Clinical Trial: IMVAMUNE® Smallpox Vaccine in Adult Healthcare Personnel at Risk for Monkeypox in the Democratic Republic of the Congo

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open-Label Prospective Cohort Study of IMVAMUNE® Smallpox Vaccine in Adult Healthcare Personnel at Risk for Monkeypox in the Democratic Republic of the Congo

Brief Summary:

Monkeypox is a febrile rash illness caused by the monkeypox virus. Its natural occurrence in the DRC puts healthcare and frontline workers at high risk of acquiring monkeypox virus infections that can prevent them from performing work duties, compromise the overall healthcare delivery in an already fragile system, and can result in death (case fatality estimates are approximately 10%).

This is an open-label prospective cohort study in up to 1,000 eligible healthcare workers at risk of monkeypox infection through their daily work. The study will document monkeypox exposure and infection in participants while concurrently evaluating the immunogenicity and safety of the vaccine, IMVAMUNE, in healthcare personnel in the DRC. Participation in the study is voluntary and open to male and female healthcare personnel ages 18 years and older in Tshuapa Province in The Democratic Republic of Congo who are at risk of monkeypox virus infection through their daily work or laboratory personnel performing diagnostic testing for monkeypox virus.


Detailed Summary:

Orthopoxvirus infections produce antibody responses that are cross-protective against other viruses within the genus. It is this property of orthopoxviruses that allows a vaccine for vaccinia virus against smallpox to be used to provide protection against monkeypox. Studies performed during and in the immediate aftermath of smallpox eradication demonstrated that smallpox vaccination (with a first generation vaccine) could confer protection against infection with monkeypox virus. Newer, third generation vaccines such as IMVAMUNE®, an attenuated (replication deficient) strain of vaccinia virus may offer an alternative safer source of vaccine-derived protection.

The clinical presentation of monkeypox infection is similar to smallpox, although it is less transmissible human-to-human than smallpox and less deadly (case fatality estimates for monkeypox are approximately 10%). Naturally-occurring human monkeypox is largely restricted to remote regions of the Congo Basin forest in Central Africa. This study is the first rigorous evaluation of IMVAMUNE® in a region where natural Orthopoxvirus transmission occurs at appreciable and predictable rates. Healthcare and frontline workers in the DRC are currently at high risk of acquiring monkeypox virus infection that prevents them from performing work duties, compromises healthcare delivery in an already fragile system, and can result in death.

This open-label prospective cohort study in up to 1,000 healthcare personnel at risk of monkeypox infection through their daily work will document monkeypox virus exposure and infection in vaccinated participants while concurrently evaluating the immunogenicity and safety of IMVAMUNE vaccine. Study participation is voluntary and open to male and female healthcare personnel ages 18 years and older in Tshuapa Province in the DRC. Particip
Sponsor: Centers for Disease Control and Prevention

Current Primary Outcome:

  • Proportion of participants who develop suspected or confirmed monkeypox virus infection following receipt of IMVAMUNE® [ Time Frame: 2 years following initial vaccination ]
  • Proportion of participants who experience exposure to monkeypox virus following receipt of IMVAMUNE® [ Time Frame: 2 years following initial vaccination ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of participants who have orthopoxvirus antibody responses on days 0, 14, 28, 42, 180, 365, 545, and 730 days after the receipt of the first dose of vaccine [ Time Frame: 2 years following initial vaccination ]
  • Distribution of geometric means (GMTs) on days 0, 14, 28, 42, 180, 365, 545, and 730 days after the receipt of the first dose of vaccine [ Time Frame: 2 years following initial vaccination ]
  • Adverse event and serious adverse event information [ Time Frame: 2 years following initial vaccination ]


Original Secondary Outcome: Same as current

Information By: Centers for Disease Control and Prevention

Dates:
Date Received: September 7, 2016
Date Started: February 23, 2017
Date Completion: February 2020
Last Updated: February 27, 2017
Last Verified: February 2017