and myalgia [8] . Up to 95% of the sample produced a glycoprotein-specific antibody response against the administered antigen, demonstrating the favorable efficacy observed with the use of this vaccine [8] .…”

Section: Dear Editormentioning

confidence: 99%

“…There are several vaccinations under development, currently being tested through non-human trials. However, a phase 1, open-label, clinical trial was performed on human participants, utilizing the cAd3-Marburg on healthy participants [8] . The trial observed mild to moderate reactogenicity with commonly mild symptoms post-vaccination, including tenderness at the site of injection, headache, and myalgia [8] .…”

Section: Dear Editormentioning

confidence: 99%

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Marburg virus: a potential outbreak on the horizon?

Larik,

Shiraz,

Iftekhar

et al. 2023

International Journal of Surgery: Global Health

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“…Chimpanzee adenovirus vectored (cAd3‐Marburg) vaccine was tried on 40 healthy human volunteers and the clinical response titre was estimated. Although it induced neutralizing antibodies in 95% cases, results demonstrated that nearly half of the volunteers developed mild vaccination side‐effects like pain at injection site, malaise, headache, and myalgia 47 …”

Section: Vaccines Developmentmentioning

confidence: 99%

The neglected continuously emerging Marburg virus disease in Africa: A global public health threat

Srivastava,

Kutikuppala,

Shanker

et al. 2023

Health Science Reports

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Background and AimSevere viral hemorrhagic fever (VHF) is caused by Marburg virus which is a member of the Filoviridae (filovirus) family. Many Marburg virus disease (MVD) outbreaks are reported in five decades. A major notable outbreak with substantial reported cases of infections and deaths was in 2022 in Uganda. The World Health Organisation (WHO) reported MVD outbreak in Ghana in July 2022 following the detection of two probable VHF patients there. Further, the virus was reported from two other African countries, the Equatorial Guinea (February 2023) and Tanzania (March 2023). There have been 35 deaths out of 40 reported cases in Equatorial Guinea, and six of the nine confirmed cases in Tanzania so far.MethodsData particularly on the several MVD outbreaks as reported from the African countries were searched on various databases including the Pubmed, Scopus, and Web‐of‐science. Also, the primary data and reports from health agencies like the WHO and the Centers for Disease Control and Prevention CDC) were evaluated and the efficacy reviewed.ResultsChiroptera in general and bat species like Rousettus aegyptiacus and Hipposideros caffer in particular are natural reservoirs of the Marburg virus. MVD‐infected nonhuman primate African fruit‐bat and the MVD‐infected humans pose significant risk in human infections. Cross‐border viral transmission and its potential further international ramification concerns raise the risk of its rapid spread and a potential outbreak. Occurrence of MVD is becoming more frequent in Africa with higher case fatality rates. Effective prophylactic and therapeutic interventions to counter this deadly virus are suggested.ConclusionIn the face of the lack of effective therapeutics and preventives against MVD, supportive care is the only available option which contributes to the growing concern and disease severity. In view of the preventive approaches involving effective surveillance and monitoring system following the “One Health” model is extremely beneficial to ensure a healthy world for all, this article aims at emphasizing several MVD outbreaks, epidemiology, zoonosis of the virus, current treatment strategies, risk assessments, and the mitigation strategies against MVD.

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Safety, tolerability, and immunogenicity of the chimpanzee adenovirus type 3-vectored Marburg virus (cAd3-Marburg) vaccine in healthy adults in the USA: a first-in-human, phase 1, open-label, dose-escalation trial

Cited by 27 publications

References 35 publications

The re-emergence of Marburg virus Disease in West Africa: how prepared is the sub-region for preventing recurrent zoonotic outbreaks?

The re-emergence of Marburg virus Disease in West Africa: how prepared is the sub-region for preventing recurrent zoonotic outbreaks?

Marburg virus: a potential outbreak on the horizon?

The neglected continuously emerging Marburg virus disease in Africa: A global public health threat

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